NCT05677373

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

Withdrawn Phase 1, PHASE2 Last updated 18 August 2023

What this trial tests

Phase 1, PHASE2 trial testing BRD4 Inhibitor PLX2853 in Advanced Uveal Melanoma. Withdrawn.

Timeline

13 January 2023

Primary endpoint
31 July 2025

31 July 2025

Quick facts

Lead sponsor	Alliance for Clinical Trials in Oncology
Phase	Phase 1, PHASE2
Status	Withdrawn
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Start date	13 January 2023
Primary completion	31 July 2025
Estimated completion	31 July 2025

Drugs / interventions tested

• BRD4 Inhibitor PLX2853 — full drug profile →
• Trametinib (trametinib) — full drug profile →
• Computed Tomography
• Magnetic Resonance Imaging
• Biospecimen collection — full drug profile →
• Biospecimen collection — full drug profile →

Conditions studied

• Advanced Uveal Melanoma — all drugs for Advanced Uveal Melanoma →
• Metastatic Uveal Melanoma — all drugs for Metastatic Uveal Melanoma →
• Unresectable Uveal Melanoma — all drugs for Unresectable Uveal Melanoma →

Sponsor

Alliance for Clinical Trials in Oncology

Who can join

18 and older, any sex, with Advanced Uveal Melanoma or Metastatic Uveal Melanoma. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

5 peer-reviewed publications reference this trial (live from Europe PMC):

1. Epigenetics-targeted drugs: current paradigms and future challenges.
   Dai W, Qiao X, Fang Y, Guo R, et al · · 2024 · cited 131× · PMID 39592582 · DOI 10.1038/s41392-024-02039-0
2. Super enhancer lncRNAs: a novel hallmark in cancer.
   Song P, Han R, Yang F. · · 2024 · cited 22× · PMID 38566153 · DOI 10.1186/s12964-024-01599-6
3. Oncolytic Viruses and Immunotherapy for the Treatment of Uveal Melanoma and Retinoblastoma: The Current Landscape and Novel Advances.
   Kulbay M, Tuli N, Mazza M, Jaffer A, et al · · 2025 · cited 8× · PMID 39857692 · DOI 10.3390/biomedicines13010108
4. The role of signaling pathways mediated by the GPCRs CysLTR1/2 in melanocyte proliferation and senescence.
   Huber T, Horioka-Duplix M, Chen Y, Saca VR, et al · · 2024 · cited 5× · PMID 39288219 · DOI 10.1126/scisignal.adp3967
5. Epigenetics of Malignant Melanoma: Mechanisms, Diagnostic Approaches and Therapeutic Applications.
   Hong SG, Murphy GF, Lian CG. · · 2026 · PMID 41930165 · DOI 10.32604/or.2026.073894