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Belvarafenib + Cobimetinib/Nivolumab for Melanoma
Study Summary
This trial will study the safety and effectiveness of belvarafenib, a new drug for NRAS-mutant melanoma that has progressed despite anti-PD-1/PD-L1 therapy.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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Who is running the clinical trial?
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- 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.
- Group 1: Belvarafenib Plus Cobimetinib Plus Nivolumab
- Group 2: Belvarafenib Monotherapy
- Group 3: Belvarafenib Plus Cobimetinib
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- 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.
Frequently Asked Questions
Is this experiment currently seeking volunteers?
"Affirmative. According to clinicaltrials.gov, this scientific investigation is presently recruiting volunteers; it was initially posted on May 13th 2021 and updated lastly on November 19th 2022. A total of 98 participants are being enrolled at 12 distinct locations."
Does this research trial constitute a unique foray into the field?
"Since its initial evaluation by Hoffmann-La Roche in 2008, involving a cohort of 720 patients, Atezolizumab has become the subject of 373 active studies across 74 countries and 1651 cities. This medication was approved for Phase 2 trials after the first study's completion."
Are there any extant reports detailing the efficacy of Atezolizumab in clinical trials?
"Atezolizumab was first trialled in 2008 at SCRI Tennessee Oncology Chattanooga and has since been the subject of 101 completed studies. At present, there are 373 active trials with numerous locations based out of New york City."
How is atezolizumab typically employed in a therapeutic setting?
"Atezolizumab is commonly used to manage small cell lung cancer, but can also be beneficial for treating metastatic melanoma, unsalvageable tumors of the skin, and other malignant growths."
Has Atezolizumab received regulatory clearance from the FDA?
"There is only scant evidence of safety and efficacy, so Atezolizumab was rated a 1 on our team's scale."
What is the current scope of implementation for this clinical investigation?
"Presently, there are a dozen locations with active involvement in this clinical trial. Notable medical centres include Memorial Sloan Kettering (New york), Tennessee Oncology (Nashville) and University of Colorado Cancer Center (Aurora). Additionally, 9 other sites have been approved to participate."
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