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Combination Therapy for Melanoma
Study Summary
This trial is testing a combination of immunotherapies and targeted therapies to treat high-risk stage III melanoma. Vemurafenib and cobimetinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Immunotherapy with monoclonal antibodies, such as atezolizumab and tiragolumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread.
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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- I do not have any uncontrolled illnesses or active infections.I have received cancer treatments or been part of a study before registering.I am 18 years old or older.I haven't had cancer, except for melanoma, in the last 3 years.I have had melanoma spread beyond the lymph nodes or to my brain.I have a history of specific eye retina problems.I am not on any systemic immunosuppressive medications or required diets that are not allowed.My melanoma has spread to more than one lymph node area.My melanoma is confirmed to be at stage III.I am willing to stop any cancer treatments before joining the study.I have had a previous transplant of stem cells or an organ.I do not have major heart issues, stroke, severe bleeding, uncontrolled diabetes, or serious mental health/social problems.I will be taking medication that can affect my heart's rhythm.My condition can be treated with surgery.I am not on any experimental drugs for my cancer.My melanoma has been tested for the BRAFV600 mutation.I need treatment for my active psoriasis.I have had treatment for melanoma before, with some exceptions.I have had major surgery recently or expect to need one soon.I have a significant liver condition.My melanoma is suspected to have spread beyond the lymph nodes.I am willing to provide tissue samples for BRAF testing and research.I am fully active or can carry out light work.I have a history of nutrient absorption problems or significant metabolic issues.I have had radiation therapy for melanoma.I have a history of certain lung and autoimmune diseases.I have signs of an infection or have recently used antibiotics.
- Group 1: Arm B - CLOSED (cobimetinib, atezolizumab)
- Group 2: Arm C (atezolizumab, tiragolumab)
- Group 3: Arm A - CLOSED (vemurafenib, cobimetinib, atezolizumab)
- 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
What pathologies has Cobimetinib been proven to be efficacious for?
"Cobimetinib is frequently used to manage small cell lung cancer, and has been found effective against other forms of cancers such as metastatic melanoma, non-small cell lung carcinoma, and unresectable melanoma."
Are there any precarious risks associated with taking Cobimetinib?
"Our internal ratings at Power gave cobimetinib a score of 2, as sufficient data has been collected to confirm its safety but there is still no evidence of efficacy."
What is the maximum possible enrollment for this research endeavor?
"Affirmative. Clinicaltrials.gov indicates that the medical experiment, which was originally posted on June 22nd 2018, is currently enrolling participants. Approximately 30 subjects must be recruited between 2 clinical locations."
Are any opportunities available for participants in this investigation?
"Affirmative. According to clinicaltrials.gov, this scientific trial is currently enrolling 30 patients from two separate sites; the first posting was on June 22nd 2018 and its most recent update happened October 21st 2022."
Is this endeavor the inaugural attempt of its type?
"Research into cobimetinib began in 2008 and was initiated by Hoffmann-La Roche. The first research study, which involved 720 patients, lead to the drug's Phase 2 approval. Currently there are 391 active trials for cobimetinib taking place across 74 countries and 1735 cities worldwide."
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