Study on IDE196 (Darovasertib) and Crizotinib as First-line Treatment for Metastatic Uveal Melanoma

Sponsor: IDEAYA Biosciences

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT05987332

Provider View

This clinical trial is testing a new combination of drugs, IDE196 and Crizotinib, to see if they are effective as a first treatment option for patients with metastatic uveal melanoma, a type of eye cancer that has spread.

Patient Parameters

Program Overview

The study aims to find out if the combination of IDE196 and Crizotinib can help treat metastatic uveal melanoma, a type of eye cancer that has spread to other parts of the body. Participants will be randomly assigned to receive either the new drug combination or one of the standard treatments chosen by the study doctor, which could include pembrolizumab, ipilimumab with nivolumab, or dacarbazine.

Description

This clinical trial is divided into several stages to evaluate the safety and effectiveness of the drug combination IDE196 and Crizotinib for treating metastatic uveal melanoma. In the initial phase, different doses of IDE196 combined with Crizotinib will be tested to find the best dose. Participants will be randomly assigned to receive either the new drug combination or a standard treatment chosen by the study doctor. Once the best dose is determined, the study will continue to test this dose against the standard treatments in further phases. The goal is to see if the new combination can better control the cancer compared to existing treatments.

Eligibility Criteria

Inclusion Criteria

  • Diagnosed with metastatic uveal melanoma, confirmed by lab tests.
  • Negative for a specific genetic marker called HLA-A*02:01.
  • Have not received any previous treatments for advanced or metastatic cancer.
  • Have measurable cancer that can be tracked using standard criteria.
  • Able to safely receive and absorb the study drugs.
  • In good overall health with a performance status of 0 or 1, meaning fully active or restricted in physically strenuous activity but ambulatory.
  • Expected to live for at least 3 more months.
  • Have adequate organ function as determined by specific medical tests.

Exclusion Criteria

  • Have previously been treated with certain types of cancer drugs, including PKC inhibitors, MET inhibitors, or GNAQ/11 inhibitors.
  • Have another active cancer.
  • Have unresolved side effects from previous cancer treatments.
  • Have untreated or symptomatic brain metastases, or require steroids for brain metastases.
  • Have active infections like HIV, hepatitis B, or hepatitis C.
  • Have active adrenal insufficiency, colitis, or inflammatory bowel disease.
  • Have a history of lung diseases like interstitial lung disease or pneumonitis.
  • Have an active infection needing antibiotics.
  • Have used certain blood cell growth factors before starting the study drug.
  • Are pregnant or breastfeeding.
  • Have a history of severe allergic reactions to similar drugs.
  • Cannot safely receive the standard treatments chosen by the study doctor.
  • Have any other condition that might increase risks or interfere with the study.

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