Vemurafenib for Advanced Cancers with BRAF V600 Mutations

Recruiting at 119 trial locations

Overseen by AeRang Kim

Age: < 65

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: National Cancer Institute (NCI)

No Placebo Group

Prior Safety Data

Breakthrough Therapy

Approved in 3 Jurisdictions

Trial Summary

What is the purpose of this trial?

This phase II Pediatric MATCH trial studies how well vemurafenib works in treating patients with solid tumors, non-Hodgkin lymphoma, or histiocytic disorders with BRAF V600 mutations that have spread to other places in the body (advanced) and have come back (recurrent) or do not respond to treatment (refractory). Vemurafenib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.

Research Team

AeRang Kim

Principal Investigator

Children's Oncology Group

Eligibility Criteria

This trial is for kids and teens with advanced solid tumors, lymphoma, or histiocytic disorders that have a specific mutation (BRAF V600) and haven't responded to other treatments. They should be recovering from previous therapies, able to perform daily activities at least minimally despite any neurological issues, and not have been treated with BRAF inhibitors before.

Inclusion Criteria

My cancer can be seen and measured on scans, or if I have neuroblastoma, it shows up on an MIBG scan.

I can do most daily activities by myself, even if I use a wheelchair.

All patients and/or their parents or legally authorized representatives must sign a written informed consent; assent, when appropriate, will be obtained according to institutional guidelines

Exclusion Criteria

Patients who are currently receiving another investigational drug

I am taking medication to prevent graft-versus-host disease after a bone marrow transplant.

You have had an organ transplant in the past.

Treatment Details

Interventions

• Vemurafenib (Kinase Inhibitor)

Trial Overview The study tests how well vemurafenib works on patients with certain mutations in their cancer cells. It's designed to see if this drug can stop the growth of tumor cells by blocking enzymes they need to grow. The trial includes lab biomarker analysis as part of its procedures.

Participant Groups

Group I: Treatment (vemurafenib) Experimental Treatment 2 Interventions

Patients receive vemurafenib PO BID on day 1-28. Cycles repeat every 28 days for up to 2 years in the absence of disease progression or unacceptable toxicity.

Vemurafenib is already approved in Canada for the following indications:

Approved in Canada as Zelboraf for:

• Unresectable or metastatic melanoma with BRAF V600E mutation

Who Is Running the Clinical Trial?

National Cancer Institute (NCI)

Lead Sponsor

Trials

14,080

Recruited

41,180,000+