Colorectal Cancer MetastaticPhase 2NCT03007407
Study of Durvalumab and Tremelimumab After Radiation for Microsatellite Stable Metastatic Colorectal Cancer Progressing on Chemotherapy
A Phase 2 study testing durvalumab and Tremelimumab in people with Colorectal Cancer Metastatic, run by NSABP Foundation Inc at 18 sites in United States.
Trial summary
This study is being done to look at the safety and response to the combination of two investigational drugs, tremelimumab and durvalumab, when given after radiation therapy for patients with microsatellite stable (MSS) metastatic colorectal cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colorectal Cancer Metastatic
- What is being tested?
- durvalumab and Tremelimumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 18 sitesUnited States
- Study dates
- 31 Jul 2017to 9 Aug 2019
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- The ECOG performance status must be 0 or 1.
- There must be histologic confirmation of a diagnosis of colorectal adenocarcinoma.
- The tumor must have been determined to be microsatellite stable (MSS).
- There must be documentation by positron emission tomography (PET)/computed tomography (CT) scan, CT scan, or magnetic resonance imaging (MRI), that the patient has evidence of measurable metastatic disease per RECIST 1.1.
- Patients must have an accessible metastatic lesion for pretreatment core biopsy.
- Unless either drug is medically contraindicated, patients must have received oxaliplatin and irinotecan as part of standard metastatic chemotherapy regimens.
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- The patient must have multiple sites of metastatic disease with at least one lesion amenable to treatment with stereotactic radiation therapy (SBRT) in the lung or liver and at least one lesion not being irradiated and meeting RECIST 1.1.
- At the time of study entry, blood counts performed within 2 weeks prior to study entry must meet the following criteria:
- ANC (absolute neutrophil count) must be greater than or equal to 1500/mm3,
- Platelet count must be greater than or equal to 100,000/mm3; and
- Hemoglobin must be greater than or equal to 9 g/dL.
- The following criteria for evidence of adequate hepatic function performed within 2 weeks prior to study entry must be met:
- Total bilirubin must be less than or equal to 1.5 x ULN (upper limit of normal) for the lab unless the patient has a bilirubin elevation greater than 1.5 x ULN to 3 x ULN due to Gilbert's disease or similar syndrome involving slow conjugation of bilirubin; and
- AST (aspartate aminotransferase)and ALT (alanine transaminase) must be less than or equal to 2.5 x ULN for the lab with the following exception: for patients with documented liver metastases, AST and ALT must be less than or equal to 5 x ULN.
- Adequate renal function within 4 weeks prior to study entry, defined as serum creatinine less than or equal to 1.5 x ULN for the lab or measured or calculated creatinine clearance greater than 40 mL/min by Cockcroft-Gault formula.
- All hematologic, gastrointestinal, and genitourinary chemotherapy toxicities must be less than Grade 2 at the time study therapy is to begin. (Note: Transfusions may be used to correct hemoglobin for patients experiencing anemia from therapy who otherwise would be eligible for the study.
- Patients with reproductive potential (male/female) must agree to use accepted and highly effective methods of contraception while receiving study therapy and for at least 6 months after the completion of study therapy. The definition of effective method of contraception will be based on the investigator's discretion.
- Female patients must either be of non-reproductive potential (i.e., post-menopausal by history: greater than or equal to 60 years old and no menses for greater than or equal to 1 year without an alternative medical cause; OR history of hysterectomy, OR history of bilateral tubal ligation, OR history of bilateral oophorectomy) or must have a negative serum pregnancy test upon study entry.
Who cannot join
- Diagnosis of anal or small bowel carcinoma.
- Colorectal cancer other than adenocarcinoma, e.g., sarcoma, lymphoma, carcinoid.
- Previous therapy with any PD-1 or PD-L1 (programmed cell death-1 (PD-1) protein, programmed death ligand-1 (PDL-1) protein inhibitor including durvalumab or anti-CTLA4 (including tremelimumab) for any malignancy.
- Receipt of live attenuated vaccination within 30 days prior to study entry or within 30 days of receiving study therapy.
- Active or chronic hepatitis B or hepatitis C.
- Symptomatic or uncontrolled brain metastases requiring concurrent treatments, uncontrolled spinal cord compression, carcinomatous meningitis, or new evidence of brain or leptomeningeal disease; uncontrolled seizures.
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- Active infection or chronic infection requiring chronic suppressive antibiotics.
- Active or documented inflammatory disease.
