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OncoMatch/Clinical Trials/NCT05768178

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

Is NCT05768178 recruiting? Yes, currently enrolling (May 2026). This Phase 2/3 trial studies multiple treatments including Vemurafenib and Cobimetinib for haematological malignancy.

Phase 2/3RecruitingCancer Research UKNCT05768178Data as of May 2026

Treatment: Vemurafenib · CobimetinibThis clinical trial is looking at a combination of drugs called vemurafenib and cobimetinib. Vemurafenib is approved as standard of care for adult patients with unresectable or metastatic melanoma. Cobimetinib is approved as standard of care in combination with vemurafenib for the treatment of adult patients with unresectable or metastatic melanoma. This means it has gone through clinical trials and been approved by the Medicines and Healthcare products Regulatory Agency (MHRA) in the UK. Cobimetinib and vemurafenib work in patients with these types of cancers which have certain changes in the cancer cells called BRAF V600 mutation-positive. Investigators now wish to find out if it will be useful in treating patients with other cancer types which are also BRAF V600 mutation-positive. If the results are positive, the study team will work with the NHS and the Cancer Drugs Fund to see if these drugs can be routinely accessed for patients in the future. This trial is part of a trial programme called DETERMINE. The programme will also look at other anti-cancer drugs in the same way, through matching the drug to rare cancer types or ones with specific mutations.

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Extracted eligibility criteria

Cancer type

Acute Myeloid Leukemia

Acute Lymphoblastic Leukemia

Non-Hodgkin Lymphoma

Multiple Myeloma

Myelodysplastic Syndrome

Chronic Lymphocytic Leukemia

Melanoma

Thyroid Cancer

Ovarian Cancer

Colorectal Cancer

Non-Small Cell Lung Carcinoma

Glioblastoma

Biomarker criteria

Required: BRAF V600 mutation

malignancy harbouring any actionable BRAF V600 mutation using an analytically validated next-generation sequencing method

Prior therapy

Cannot have received: same class of drug

Exception: unless presence of a resistance alteration known to be potentially sensitive to either vemurafenib or cobimetinib; prior sorafenib use is permissible following a washout period of 10 days

Prior treatment with the same class of drug unless presence of a resistance alteration known to be potentially sensitive to either vemurafenib or cobimetinib. Prior sorafenib use is permissible following a washout period of 10 days.

Lab requirements

Blood counts

Adequate organ function as per haematological and biochemical indices within the ranges defined in the protocol

Kidney function

Adequate organ function as per haematological and biochemical indices within the ranges defined in the protocol

Liver function

Adequate organ function as per haematological and biochemical indices within the ranges defined in the protocol

Adequate organ function as per haematological and biochemical indices within the ranges defined in the protocol

Structured fields extracted by AI. May contain errors — verify against the official protocol.

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