Study on Rigosertib and Pembrolizumab for Treating Unremovable or Spread Melanoma Resistant to PD-1 Inhibitors

Sponsor: Vanderbilt-Ingram Cancer Center

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT05764395

Provider View

This clinical trial is testing a new combination of drugs, rigosertib and pembrolizumab, to see if they can help treat melanoma that cannot be removed by surgery or has spread, and has not responded to previous treatments with PD-1 inhibitors.

Patient Parameters

Program Overview

This phase II study is exploring how well the combination of rigosertib and pembrolizumab works in treating melanoma that cannot be surgically removed or has spread to other parts of the body, and has not responded to previous treatments with PD-1 or PD-L1 inhibitors. Rigosertib may help stop tumor growth by blocking certain enzymes and enhancing the immune system's response to cancer. Pembrolizumab, an immunotherapy drug, may help the immune system attack cancer cells and prevent them from growing and spreading. The study aims to find out if using both drugs together is more effective than using them separately.

Description

The main goal of this study is to see how effective rigosertib and pembrolizumab are in treating patients with metastatic melanoma that has not responded to PD-1 inhibitors. The study will also look at how long patients live without the cancer getting worse, the safety and side effects of the treatment, and overall survival rates. Additionally, researchers will explore changes in immune cells within the tumor during treatment.

Participants will take rigosertib by mouth and receive pembrolizumab through an IV. They will undergo CT or MRI scans and provide blood samples at the start and during the study. Some may also have a tissue biopsy at these times.

Eligibility Criteria

Inclusion Criteria

  • Adults aged 18 or older with a confirmed diagnosis of melanoma that cannot be removed by surgery or has spread.
  • Must agree to use contraception during treatment and for a specified period after the last dose.
  • Must have previously been treated with PD-1 or PD-L1 inhibitors and shown disease progression.
  • If the cancer has a BRAF V600 mutation, must have tried BRAF-targeted therapy.
  • Must provide a tumor sample for analysis.
  • Must have measurable disease based on specific criteria.
  • Must have a good performance status and meet certain blood and organ function requirements.

Exclusion Criteria

  • Have a type of melanoma that starts in the eye or mucous membranes.
  • Women who are pregnant or breastfeeding.
  • Have received certain cancer treatments or participated in other clinical trials recently.
  • Have a history of severe allergic reactions to the study drugs.
  • Have active autoimmune diseases or infections.
  • Have other serious health conditions that could interfere with the study.
  • Have a history of other cancers that are currently active or have been treated in the past two years, except for certain skin cancers or in situ cancers.
  • Have untreated or active brain metastases unless stable after treatment.

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