IDE196 (Darovasertib) in Combination With Crizotinib as First-line Therapy in Metastatic Uveal Melanoma

Running, not enrolling · Phase 2/Phase 3

Conditions studied: Metastatic Uveal Melanoma

In brief

This is a Phase 2/3, multi-arm, multi-stage, open-label study of human leukocyte antigen (HLA)-A\*02:01 negative participants with metastatic uveal melanoma (MUM) who will be randomized to receive either IDE196 + crizotinib or investigator's choice of treatment (pembrolizumab, ipilimumab + nivolumab, or dacarbazine).

Key facts

Study ID

NCT05987332

Run by

IDEAYA Biosciences

People needed

420

Starts

2023-10-31

Expected to finish

2028-01-15

Last updated by the study team

2026-02-17

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Histological or cytological confirmed Metastatic Uveal Melanoma
• HLA-A*02:01 negative
• No prior systemic therapy in the metastatic or advanced setting regional or liver-directed therapy. Ablations or surgical resection of oligometastatic disease, and neoadjuvant or adjuvant therapy is allowed
• Measurable disease per RECIST 1.1
• Able to be safely administered and absorb study therapy
• ECOG performance status 0 or 1
• Life expectancy of ≥3 months
• Adequate organ function

You may not qualify if…

• Previous treatment with a PKC inhibitor (including prior treatment with IDE196), an inhibitor directly targeting MET, or an inhibitor directly targeting GNAQ/11
• Concurrent malignant disease
• AEs from prior anti-cancer therapy that have not resolved to Grade ≤1
• Symptomatic or untreated central nervous system (CNS) metastases, or CNS metastases that require corticosteroids
• High risk of syncope or falls
• Known AIDS related illness
• Active adrenal insufficiency, active colitis, or active inflammatory bowel disease
• History of interstitial lung disease, active pneumonitis, or history of pneumonitis requiring steroids
• Active infection requiring systemic antibiotic therapy or active Hepatitis B/C
• Major surgery, radiotherapy, or use of hematopoietic colony-stimulating factors (CSF) within 2 weeks prior to start of study drug
• Females who are pregnant or breastfeeding
• History of severe hypersensitivity reactions (eg, anaphylaxis) to other biologic drugs or monoclonal antibodies
• Contraindication for treatment with investigator's choice therapies as per applicable labelling
• History of stroke within the last 6 months of the first dose of study drug
• Impaired Cardiac function or clinically significant cardiac diseases, including angina pectoris or acute myocardial infarction <= 6 months prior to start of study treatment
• Has any other condition that may increase the risk associated with study participation or may interfere with the interpretation of study results and, in the opinion of the investigator, would make the participant inappropriate for entry into the study, including institutionalization on the basis of an official or court order

Where it is running

• Moores Cancer Center — La Jolla, California, United States
• UCLA Medical Center — Los Angeles, California, United States
• The Angeles Clinic and Research Institute — Los Angeles, California, United States
• California Pacific Medical Center (CPMC) — San Francisco, California, United States
• University of California San Francisco — San Francisco, California, United States
• University of Colorado Cancer Center — Aurora, Colorado, United States
• SCRI at HealthONE — Denver, Colorado, United States
• University of Miami Sylvester Comprehensive Cancer Center — Miami, Florida, United States
• Moffitt Cancer Center — Tampa, Florida, United States
• Northside Hospital Atlanta — Atlanta, Georgia, United States
• University of Iowa — Iowa City, Iowa, United States
• Massachusetts General Hospital — Boston, Massachusetts, United States
• Dana Farber Cancer Institute — Boston, Massachusetts, United States
• The Cancer and Hematology Centers — Grand Rapids, Michigan, United States
• Minnesota Oncology Hematology, P.A. — Burnsville, Minnesota, United States
• Mayo Clinic — Rochester, Minnesota, United States
• Washington University School of Medicine — St Louis, Missouri, United States
• Roswell Park Cancer Institute — Buffalo, New York, United States
• Northwell Health — Manhasset, New York, United States
• Memorial Sloan Kettering Cancer Center — New York, New York, United States
• Duke University Health System — Durham, North Carolina, United States
• University of Cincinnati — Cincinnati, Ohio, United States
• The Cleveland Clinic Foundation — Cleveland, Ohio, United States
• Thomas Jefferson University — Philadelphia, Pennsylvania, United States
• Honor Health — Scottsdale, Arizona, United States

Full record on ClinicalTrials.gov

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