- Known history of human immunodeficiency virus (HIV) or acquired immunodeficiency-related (AIDS) illnesses.
- Current or prior use of immunosuppressive medication within 28 days before the first dose of study therapy with the exceptions of intranasal corticosteroids or systemic corticosteroids at physiological doses that do not exceed 10mg/day of prednisone or an equivalent corticosteroid.
- History of allogeneic organ transplantation.
- Any of the following cardiac conditions:
- Documented NYHA (New York Heart Association) Class III or IV congestive heart failure,
- Myocardial infarction within 6 months prior to study entry,
- Unstable angina within 6 months prior to study entry,
- Symptomatic arrhythmia. If QTc (corrected QT interval) greater than or equal to 470ms, confirmation of eligible QTc requires mean calculation from 2 additional electrocardiograms (ECGs) 2-5 minutes apart using Fridericia's Correction Formula (mean less than 470 ms).
- Uncontrolled high blood pressure defined as systolic blood pressure (BP) greater than or equal to 150 mmHg or diastolic BP greater than or equal to 100 mmHg with or without anti-hypertensive medication. Patients with initial BP elevations are eligible if initiation or adjustment of BP medication lowers pressure to meet entry criteria.
- Active or prior documented inflammatory bowel disease (e.g., Crohn's disease, ulcerative colitis).
- Ongoing or active gastritis or peptic ulcer disease.
- Active bleeding diatheses.
- Known history of previous diagnosis of tuberculosis.
- History of hypersensitivity to durvalumab or tremelimumab or any excipients of these drugs.
- Known history or confirmation of active pneumonia, pneumonitis, symptomatic interstitial lung disease, or definitive evidence of interstitial lung disease described on CT scan, MRI, or chest x-ray in asymptomatic patients; dyspnea at rest requiring current continuous oxygen therapy.
- Active or prior documented autoimmune disease within the past 2 years. (Note: Patients with vitiligo, Grave disease, or psoriasis not requiring systemic treatment within the past 2 years are eligible.)
- Other malignancies unless the patient is considered to be disease-free and has completed therapy for the malignancy greater than or equal to 12 months prior to study entry. Patients with the following cancers are eligible if diagnosed and treated within the past 12 months: carcinoma in situ of the cervix, and basal cell and squamous cell carcinoma of the skin.
- Psychiatric or addictive disorders or other conditions that, in the opinion of the investigator, would preclude the patient from meeting the study requirements or interfere with interpretation of study results.
- Pregnancy or lactation at the time of study entry. (Note: Pregnancy testing should be performed within 14 days prior to study entry according to institutional standards for women of childbearing potential.)
- Use of any investigational agent. Use and/or receipt of the last dose of anti-cancer therapy (chemotherapy, immunotherapy, endocrine therapy, targeted therapy, biologic therapy, tumor embolization, monoclonal anti-bodies) within 14 days prior to the first dose of study therapy.
- Use of any investigational agent within 4 weeks of starting study therapy.
Trial locations and contacts
18 sites in 1 country.
18 sites in 1 country
United States18 sites
Trinity Health Michigan
Ann Arbor, Michigan, 48106
University of Michigan
Ann Arbor, Michigan, 48109
St. Joseph Mercy-Brighton
Brighton, Michigan, 48114
St. Joseph Mercy-Canton
Canton, Michigan, 48188
Centralia Oncology Clinic
Centralia, Illinois, 62801
St Joseph Mercy-Chelsea
Chelsea, Michigan, 48118
Cancer Care Specialists of Central Illinois
Decatur, Illinois, 62526
City of Hope
Duarte, California, 91010
Cancer Care Specialists of Central Illinois/Crossroads Cancer Center
Effingham, Illinois, 62401
UF Health Davis Cancer Pavilion and Shands Med Plaza
Gainesville, Florida, 32608
UF Health Shands Cancer Hospital
Gainesville, Florida, 32608
UF Health Shands Hospital
Gainesville, Florida, 32610
University of Florida
Gainesville, Florida, 32610
Smilow Cancer Hospital at Yale-New Haven
New Haven, Connecticut, 06510
Smilow Cancer Hospital Care Center at North Haven
North Haven, Connecticut, 06473
University of Florida Health Cancer Center at Orlando Health
Orlando, Florida, 32806
Thomas Jefferson University
Philadelphia, Pennsylvania, 19107
Cancer Care Specialists of Central Illinois-Swansea
Swansea, Illinois, 62226
About this study
Official title: A Phase II Study of the Dual Immune Checkpoint Blockade With Durvalumab (MEDI4736) Plus Tremelimumab Following Palliative Hypofractionated Radiation in Patients With Microsatellite Stable (MSS) Metastatic Colorectal Cancer Progressing on Chemotherapy
This study is being done to look at the safety and response to the combination of two investigational drugs, tremelimumab and durvalumab, when given after radiation therapy for patients with microsatellite stable (MSS) metastatic colorectal cancer. Tremelimumab and durvalumab recognize specific proteins on the surface of cancer cells and trigger the immune system to destroy the cancer cells.
