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

NCT05677373 · Status: WITHDRAWN · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL

Last updated 2023-08-18

No results posted yet for this study

Summary

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.

Conditions

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

Interventions

DRUG

BRD4 Inhibitor PLX2853

Given PO

DRUG

Trametinib

Given PO

PROCEDURE

Computed Tomography

Undergo CT with contrast

PROCEDURE

Magnetic Resonance Imaging

Undergo MRI with contrast

PROCEDURE

Biospecimen collection

Undergo collection of blood

PROCEDURE

Biospecimen collection

Correlative studies

Sponsors & Collaborators

  • Alliance for Clinical Trials in Oncology

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-01-13
Primary Completion
2025-07-31
Completion
2025-07-31
FDA Drug
Yes

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05677373 on ClinicalTrials.gov