Advanced LymphomaPhase 2NCT02465060
Targeted Therapy Directed by Genetic Testing in Treating Patients With Advanced Refractory Solid Tumors, Lymphomas, or Multiple Myeloma (The MATCH Screening Trial)
A Phase 2 study testing Adavosertib, Afatinib and Afatinib Dimaleate in people with Advanced Lymphoma and Advanced Malignant Solid Neoplasm, run by National Cancer Institute (NCI) at 1,410 sites in 3 countries.
Trial summary
This phase II MATCH screening and multi-sub-trial studies how well treatment that is directed by genetic testing works in patients with solid tumors, lymphomas, or multiple myelomas that may have spread from where it first started to nearby tissue, lymph nodes, or distant parts of the body (advanced) and does not… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Lymphoma, Advanced Malignant Solid Neoplasm, Bladder Carcinoma
- What is being tested?
- Adavosertib, Afatinib and Afatinib Dimaleate
- Type of treatment
- Pill or oral medicine, Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6,452 participants
- Where
- 1,410 sitesin 3 countries
- Study dates
- 17 Aug 2015to 31 Dec 2027
- Phase
- Phase 2
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ELIGIBILITY CRITERIA FOR SCREENING BIOPSY (STEP 0)
- Patients must be >= 18 years of age. Because no dosing or adverse event data are currently available on the use of study investigational agents in patients < 18 years of age, children are excluded from this study
- Patients of childbearing potential must have a negative serum pregnancy test within 2 weeks prior to registration; patients that are pregnant or breast feeding are excluded; a patient of childbearing potential is anyone, regardless of whether they have undergone tubal ligation, who meets the following criteria:
- Has achieved menarche at some point
- Has not undergone a hysterectomy or bilateral oophorectomy; or
- Has not been naturally postmenopausal for at least 24 consecutive months (i.e., has had menses at any time in the preceding 24 consecutive months)
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- Patients must not expect to conceive or father children by using accepted and effective method(s) of contraception or by abstaining from sexual intercourse prior to study entry, for the duration of study participation, and for 4 months after completion of study; should a patient or partner of the patient become pregnant or suspect a pregnancy while participating in this study, the treating physician should be informed immediately
- Patients must have histologically documented solid tumors or histologically confirmed diagnosis of lymphoma or multiple myeloma requiring therapy and meet one of the following criteria:
- Patients must have progressed following at least one line of standard systemic therapy and there must not be other approval/standard therapy available that has been shown to prolong overall survival (i.e. in a randomized trial against another standard treatment or by comparison to historical controls); patients who cannot receive other standard therapy that has been shown to prolong overall survival due to medical issues will be eligible, if other eligibility criteria are met; if the patient is currently receiving therapy, the clinician must have assessed that the current therapy is no longer benefitting the patient prior to enrolling on MATCH, regardless of whether it is considered standard OR
- Patients for whose disease no standard treatment exists that has been shown to prolong overall survival
- NOTE: No other prior malignancy is allowed except for the following:
- Adequately treated basal cell or squamous cell skin cancer
- In situ cervical cancer
- Adequately treated stage I or II cancer from which the patient is currently in complete remission
- Any other cancer from which the patient has been disease-free for 5 years
- Patients must have measurable disease
- Patients must meet the criteria below
- Tumor tissue for the confirmation of "rare variant" by the MATCH assay is to be submitted, preferably from the same time of collection as that used to determine patient candidacy for treatment arm assignment
- Registration to Step 0 must occur after stopping prior systemic anti-cancer therapy. There is no specific duration for which patients must be off treatment prior to registration to Step 0, as long as all eligibility criteria are met
- Patients may have received other non-targeted, immunotherapy or targeted treatment between the prior genetic testing at the outside lab and registration to Step 0. The decision to stop such treatment in favor of participation in MATCH, if no further clinical benefit is expected, is per the treating physician's discretion. Documentation of a lack of response to the prior treatment is not required in these cases
- Patients with an applicable "rare variant" must be able to meet the eligibility criteria for the appropriate subprotocols within 4 weeks following notification of treatment assignment
- Patient meets one of the following criteria:
- Patient is a candidate for Z1M based on local Clinical Laboratory Improvement Act (CLIA) assessment of mismatch repair deficiency (MMRd) by immunohistochemistry (IHC) or microsatellite instability (MSI) status by polymerase chain reaction (PCR), adequate tumor tissue is available for submission for mandatory central screening IHC and the patient will be able to meet the eligibility criteria for Z1M within 4 weeks following notification of treatment assignment OR
- The sites have received results from one of the designated outside laboratories indicating a "rare variant" that is an actionable Mutation of Interest (aMOI) for specific select subprotocols
- NOTE: There is no particular window of time after receiving the sequencing report notification of potential eligibility from an outside lab in which the patient must be registered to Step 0, but treatment slots will be assigned on a first come, first serve basis to those who do register to Step 0, and are not held for those notified of potential eligibility who do not register to Step 0
- NOTE: Treatment assignment (and the start of the associated deadline for Step 1 registration) may occur shortly after Step 0 registration. Note that certain "rare variant" arms require submission of archival tissue for central IHC testing to determine treatment assignment. For those arms, adequate tissue for the central IHC is required to be available for submission
- NOTE: Other potential aMOIs that would be eligibility criteria for "NON RARE" arms, as determined by the designated laboratories, are not applicable for this process in MATCH
- Patient must not require the use of full dose coumarin-derivative anticoagulants such as warfarin; low molecular weight heparin is permitted for prophylactic or therapeutic use; factor X inhibitors are permitted
- NOTE: Warfarin may not be started while enrolled in the EAY131 study
- Stopping the anticoagulation for biopsy should be per site standard operating procedure (SOP)
- Patients must have Eastern Cooperative Oncology Group (ECOG) performance status =< 1 and a life expectancy of at least 3 months
- Patients must not currently be receiving any other investigational agents
- Patients must not have any uncontrolled intercurrent illness including, but not limited to:
- Symptomatic congestive heart failure (New York Heart Association [NYHA] classification of III/IV)
- Unstable angina pectoris or coronary angioplasty, or stenting within 6 months prior to registration to Step 0, 2, 4, 6
- Cardiac arrhythmia (ongoing cardiac dysrhythmias of National Cancer Institute [NCI] Common Terminology Criteria for Adverse Events [CTCAE] version [v]4 grade >= 2)
- Psychiatric illness/social situations that would limit compliance with study requirements
- Intra-cardiac defibrillators
- Known cardiac metastases
- Abnormal cardiac valve morphology (>= grade 2) documented by echocardiogram (ECHO) (as clinically indicated); (subjects with grade 1 abnormalities [i.e., mild regurgitation/stenosis] can be entered on study); subjects with moderate valvular thickening should not be entered on study
- NOTE: To receive an agent, patient must not have any uncontrolled intercurrent illness such as ongoing or active infection; patients with infections unlikely to be resolved within 2 weeks following screening should not be considered for the trial
- Patients must be able to swallow tablets or capsules; a patient with any gastrointestinal disease that would impair ability to swallow, retain, or absorb drug is not eligible
- Patients who are human immunodeficiency virus (HIV)-positive are eligible if:
- CD4+ cell count greater or equal to 250 cells/mm^3
- If patient is on antiretroviral therapy, there must be minimal interactions or overlapping toxicity of the antiretroviral therapy with the experimental cancer treatment; for experimental cancer therapeutics with CYP3A/4 interactions, protease inhibitor therapy is disallowed; suggested regimens to replace protease inhibitor therapy include dolutegravir given with tenofovir/emtricitabine; raltegravir given with tenofovir and emtricitabine; once daily combinations that use pharmacologic boosters may not be used
- No history of non-malignancy acquired immune deficiency syndrome (AIDS)-defining conditions other than historical low CD4+ cell counts
- Probable long-term survival with HIV if cancer were not present
- Any prior therapy, radiotherapy (except palliative radiation therapy of 30 gray [Gy] or less), or major surgery must have been completed >= 4 weeks prior to start of treatment; all adverse events due to prior therapy have resolved to a grade 1 or better (except alopecia and lymphopenia) by start of treatment; palliative radiation therapy must have been completed at least 2 weeks prior to start of treatment; the radiotherapy must not be to a lesion that is included as measurable disease
- NOTE: Prostate cancer patients may continue their luteinizing hormone-releasing hormone (LHRH) agonist
- NOTE: For patients entering the study via the original screening process, patients may receive non-protocol treatment after biopsy (if clinically indicated) until they receive notification of results; however, lack of response must be documented prior to registration to Step 1; new non-protocol treatment will NOT be permitted as intervening therapy after registration to Step 0; the only intervening treatment permitted is prior therapy that the patient already received prior to Step 0 registration; the decision to stop the intervening non-protocol treatment will be left up to the treating physician if patient has an aMOI; however, patients will need to be off such therapy for at least 4 weeks before receiving any MATCH protocol treatment
