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Recurrent MelanomaPhase 2NCT02094872

Molecularly Targeted Therapy in Treating Patients With BRAF Wild-type Melanoma That is Metastatic

A Phase 2 study testing cytology specimen collection procedure, MEK 162 therapy or molecularly targeted therapy and therapeutic procedure in people with Recurrent Melanoma and Stage IIIA Melanoma, run by Yale University at 8 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

This phase II trial studies how well molecularly targeted therapy works in treating patients with melanoma that has spread to other parts of the body. Patients must have received or do not qualify for prior immunotherapy. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
cytology specimen collection procedure, MEK 162 therapy or molecularly targeted therapy and therapeutic procedure
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
49 participants
Where
8 sitesUnited States
Study dates
May 2014to Dec 2018
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

  • Patient with metastatic or locally advanced and unresectable BRAF wild-type melanoma who have either progressed following previous treatment of immunotherapy, or are not eligible for immunotherapy; pts. are defined as "BRAF wild-type" if they test negative for V600 mutations based on a Clinical Laboratory Improvement Amendments (CLIA) certified assay
  • Patients must have tumor accessible by interventional radiology or surgical intervention and suitable for biopsy (BX) with 5-6 passes of a 16 or 18 gauge needle for core BX (defined as at least 1 cm^3 tumor/50 mg accessible for BX), and must agree to undergo up to two surgical resections/biopsies to collect tumor for research purposes; the first of these biopsies will occur at the beginning of the study, prior to genetic analysis and Rx; the second BX will be performed at the time of DZ progression/end of study should funding be available
  • Patients must have measurable DZ (per Response Evaluation Criteria in Solid Tumors [RECIST] version 1.1 [v1.1] criteria), defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded for non-nodal lesions and short axis for nodal lesions) as >= 20 mm with conventional techniques or as >= 10 mm with spiral computed tomography (CT) scan, magnetic resonance imaging (MRI), or a subcutaneous or superficial lesion that can be measured with calipers by clinical exam; for lymph nodes, the short axis must be >= 15 mm
  • Previous therapies: prior radiation therapies, immunotherapies, and investigational therapies are allowed as follows.
  • Radiation: prior radiation therapy (RT) is allowed with the following conditions:
  • Patients who have received minimal RT (=< 5% of their total marrow volume) must have completed it >= 2 weeks prior to the initiation of study Rx
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  • Patients who have received RT that constituted > 5% but < 50% of their total marrow volume must have completed it >= 4 weeks prior to the initiation of study treatment
  • Patients who have received prior radiation to 50% or more of their total marrow volume will be excluded
  • Patients may be biopsied while undergoing RT as long as BX site is not in the radiation portal; however, they still have to wait the required amount of time from radiation to treatment even though the tumor board may have already occurred and a treatment plan assigned
  • Other therapies: prior investigational or targeted therapies and immunotherapies may be allowed following discussion with the PI (PI); if the PI deems the prior treatment acceptable, patients must not have received these therapies for 28 days or five half-lives of the drug (whichever is lesser) prior to the initiation of study treatment and must have full recovery from any acute effects of these therapies; prior therapy with mitogen-activated protein kinase (MEK) inhibitors will not be allowed
  • Patients with chronic grade 2 toxicity may be eligible at the discretion of the PI if the condition has been stable, and not worsening, for at least 30 days; pts. with ongoing alopecia of any grade will be eligible
  • Patient must have a life expectancy of >= 3 months, as estimated by the treating oncologist
  • Patient must have an Eastern Cooperative Oncology Group (ECOG) performance status =< 2
  • Hemoglobin >= 9 g/dL
  • Leukocytes >= 3,000/microliter (mcL)
  • Absolute neutrophil count (ANC) >= 1,500/mcL
  • Platelets (PLT) >= 100,000/mcL
  • Aspartate aminotransferase (AST) =< 2.5 x upper limit of normal (ULN); if liver metastases are present, =< 5 x ULN
  • Alanine aminotransferase (ALT) =< 2.5 x ULN; if liver metastases are present, =< 5 x ULN
  • Bilirubin =< 1.5 x ULN
  • Creatinine =< 1.5 x ULN OR calculated or measured creatinine clearance >= 50 mL/min/1.73 m^2 for pts. with creatinine above institutional normal
  • If available, pt. must agree to provide archival tissue for research purposes (either archival paraffin tissue block or 10 unstained slides of a primary or metastatic melanoma lesion) prior to enrollment; samples should be shipped within 1 month after enrollment
  • Patient agrees to having a blood sample (a minimum of 10 mL, with 20 mL preferred) drawn and analyzed to compare their normal genetic profile to that of their tumor sample
  • Patient must be able to tolerate oral medication
  • Women of child-bearing potential and men must agree to use 2 forms of adequate contraception (hormonal or barrier method of birth control; abstinence) for the duration of study participation, and for four months following completion of study therapy; should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately; women who become pregnant must immediately discontinue Rx with any study therapy; male pts. should avoid impregnating a female partner; male pts., even if surgically sterilized, (i.e. post-vasectomy) must agree to one of the following: practice effective barrier contraception during the entire study Rx period and through 4 months after the last dose of study drug, or completely abstain from sexual intercourse
  • Patient must have the ability to understand and the willingness to sign a written informed consent document
  • Patient must be willing and able to comply with the protocol for the duration of the study, including attending scheduled visits, examinations, the BX procedure, and having their tumor and blood molecularly characterized
  • Patient understands they must meet all inclusion and exclusion criteria in the drug specific appendix for which they were assigned.

