A phase 2/3, multiarm, multistage, open-label study in HLA-A*02:01-negative patients1
Currently active but not enrolling
The trial at a glance
OptimUM-02 is designed to evaluate the safety, tolerability, pharmacokinetics, dose-exposure relationship, and anti-tumor activity of darovasertib in combination with crizotinib versus the investigator’s choice of treatment (pembrolizumab, ipilimumab + nivolumab, or dacarbazine) in HLA-A*02:01-negative patients with metastatic uveal melanoma (mUM).1
Patients with treatment-naive HLA-A*02:01-negative mUM
Phase 2b (N≈260) | Phase 3 (N≈120 additional patients)1,2
*Pembrolizumab, ipilimumab + nivolumab, or dacarbazine.
Primary endpoints1
- Progression-free survival by blinded independent review committee
- Overall survival
SELECT INCLUSION CRITERIA1
- Age 18 years or older
- Histologically or cytologically confirmed metastatic uveal HLA-A*02:01-negative melanoma
- No prior systemic therapy in the metastatic or advanced setting or regional, liver-directed therapy. Ablations or surgical resection of oligometastatic disease, and neoadjuvant or adjuvant therapy, are allowed
- Measurable disease per RECIST 1.1
- Ability to be safely administered and absorb study therapy
- ECOG performance status ≤1 and life expectancy ≥3 months
- Adequate organ function
SELECT EXCLUSION CRITERIA1
- Prior treatment with a PKC inhibitor, MET inhibitor, or GNAQ/11 inhibitor
- 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 hepatitis B or hepatitis 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 prior to start of study drug
- History of stroke within the last 6 months of the first dose of study drug
AE, adverse event; BID, twice daily; ECOG, Eastern Cooperative Oncology Group; HLA-A*02:01, human leukocyte antigen A02:01 major histocompatibility complex class I allele; MET, mesenchymal-epithelial transition; PKC, protein kinase C; RECIST, Response Evaluation Criteria in Solid Tumors.
Trial site locations
OptimUM-02 is available globally. Browse below to view participating sites.
New South Wales, Australia
Westmead Hospital
Sydney, NSW 2145
Queensland, Australia
Princess Alexander Hospital
Brisbane 4102
South Australia, Australia
Queen Elizabeth Hospital
Adelaide 5011
Victoria, Australia
Peter MacCallum Cancer Centre
Melbourne, Victoria 3000
Victoria, Australia
Alfred Health
Melbourne, Victoria 3168
Washington, Australia
Sir Charles Gairdner Hospital
Perth, Washington 6009
Brabant, Belgium
Algemene Medische Oncologie UZ
Leuven 3000
Brussels, Belgium
Cliniques Universitaires Saint Luc
Brussels 1200
Alberta, Canada
Cross Cancer Institute, University of Alberta
Edmonton, AB T6G 1Z2
British Columbia, Canada
BC Cancer Agency
Vancouver, British Columbia V5Z4C2
Ontario, Canada
Princess Margaret Cancer Centre
Toronto, Ontario M5G 2M9
Quebec, Canada
Centre Hospitalier de l'Universite de Montreal-CHUM
Montreal, Quebec H2X 0C1
London, England
Mount Vernon Cancer Centre East & North Herts NHS Trust
Northwood HA6 2RN
Merseyside, England
The Clatterbridge Cancer Centre NHS Foundation Trust
Wirral CH63 4JY
Auvergne-Rhône-Alpes, France
Le Centre Léon Bérard
Lyon 69008
Île-de-France, France
Institut Curie
Paris 75005
Baden-Württemberg, Germany
NCT Heidelberg
Heidelberg 69120
Berlin, Germany
Charité–Universitätsmedizin Berlin
Berlin 12203
North Rhine-Westphalia, Germany
Universitätsklinikum Köln
Cologne 50937
North Rhine-Westphalia, Germany
Universitätsklinikum Essen (AöR)
Essen 45147
Saxony, Germany
Universitätsklinikum Carl Gustav Carus Dresden
Dresden 1307
Jerusalem District, Israel
Hadassah Medical Center
Jerusalem 91120
Tel Aviv District, Israel
Sheba Medical Center
Ramat Gan 52621
Campania, Italy
Istituto Nazionale dei Tumori Fondazione Pascale
Naples 80131
Lazio, Italy