- NOTE: For patients entering the study via a designated outside laboratory, no intervening systemic non-protocol treatment is permitted after Step 0 registration; all other eligibility requirements still apply to these patients, including the washouts for prior therapy noted above in this section, the time restrictions outlined, and the eligibility criteria for the intended subprotocol
- Patients with brain metastases or primary brain tumors must have completed treatment, surgery or radiation therapy >= 4 weeks prior to start of treatment
- Patients must have discontinued steroids >= 1 week prior to registration to Step 0 and remain off steroids thereafter, except as permitted; patients with glioblastoma (GBM) must have been on stable dose of steroids, or be off steroids, for one week prior to registration to treatment (Step 1, 3, 5, 7)
- NOTE: The following steroids are permitted (low dose steroid use is defined as prednisone 10 mg daily or less, or bioequivalent dose of other corticosteroid):
- Temporary steroid use: e.g. for CT imaging in setting of contrast allergy
- Low dose steroid use for appetite
- Chronic inhaled steroid use
- Steroid injections for joint disease
- Stable dose of replacement steroid for adrenal insufficiency or low doses for non-malignant disease
- Topical steroid
- Steroids required to manage toxicity related to study treatment, as described in the subprotocols
- Steroids required as pre- or post-chemotherapy medication for acceptable intervening chemotherapy
- NOTE: Steroids must be completed alongside last dose of chemotherapy
- Leukocytes >= 3,000/mcL (within 2 weeks prior to screening step registration and within 4 weeks prior to treatment step registration)
- Absolute neutrophil count (ANC) >= 1,500/mcL (within 2 weeks prior to screening step registration and within 4 weeks prior to treatment step registration)
- Platelets >= 100,000/mcL (within 2 weeks prior to screening step registration and within 4 weeks prior to treatment step registration)
- NOTE: Patients with documented bone marrow involvement by lymphoma are not required to meet the above hematologic parameters, but must have a platelet count of at least 75,000/mcL and neutrophil count of at least 1,000/mcL
- Total bilirubin =< 1.5 x institutional upper limit of normal (ULN) (unless documented Gilbert's syndrome, for which bilirubin =< 3 x institutional ULN is permitted) (within 2 weeks prior to screening step registration and within 4 weeks prior to treatment step registration)
- Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) =< 2.5 x institutional ULN (up to 5 times ULN in presence of liver metastases) (within 2 weeks prior to screening step registration and within 4 weeks prior to treatment step registration)
- Creatinine clearance >= 45 mL/min/1.73 m^2 for patients with creatinine levels above institutional ULN
- As defined by the Cockcroft-Gault equation (within 2 weeks prior to screening step registration and within 4 weeks prior to treatment step registration)
- Patients must have an electrocardiogram (ECG) within 8 weeks prior to registration to screening step and must meet the following cardiac criteria:
- Resting corrected QT interval (QTc) =< 480 msec
- NOTE: If the first recorded QTc exceeds 480 msec, two additional, consecutive ECGs are required and must result in a mean resting QTc =< 480 msec; it is recommended that there are 10-minute (+/- 5 minutes) breaks between the ECGs
- The following only need to be assessed if the mean QTc > 480 msec
- Check potassium and magnesium serum levels
- Correct any identified hypokalemia and/or hypomagnesemia and may repeat ECG to confirm exclusion of patient due to QTc
- For patients with heart rate (HR) 60-100 beats per minute (bpm), no manual read of QTc is required
- For patients with baseline HR < 60 or > 100 bpm, manual read of QT by trained personnel is required, with Fridericia correction applied to determine QTc
- Patient must not have hypokalemia (value < institutional lower limit of normal)
- No factors that increase the risk of QTc prolongation or risk of arrhythmic events such as heart failure, congenital long QT syndrome, family history of long QT syndrome or unexplained sudden death under 40 years of age or any concomitant medication known to prolong the QT interval
- NOTE: Patient must be taken off prohibited medication prior to registration to the screening step (Step 0, 2, 4, 6) and remain off these medications thereafter, unless permitted on a subprotocol for the management of treatment related toxicity; patient must be off the drug for at least 5 half-lives prior to registration to the treatment step (Step 1, 3, 5, 7); the medication half-life can be found in the package insert for Food and Drug Administration (FDA) approved drugs
- ELIGIBILITY CRITERIA FOR FIRST TREATMENT (STEP 1)
- NOTE: For patients entering step 0 with assay results from outside laboratories, no systemic treatment is allowed after step 0 registration
- As MATCH is designed to add additional subprotocols, implement limited expansions of accrual for certain subprotocols, and/or amend existing arm-specific eligibility criteria, some patients entering under the original screening method may be eligible to have their results rerun in MATCHbox, even if they did not match to a treatment initially or did not receive a treatment assignment due to a lack of available assignment slots; patients whose sequence results will be rerun through MATCHbox must also meet the following criteria:
- Samples must have been collected within 5 months of the activation of the addendum, as there is an additional month needed to get the patients on trial
- Patient has not had treatment within the 5 months that resulted in a PR or better after the performance of the screening assessment
- Patient must meet eligibility criteria, including performance status 1 or better and life expectancy of at least 3 months
- Patients must meet the eligibility requirements with the following exceptions:
- Patients may have received other non-targeted, immunotherapy or targeted treatment, which could be stopped in favor of returning to MATCH, if no response to the interim treatment has occurred and no further benefit is expected from this interim treatment, per the treating physician's discretion; documentation of a lack of response to the interim treatment is not required in these cases; however, the following restrictions apply:
- Enrollment onto another investigational therapeutic study is not permitted
- Patient cannot be responding to interim treatment, since the benefit of the MATCH treatment is unknown and may deprive patient of an effective treatment if it were given when a patient is responding to another treatment
- NOTE: Patients meeting these criteria will NOT be biopsied at this time point; instead, their step 0 results will be re-interrogated to determine if another treatment is available
- ELIGIBILITY CRITERIA FOR SECOND SCREENING (STEP 2)
- Patient's disease has progressed on Step 1 treatment or patient could not tolerate assigned treatment
- NOTE: PATIENTS ENTERING STEP 1 WITH A "RARE VARIANT" FROM AN "OUTSIDE" LAB ARE NOT ELIGIBLE FOR STEP 2
- No response and progression (or inability to tolerate further treatment) occurred < 6 months from start of step 1 treatment
- NOTE: Patients meeting these criteria will NOT be biopsied at this time point; instead, their step 0 MATCH assay results will be re-interrogated to determine if another treatment is available upon registration to this study step; it is not necessary to confirm the availability of another potential treatment assignment in advance; only aMOIs detected by the MATCH assay may be used for the determination of eligibility to a relevant subprotocol OR
- Progression (or inability to tolerate further treatment) occurred after a (1) response OR (2) after >= 6 months from start of step 1 treatment; patient must have tumor amenable to percutaneous biopsy and be willing and able to undergo a tumor biopsy or bone marrow aspirate for collection and submission of tumor tissue OR patient will be undergoing a procedure due to medical necessity during which the tissue may be collected for the central determination of the presence of one or more of the specific "actionable" mutations/amplifications of interest (aMOI); archived specimens cannot be accepted
- Patients must meet eligibility criteria as defined in step 0
- Patient must not have been assigned to step 1 treatment based on a "rare variant" determined by a designated outside laboratory
- ELIGIBILITY CRITERIA FOR SECOND TREATMENT (STEP 3)
- NOTE: If screening biopsy samples were submitted during step 2, patients may receive non-protocol treatment after biopsy (if clinically indicated) until they receive notification of results however, lack of response must be documented prior to registration to step 3; new non-protocol treatment will NOT be permitted as intervening therapy after registration to step 2; the decision to stop the intervening nonprotocol treatment will be left up to the treating physician if patient has an aMOI; waiting periods as described will apply
- ELIGIBILITY CRITERIA FOR THIRD SCREENING (STEP 4)
- Patient's disease has progressed on step 3 treatment or patient could not tolerate assigned treatment
- Patient must meet one of the following criteria:
- No response and progression (or inability to tolerate further treatment) occurred < 6 months from start of step 3 (second) treatment AND a biopsy was performed at step 2 screening
- NOTE: Patients meeting these criteria will NOT be biopsied at this time point; instead, their latest MATCH assay results will be re-interrogated to determine if another treatment is available upon registration to this study step; it is not necessary to confirm the availability of another potential treatment assignment in advance OR
- Progression (or inability to tolerate further treatment) occurred on step 3 treatment and a biopsy was not performed at step 2 screening (due to presence of a
Who cannot join
None listed.
Trial locations and contacts
1,410 sites in 3 countries.