Who cannot join

  • Patients with peripheral neuropathy >= grade 2 are not permitted unless discussed with the PI and only in unique circumstances (i.e. unilateral neuropathy due to trauma)
  • Patient has DZ that tests positive for BRAF V600 mutations based on the results of a CLIA certified assay
  • Patients with active infection at time of BX
  • Patients with any evidence of severe or uncontrolled systemic DZ(s) including known cases of hepatitis B or C or human immunodeficiency virus (HIV); screening for chronic conditions is not required, although pts. known to have such conditions at screening should not be included
  • Any patient requiring chronic maintenance of red blood cell, white blood cell or granulocyte counts through the use of blood transfusions or growth factor support (e.g. Neulasta®, Neupogen®)
  • Patients with a prior history of seizures within the past year unrelated to brain metastases
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  • Patients with known active progressive brain metastases; pts. with prior treated brain metastases are allowed, providing that they were not accompanied by seizures within the past year and that a baseline brain MRI scan prior to study entry demonstrates no current evidence of active brain metastases; all pts. with prior treated brain metastases must be stable for > 1 months after treatment and off steroid treatment prior to study enrollment
  • Patients receiving any other anti-cancer therapy (cytotoxic, biologic, radiation, or hormonal other than for replacement) except for medications that are prescribed for supportive care but may potentially have an anti-cancer effect (i.e. megestrol acetate, bisphosphonates); these medications must have been started >= month prior to enrollment on this study; pts. may be on low molecular weight heparin or direct factor Xa inhibitors
  • Patients with any clinically significant medical condition which, in the opinion of the investigator, makes it undesirable for the pt. to participate in the study or which could jeopardize compliance with protocol requirements including, but not limited to: ongoing or active infection, significant uncontrolled hypertension, or severe psychiatric illness/social situations
  • Patients with preexisting cardiac conditions, including uncontrolled or symptomatic angina, arrhythmias, or congestive heart failure will not be eligible
  • Patients with left ventricular ejection fraction (LVEF) < 45% will not be eligible
  • Patients with either of the following within 6 months before the first dose of study treatment:
  • Stroke (including transient ischemic attack [TIA], or other ischemic event)
  • Myocardial infarction
  • Patients with acute gastrointestinal bleeding within 1 month of study entry
  • Patients who have, at screening, corrected QT interval using Fridericia's formula (QTcF) >= 450 msec for males and QTcF >= 470 for females
  • Patients with a co-morbid condition(s) that, in the opinion of the investigator, prevents safe surgery/BX procedure
  • Patients with malabsorption syndrome or other condition that would interfere with intestinal absorption or ability to swallow oral medication
  • Pregnant or nursing women; breastfeeding must be discontinued prior to Rx
  • Patients who have received organ transplant
  • Patients who have had major surgery within 14 days of study enrollment
  • Patients diagnosed or treated for another malignancy within 3 years of enrollment, with the exception of complete resection of basal cell carcinoma or squamous cell carcinoma of the skin, or an in situ malignancy. Patients with a low grade prostate cancer, not on hormonal therapy, for which the disease is confined to the prostate may be considered eligible by the overall Principal Investigator on a case by case basis.

Trial locations and contacts

8 sites in 1 country.