In order to learn more about certain characteristics of colorectal cancer tumors, this study includes special research tests using samples from diagnostic tumors, fresh tumor samples from an area where the cancer has spread, and blood samples.
Read the detailed description
The FC-9 study is designed as a phase II, open label, single arm study of the dual immune checkpoint blockade with the combination of durvalumab and tremelimumab following hypofractionated palliative radiation in patients with microsatellite stable (MSS) metastatic colorectal cancer (mCRC) who have progressed on chemotherapy. The primary aim is to determine the anti-tumor efficacy of the dual immune checkpoint blockade with durvalumab plus tremelimumab. The secondary aims are to determine the clinical benefit rate, duration of response, tolerability and correlates of response. Tumor response at unirradiated target lesions will be measured at baseline and every 2 cycles using RECIST 1.1.
Following three doses of hypofractionated palliative radiation (Days -2, -1, and Day 0 prior to Cycle 1), patients will receive the combination of tremelimumab (75 mg IV infusion) and durvalumab (1500 mg IV infusion) on Day 1 for 4 cycles. Beginning with Cycle 5 through Cycle 24, patients will receive durvalumab alone (1500 mg/IV infusion) on Day 1 of each 28 day cycle.
The sample size will be between 12 and 21 evaluable patients. Twelve evaluable patients will be treated in the first stage of the study. If there are no responses among the 12 evaluable patients, the study will be terminated. If the study goes on to the second stage, a total of 21 evaluable patients will be studied.
Submission of tumor tissue and blood samples for FC-9 correlative science studies will be a study requirement for all patients. Requirements will include archived tumor samples from the diagnostic biopsy; additional biopsies of fresh tissue from an accessible lesion prior to radiation therapy and after 2 cycles of study therapy; and blood sample collections.
- Conditions
- Colorectal Cancer Metastatic
- Being tested
- durvalumab, Tremelimumab
- Keywords
- microsatellite stable, MSS, durvalumab, tremelimumab, mCRC, NSABP
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
durvalumabDrug
Also called MEDI4736
Following three doses of hypofractionated palliative radiation (Days -2, -1, and Day 0 prior to Cycle 1), patients will receive durvalumab (1500 mg IV infusion) on Day 1 for 4 cycles (in combination with tremelimumab). Beginning with Cycle 5 through Cycle 12, patients will receive durvalumab alone (1500 mg/IV infusion) on Day 1 of each 28 day cycle.
TremelimumabDrug
Following three doses of hypofractionated palliative radiation (Days -2, -1, and Day 0 prior to Cycle 1), patients will receive tremelimumab (75 mg IV infusion) on Day 1 for 4 cycles (in combination with durvalumab).
| Study group | Role | What they receive |
|---|---|---|
| durvalumab and tremelimumab | Experimental | Not described Receives: Drug: durvalumab; Drug: Tremelimumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Objective Response Rate (ORR) of Dual Immune Checkpoint Blockade by RECIST 1.1
Complete Response (CR): Disappearance of all non-target lesions and normalization of tumor marker level. All lymph nodes must be <10mm on the short axis.
Partial Response (PR): 30% or more decrease in the sum of diameters of target lesions. The reference the baseline sums of diameters. Progressive Disease (PD): 20% or more increase in the sum of diameters of target lesions. The reference is the smallest sum while on study (including the baseline sum if that is the smallest on study). In addition to the relative 20% increase, the sum must also demonstrate an absolute increase 5mm or more. (Note: any appearance of one or more new lesions is also considered progression).Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD. The reference is the smallest sum of diameters while on study.