305 sites in 3 countries
United States300 sites
Hawaii Cancer Care - Westridge
‘Aiea, Hawaii, 96701
Pali Momi Medical Center
‘Aiea, Hawaii, 96701
Queen's Cancer Center - Pearlridge
‘Aiea, Hawaii, 96701
Straub Pearlridge Clinic
‘Aiea, Hawaii, 96701
The Cancer Center of Hawaii-Pali Momi
‘Aiea, Hawaii, 96701
The Queen's Medical Center - West Oahu
‘Ewa Beach, Hawaii, 96706
Avera Cancer Institute-Aberdeen
Aberdeen, South Dakota, 57401
Providence Regional Cancer System-Aberdeen
Aberdeen, Washington, 98520
Jefferson Abington Hospital
Abington, Pennsylvania, 19001
Hickman Cancer Center
Adrian, Michigan, 49221
Riverwood Healthcare Center
Aitkin, Minnesota, 56431
Lovelace Medical Center-Downtown
Albuquerque, New Mexico, 87102
Southwest Gynecologic Oncology Associates Inc
Albuquerque, New Mexico, 87106
University of New Mexico Cancer Center
Albuquerque, New Mexico, 87106
New Mexico Oncology Hematology Consultants
Albuquerque, New Mexico, 87109
Presbyterian Kaseman Hospital
Albuquerque, New Mexico, 87110
Lehigh Valley Hospital-Cedar Crest
Allentown, Pennsylvania, 18103
Aultman Alliance Community Hospital
Alliance, Ohio, 44601
OSF Saint Anthony's Health Center
Alton, Illinois, 62002
UPMC Altoona
Altoona, Pennsylvania, 16601
American Fork Hospital / Huntsman Intermountain Cancer Center
American Fork, Utah, 84003
Mary Greeley Medical Center
Ames, Iowa, 50010
McFarland Clinic - Ames
Ames, Iowa, 50010
Community Hospital of Anaconda
Anaconda, Montana, 59711
Cancer Care Center at Island Hospital
Anacortes, Washington, 98221
Kaiser Permanente-Anaheim
Anaheim, California, 92806
Anchorage Associates in Radiation Medicine
Anchorage, Alaska, 98508
Anchorage Radiation Therapy Center
Anchorage, Alaska, 99504
Alaska Breast Care and Surgery LLC
Anchorage, Alaska, 99508
Alaska Oncology and Hematology LLC
Anchorage, Alaska, 99508
Alaska Regional Hospital
Anchorage, Alaska, 99508
Alaska Women's Cancer Care
Anchorage, Alaska, 99508
Anchorage Oncology Centre
Anchorage, Alaska, 99508
Katmai Oncology Group
Anchorage, Alaska, 99508
Providence Alaska Medical Center
Anchorage, Alaska, 99508
AnMed Health Cancer Center
Anderson, South Carolina, 29621
Trinity Health Saint Joseph Mercy Hospital Ann Arbor
Ann Arbor, Michigan, 48106
C S Mott Children's Hospital
Ann Arbor, Michigan, 48109
University of Michigan Rogel Cancer Center
Ann Arbor, Michigan, 48109
Luminis Health Anne Arundel Medical Center
Annapolis, Maryland, 21401
Aspirus Cancer Care-Antigo-Volm Cancer Center
Antigo, Wisconsin, 54409
Kaiser Permanente-Deer Valley Medical Center
Antioch, California, 94531
Ascension Northeast Wisconsin-Saint Elizabeth Cancer Center-Appleton
Appleton, Wisconsin, 54915
Mission Hope Medical Oncology - Arroyo Grande
Arroyo Grande, California, 93420
PCR Oncology
Arroyo Grande, California, 93420
Mission Hospital
Asheville, North Carolina, 28801
AdventHealth Infusion Center Asheville
Asheville, North Carolina, 28803
Messino Cancer Centers
Asheville, North Carolina, 28806
Hope Women's Cancer Centers-Asheville
Asheville, North Carolina, 28816
Duluth Clinic Ashland
Ashland, Wisconsin, 54806
Northwest Wisconsin Cancer Center
Ashland, Wisconsin, 54806
University Cancer and Blood Center LLC
Athens, Georgia, 30607
Emory University Hospital Midtown
Atlanta, Georgia, 30308
Piedmont Hospital
Atlanta, Georgia, 30309
Emory University Hospital/Winship Cancer Institute
Atlanta, Georgia, 30322
Emory Saint Joseph's Hospital
Atlanta, Georgia, 30342
Northside Hospital
Atlanta, Georgia, 30342
Sutter Auburn Faith Hospital
Auburn, California, 95602
Sutter Cancer Centers Radiation Oncology Services-Auburn
Auburn, California, 95603
MultiCare Auburn Medical Center
Auburn, Washington, 98001
Augusta University Medical Center
Augusta, Georgia, 30912
Harold Alfond Center for Cancer Care
Augusta, Maine, 04330
Rocky Mountain Cancer Centers-Aurora
Aurora, Colorado, 80012
The Medical Center of Aurora
Aurora, Colorado, 80012
UCHealth University of Colorado Hospital
Aurora, Colorado, 80045
Rush-Copley Medical Center
Aurora, Illinois, 60504
Dell Seton Medical Center at The University of Texas
Austin, Texas, 78701
Mount Sinai Comprehensive Cancer Center at Aventura
Aventura, Florida, 33180
Virginia Mason Bainbridge Island Medical Center
Bainbridge Island, Washington, 98110
Saint Alphonsus Cancer Care Center-Baker City
Baker City, Oregon, 97814
AIS Cancer Center at San Joaquin Community Hospital
Bakersfield, California, 93301
Kaiser Permanente-Baldwin Park
Baldwin Park, California, 91706
University of Maryland/Greenebaum Cancer Center
Baltimore, Maryland, 21201
Greater Baltimore Medical Center
Baltimore, Maryland, 21204
Sinai Hospital of Baltimore
Baltimore, Maryland, 21215
MedStar Union Memorial Hospital
Baltimore, Maryland, 21218
MedStar Franklin Square Medical Center/Weinberg Cancer Institute
Baltimore, Maryland, 21237
MedStar Good Samaritan Hospital
Baltimore, Maryland, 21239
Johns Hopkins University/Sidney Kimmel Cancer Center
Baltimore, Maryland, 21287
Eastern Maine Medical Center
Bangor, Maine, 04401
CommonSpirit Saint Joseph Hospital - Bardstown
Bardstown, Kentucky, 40004
LSU Health Baton Rouge-North Clinic
Baton Rouge, Louisiana, 70805
Baton Rouge General Medical Center
Baton Rouge, Louisiana, 70806
Our Lady of the Lake Physician Group
Baton Rouge, Louisiana, 70808
Our Lady of The Lake
Baton Rouge, Louisiana, 70808
Hematology/Oncology Clinic PLLC
Baton Rouge, Louisiana, 70809
Louisiana Hematology Oncology Associates LLC
Baton Rouge, Louisiana, 70809
Mary Bird Perkins Cancer Center
Baton Rouge, Louisiana, 70809
Ochsner Health Center-Summa
Baton Rouge, Louisiana, 70809
The NeuroMedical Center-Clinic
Baton Rouge, Louisiana, 70810
Medical Center of Baton Rouge
Baton Rouge, Louisiana, 70816
Our Lady of the Lake Medical Oncology
Baton Rouge, Louisiana, 70817
Ochsner High Grove
Baton Rouge, Louisiana, 70836
Bronson Battle Creek
Battle Creek, Michigan, 49017
Essentia Health - Baxter Clinic
Baxter, Minnesota, 56425
South Shore University Hospital
Bay Shore, New York, 11706
UHHS-Chagrin Highlands Medical Center
Beachwood, Ohio, 44122
Beaufort Memorial Hospital
Beaufort, South Carolina, 29902
UPMC-Heritage Valley Health System Beaver
Beaver, Pennsylvania, 15009
Indu and Raj Soin Medical Center
Beavercreek, Ohio, 45431
MaineHealth Waldo Hospital
Belfast, Maine, 04915
Nebraska Medicine-Bellevue
Bellevue, Nebraska, 68123
Overlake Medical Center
Bellevue, Washington, 98004
Kaiser Permanente-Bellflower
Bellflower, California, 90706
PeaceHealth Saint Joseph Medical Center
Bellingham, Washington, 98225
Strecker Cancer Center-Belpre
Belpre, Ohio, 45714
Sanford Joe Lueken Cancer Center
Bemidji, Minnesota, 56601
Saint Charles Health System
Bend, Oregon, 97701
Alta Bates Summit Medical Center-Herrick Campus
Berkeley, California, 94704
Central Vermont Medical Center/National Life Cancer Treatment
Berlin Corners, Vermont, 05602
Walter Reed National Military Medical Center
Bethesda, Maryland, 20889-5600
National Institutes of Health Clinical Center
Bethesda, Maryland, 20892
Lehigh Valley Hospital - Muhlenberg
Bethlehem, Pennsylvania, 18017
Beverly Hospital
Beverly, Massachusetts, 01915
MaineHealth Maine Medical Center - Biddeford
Biddeford, Maine, 04005
Billings Clinic Cancer Center
Billings, Montana, 59101
Saint Vincent Healthcare
Billings, Montana, 59101
Saint Vincent Frontier Cancer Center
Billings, Montana, 59102
University of Alabama at Birmingham Cancer Center
Birmingham, Alabama, 35233
Sanford Bismarck Medical Center
Bismarck, North Dakota, 58501
OSF Saint Joseph Medical Center
Bloomington, Illinois, 61701
Illinois CancerCare-Bloomington
Bloomington, Illinois, 61704
Saint Elizabeth Boardman Hospital
Boardman, Ohio, 44512
Prisma Health Cancer Institute - Spartanburg
Boiling Springs, South Carolina, 29316
Saint Alphonsus Cancer Care Center-Boise
Boise, Idaho, 83706
Saint Luke's Cancer Institute - Boise
Boise, Idaho, 83712
Central Care Cancer Center - Bolivar
Bolivar, Missouri, 65613
Parkland Health Center-Bonne Terre
Bonne Terre, Missouri, 63628
McFarland Clinic - Boone
Boone, Iowa, 50036
Tufts Medical Center
Boston, Massachusetts, 02111
Massachusetts General Hospital Cancer Center
Boston, Massachusetts, 02114
Boston Medical Center
Boston, Massachusetts, 02118
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
Dana-Farber Cancer Institute
Boston, Massachusetts, 02215
Boulder Community Foothills Hospital
Boulder, Colorado, 80303
Rocky Mountain Cancer Centers-Boulder
Boulder, Colorado, 80304
Bozeman Health Deaconess Hospital
Bozeman, Montana, 59715
Essentia Health Saint Joseph's Medical Center
Brainerd, Minnesota, 56401
Cox Cancer Center Branson
Branson, Missouri, 65616
Northeast Georgia Medical Center Braselton
Braselton, Georgia, 30517
Lafayette Family Cancer Center-EMMC
Brewer, Maine, 04412
Ocean University Medical Center
Brick, New Jersey, 08724
United Hospital Center
Bridgeport, West Virginia, 26330
Trinity Health IHA Medical Group Hematology Oncology - Brighton
Brighton, Michigan, 48114
Trinity Health Medical Center - Brighton
Brighton, Michigan, 48114
Ascension Southeast Wisconsin Hospital-Elmbrook Campus-Brookfield
Brookfield, Wisconsin, 53045
State University of New York Downstate Medical Center
Brooklyn, New York, 11203
Henry Ford Cancer Institute-Downriver
Brownstown, Michigan, 48183
Saint Joseph Regional Cancer Center
Bryan, Texas, 77802
Bryn Mawr Hospital
Bryn Mawr, Pennsylvania, 19010
Roswell Park Cancer Institute
Buffalo, New York, 14263
Providence Saint Joseph Medical Center/Disney Family Cancer Center
Burbank, California, 91505
Saint Anne Hospital
Burien, Washington, 98166
Mills-Peninsula Medical Center
Burlingame, California, 94010
Lahey Clinic
Burlington, Massachusetts, 01805
University of Vermont Medical Center
Burlington, Vermont, 05401
University of Vermont and State Agricultural College
Burlington, Vermont, 05405
Aurora Cancer Care-Southern Lakes VLCC
Burlington, Wisconsin, 53105
Fairview Ridges Hospital
Burnsville, Minnesota, 55337
Minnesota Oncology - Burnsville
Burnsville, Minnesota, 55337
