Testing the Safety and Effectiveness of Combining Two Drugs, PLX2853 and Trametinib in the Treatment of Advanced Uveal Melanoma

Sponsor
Alliance for Clinical Trials in Oncology
Study ID
NCT05677373
Phase
PHASE1/PHASE2
Status
Withdrawn

Conditions

  • Advanced Uveal Melanoma
  • Metastatic Uveal Melanoma
  • Unresectable Uveal Melanoma

Eligibility Criteria

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

Interventions

  • BRD4 Inhibitor PLX2853 — DRUG
    Given PO
  • Trametinib — DRUG
    Given PO
  • Computed Tomography — PROCEDURE
    Undergo CT with contrast
  • Magnetic Resonance Imaging — PROCEDURE
    Undergo MRI with contrast
  • Biospecimen collection — PROCEDURE
    Undergo collection of blood
  • Biospecimen collection — PROCEDURE
    Correlative studies

Study Details

This phase I/II trial tests the safety, side effects, and best dose of PLX2853 in combination with trametinib in treating patients with uveal (eye) melanoma that has spread to other places in the body (metastatic) or nearby tissues or lymph nodes (locally advanced), or that cannot be removed by surgery (unresectable). PLX2853 works by targeting and inhibiting certain activities within cells that promote tumor growth. By inhibiting these activities, PLX2853 may help to stabilize or reduce the growth of tumor cells. Trametinib is in a class of medications called kinase inhibitors. It works by blocking the action of an abnormal protein that signals tumor cells to multiply. This helps stop the spread of tumor cells. Giving PLX2853 in combination with trametinib may help to shrink and stabilize tumor cells in patients with advanced uveal melanoma.

Key Dates

Start date
Jan 13, 2023
Status verified
Aug 2023
Primary completion
Jul 31, 2025
Completion
Jul 31, 2025

Study Design

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

Arms

  • Experimental: Treatment (PLX2853, trametinib)
    Patients receive PLX2853 PO in combination with trametinib PO throughout the study. Patients also undergo collection of blood at screening and on study. Patients also undergo CT or MRI with contrast and collection of blood at screening and on study.

Primary Outcome Measure

Maximum tolerated dose (MTD) (Phase I) [ Time Frame: Up to 28 days (Cycle 1) ]

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