Defactinib + VS-6766 for Uveal Melanoma

Recruiting in Palo Alto (17 mi)

Overseen byRino Seedor, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Thomas Jefferson University

No Placebo Group

Prior Safety Data

Trial Summary

What is the purpose of this trial?

This trial studies the effect of combining two drugs, defactinib and VS-6766, in patients with metastatic uveal melanoma. These drugs aim to block signals in cancer cells that make them grow and spread, potentially slowing down or stopping the cancer. Everolimus has been studied in combination with other drugs for its potential to inhibit cancer cell growth in various types of tumors, including uveal melanoma.

Research Team

Rino Seedor, MD

Principal Investigator

Thomas Jefferson University

Eligibility Criteria

Adults with metastatic uveal melanoma, good heart function, and no severe systemic diseases. They must not be pregnant or breastfeeding and agree to use effective contraception. Participants need stable vital signs and blood counts within specific ranges, can't have had recent major surgery or certain treatments, and must not have active infections like hepatitis or HIV.

Inclusion Criteria

My white blood cell count is high enough for the trial.

I have signed and understand the consent form and can follow the treatment plan.

I am fully active or can carry out light work.

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Exclusion Criteria

Any other condition which in the Investigator's opinion would not make the patient a good candidate for the clinical trial

I cannot take pills by mouth or have issues absorbing them due to stomach surgery or active bowel inflammation.

I haven't had major surgery in the last 4 weeks or minor surgery in the last 2 weeks.

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Treatment Details

Interventions

Defactinib Hydrochloride (Protein Kinase Inhibitor)
Raf/MEK Inhibitor VS-6766 (Protein Kinase Inhibitor)

Trial OverviewThe trial is testing a combination of two drugs: Defactinib Hydrochloride and Raf/MEK Inhibitor VS-6766 on patients with metastatic uveal melanoma. It aims to see if blocking cell signaling pathways slows down cancer growth or shrinks tumors.

Participant Groups

1Treatment groups

Experimental Treatment

Group I: Treatment (defactinib, VS-6766)Experimental Treatment3 Interventions

Patients receive defactinib PO BID and VS-6766 PO BIW (Monday and Thursday or Tuesday and Friday) for 3 weeks in every cycle. Cycles repeat every 28 days for up to 2 years in the absence of disease progression or unacceptable toxicity.