UPMC Hillman Cancer Center at Butler Health System
Butler, Pennsylvania, 16001
Saint James Community Hospital and Cancer Treatment Center
Butte, Montana, 59701
Saint Alphonsus Cancer Care Center-Caldwell
Caldwell, Idaho, 83605
Cambridge Medical Center
Cambridge, Minnesota, 55008
Sutter Cancer Centers Radiation Oncology Services-Cameron Park
Cameron Park, California, 95682
UPMC Camp Hill
Camp Hill, Pennsylvania, 17011
Illinois CancerCare-Canton
Canton, Illinois, 61520
Trinity Health IHA Medical Group Hematology Oncology - Canton
Canton, Michigan, 48188
Trinity Health Medical Center - Canton
Canton, Michigan, 48188
Cleveland Clinic Mercy Hospital
Canton, Ohio, 44708
Aultman Health Foundation
Canton, Ohio, 44710
Mercy Cancer Center - Cape Girardeau
Cape Girardeau, Missouri, 63703
Saint Francis Medical Center
Cape Girardeau, Missouri, 63703
AtlantiCare Health Park-Cape May Court House
Cape May Court House, New Jersey, 08210
Memorial Hospital of Carbondale
Carbondale, Illinois, 62902
Carlisle Regional Cancer Center
Carlisle, Pennsylvania, 17015
Caro Cancer Center
Caro, Michigan, 48723
Saint Anthony Regional Hospital
Carroll, Iowa, 51401
Carson Tahoe Regional Medical Center
Carson City, Nevada, 89703
SIH Cancer Institute
Carterville, Illinois, 62918
Illinois CancerCare-Carthage
Carthage, Illinois, 62321
Waverly Hematology Oncology
Cary, North Carolina, 27518
Eden Hospital Medical Center
Castro Valley, California, 94546
Sandra L Maxwell Cancer Center
Cedar City, Utah, 84720
Physicians' Clinic of Iowa PC
Cedar Rapids, Iowa, 52402
Mercy Hospital
Cedar Rapids, Iowa, 52403
Oncology Associates at Mercy Medical Center
Cedar Rapids, Iowa, 52403
Rocky Mountain Cancer Centers - Centennial
Centennial, Colorado, 80112
Dayton Physicians LLC-Miami Valley South
Centerville, Ohio, 45459
Miami Valley Hospital South
Centerville, Ohio, 45459
Centralia Oncology Clinic
Centralia, Illinois, 62801
Providence Regional Cancer System-Centralia
Centralia, Washington, 98531
Christiana Care Health System-Concord Health Center
Chadds Ford, Pennsylvania, 19317
Chambersburg Hospital
Chambersburg, Pennsylvania, 17201
UNC Lineberger Comprehensive Cancer Center
Chapel Hill, North Carolina, 27599
Geauga Hospital
Chardon, Ohio, 44024
Roper Hospital
Charleston, South Carolina, 29401
Charleston Oncology - Roper
Charleston, South Carolina, 29403
Lowcountry Hematology Oncology PA-North Charleston
Charleston, South Carolina, 29406
Bon Secours Saint Francis Hospital
Charleston, South Carolina, 29414
Charleston Oncology - Saint Francis
Charleston, South Carolina, 29414
Lowcountry Oncology Associates - West Ashley
Charleston, South Carolina, 29414
Medical University of South Carolina
Charleston, South Carolina, 29425
Vandalia Health/CAMC Institute for Academic Medicine
Charleston, West Virginia, 25304
Novant Health Presbyterian Medical Center
Charlotte, North Carolina, 28204
Novant Health Carolina Surgical - Randolph
Charlotte, North Carolina, 28207
Oncology Specialists of Charlotte
Charlotte, North Carolina, 28207
Southern Oncology Specialists-Charlotte
Charlotte, North Carolina, 28262
Memorial Hospital
Chattanooga, Tennessee, 37404
Chelsea Hospital
Chelsea, Michigan, 48118
Trinity Health IHA Medical Group Hematology Oncology - Chelsea Hospital
Chelsea, Michigan, 48118
Saint Luke's Hospital
Chesterfield, Missouri, 63017
Cheyenne Regional Medical Center-West
Cheyenne, Wyoming, 82001
Mount Sinai Hospital Medical Center
Chicago, Illinois, 60608
Northwestern University
Chicago, Illinois, 60611
John H Stroger Jr Hospital of Cook County
Chicago, Illinois, 60612
Rush MD Anderson Cancer Center
Chicago, Illinois, 60612
University of Illinois
Chicago, Illinois, 60612
Swedish Covenant Hospital
Chicago, Illinois, 60625
University of Chicago Comprehensive Cancer Center
Chicago, Illinois, 60637
Advocate Illinois Masonic Medical Center
Chicago, Illinois, 60657
Adena Regional Medical Center
Chillicothe, Ohio, 45601
Ascension Calumet Hospital-Chilton
Chilton, Wisconsin, 53014
Marshfield Clinic-Chippewa Center
Chippewa Falls, Wisconsin, 54729
Oncology Hematology Care Inc-Eden Park
Cincinnati, Ohio, 45202
Oncology Hematology Care Inc-Mercy West
Cincinnati, Ohio, 45211
The Christ Hospital
Cincinnati, Ohio, 45219
Good Samaritan Hospital - Cincinnati
Cincinnati, Ohio, 45220
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229
Oncology Hematology Care Inc-Anderson
Cincinnati, Ohio, 45230
Oncology Hematology Care Inc-Kenwood
Cincinnati, Ohio, 45236
Bethesda North Hospital
Cincinnati, Ohio, 45242
Oncology Hematology Care Inc-Blue Ash
Cincinnati, Ohio, 45242
TriHealth Cancer Institute-Westside
Cincinnati, Ohio, 45247
TriHealth Cancer Institute-Anderson
Cincinnati, Ohio, 45255
Siteman Cancer Center at Saint Peters Hospital
City of Saint Peters, Missouri, 63376
Clackamas Radiation Oncology Center
Clackamas, Oregon, 97015
Providence Cancer Institute Clackamas Clinic
Clackamas, Oregon, 97015
Hematology Oncology Consultants-Clarkston
Clarkston, Michigan, 48346
Newland Medical Associates-Clarkston
Clarkston, Michigan, 48346
Case Western Reserve University
Cleveland, Ohio, 44106
MetroHealth Medical Center
Cleveland, Ohio, 44109
Cleveland Clinic Foundation
Cleveland, Ohio, 44195
Southeastern Medical Oncology Center-Clinton
Clinton, North Carolina, 28328
Henry Ford Hematology Oncology - Hayes
Clinton Township, Michigan, 48038
Henry Ford Macomb Hospital-Clinton Township
Clinton Township, Michigan, 48038
Mercy Cancer Center-West Lakes
Clive, Iowa, 50325
UI Health Care Mission Cancer and Blood - West Des Moines Clinic
Clive, Iowa, 50325
Community Cancer Institute
Clovis, California, 93611
University Oncology Associates
Clovis, California, 93611
AdventHealth Infusion Center Haywood
Clyde, North Carolina, 28721
Big Horn Basin Cancer Center
Cody, Wyoming, 82414
Billings Clinic-Cody
Cody, Wyoming, 82414
Kootenai Health - Coeur d'Alene
Coeur d'Alene, Idaho, 83814
Coffeyville Regional Medical Center
Coffeyville, Kansas, 67337
Main Line Health Center-Collegeville
Collegeville, Pennsylvania, 19426
Integrity Oncology PLLC-Collierville
Collierville, Tennessee, 38017
Penrose-Saint Francis Healthcare
Colorado Springs, Colorado, 80907
Rocky Mountain Cancer Centers-Penrose
Colorado Springs, Colorado, 80907
UCHealth Memorial Hospital Central
Colorado Springs, Colorado, 80909
Memorial Hospital North
Colorado Springs, Colorado, 80920
Saint Francis Cancer Center
Colorado Springs, Colorado, 80923
MU Health - University Hospital/Ellis Fischel Cancer Center
Columbia, Missouri, 65212
John B Amos Cancer Center
Columbus, Georgia, 31904
Baptist Memorial Hospital and Cancer Center-Golden Triangle
Columbus, Mississippi, 39705
Ohio State University Comprehensive Cancer Center
Columbus, Ohio, 43210
Mount Carmel East Hospital
Columbus, Ohio, 43213
Columbus Oncology and Hematology Associates Inc
Columbus, Ohio, 43214
Riverside Methodist Hospital
Columbus, Ohio, 43214
Grant Medical Center
Columbus, Ohio, 43215
The Mark H Zangmeister Center
Columbus, Ohio, 43219
Mount Carmel Health Center West
Columbus, Ohio, 43222
Doctors Hospital
Columbus, Ohio, 43228
John Muir Medical Center-Concord
Concord, California, 94520
New Hampshire Oncology Hematology PA-Concord
Concord, New Hampshire, 03301
UT MD Anderson - The Woodlands
Conroe, Texas, 77384
Cookeville Regional Medical Center
Cookeville, Tennessee, 38501
Mercy Hospital
Coon Rapids, Minnesota, 55433
Bay Area Hospital
Coos Bay, Oregon, 97420
UM Sylvester Comprehensive Cancer Center at Coral Gables
Coral Gables, Florida, 33146
UM Sylvester Comprehensive Cancer Center at Coral Springs
Coral Springs, Florida, 33065
Baptist Health Corbin
Corbin, Kentucky, 40701
Commonwealth Cancer Center-Corbin
Corbin, Kentucky, 40701
City of Hope Corona
Corona, California, 92882
Good Samaritan Hospital
Corvallis, Oregon, 97330
UC Irvine Health Cancer Center-Newport
Costa Mesa, California, 92627
Alegent Health Mercy Hospital
Council Bluffs, Iowa, 51503
Heartland Oncology and Hematology LLP
Council Bluffs, Iowa, 51503
Methodist Jennie Edmundson Hospital
Council Bluffs, Iowa, 51503
Mary Bird Perkins Cancer Center - Covington
Covington, Louisiana, 70433
Northshore Oncology Associates-Covington
Covington, Louisiana, 70433
Ochsner Hematology Oncology North Shore - Covington (West Region)
Covington, Louisiana, 70433
Women's Cancer Care-Covington
Covington, Louisiana, 70433
UPMC Hillman Cancer Center - Passavant - Cranberry
Cranberry Township, Pennsylvania, 16066
Greater Regional Medical Center
Creston, Iowa, 50801
Oncology Hematology Care Inc-Crestview
Crestview Hills, Kentucky, 41017
Siteman Cancer Center at West County Hospital
Creve Coeur, Missouri, 63141
Michiana Hematology Oncology PC-Crown Point
Crown Point, Indiana, 46307
AMG Crystal Lake - Oncology
Crystal Lake, Illinois, 60014
Aurora Saint Luke's South Shore
Cudahy, Wisconsin, 53110
Puerto Rico4 sites
Cancer Center-Metro Medical Center Bayamon
Bayamón, 00959-5060
Doctors Cancer Center
Manati, 00674
San Juan Community Oncology Group
San Juan, 00917
San Juan City Hospital
San Juan, 00936
About this study
Official title: Molecular Analysis for Therapy Choice (MATCH)
This phase II MATCH screening and multi-sub-trial studies how well treatment that is directed by genetic testing works in patients with solid tumors, lymphomas, or multiple myelomas that may have spread from where it first started to nearby tissue, lymph nodes, or distant parts of the body (advanced) and does not respond to treatment (refractory). Patients must have progressed following at least one line of standard treatment or for which no agreed upon treatment approach exists. Genetic tests look at the unique genetic material (genes) of patients' tumor cells. Patients with genetic abnormalities (such as mutations, amplifications, or translocations) may benefit more from treatment which targets their tumor's particular genetic abnormality. Identifying these genetic abnormalities first may help doctors plan better treatment for patients with solid tumors, lymphomas, or multiple myeloma.
