Defactinib and VS-6766 for the Treatment of Patients With Metastatic Uveal Melanoma

Part of paid clinical trials in Philadelphia, Pennsylvania.

Sponsor
Thomas Jefferson University
Study ID
NCT04720417
Phase
PHASE2
Status
Terminated

Conditions

  • Metastatic Uveal Melanoma

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Defactinib Hydrochloride — DRUG
    Given PO
  • Raf/MEK Inhibitor VS-6766 — DRUG
    Given PO
  • Biopsy — PROCEDURE
    Undergo tumor biopsy

Study Details

This phase II trial studies the effect of combining defactinib and VS-6766 in treating patients with uveal melanoma that has spread to other places in the body (metastatic). The way cells communicate with one another (different cell signaling pathways) are overactive in uveal melanoma tumor cells. Giving defactinib together with VS-6766 may block pathways that are important for the growth of uveal melanoma cells, and may result in shrinkage or stabilization of the cancer and prolonged time to disease progression and survival.

Key Dates

Start date
Jan 26, 2021
Status verified
Jul 2025
Primary completion
Apr 30, 2024
Completion
Apr 30, 2024

Study Design

Enrollment
13 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment (defactinib, VS-6766)
    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.

Primary Outcome Measure

Best Overall Response [ Time Frame: From baseline through last follow-up visit (up to 24 months per participant) ]

Locations (1)

FacilityCityStateZIPSite coordinators
Sidney Kimmel Cancer Center at Thomas Jefferson UniversityPhiladelphiaPennsylvania19107-

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Sidney Kimmel Cancer Center at Thomas Jefferson University· Philadelphia, PA

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