Ulixertinib for Cancer

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: National Cancer Institute (NCI)

Must be taking: Kinase inhibitors

Must not be taking: MEK inhibitors, ERK inhibitors

Disqualifiers: Glaucoma, CNS malignancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 4

Duration: Up to 3 years

35 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. However, it does mention that you must not have used MEK or ERK 1/2 inhibitors before. It's best to discuss your current medications with the trial team.

What is the purpose of this trial?

This phase II MATCH treatment trial tests how well BVD-523FB (ulixertinib) works in treating patients with cancer that has certain genetic changes. BVD-523FB (ulixertinib) is used in patients whose cancer has a mutated (changed) form of a gene called BRAF. It is in a class of medications called kinase inhibitors. It works by blocking the action of proteins that signal cancer cells to multiply. This helps slow or stop the spread of cancer cells.

Research Team

Vivek Subbiah

Principal Investigator

ECOG-ACRIN Cancer Research Group

Eligibility Criteria

This trial is for cancer patients with a specific genetic change in the BRAF gene. It's open to those with various cancers, including tumors, lymphoma, and multiple myeloma. Participants must have measurable disease and be able to undergo procedures like echocardiography and biopsies.

Inclusion Criteria

Patients must have met applicable eligibility criteria in the Master MATCH Protocol EAY131/ NCI-2015-00054 prior to registration to treatment subprotocol

My heart's pumping ability is within the normal range.

Patients must fulfill all eligibility criteria of MATCH Master Protocol at the time of registration to treatment step (Step 1, 3, 5, 7)

Exclusion Criteria

My cancer has a BRAF V600 mutation.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Treatment

Participants receive BVD-523FB (ulixertinib) orally twice daily on days 1-28 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Up to 3 years

Regular visits for imaging and blood sample collection

Follow-up

Participants are monitored for safety and effectiveness after treatment completion, with follow-ups every 3 months for 2 years and then every 6 months for 1 year.

3 years

Follow-up visits every 3 months for 2 years, then every 6 months for 1 year

Treatment Details

Interventions

• Ulixertinib

Trial Overview The focus of this phase II trial is BVD-523FB (ulixertinib), a kinase inhibitor aimed at treating cancers with mutated BRAF genes. The study will assess how well it stops cancer cells from multiplying by blocking protein signals.

Participant Groups

Group I: Treatment (BVD-523FB [ulixertinib]) Experimental Treatment 7 Interventions

Patients receive BVD-523FB (ulixertinib) PO BID on days 1-28 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Additionally, patients undergo CT or MRI and blood sample collection throughout the trial. Patients also undergo ECHO or nuclear study (MUGA or similar scan) during screening and on study. Patients may also undergo biopsies on study.

Ulixertinib is already approved in United States for the following indications:

Approved in United States as Ulixertinib for:

• None (investigational)

Who Is Running the Clinical Trial?

National Cancer Institute (NCI)

Lead Sponsor

Trials

14,080

Recruited

41,180,000+