Read the detailed description
PRIMARY OBJECTIVE:
- To evaluate the proportion of patients with objective response (OR) to targeted study agent(s) in patients with advanced refractory cancers/lymphomas/multiple myeloma.
SECONDARY OBJECTIVES:
- To evaluate the proportion of patients alive and progression free at 6 months of treatment with targeted study agent in patients with advanced refractory cancers/lymphomas/multiple myeloma.
II. To evaluate time until death or disease progression. III. To identify potential predictive biomarkers beyond the genomic alteration by which treatment is assigned or resistance mechanisms using additional genomic, ribonucleic acid (RNA), protein and imaging-based assessment platforms.
IV. To assess whether radiomic phenotypes obtained from pre-treatment imaging and changes from pre- through post-therapy imaging can predict objective response and progression free survival and to evaluate the association between pre-treatment radiomic phenotypes and targeted gene mutation patterns of tumor biopsy specimens.
OUTLINE:
STEP 0 (Screening): Patients undergo biopsy along with molecular characterization of the biopsy material for specific, pre-defined mutations, amplifications, or translocations of interest via tumor sequencing and immunohistochemistry. Consenting patients also undergo collection of blood samples for research purposes.
STEPS 1, 3, 5, 7 (Treatment): Patients are assigned to 1 of 38 treatment subprotocols based on molecularly-defined subgroup. (See Arms Section)
STEPS 2, 4, 6 (Screening): Patients experiencing disease progression on the prior Step treatment or who could not tolerate the assigned treatment undergo review of their previous biopsy results to determine if another treatment is available or undergo another biopsy. Patients may have a maximum of 2 screening biopsies and 2 treatments per biopsy.
STEP 8 (Optional Research): Consenting patients undergo end-of-treatment biopsy and collection of blood samples for research purposes.
Additionally, patients may undergo a computed tomography (CT) scan, magnetic resonance imaging, and/or radionuclide imaging throughout the trial.
After completion of study treatment, patients are followed up every 3 months for 2 years and then every 6 months for 1 year.
- Conditions
- Advanced Lymphoma, Advanced Malignant Solid Neoplasm, Bladder Carcinoma, Breast Carcinoma, Cervical Carcinoma, Colon Carcinoma
- Being tested
- Adavosertib, Afatinib, Afatinib Dimaleate, Binimetinib, Biopsy Procedure
- Medical subject headings
- Urinary Bladder Neoplasms, Breast Neoplasms, Uterine Cervical Neoplasms, Colonic Neoplasms, Colorectal Neoplasms, Endometrial Neoplasms, Esophageal Neoplasms, Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AdavosertibDrug
Also called AZD 1775, AZD-1775, AZD1775, MK 1775
Given PO
AfatinibDrug
Also called BIBW 2992, BIBW-2992, BIBW2992
Given PO
Afatinib DimaleateDrug
Also called (2E)-N-(4-((3-Chloro-4-fluorophenyl)amino)-7-(((3S)-tetrahydrofuran-3-yl)oxy)quinazolin- 6-yl)-4-(dimethylamino)but-2-enamide bis(hydrogen (2Z)-but-2-enedioate), BIBW 2992MA2, BIBW2992 MA2, Gilotrif
Given PO
BinimetinibDrug
Also called ARRY 162, ARRY 438162, ARRY-162, ARRY-438162
Given PO
Biopsy ProcedureProcedure or surgery
Also called Biopsy, BIOPSY_TYPE, Bx
Undergo tumor biopsy
Biospecimen CollectionProcedure or surgery
Also called Biological Sample Collection, Biospecimen Collected, Sample Collection, Specimen Collection
Undergo collection of blood samples
CapivasertibDrug
Also called AZD 5363, AZD-5363, AZD5363, Truqap
Given PO
Computed TomographyProcedure or surgery
Also called CAT, CAT Scan, Computed Axial Tomography, Computerized Axial Tomography
Undergo computed tomography (CT)
CopanlisibDrug
Also called BAY 80 6946, BAY 80-6946, BAY 806946, BAY-80-6946
Given IV
Copanlisib HydrochlorideDrug
Also called 5-Pyrimidinecarboxamide, 2-Amino-N-(2,3-dihydro-7-methoxy-8-(3-(4-morpholinyl)propoxy)imidazo(1,2-C)quinazolin-5-yl)-, Hydrochloride (1:2), Aliqopa, BAY 80-6946 Dihydrochloride, BAY-80-6946 Dihydrochloride
Given IV
CrizotinibDrug
Also called Alkixen, Crizocent, MET Tyrosine Kinase Inhibitor PF-02341066, PF 02341066
Given PO
Cytology Specimen Collection ProcedureOther
Also called Cytologic Sampling
Optional correlative studies
DabrafenibDrug
Also called BRAF Inhibitor GSK2118436, GSK 2118436, GSK 2118436A, GSK-2118436
Given PO
Dabrafenib MesylateDrug
Also called Dabrafenib Methanesulfonate, GSK2118436 Methane Sulfonate Salt, GSK2118436B, Tafinlar
Given PO
DasatinibDrug
Also called BMS 354825, BMS-354825, BMS354825, Dasatinib Hydrate
Given PO
DefactinibDrug
Also called PF-04554878, VS-6063
Given PO
Defactinib HydrochlorideDrug
Given PO
Echocardiography TestProcedure or surgery
Also called EC, Echocardiography
Undergo echocardiography (ECHO)
ErdafitinibDrug
Also called Balversa, JNJ 42756493, JNJ-42756493, JNJ42756493
Given PO
FexagratinibDrug
Also called ABSK-091, ABSK091, AZD4547, FGFR Inhibitor AZD4547
Given PO
IpatasertibDrug
Also called GDC 0068, GDC-0068, GDC0068, RG 7440
Given PO
Laboratory Biomarker AnalysisOther
Undergo molecular analysis
LarotrectinibDrug
Also called ARRY 470, LOXO 101, LOXO-101, LOXO101
Given PO
Larotrectinib SulfateDrug
Also called ARRY 470 Sulfate, LOXO 101 Sulfate, LOXO-101 Sulfate, Vitrakvi
Given PO
Magnetic Resonance ImagingProcedure or surgery
Also called Magnetic Resonance, Magnetic Resonance Imaging (MRI), Magnetic resonance imaging (procedure), Magnetic Resonance Imaging Scan
Undergo magnetic resonance imaging (MRI)
Multigated Acquisition ScanProcedure or surgery
Also called Blood Pool Scan, Equilibrium Radionuclide Angiography, Gated Blood Pool Imaging, Gated Heart Pool Scan
Undergo MUGA
NivolumabBiological
Also called ABP 206, BCD-263, BMS 936558, BMS-936558
Given IV
OsimertinibDrug
Also called AZD 9291, AZD-9291, AZD9291, Mereletinib
Given PO
PalbociclibDrug
Also called 6-Acetyl-8-cyclopentyl-5-methyl-2-((5-(piperazin-1-yl)pyridin-2-yl)amino)-8h-pyrido(2,3-d)pyrimidin-7-one, Ibrance, PD 0332991, PD 332991
Given PO
PertuzumabBiological
Also called 2C4, 2C4 Antibody, BCD-178, EG1206A
Given IV
PI3K-beta Inhibitor GSK2636771Drug
Also called GSK-2636771, GSK2636771
Given PO
Radiologic ExaminationProcedure or surgery
Also called Radiologic Evaluation, Radiologic Exam
Undergo radiologic evaluation
Radionuclide ImagingProcedure or surgery
Also called Gamma Scan, NM, Nuclear Medicine, nuclear medicine scan
Undergo nuclear study
RelatlimabBiological
Also called BMS 986016, BMS-986016, BMS986016, Immunoglobulin G4, Anti-(human Lymphocyte Activation Gene-3 Protein) (Human Heavy Chain), Disulfide with Human Light Chain, Dimer
Given IV
SapanisertibDrug
Also called INK-128, INK128, MLN-0128, MLN0128
Given PO
Sunitinib MalateDrug
Also called SU 011248, SU 11248, SU-011248, SU-11248
Given PO
TaselisibDrug
Also called GDC-0032, RO5537381
Given PO
TrametinibDrug
Also called GSK 1120212, GSK 212, GSK-1120212, GSK-212
Given PO
TrastuzumabBiological
Also called ABP 980, ALT02, Biceltis, CANMab
Given IV
Trastuzumab EmtansineBiological
Also called Ado Trastuzumab Emtansine, ADO-Trastuzumab Emtansine, Kadcyla, PRO 132365
Given IV
UlixertinibDrug
Also called BVD-523, VRT752271
Give PO
VismodegibDrug
Also called Erivedge, GDC 0449, GDC-0449, GDC0449
Given PO
| Study group | Role | What they receive |
|---|---|---|
| Subprotocol A (EGFR activating mutation) | Experimental | Patients with EGFR activating mutation receive afatinib orally (PO) once daily (QD) on days 1-28 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Additionally, patients undergo CT or MRI during screening and on study, as well as during follow-up as clinically necessary. Patients may also undergo ECHO or nuclear study throughout the trial as clinically necessary. Patients undergo biopsies and blood sample collection on study. Receives: Drug: Afatinib; Drug: Afatinib Dimaleate; Procedure: Biopsy Procedure; Procedure: Biospecimen Collection; Procedure: Computed Tomography; Other: Cytology Specimen Collection Procedure; Procedure: Echocardiography Test; Other: Laboratory Biomarker Analysis; Procedure: Magnetic Resonance Imaging; Procedure: Radionuclide Imaging |
| Subprotocol B (HER2 activating mutation) | Experimental | Patients with HER2 activating mutation receive afatinib PO QD on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Receives: Drug: Afatinib; Drug: Afatinib Dimaleate; Other: Cytology Specimen Collection Procedure; Other: Laboratory Biomarker Analysis |
| Subprotocol C1 (MET amplification) | Experimental | Patients with MET amplification receive crizotinib PO BID on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients also undergo radiologic evaluation and collection of blood samples throughout the study. Patients may undergo biopsy at screening, on study, and/or at end of treatment. Receives: Procedure: Biopsy Procedure; Procedure: Biospecimen Collection; Drug: Crizotinib; Other: Cytology Specimen Collection Procedure; Other: Laboratory Biomarker Analysis; Procedure: Radiologic Examination |