8 sites in 1 country

United States8 sites

  • University of Michigan Comprehensive Cancer Center

    Ann Arbor, Michigan, 48109-0944

  • Baylor Sammons Cancer Center

    Dallas, Texas, 75246

  • Barbara Ann Karmanos Cancer Institute

    Detroit, Michigan, 48201

  • Mayo Clinic Cancer Center

    Jacksonville, Florida, 32224

  • Vanderbilt University Medical Center

    Nashville, Tennessee, 37240

  • Smilow Cancer Hospital at Yale-New Haven

    New Haven, Connecticut, 06520-8028

  • Mayo Clinic Cancer Center

    Rochester, Minnesota, 55905

  • Mayo Clinic Cancer Center

    Scottsdale, Arizona, 85259-5499

Other trials in United States

About this study

Official title: Stand Up to Cancer Consortium Genomics-Enabled Medicine for Melanoma (G.E.M.M.): Using Molecularly-Guided Therapy for Patients With BRAF Wild-Type (BRAFwt) Metastatic Melanoma

This phase II trial studies how well molecularly targeted therapy works in treating patients with melanoma that has spread to other parts of the body. Patients must have received or do not qualify for prior immunotherapy. Targeted therapy is a type of treatment that uses drugs or other substances to identify and attack specific types of cancer cells with less harm to normal cells. Molecularly targeted therapy works by treating patients with substances that kill cancer cells by targeting key molecules involved in cancer cell growth.

Read the detailed description

PRIMARY OBJECTIVES:

  1. To determine the difference in best overall response rate (BORR) between patients treated with MEK162 following personalized molecularly guided assignment vs. a historical BORR of 7% in this patient population.

SECONDARY OBJECTIVES:

  1. To evaluate the safety of performing individualized drug therapy (including novel agents and commercially-available agents) in the context of a personalized medicine clinical trial.

II. To define the difference in progression free survival (PFS) between patients treated with MEK162 following personalized molecularly guided assignment vs. a historical PFS rate of 2 months in this patient population.

III. To continually assess data in real time so as to iteratively refine and standardize a set of statistical and informatics methodologies for matching treatments to the patient's tumor, based on the molecular profile.

OUTLINE:

Patients undergo collection of tissue and blood samples for deoxyribonucleic acid (DNA) and ribonucleic acid (RNA) analysis via sequencing. Based on the results of the DNA and RNA analysis, patients receive molecularly targeted therapy. Treatment continues in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up for 30 days.

Being tested
cytology specimen collection procedure, MEK 162 therapy or molecularly targeted therapy, therapeutic procedure, laboratory biomarker analysis, quality-of-life assessment
Medical subject headings
Melanoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • cytology specimen collection procedureOther

    Also called cytologic sampling

    Undergo collection of tissue and blood samples

  • MEK 162 therapy or molecularly targeted therapyDrug

    molecularly targeted therapy, MEK 162 therapy

  • therapeutic procedureProcedure or surgery

    Also called Therapeutic Interventions, Therapeutic Method, Therapeutic Technique, Therapy

  • laboratory biomarker analysisOther

    Correlative studies

  • quality-of-life assessmentOther

    Also called quality of life assessment

    Ancillary studies

Study groups in NCT02094872
Study groupRoleWhat they receive
Arm I (molecularly targeted therapy)ExperimentalPatients undergo collection of tissue and blood samples for DNA and RNA analysis via sequencing. Based on the results of the DNA and RNA analysis, patients receive molecularly targeted therapy. Treatment continues in the absence of disease progression or unacceptable toxicity.
Receives: Other: cytology specimen collection procedure; Drug: MEK 162 therapy or molecularly targeted therapy; Procedure: therapeutic procedure; Other: laboratory biomarker analysis; Other: quality-of-life assessment

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Best Overall Response Rate (BORR)

    The best overall response rate (BORR) was assessed up to 1 year.

    Measured: Up to 1 year

Secondary outcomes (1)

  1. Progression-Free Survival (PFS)

    A log rank test will be performed for the comparison between the two groups.

    Measured: From start of treatment to time of progression or death, whichever occurs first, assessed up to 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Mar 2014 (estimated)
  2. Study startMay 2014
  3. Primary completionDec 2018
  4. Study completionDec 2018

Resources

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
49 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02094872
Sponsor's protocol ID
1408014446
Other IDs
NCI-2014-00670, WIRB Pro #20140190, WO #1-822810-1, Invest #161467, Study #1144561, 2013-184, P30CA022453
Status last verified
Dec 2019
First submitted
18 Mar 2014
Last updated
2 Jan 2020
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing cytology specimen collection procedure, MEK 162 therapy or molecularly targeted therapy and therapeutic procedure in people with Recurrent Melanoma and Stage IIIA Melanoma, run by Yale University at 8 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 28 inclusion and 22 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 2 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 8 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 2 Jan 2020). 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?

Best Overall Response Rate (BORR) (time frame: Up to 1 year). 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 NCT02094872.

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 2 Jan 2020.

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