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MAPK Inhibitor
Belvarafenib + Cobimetinib/Nivolumab for Melanoma
Phase 1
Waitlist Available
Research Sponsored by Genentech, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Tumor specimen availability
ECOG Performance Status of 0 or 1
Must not have
Treatment with systemic immunotherapy agents (e.g., anti-CTLA4, anti-PD(L)1, cytokine therapy, investigational therapy, etc.) within 28 days prior to C1D1
History or signs/symptoms of clinically significant cardiovascular disease
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to approximately 4 years
Awards & highlights
No Placebo-Only Group
Summary
This trial tests belvarafenib alone and in combination with other drugs for advanced melanoma patients who haven't responded to previous treatments. The drugs aim to stop cancer growth or help the immune system fight the cancer.
Who is the study for?
This trial is for adults with advanced melanoma that has an NRAS mutation and worsened after anti-PD-1/PD-L1 therapy. They can have had up to two cancer treatments before, but not certain drugs like pan-RAF inhibitors or MEK inhibitors (for cobimetinib arm). No serious liver disease, untreated brain metastases, significant heart issues, autoimmune diseases, or immune deficiencies are allowed.
What is being tested?
The study tests the safety and effectiveness of belvarafenib alone and combined with cobimetinib or both cobimetinib and nivolumab in treating advanced melanoma with NRAS mutations. Participants will be assessed for how their bodies handle the drugs (pharmacokinetics) and how well their tumors respond.
What are the potential side effects?
Possible side effects include skin reactions from belvarafenib; vision changes from cobimetinib; fatigue, digestive issues, skin problems from nivolumab; as well as general risks like infection due to immune system effects.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I can provide a sample of my tumor for testing.
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I am fully active or can carry out light work.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I haven't had immunotherapy or similar treatments in the last 28 days.
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I have a history of serious heart problems.
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I stopped taking anti-PD(L)1 therapy due to a severe side effect.
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I have been treated with a pan-RAF inhibitor before.
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I have previously been treated with a MEK inhibitor.
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I have a significant liver condition.
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I have brain metastases that are causing symptoms or getting worse.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to approximately 4 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to approximately 4 years
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Percentage of Participants With Adverse Events
Secondary study objectives
Duration of response (DOR) according to RECIST v1.1
Objective response rate (ORR) according to RECIST v1.1
Overall survival (OS)
+1 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
3Treatment groups
Experimental Treatment
Group I: Belvarafenib Plus Cobimetinib Plus NivolumabExperimental Treatment1 Intervention
Recommended dose (RD) and schedule of belvarafenib and cobimetinib plus nivolumab IV infusion every 4 weeks (Q4W) in a run-in phase followed by an expansion phase
Group II: Belvarafenib Plus CobimetinibExperimental Treatment1 Intervention
Recommended dose (RD) and schedule of belvarafenib and cobimetinib selected based on the safety data, tolerability, pharmacokinetics, and anti-tumor activity tested in dose-finding phase followed by an expansion phase.
Group III: Belvarafenib MonotherapyExperimental Treatment1 Intervention
Twice daily (BID), continuous dosing.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cobimetinib
2017
Completed Phase 3
~3300
Nivolumab
2014
Completed Phase 3
~5220
Research Highlights
Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Melanoma treatments often target specific molecular pathways involved in tumor growth and immune evasion. RAF kinase inhibitors like Belvarafenib block the RAF/MEK/ERK signaling pathway, which is frequently mutated in melanoma, thereby inhibiting tumor cell proliferation.
Immune checkpoint inhibitors, such as nivolumab and ipilimumab, enhance the body's immune response against melanoma cells by blocking proteins that suppress immune activity. Combination therapies, which may include RAF inhibitors with MEK inhibitors or immune checkpoint inhibitors, aim to overcome resistance and improve efficacy.
Understanding these mechanisms is crucial for melanoma patients as it helps tailor treatments to their specific genetic mutations and improve outcomes.
Is combination therapy the next step to overcome resistance and reduce toxicities in melanoma?
Is combination therapy the next step to overcome resistance and reduce toxicities in melanoma?
Find a Location
Who is running the clinical trial?
Genentech, Inc.Lead Sponsor
1,555 Previous Clinical Trials
569,235 Total Patients Enrolled
34 Trials studying Melanoma
1,652 Patients Enrolled for Melanoma
Clinical TrialsStudy DirectorHoffmann-La Roche
2,220 Previous Clinical Trials
895,375 Total Patients Enrolled
50 Trials studying Melanoma
42,628 Patients Enrolled for Melanoma
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have had a disease that affects your immune system, or your immune system does not work properly.You have a disease that can be measured using a specific set of guidelines.My cancer has a documented NRAS mutation within the last 5 years.I haven't had immunotherapy or similar treatments in the last 28 days.I have a history of serious heart problems.I can provide a sample of my tumor for testing.My blood and organs are functioning well.I stopped taking anti-PD(L)1 therapy due to a severe side effect.My melanoma has worsened after treatment with specific immune therapies.I have been treated with a pan-RAF inhibitor before.You have a history of eye problems found during an eye exam (for the cobimetinib treatment).I have previously been treated with a MEK inhibitor.I have a significant liver condition.I am fully active or can carry out light work.I have brain metastases that are causing symptoms or getting worse.
Research Study Groups:
This trial has the following groups:- Group 1: Belvarafenib Plus Cobimetinib Plus Nivolumab
- Group 2: Belvarafenib Monotherapy
- Group 3: Belvarafenib Plus Cobimetinib
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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