| Subprotocol C2 (MET exon 14 deletion/mutation) | Experimental | Patients with MET exon 14 deletion or other mutations that disrupt exon 14 receive crizotinib PO BID on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients undergo tumor biopsy on study and undergo radiologic evaluation and blood sample collection throughout the study. Receives: Procedure: Biopsy Procedure; Procedure: Biospecimen Collection; Drug: Crizotinib; Other: Cytology Specimen Collection Procedure; Other: Laboratory Biomarker Analysis; Procedure: Radiologic Examination |
| Subprotocol E (EGFR T790M or rare activating mutation) | Experimental | Patients with EGFR T790M or rare activating mutation receive osimertinib (AZD9291) PO QD on days 1-28 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients also undergo radiologic evaluation throughout the trial, ECHO or multigated acquisition scan (MUGA) during screening, and biopsy and collection of blood samples on trial and at end of treatment. Receives: Procedure: Biopsy Procedure; Procedure: Biospecimen Collection; Other: Cytology Specimen Collection Procedure; Procedure: Echocardiography Test; Other: Laboratory Biomarker Analysis; Procedure: Multigated Acquisition Scan; Drug: Osimertinib; Procedure: Radiologic Examination |
| Subprotocol F (ALK translocation) | Experimental | Patients with ALK translocation receive crizotinib PO twice daily (BID) on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Receives: Drug: Crizotinib; Other: Cytology Specimen Collection Procedure; Other: Laboratory Biomarker Analysis |
| Subprotocol G (ROS1 translocation or inversion) | Experimental | Patients with ROS1 translocation or inversion receive crizotinib PO BID on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Receives: Drug: Crizotinib; Other: Cytology Specimen Collection Procedure; Other: Laboratory Biomarker Analysis |
| Subprotocol H (BRAF V600E/R/K/D mutation) | Experimental | Patients with BRAF V600E/R/K/D mutation receive dabrafenib PO BID and trametinib PO QD on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Receives: Other: Cytology Specimen Collection Procedure; Drug: Dabrafenib; Drug: Dabrafenib Mesylate; Other: Laboratory Biomarker Analysis; Drug: Trametinib |
| Subprotocol I (PIK3CA mutation) | Experimental | Patients with PIK3CA mutation without RAS mutation or PTEN loss receive taselisib PO QD on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Receives: Other: Cytology Specimen Collection Procedure; Other: Laboratory Biomarker Analysis; Drug: Taselisib |
| Subprotocol J (HER2 amplification >= 7 copy numbers) | Experimental | Patients receive pertuzumab IV over 30-60 minutes and trastuzumab IV over 30 minutes on day 1 of each cycle. Cycles repeat every 3 weeks in the absence of disease progression or unacceptable toxicity. Patients also undergo radiologic evaluation throughout the trial, ECHO at screening and end of treatment, and biopsy and collection of blood samples on trial and at end of treatment. Receives: Procedure: Biopsy Procedure; Procedure: Biospecimen Collection; Procedure: Echocardiography Test; Other: Laboratory Biomarker Analysis; Biological: Pertuzumab; Procedure: Radiologic Examination; Biological: Trastuzumab |
| Subprotocol K1 (FGFR amplification) | Experimental | Patients with FGFR amplification receive erdafitinib PO QD on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients also undergo CT and MRI throughout study. Patients may also undergo blood sample collection and tumor biopsy throughout the trial. Receives: Procedure: Biopsy Procedure; Procedure: Biospecimen Collection; Procedure: Computed Tomography; Other: Cytology Specimen Collection Procedure; Drug: Erdafitinib; Other: Laboratory Biomarker Analysis; Procedure: Magnetic Resonance Imaging |
| Subprotocol K2 (FGFR mutation or fusion) | Experimental | Patients with FGFR mutation or fusion receive erdafitinib PO QD on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Additionally, patients undergo blood sample collection, CT or MRI, and tumor biopsy throughout the study. Receives: Procedure: Biopsy Procedure; Procedure: Biospecimen Collection; Procedure: Computed Tomography; Other: Cytology Specimen Collection Procedure; Drug: Erdafitinib; Other: Laboratory Biomarker Analysis; Procedure: Magnetic Resonance Imaging |
| Subprotocol L (mTOR mutation) | Experimental | Patients with mTOR mutation receive sapanisertib PO daily on days 1-28. Cycles repeat every 3 weeks in the absence of disease progression or unacceptable toxicity. Receives: Other: Cytology Specimen Collection Procedure; Other: Laboratory Biomarker Analysis; Drug: Sapanisertib |
| Subprotocol M (TSC1 or TSC2 mutation) | Experimental | Patients with TSC1 or TSC2 mutation receive sapanisertib PO daily on days 1-28. Cycles repeat every 3 weeks in the absence of disease progression or unacceptable toxicity. Receives: Other: Cytology Specimen Collection Procedure; Other: Laboratory Biomarker Analysis; Drug: Sapanisertib |
| Subprotocol N (PTEN mutation or deletion and PTEN expression) | Experimental | Patients with PTEN mutation or deletion and PTEN expression receive PI3K-beta inhibitor GSK2636771 PO QD on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Receives: Other: Cytology Specimen Collection Procedure; Other: Laboratory Biomarker Analysis; Drug: PI3K-beta Inhibitor GSK2636771 |
| Subprotocol P (PTEN loss) | Experimental | Patients with PTEN loss receive PI3K-beta inhibitor GSK2636771 PO QD on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Receives: Other: Cytology Specimen Collection Procedure; Other: Laboratory Biomarker Analysis; Drug: PI3K-beta Inhibitor GSK2636771 |
| Subprotocol Q (HER2 amplification) | Experimental | Patients with HER2 amplification receive trastuzumab emtansine intravenously (IV) over 30-90 minutes on day 1. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Receives: Other: Cytology Specimen Collection Procedure; Other: Laboratory Biomarker Analysis; Biological: Trastuzumab; Biological: Trastuzumab Emtansine |
| Subprotocol R (BRAF fusion or BRAF non-V600 mutation) | Experimental | Patients with BRAF fusion or BRAF non-V600 mutation receive trametinib PO QD on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Receives: Other: Cytology Specimen Collection Procedure; Other: Laboratory Biomarker Analysis; Drug: Trametinib |
| Subprotocol S1 (NF1 mutation) | Experimental | Patients with NF1 mutation receive trametinib PO QD on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Receives: Other: Cytology Specimen Collection Procedure; Other: Laboratory Biomarker Analysis; Drug: Trametinib |
| Subprotocol S2 (GNAQ or GNA11 mutation) | Experimental | Patients with GNAQ or GNA11 mutation receive trametinib PO QD on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Receives: Other: Cytology Specimen Collection Procedure; Other: Laboratory Biomarker Analysis; Drug: Trametinib |
| Subprotocol T (SMO or PTCH1 mutation) | Experimental | Patients with SMO or PTCH1 mutation receive vismodegib PO QD on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients undergo ECHO or nuclear study during screening, tumor biopsy on study and CT scan, MRI and blood sample collection throughout the study. Receives: Procedure: Biopsy Procedure; Procedure: Biospecimen Collection; Procedure: Computed Tomography; Other: Cytology Specimen Collection Procedure; Procedure: Echocardiography Test; Other: Laboratory Biomarker Analysis; Procedure: Magnetic Resonance Imaging; Procedure: Radionuclide Imaging; Drug: Vismodegib |
| Subprotocol U (NF2 inactivating mutation) | Experimental | Patients with NF2 inactivating mutation receive defactinib PO BID on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Receives: Other: Cytology Specimen Collection Procedure; Drug: Defactinib; Drug: Defactinib Hydrochloride; Other: Laboratory Biomarker Analysis |
| Subprotocol V (cKIT exon 9, 11, 13, or 14 mutation) | Experimental | Patients with cKIT exon 9, 11, 13, or 14 mutation receive sunitinib PO QD on days 1-28 of each cycle. Cycles repeat every 42 days in the absence of disease progression or unacceptable toxicity. Additionally, patients undergo CT or MRI during screening and on study, as well as during follow-up as clinically necessary. Patients also undergo ECHO or nuclear study throughout the trial as clinically necessary. Patients undergo biopsies and blood sample collection on study. Receives: Procedure: Biopsy Procedure; Procedure: Biospecimen Collection; Procedure: Computed Tomography; Other: Cytology Specimen Collection Procedure; Procedure: Echocardiography Test; Other: Laboratory Biomarker Analysis; Procedure: Magnetic Resonance Imaging; Procedure: Radionuclide Imaging; Drug: Sunitinib Malate |
