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Clinical Trials in the UK / NCT05987332
Active, not recruiting Phase 2/3

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

NCT05987332 · tracked via the Priya Life Science UK tracker
Sponsor
IDEAYA Biosciences
Phase
Phase 2/3
Started
2023-10-31
Last updated
2026-02-17

Condition(s) studied

Metastatic Uveal Melanoma

Investigational drug(s) / intervention(s)

IDE196CrizotinibPembrolizumabIpilimumabNivolumabDacarbazine

IDE196: Dosed orally, twice daily

Crizotinib: Dosed orally, twice daily

Pembrolizumab: IV administration every 3 weeks

Ipilimumab: IV administration every 3 weeks for 4 Cycles

Nivolumab: IV administration every 3 Weeks for 4 Cycles, thereafter every 4 Weeks maintenance

Dacarbazine: IV administration every 3 Weeks

Study summary

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).

Eligibility

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
No
Inclusion Criteria: * 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 Exclusion Criteria: * 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

Primary outcome measure(s)

Trial sites (68)

FacilityCityRegionStatus
Honor Health Scottsdale Arizona
Moores Cancer Center La Jolla California
UCLA Medical Center Los Angeles California
The Angeles Clinic and Research Institute Los Angeles California
California Pacific Medical Center (CPMC) San Francisco California
University of California San Francisco San Francisco California
University of Colorado Cancer Center Aurora Colorado
SCRI at HealthONE Denver Colorado
University of Miami Sylvester Comprehensive Cancer Center Miami Florida
Moffitt Cancer Center Tampa Florida
Northside Hospital Atlanta Atlanta Georgia
University of Iowa Iowa City Iowa
Massachusetts General Hospital Boston Massachusetts
Dana Farber Cancer Institute Boston Massachusetts
The Cancer and Hematology Centers Grand Rapids Michigan
Minnesota Oncology Hematology, P.A. Burnsville Minnesota
Mayo Clinic Rochester Minnesota
Washington University School of Medicine St Louis Missouri
Roswell Park Cancer Institute Buffalo New York
Northwell Health Manhasset New York
Memorial Sloan Kettering Cancer Center New York New York
Duke University Health System Durham North Carolina
University of Cincinnati Cincinnati Ohio
The Cleveland Clinic Foundation Cleveland Ohio
Thomas Jefferson University Philadelphia Pennsylvania
University of Pittsburgh Medical Center Pittsburgh Pennsylvania
SCRI Oncology Partners Nashville Tennessee
Texas Oncology- DFW Dallas Texas
UT Southwestern Medical Center Dallas Texas
Houston Methodist Cancer Center Houston Texas
MD Anderson Cancer Center Houston Texas
Westmead Hospital Sydney New South Wales
Princess Alexander Hospital Brisbane Queensland
Peter MacCallum Cancer Centre Melbourne Victoria
Alfred Health Melbourne Victoria
Sir Charles Gairdner Hospital Perth Washington
Queen Elizabeth Hospital Adelaide Australia
Cliniques Universitaires Saint Luc Brussels Belgium
Algemene Medische Oncologie UZ Leuven Belgium
Cross Cancer Institute, University of Alberta Edmonton Alberta

+ 28 more sites — see the full list on the official registry below.

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05987332 on ClinicalTrials.gov ↗ ← All trials in the UK