4 Participants Needed

Vemurafenib for Advanced Cancers with BRAF V600 Mutations

Recruiting at 119 trial locations
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial
Breakthrough TherapyThis drug has been fast-tracked for approval by the FDA given its high promise
Approved in 3 JurisdictionsThis treatment is already approved in other countries

What You Need to Know Before You Apply

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.

Who Is on the Research Team?

AK

AeRang Kim

Principal Investigator

Children's Oncology Group

Are You a Good Fit for This Trial?

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
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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.
See 9 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive vemurafenib orally twice daily in 28-day cycles, repeated for up to 2 years

Up to 2 years

Follow-up

Participants are monitored for safety and effectiveness after treatment

30 days

Long-term Follow-up

Participants are monitored for progression-free survival and changes in tumor genomics

Up to 5 years

What Are the Treatments Tested in This Trial?

Interventions

  • Vemurafenib
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.
How Is the Trial Designed?
1Treatment groups
Experimental Treatment
Group I: Treatment (vemurafenib)Experimental Treatment2 Interventions

Vemurafenib is already approved in United States, European Union, Canada for the following indications:

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Approved in United States as Zelboraf for:
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Approved in European Union as Zelboraf for:
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Approved in Canada as Zelboraf for:

Find a Clinic Near You

Who Is Running the Clinical Trial?

National Cancer Institute (NCI)

Lead Sponsor

Trials
14,080
Recruited
41,180,000+
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