DETERMINE Umbrella-Basket Trial Evaluating Vemurafenib and Cobimetinib in Adults With BRAF Positive Rare and Common Cancers

What this Trial Is About

Researchers are evaluating a combination of two drugs, vemurafenib and cobimetinib, in adults with rare cancers or less common cases of common cancers that have a specific mutation called BRAF V600. This trial is part of the DETERMINE program, which aims to match targeted therapies to rare or molecularly defined cancers. The goal is to see if these drugs, already approved for certain melanoma patients, could be helpful for other cancer types with the same mutation, potentially leading to wider access through the NHS and Cancer Drugs Fund. Participants will receive vemurafenib orally twice daily at a dose of 960 mg throughout 28-day cycles, and cobimetinib orally once daily at 60 mg for 21 days followed by a 7-day break each cycle. Treatment continues until the cancer progresses without benefit, unacceptable side effects occur, or the patient chooses to stop. Before treatment, patients undergo biopsy and blood sample collection. After treatment ends, patients are followed up every three months for two years to monitor health and disease status. Throughout the study, patients will have disease assessments every two cycles (56 days) and at the end of treatment, with less frequent follow-ups after 24 weeks if agreed with the sponsor. Blood samples and quality of life surveys are collected regularly during treatment and follow-up. Researchers will measure tumor response, duration of response, survival times, and adverse reactions to assess the treatments. The whole study participation can last up to five years including treatment and follow-up periods.

DETERMINE Trial Treatment Arm 05: Vemurafenib in Combination With Cobimetinib in Adult Patients With BRAF Positive Cancers.