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Kinase Inhibitor
Vemurafenib + Cobimetinib for Melanoma
Phase 2
Waitlist Available
Led By Teresa Petrella, MD, BSc, MSc
Research Sponsored by Sunnybrook Health Sciences Centre
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 5 years
Awards & highlights
Study Summary
This trial will test a new two-drug therapy for people with melanoma that has spread to other parts of the body. The therapy will be given for two months before surgery, then continued after surgery for up to twelve months.
Who is the study for?
This trial is for adults with BRAF V600 mutation-positive Stage IIIB and C melanoma, who haven't had treatment for advanced disease, can undergo surgery after drug therapy, and are willing to use contraception. Excluded are pregnant or breastfeeding individuals, those with autoimmune diseases or other active cancers (except certain skin cancers), liver disease, uncontrolled heart conditions, or infections requiring antibiotics.Check my eligibility
What is being tested?
The study tests the combination of drugs Vemurafenib and Cobimetinib as a pre-surgery (neoadjuvant) treatment in melanoma patients with palpable lymph node metastases. Participants will take these drugs for two months before surgery, then resume post-surgery possibly followed by radiation therapy. Treatment lasts up to 12 months with a five-year follow-up period.See study design
What are the potential side effects?
Potential side effects include joint pain, fatigue, hair loss, rash or itchy skin; sun sensitivity; heart rhythm changes; eye problems like blurred vision; liver function changes; increased risk of developing new skin cancers.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~5 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
The feasibility of treating patients with unresectable melanoma and palpable lymph node metastases that harbor the BRAF mutation with neoadjuvant vemurafenib.
Secondary outcome measures
Disease Free Survival (DFS) and Overall Survival (OS).
Immunohistochemical correlates of tumor response.
Local-regional recurrence rates after treatment with neo-adjuvant vemurafenib.
+3 moreTrial Design
1Treatment groups
Experimental Treatment
Group I: Vemurafenib, pill, twice dailyExperimental Treatment2 Interventions
Vemurafenib, 960 mg, oral, twice daily plus Cobimetinib, 60 mg, oral, four times daily
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Vemurafenib
FDA approved
Cobimetinib
FDA approved
Find a Location
Who is running the clinical trial?
Sunnybrook Health Sciences CentreLead Sponsor
656 Previous Clinical Trials
1,550,598 Total Patients Enrolled
1 Trials studying Melanoma
20 Patients Enrolled for Melanoma
Teresa Petrella, MD, BSc, MScPrincipal InvestigatorSunnybrook Health Sciences Centre
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have a condition called acromegaly.You have a condition where your immune system attacks your own body, like lupus or Crohn's disease.You have had radiation therapy or major surgery within the 14 days before starting the study treatment.You have not received any treatment for your current cancer recurrence, except for immunotherapy given before the cancer spread to the lymph nodes, which ended at least 3 months before starting the study treatment.You have been treated with a RAF or MEK pathway inhibitor before.You have had cancer in the past three years, except for specific types that have been removed by surgery.There is evidence that the cancer has spread to other parts of the body.You have had serious liver problems in the past, currently abuse alcohol, or have been diagnosed with HIV, hepatitis B, or hepatitis C.You have uncontrolled glaucoma, retinal venous occlusion (RVO), or hypertensive retinopathy.You have not received any treatment for your locally advanced unresectable disease.You have melanoma that has spread to nearby lymph nodes and surgery is not the best option for you.You have an ongoing infection or need to take antibiotics regularly to control a long-term infection.You have a history of trouble absorbing nutrients or other important body functions.You have a specific mutation called BRAF V600.You have a measurable tumor according to specific guidelines for evaluating tumor size.Women who could become pregnant must have a negative pregnancy test within 14 days before starting treatment.You cannot have St. John's wort or hyperforin, grapefruit juice, or certain eye conditions that could be risky during the study.You have serious heart problems including unstable angina, severe congestive heart failure, or abnormal heart rhythm, or uncontrolled high blood pressure.You can have had treatment before, but it must have been at least 3 months before starting this study.You are in good enough health to carry out daily activities without help.Your blood, kidney, and liver health must be good within a week before starting the medications vemurafenib and cobimetinib.
Research Study Groups:
This trial has the following groups:- Group 1: Vemurafenib, pill, twice daily
Awards:
This trial has 3 awards, including:- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- Approved for 5 Other Conditions - This treatment demonstrated efficacy for 5 other conditions.
- 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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Could you provide some additional context on Vemurafenib's clinical trial history?
"Vemurafenib was first studied in 2012 at James Graham Brown Cancer Center-University of Louisville. As of right now, there have been a total of 73 completed clinical trials. Out of the 80 live trials, many are based in Montreal, Quebec."
Answered by AI
Could you please outline the risks associated with Vemurafenib?
"Vemurafenib has only been proven safe in clinical trials, not effective. Therefore, it received a score of 2."
Answered by AI
Are those suffering from the target ailment currently being accepted into the program?
"This research is no longer looking for volunteers. The trial was first posted on August 1st, 2015 and the most recent update was on October 25th, 2022. If you're interested in other studies, there are 817 trials actively recruiting patients with melanoma and 80 trials for Vemurafenib that need participants."
Answered by AI
How many people can sign up for this research project?
"This trial is not currently looking for new patients, though this may change in the future. According to the updated information on clinicaltrials.gov, this study was last posted on October 25th, 2022. If you are interested in similar studies, 817 trials involving melanoma and 80 Vemurafenib trials are still recruiting participants."
Answered by AI
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