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

Description

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).

Conditions

Metastatic Uveal Melanoma

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Study Overview

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Study Details

Study overview

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).

IDE196 (Darovasertib) in Combination With Crizotinib Versus Investigator's Choice of Treatment as First-line Therapy in HLA-A2 Negative Metastatic Uveal Melanoma (DAR-UM-2)

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

Condition
Metastatic Uveal Melanoma
Intervention / Treatment

-

Contacts and Locations

Scottsdale

Honor Health, Scottsdale, Arizona, United States, 85258

La Jolla

Moores Cancer Center, La Jolla, California, United States, 92093

Los Angeles

UCLA Medical Center, Los Angeles, California, United States, 90024

Los Angeles

The Angeles Clinic and Research Institute, Los Angeles, California, United States, 90025

San Francisco

California Pacific Medical Center (CPMC), San Francisco, California, United States, 94115

San Francisco

University of California San Francisco, San Francisco, California, United States, 94143

Aurora

University of Colorado Cancer Center, Aurora, Colorado, United States, 80045

Denver

SCRI at HealthONE, Denver, Colorado, United States, 80218

Miami

University of Miami Sylvester Comprehensive Cancer Center, Miami, Florida, United States, 33136

Tampa

Moffitt Cancer Center, Tampa, Florida, United States, 33612

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * Histological or cytological confirmed Metastatic Uveal Melanoma
  • * HLA-A\*02:01 negative
  • * No prior systemic therapy in the metastatic or advanced setting or 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
  • * 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
  • * Known AIDS related illness or active Hep B/C
  • * Active adrenal insufficiency, active colitis, or active inflammatory bowel disease
  • * History of interstitial lung disease, active pneumonitis, or history of pneumonitis
  • * Active infection requiring systemic antibiotic therapy
  • * Use of hematopoietic colony-stimulating factors (CSF) 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
  • * 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

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

IDEAYA Biosciences,

Hetal Patel, MD, MSHS, CHCQM, STUDY_DIRECTOR, IDEAYA Biosciences

Study Record Dates

2028-01-15