| Subprotocol W (FGFR pathway aberrations) | Experimental | Patients with FGFR1-3 mutation or translocation receive FGFR Inhibitor AZD4547 PO BID on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Receives: Other: Cytology Specimen Collection Procedure; Drug: Fexagratinib; Other: Laboratory Biomarker Analysis |
| Subprotocol X (DDR2 S768R, I638F, or L239R mutation) | Experimental | Patients with DDR2 S768R, I638F, or L239R mutation receive dasatinib PO QD on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Receives: Other: Cytology Specimen Collection Procedure; Drug: Dasatinib; Other: Laboratory Biomarker Analysis |
| Subprotocol Y (Akt mutation) | Experimental | Patients with Akt mutation receive capivasertib PO BID on days 1-4, 8-11, 15-18, and 22-25. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Receives: Drug: Capivasertib; Other: Cytology Specimen Collection Procedure; Other: Laboratory Biomarker Analysis |
| Subprotocol Z1A (NRAS mutation in codon 12, 13, or 61) | Experimental | Patients with NRAS mutation in codon 12, 13, or 61 receive binimetinib PO BID on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Receives: Drug: Binimetinib; Other: Cytology Specimen Collection Procedure; Other: Laboratory Biomarker Analysis |
| Subprotocol Z1B (CCND1, 2, or 3 amplification with Rb by IHC) | Experimental | Patients with CCND1, 2, or 3 amplification that have tumor Rb expression by IHC receive palbociclib PO QD for 21 days. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Receives: Other: Cytology Specimen Collection Procedure; Other: Laboratory Biomarker Analysis; Drug: Palbociclib |
| Subprotocol Z1C (CDK4 or CDK6 amplification and Rb protein) | Experimental | Patients with CDK4 or CDK6 amplification and tumor Rb protein receive palbociclib PO QD on days 1-21. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Receives: Other: Cytology Specimen Collection Procedure; Other: Laboratory Biomarker Analysis; Drug: Palbociclib |
| Subprotocol Z1D (Loss of MLH1 or MSH2 by IHC) | Experimental | Patients with mismatch repair deficiency (loss of MLH1 or MSH2 by IHC) receive nivolumab IV over 30 minutes on days 1 and 15 for 4 cycles and then on day 1 every 28 days. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Receives: Other: Cytology Specimen Collection Procedure; Other: Laboratory Biomarker Analysis; Biological: Nivolumab |
| Subprotocol Z1E (NTRK1, NTRK2 or NTRK3 gene fusion) | Experimental | Patients with NTRK1, NTRK2, or NTRK3 gene fusion receive larotrectinib (LOXO-101) PO BID on days 1-28 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Additionally, patients undergo CT or MRI during screening and on study, as well as during follow-up as clinically necessary. Patients also undergo biopsies and blood sample collection on study. Receives: Procedure: Biopsy Procedure; Procedure: Biospecimen Collection; Procedure: Computed Tomography; Other: Cytology Specimen Collection Procedure; Other: Laboratory Biomarker Analysis; Drug: Larotrectinib; Drug: Larotrectinib Sulfate; Procedure: Magnetic Resonance Imaging |
| Subprotocol Z1F (PIK3CA mutation) | Experimental | Patients receive copanlisib IV over 1 hour on days 1, 8, and 15 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients also undergo tumor biopsies at screening and end of treatment as well as CT or MRI at baseline and repeated every 2 cycles for the first 26 cycles then every 3 cycles thereafter until progressive disease or start of another MATCH treatment step. Receives: Procedure: Biopsy Procedure; Procedure: Computed Tomography; Drug: Copanlisib; Drug: Copanlisib Hydrochloride; Other: Cytology Specimen Collection Procedure; Procedure: Magnetic Resonance Imaging |
| Subprotocol Z1G (PTEN loss) | Experimental | Patients with PTEN loss receive copanlisib IV over 1 hour on days 1, 8, and 15. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Receives: Drug: Copanlisib; Drug: Copanlisib Hydrochloride; Other: Cytology Specimen Collection Procedure; Other: Laboratory Biomarker Analysis |
| Subprotocol Z1H (PTEN mutation) | Experimental | Patients with PTEN mutation receive copanlisib IV over 1 hour on days 1, 8, and 15. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Receives: Drug: Copanlisib; Drug: Copanlisib Hydrochloride; Other: Cytology Specimen Collection Procedure; Other: Laboratory Biomarker Analysis |
| Subprotocol Z1I (BRCA1 or BRCA2 gene mutation) | Experimental | Patients with BRCA1 or BRCA2 gene mutation receive adavosertib PO QD for 5 days for 2 weeks. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Receives: Drug: Adavosertib; Other: Cytology Specimen Collection Procedure; Other: Laboratory Biomarker Analysis |
| Subprotocol Z1K (AKT mutation) | Experimental | Patients receive ipatasertib PO QD. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Receives: Other: Cytology Specimen Collection Procedure; Drug: Ipatasertib; Other: Laboratory Biomarker Analysis |
| Subprotocol Z1L (BRAF fusion, aberration or non-V600 mutation) | Experimental | Patients with a BRAF non-V600 mutation or BRAF fusion, or another BRAF aberration receive ulixertinib (BVD-523FB) PO BID on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Receives: Other: Cytology Specimen Collection Procedure; Other: Laboratory Biomarker Analysis; Drug: Ulixertinib |
| Subprotocol Z1M (LAG-3 expression >= 1%) | Experimental | Patients receive nivolumab IV over 30 minutes and relatlimab IV over 30 minutes on day 1.Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Receives: Other: Cytology Specimen Collection Procedure; Other: Laboratory Biomarker Analysis; Biological: Nivolumab; Biological: Relatlimab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective response rate (ORR)
ORR is defined as the percentage of patients whose tumors have a complete or partial response to treatment among analyzable patients. Objective response is defined consistent with Response Evaluation Criteria in Solid Tumors version 1.1, the Cheson (2014) criteria for lymphoma patients, and the Response Assessment in Neuro-Oncology criteria for glioblastoma patients. 90% two-sided confidence interval is calculated for ORR. For the purposes of this study, patients should be re-evaluated for response:
- For treatments given in 21 day (3 week) cycles: every 3 cycles (9 weeks) for the first 33 cycles, and every 4 cycles thereafter (12 weeks)
- For treatments given in 28 day (4 week) cycles: every 2 cycles (8 weeks) for the first 26 cycles, and every three cycles thereafter (12 weeks)
- For treatments given in 42 day (6 week) cycles: every 2 cycles (12 weeks)
Measured: Up to 3 years
Secondary outcomes (3)
Overall survival (OS)
Will be evaluated specifically for each drug (or step). OS will be estimated using the Kaplan-Meier method.
Measured: From start of treatment on that step until death, or censored at the date of last contact, assessed up to 3 years
6-month progression free survival (PFS) rate
Progression free survival is defined as time from treatment start date to date of progression or death from any cause, whichever occurs first. Disease progression was evaluated using the Response Evaluation Criteria in Solid Tumors version 1.1, the Cheson (2014) criteria for lymphoma patients, and the Response Assessment in Neuro-Oncology criteria for glioblastoma patients. Please refer to the protocol for detailed definitions of disease progression. 6 month PFS rate was estimated using the Kaplan-Meier method, which can provide a point estimate for any specific time point.
Measured: From start of treatment on that step until determination of disease progression or death from any cause, censored at the date of last disease assessment for patients who have not progressed, assessed at 6 months
Progression free survival
PFS was defined as time from treatment start date to date of disease progression or death from any causes, whichever occurred first. Median PFS was estimated using the Kaplan-Meier method. Disease progression was evaluated using the Response Evaluation Criteria in Solid Tumors version 1.1, the Cheson (2014) criteria for lymphoma patients, and the Response Assessment in Neuro-Oncology criteria for glioblastoma patients. Please refer to the protocol for detailed definitions of disease progression.
Measured: From start of treatment on that step until determination of disease progression or death from any cause, censored at the date of last disease assessment for patients who have not progressed, assessed up to 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2015 (estimated)
- Study start17 Aug 2015
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (15)Papers the sponsor has linked to this study.
- Other trials for Advanced LymphomaStudies of the same condition, open and under way.