Measured: Through treatment, up to 1.3 years
Secondary outcomes (3)
Percentage of Patients Who Have Achieved Clinical Benefit
Percentage of patients who have achieved clinical benefit defined as CR (complete response) and PR (partial response) and stable disease that lasts at least 4 months
Measured: At 16 weeks
Median Duration of Response to mCRC (Metastic Colorectal Cancer) Responds to Study Therapy
Median time from study entry until documentation of progression (years) in half of the patients as determined by RECIST 1.1.
Measured: Through study completetion (1.3 years)
Frequency of Adverse Events Assessed by CTCAE 4.0, From Beginning of Treatment to 90 Days After Last Dose
Frequency of adverse events categorized using the NCI Common Terminology Criteria for Adverse Events version 4.0
Measured: During treatment (max of 12 cycles; each cycle 28 days) to 90 days after last dose of study therapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jan 2017 (estimated)
- Study start31 Jul 2017
- Primary completion18 Apr 2019
- Study completion9 Aug 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Colorectal Cancer MetastaticStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- NSABP Foundation Inc
- Sponsor type
- Research network
- Responsible party
- Sponsor
- Investigators
- Norman Wolmark, MD, Principal investigator, NSABP Foundation Inc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03007407
- Sponsor's protocol ID
- NSABP FC-9
- Other IDs
- ESR-15-11514
- Status last verified
- Nov 2022
- First submitted
- 7 Dec 2016
- Last updated
- 5 Dec 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Eisenhauer EA, Therasse P, Bogaerts J, Schwartz LH, Sargent D, Ford R, Dancey J, Arbuck S, Gwyther S, Mooney M, Rubinstein L, Shankar L, Dodd L, Kaplan R, Lacombe D, Verweij J. New response evaluation criteria in solid tumours: revised RECIST guideline (version 1.1). Eur J Cancer. 2009 Jan;45(2):228-47. doi: 10.1016/j.ejca.2008.10.026.
PubMed 19097774
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Study of the Dual Immune Checkpoint Blockade With Durvalumab (MEDI4736) Plus Tremelimumab Following Palliative Hypofractionated Radiation in Patients With Microsatellite Stable (MSS) Metastatic Colorectal Cancer Progressing on Chemotherapy
- ClinicalTrials.gov ID
- NCT03007407
- Acronym / sponsor ID
- NSABP FC-9
- Conditions
- Colorectal Cancer Metastatic
- Keywords
- microsatellite stable, MSS, durvalumab, tremelimumab, mCRC, NSABP
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- NSABP Foundation IncResearch network
- Study start
- 31 Jul 2017 (actual)
- Primary completion
- 18 Apr 2019 (actual)
- Study completion
- 9 Aug 2019 (actual)
- First posted
- 2 Jan 2017 (estimated)
- Results
- Posted 5 Dec 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is being done to look at the safety and response to the combination of two investigational drugs, tremelimumab and durvalumab, when given after radiation therapy for patients with microsatellite stable (MSS) metastatic colorectal cancer. Tremelimumab and durvalumab recognize specific proteins on the surface of cancer cells and trigger the immune system to destroy the cancer cells.
In order to learn more about certain characteristics of colorectal cancer tumors, this study includes special research tests using samples from diagnostic tumors, fresh tumor samples from an area where the cancer has spread, and blood samples.
Detailed description
The FC-9 study is designed as a phase II, open label, single arm study of the dual immune checkpoint blockade with the combination of durvalumab and tremelimumab following hypofractionated palliative radiation in patients with microsatellite stable (MSS) metastatic colorectal cancer (mCRC) who have progressed on chemotherapy. The primary aim is to determine the anti-tumor efficacy of the dual immune checkpoint blockade with durvalumab plus tremelimumab. The secondary aims are to determine the clinical benefit rate, duration of response, tolerability and correlates of response. Tumor response at unirradiated target lesions will be measured at baseline and every 2 cycles using RECIST 1.1.
Following three doses of hypofractionated palliative radiation (Days -2, -1, and Day 0 prior to Cycle 1), patients will receive the combination of tremelimumab (75 mg IV infusion) and durvalumab (1500 mg IV infusion) on Day 1 for 4 cycles. Beginning with Cycle 5 through Cycle 24, patients will receive durvalumab alone (1500 mg/IV infusion) on Day 1 of each 28 day cycle.
The sample size will be between 12 and 21 evaluable patients. Twelve evaluable patients will be treated in the first stage of the study. If there are no responses among the 12 evaluable patients, the study will be terminated. If the study goes on to the second stage, a total of 21 evaluable patients will be studied.
