RecruitingPhase 2NCT04324112

Encorafenib Plus Binimetinib for People With BRAF V600 Mutated Relapsed/Refractory HCL

Phase 2 Trial of Encorafenib Plus Binimetinib for Patients With BRAF V600 Mutated Relapsed/Refractory HCL

Sponsor

National Cancer Institute (NCI)

Enrollment

45 participants

Start Date

Oct 28, 2020

Study Type

INTERVENTIONAL

Conditions

Hairy Cell Leukemia

Summary

Background: Hairy cell leukemia (HCL) does not usually respond to chemotherapy. Most people with HCL have a BRAF gene mutation. This can increase the growth of cancer cells. Vemurafenib has been tested to treat these people. However, researchers think a combination of drugs might work better. Objective: To test if treatment with a combination of encorafenib and binimetinib in BRAF mutant HCL is more effective than treatment with vemurafenib. Eligibility: People ages 18 and older with BRAF mutant HCL that did not respond to or came back after treatment Design: Participants will be screened with: Medical history Physical exam Bone marrow biopsy: A needle will be injected through the participant s skin and into a bone to remove liquid. Blood and urine tests Heart and lung function tests CT or MRI scan: Participants will lie in a machine that takes pictures of the body. They may have a contrast agent injected into a vein. Eye exam Participants will take the study drugs by mouth in 28-day cycles. They will take encorafenib daily. They will take binimetinib twice daily. They will keep a pill diary. Participants will take their temperature daily. Participants will have at least 1 visit before each cycle. Visits will include repeats of some screening tests. They will also include abdominal ultrasounds, exercise stress tests, and skin evaluations. Participants may continue treatment as long as their disease does not get worse and they do not have bad side effects. About a month after their last dose of treatment, participants will have a follow-up visit. Then they will have annual follow-ups....

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a combination of two targeted drugs — encorafenib and binimetinib — for people with a rare blood cancer called hairy cell leukemia (HCL) whose cancer has the BRAF V600 mutation and has come back or stopped responding to prior treatment. **You may be eligible if...** - You have been diagnosed with hairy cell leukemia confirmed by laboratory testing - Your cancer has the BRAF V600 mutation, confirmed by a specialist lab - Your leukemia has relapsed or was resistant to at least one prior chemotherapy treatment - You have active signs of disease (e.g., low blood counts, enlarged spleen) - You are 18 years or older - You are not eligible for, or have already tried, another specific treatment at the NCI **You may NOT be eligible if...** - Your cancer does NOT have the BRAF V600 mutation (a different trial may apply) - You have well-controlled leukemia without active symptoms - You have not yet received any standard treatment Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGbinimetinib

Binimetinib will be given orally at a dose of 45mg BID continuously for 28-day cycles with no resting period between cycles.

DRUGEncorafenib

Encorafenib will be given orally at a dose of 450mg QD continuously for 28-day cycles with no resting period between cycles.

Locations(1)

National Institutes of Health Clinical Center

Bethesda, Maryland, United States

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NCT04324112

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