- More trials run by National Cancer Institute (NCI)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Screening
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 6,452 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Cancer Institute (NCI)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Keith T Flaherty, Principal investigator, ECOG-ACRIN Cancer Research Group
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02465060
- Sponsor's protocol ID
- NCI-2015-00054
- Other IDs
- NCI-2015-00054, EAY131, EAY131, U10CA180820, U24CA196172
- Status last verified
- Sep 2026
- First submitted
- 3 Jun 2015
- Last updated
- 22 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Tsao AS, Song Z, Ho AL, Mehnert JM, Ivy P, Gray RJ, Wang V, McShane LM, Rubinstein LV, Patton DR, Williams PM, Hamilton SR, Takebe N, Ajumally R, Silhavy J, Rahmanian S, Das B, Chen L, Karlovich C, Lococo JS, Tricoli JV, Conley BA, Arteaga CL, Harris LN, O'Dwyer PJ, Chen AP, Flaherty KT. Phase II Study of Vismodegib in Patients With SMO- or PTCH1-Mutated Tumors: Results From the National Cancer Institute Molecular Analysis for Therapy Choice Eastern Cooperative Oncology Group-American College of Radiology Imaging Network Trial (EAY131) Subprotocol T. JCO Precis Oncol. 2025 Oct;9:e2500119. doi: 10.1200/PO-25-00119. Epub 2025 Oct 9.
PubMed 41066729Janku F, Jegede OA, Puhalla SL, Konstantinopoulos PA, Meric-Bernstam F, Zwiebel JA, Gray RJ, Wang XV, McShane LM, Rubinstein LV, Patton DR, Williams PM, Hamilton SR, Takebe N, Ghani S, Tricoli JV, Conley BA, Arteaga CL, Harris LN, O'Dwyer PJ, Chen AP, Flaherty KT. PIK3CB Inhibitor GSK2636771 in Cancers With PTEN Mutation/Deletion or Loss of PTEN Protein Expression: Results From the NCI-MATCH ECOG-ACRIN Trial (EAY131) Subprotocols N and P. JCO Precis Oncol. 2025 Aug;9:e2500265. doi: 10.1200/PO-25-00265. Epub 2025 Aug 27.
PubMed 40865033Gouda MA, Wei Z, Rodon J, Davies MA, Janku F, Gray RJ, Wang V, McShane LM, Rubinstein LV, Patton DR, Williams PM, Hamilton SR, Liu R, Bota DA, Swiecicki PL, Buchschacher GL, Tricoli JV, Conley BA, Arteaga CL, Harris LN, O'Dwyer PJ, Chen AP, Flaherty KT. Phase II Study of Copanlisib in Patients With PTEN Loss: Results From NCI-MATCH ECOG-ACRIN Trial (EAY131) Subprotocols Z1G and Z1H. JCO Precis Oncol. 2025 Feb;9:e2400451. doi: 10.1200/PO-24-00451. Epub 2025 Feb 6.
PubMed 39913886Zauderer MG, Jegede O, Jackman DM, Zwiebel JA, Gray RJ, Wang V, McShane LM, Rubinstein LV, Patton DR, Williams PM, Hamilton SR, Takebe N, Huang R, Carrillo JA, Brenner AJ, Tricoli JV, Conley BA, Arteaga CL, Harris LN, O'Dwyer PJ, Chen AP, Flaherty KT. Phase II Study of Defactinib (VS6063) in Patients With Tumors With NF2 Loss: Results From the NCI-MATCH ECOG-ACRIN Trial (EAY131) Subprotocol U. JCO Precis Oncol. 2024 Dec;8:e2400327. doi: 10.1200/PO.24.00327. Epub 2024 Dec 18.
PubMed 39693587Gien LT, Song Z, Poklepovic A, Collisson EA, Zwiebel JA, Gray RJ, Wang V, McShane LM, Rubinstein LV, Patton DR, Williams PM, Hamilton SR, Tricoli JV, Conley BA, Arteaga CL, Harris LN, O'Dwyer PJ, Chen AP, Flaherty KT. Phase II Study of Sunitinib in Tumors With c-KIT Mutations: Results From the NCI MATCH ECOG-ACRIN Trial (EAY131) Subprotocol V. JCO Precis Oncol. 2024 Dec;8:e2400514. doi: 10.1200/PO-24-00514. Epub 2024 Dec 12.
PubMed 39666929Chen MF, Song Z, Yu HA, Sequist LV, Lovly CM, Mitchell EP, Moscow JA, Gray RJ, Wang V, McShane LM, Rubinstein LV, Patton DR, Williams PM, Hamilton SR, Umemura Y, Tricoli JV, Conley BA, Arteaga CL, Harris LN, O'Dwyer PJ, Chen AP, Flaherty KT. Phase II Study of Osimertinib in Patients With Epidermal Growth Factor Receptor Mutations: Results From the NCI-MATCH ECOG-ACRIN (EAY131) Trial Subprotocol E. JCO Precis Oncol. 2024 Apr;8:e2300454. doi: 10.1200/PO.23.00454.
PubMed 38591867Subbiah V, Burris HA 3rd, Kurzrock R. Revolutionizing cancer drug development: Harnessing the potential of basket trials. Cancer. 2024 Jan;130(2):186-200. doi: 10.1002/cncr.35085. Epub 2023 Nov 7.
PubMed 37934000O'Dwyer PJ, Gray RJ, Flaherty KT, Chen AP, Li S, Wang V, McShane LM, Patton DR, Tricoli JV, Williams PM, Iafrate AJ, Sklar J, Mitchell EP, Takebe N, Sims DJ, Coffey B, Fu T, Routbort M, Rubinstein LV, Little RF, Arteaga CL, Marinucci D, Hamilton SR, Conley BA, Harris LN, Doroshow JH. The NCI-MATCH trial: lessons for precision oncology. Nat Med. 2023 Jun;29(6):1349-1357. doi: 10.1038/s41591-023-02379-4. Epub 2023 Jun 15.
PubMed 37322121Wisinski KB, Flamand Y, Wilson MA, Luke JJ, Tawbi HA, Hong F, Mitchell EP, Zwiebel JA, Chen H, Gray RJ, Li S, McShane LM, Rubinstein LV, Patton D, Williams PM, Hamilton SR, Behrens RJ, Pennington KP, Conley BA, Arteaga CL, Harris LN, O'Dwyer PJ, Chen AP, Flaherty KT. Trametinib in Patients With NF1-, GNAQ-, or GNA11-Mutant Tumors: Results From the NCI-MATCH ECOG-ACRIN Trial (EAY131) Subprotocols S1 and S2. JCO Precis Oncol. 2023 Apr;7:e2200421. doi: 10.1200/PO.22.00421.
PubMed 37053535Schrottmaier WC, Kral-Pointner JB, Salzmann M, Mussbacher M, Schmuckenschlager A, Pirabe A, Brunnthaler L, Kuttke M, Maier B, Heber S, Datler H, Ekici Y, Niederreiter B, Heber U, Blomgren B, Gorki AD, Soderberg-Naucler C, Payrastre B, Gratacap MP, Knapp S, Schabbauer G, Assinger A. Platelet p110beta mediates platelet-leukocyte interaction and curtails bacterial dissemination in pneumococcal pneumonia. Cell Rep. 2022 Nov 8;41(6):111614. doi: 10.1016/j.celrep.2022.111614.
PubMed 36351402Krop IE, Jegede OA, Grilley-Olson JE, Lauring JD, Mitchell EP, Zwiebel JA, Gray RJ, Wang V, McShane LM, Rubinstein LV, Patton D, Williams PM, Hamilton SR, Kono SA, Ford JM, Garcia AA, Sui XD, Siegel RD, Slomovitz BM, Conley BA, Arteaga CL, Harris LN, O'Dwyer PJ, Chen AP, Flaherty KT. Phase II Study of Taselisib in PIK3CA-Mutated Solid Tumors Other Than Breast and Squamous Lung Cancer: Results From the NCI-MATCH ECOG-ACRIN Trial (EAY131) Subprotocol I. JCO Precis Oncol. 2022 Feb;6:e2100424. doi: 10.1200/PO.21.00424.
PubMed 35138919Damodaran S, Zhao F, Deming DA, Mitchell EP, Wright JJ, Gray RJ, Wang V, McShane LM, Rubinstein LV, Patton DR, Williams PM, Hamilton SR, Suga JM, Conley BA, Arteaga CL, Harris LN, O'Dwyer PJ, Chen AP, Flaherty KT. Phase II Study of Copanlisib in Patients With Tumors With PIK3CA Mutations: Results From the NCI-MATCH ECOG-ACRIN Trial (EAY131) Subprotocol Z1F. J Clin Oncol. 2022 May 10;40(14):1552-1561. doi: 10.1200/JCO.21.01648. Epub 2022 Feb 8.
PubMed 35133871Flaherty KT, Gray RJ, Chen AP, Li S, McShane LM, Patton D, Hamilton SR, Williams PM, Iafrate AJ, Sklar J, Mitchell EP, Harris LN, Takebe N, Sims DJ, Coffey B, Fu T, Routbort M, Zwiebel JA, Rubinstein LV, Little RF, Arteaga CL, Comis R, Abrams JS, O'Dwyer PJ, Conley BA; NCI-MATCH team. Molecular Landscape and Actionable Alterations in a Genomically Guided Cancer Clinical Trial: National Cancer Institute Molecular Analysis for Therapy Choice (NCI-MATCH). J Clin Oncol. 2020 Nov 20;38(33):3883-3894. doi: 10.1200/JCO.19.03010. Epub 2020 Oct 13.
PubMed 33048619Chae YK, Hong F, Vaklavas C, Cheng HH, Hammerman P, Mitchell EP, Zwiebel JA, Ivy SP, Gray RJ, Li S, McShane LM, Rubinstein LV, Patton D, Williams PM, Hamilton SR, Mansfield A, Conley BA, Arteaga CL, Harris LN, O'Dwyer PJ, Chen AP, Flaherty KT. Phase II Study of AZD4547 in Patients With Tumors Harboring Aberrations in the FGFR Pathway: Results From the NCI-MATCH Trial (EAY131) Subprotocol W. J Clin Oncol. 2020 Jul 20;38(21):2407-2417. doi: 10.1200/JCO.19.02630. Epub 2020 May 28.
PubMed 32463741Moore KN, Mannel RS. Is the NCI MATCH trial a match for gynecologic oncology? Gynecol Oncol. 2016 Jan;140(1):161-6. doi: 10.1016/j.ygyno.2015.11.003. Epub 2015 Nov 14.
PubMed 26586415