Submission of tumor tissue and blood samples for FC-9 correlative science studies will be a study requirement for all patients. Requirements will include archived tumor samples from the diagnostic biopsy; additional biopsies of fresh tissue from an accessible lesion prior to radiation therapy and after 2 cycles of study therapy; and blood sample collections.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| durvalumab and tremelimumab | Experimental | Drug: durvalumab, Drug: Tremelimumab |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (18 listed)
- The ECOG performance status must be 0 or 1.
- There must be histologic confirmation of a diagnosis of colorectal adenocarcinoma.
- The tumor must have been determined to be microsatellite stable (MSS).
- There must be documentation by positron emission tomography (PET)/computed tomography (CT) scan, CT scan, or magnetic resonance imaging (MRI), that the patient has evidence of measurable metastatic disease per RECIST 1.1.
- Patients must have an accessible metastatic lesion for pretreatment core biopsy.
Key exclusion criteria (29 listed)
- Diagnosis of anal or small bowel carcinoma.
- Colorectal cancer other than adenocarcinoma, e.g., sarcoma, lymphoma, carcinoid.
- Previous therapy with any PD-1 or PD-L1 (programmed cell death-1 (PD-1) protein, programmed death ligand-1 (PDL-1) protein inhibitor including durvalumab or anti-CTLA4 (including tremelimumab) for any malignancy.
- Receipt of live attenuated vaccination within 30 days prior to study entry or within 30 days of receiving study therapy.
- Active or chronic hepatitis B or hepatitis C.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| durvalumabAlso: MEDI4736Following three doses of hypofractionated palliative radiation (Days -2, -1, and Day 0 prior to Cycle 1), patients will receive durvalumab (1500 mg IV infusion) on Day 1 for 4 cycles (in combination with tremelimumab). Beginning with Cycle 5 through Cycle 12, patients will receive durvalumab alone (1500 mg/IV infusion) on Day 1 of each 28 day cycle. | Drug | durvalumab and tremelimumab |
| TremelimumabFollowing three doses of hypofractionated palliative radiation (Days -2, -1, and Day 0 prior to Cycle 1), patients will receive tremelimumab (75 mg IV infusion) on Day 1 for 4 cycles (in combination with durvalumab). | Drug | durvalumab and tremelimumab |
Primary outcome
Overall Objective Response Rate (ORR) of Dual Immune Checkpoint Blockade by RECIST 1.1
Time frame: Through treatment, up to 1.3 years
Complete Response (CR): Disappearance of all non-target lesions and normalization of tumor marker level. All lymph nodes must be <10mm on the short axis. Partial Response (PR): 30% or more decrease in the sum of diameters of target lesions. The reference the baseline sums of diameters. Progressive Disease (PD): 20% or more increase in the sum of diameters of target lesions. The reference is the smallest sum while on study (including the baseline sum if that is the smallest on study). In addition to the relative 20% increase, the sum must also demonstrate an absolute increase 5mm or more. (Note: any appearance of one or more new lesions is also considered progression).Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD. The reference is the smallest sum of diameters while on study.
3 secondary outcomes
Percentage of Patients Who Have Achieved Clinical Benefit
Time frame: At 16 weeks
Median Duration of Response to mCRC (Metastic Colorectal Cancer) Responds to Study Therapy
Time frame: Through study completetion (1.3 years)
Frequency of Adverse Events Assessed by CTCAE 4.0, From Beginning of Treatment to 90 Days After Last Dose
Time frame: During treatment (max of 12 cycles; each cycle 28 days) to 90 days after last dose of study therapy
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Dec 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 19097774Eisenhauer EA, Therasse P, Bogaerts J, Schwartz LH, Sargent D, Ford R, Dancey J, Arbuck S, Gwyther S, Mooney M, Rubinstein L, Shankar L, Dodd L, Kaplan R, Lacombe D, Verweij J. New response evaluation criteria in solid tumours: revised RECIST guideline (version 1.1). Eur J Cancer. 2009 Jan;45(2):228-47. doi: 10.1016/j.ejca.2008.10.026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Norman Wolmark, MD principal investigator
NSABP Foundation Inc
18 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing durvalumab and Tremelimumab in people with Colorectal Cancer Metastatic, run by NSABP Foundation Inc at 18 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 18 inclusion and 29 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 18 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 5 Dec 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall Objective Response Rate (ORR) of Dual Immune Checkpoint Blockade by RECIST 1.1 (time frame: Through treatment, up to 1.3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03007407, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Dec 2022.