Fondazione Policlinico Gemelli IRCCS
Rome 00168
Lombardy, Italy
Fondazione IRCCS Istituto Nazionale dei Tumori
MIlan 20133
Tuscany, Italy
AOUS Policlinico Le Scotte
Siena 53100
South Holland, Netherlands
LUMC (Leids Universitair Medisch Centrum)
Leiden 2333 ZA
Pomeranian Voivodeship, Poland
Ośrodek Badań Klinicznych Wczesnych Faz, Uniwersyteckie Centrum Kliniczne w Gdańsku
Gdansk 80-214
Warsaw, Poland
Narodowy Instytut Onkologii im. Marii Skłodowskiej-Curie Państwowy Instytut Badawczy
Warsaw 02-781
Glasgow, Scotland
The Beatson West of Scotland Cancer Centre
Glasgow G12 0YN
Andalusia, Spain
Hospital Universitario Virgen Macarena
Seville 41009
Catalonia, Spain
Catalan Institute of Oncology
Llobregat 8908
Galicia, Spain
Hospital Clínico Universitario de Santiago de Compostela
Santiago de Compostela 15706
Madrid, Spain
Hospital Universitario La Paz
Madrid 28046
Valencia, Spain
Hospital General Universitario Valencia
Valencia 46014
Zurich, Switzerland
Dermatologische Klinik, USZ Flughafen Geschoss 7 - Klinische Forschung
Zürich 8058
Arizona, United States
Honor Health
Scottsdale, AZ 85258
California, United States
Moores Cancer Center
La Jolla, CA 92093
California, United States
UCLA Medical Center
Los Angeles, CA 90024
California, United States
The Angeles Clinic and Research Institute
Los Angeles, CA 90025
California, United States
California Pacific Medical Center (CPMC)
San Francisco, CA 94115
California, United States
University of California San Francisco
San Francisco, CA 94143
Colorado, United States
University of Colorado Cancer Center
Aurora, CO 80045
Colorado, United States
SCRI at HealthONE
Denver, CO 80218
Florida, United States
University of Miami Sylvester Comprehensive Cancer Center
Miami, FL 33136
Florida, United States
Moffitt Cancer Center
Tampa, FL 33612
Georgia, United States
Northside Hospital Atlanta
Atlanta, GA 30342
Iowa, United States
University of Iowa
Iowa City, IA 52242
Massachusetts, United States
Massachusetts General Hospital
Boston, MA 02114
Massachusetts, United States
Dana Farber Cancer Institute
Boston, MA 02215
Michigan, United States
The Cancer and Hematology Centers
Grand Rapids, MI 49546
Minnesota, United States
Minnesota Oncology Hematology, PA
Burnsville, MN 55337
Minnesota, United States
Mayo Clinic
Rochester, MN 55905
Missouri, United States
Washington University School of Medicine
St Louis, MO 63110
New York, United States
Roswell Park Cancer Institute
Buffalo, NY 14263
New York, United States
Northwell Health
Manhasset, NY 11030
New York, United States
Memorial Sloan Kettering Cancer Center
New York, NY 10065
North Carolina, United States
Duke University Health System
Durham, NC 27710
Ohio, United States
University of Cincinnati
Cincinnati, OH 45267
Ohio, United States
The Cleveland Clinic Foundation
Cleveland, OH 44195
Pennsylvania, United States
Thomas Jefferson University
Philadelphia, PA 19107
Pennsylvania, United States
University of Pittsburgh Medical Center
Pittsburgh, PA 15232
Tennessee, United States
SCRI Oncology Partners
Nashville, TN 37203
Texas, United States
Texas Oncology- DFW
Dallas, TX 75246
Texas, United States
UT Southwestern Medical Center
Dallas, TX 75390
Texas, United States
Houston Methodist Cancer Center
Houston, TX 77030
Texas, United States
MD Anderson Cancer Center
Houston, TX 77030
See more
Contact IDEAYA Clinical Trials to learn more.
Get in TouchDarovasertib is an investigational product and has not been approved by the U.S. Food and Drug Administration for safety or effectiveness.
References: 1. IDE196 (Darovasertib) in combination with crizotinib as first-line therapy in metastatic uveal melanoma. ClinicalTrials.gov identifier: NCT05987332. Updated November 7, 2025. Accessed January 14, 2026. https://clinicaltrials.gov/study/NCT05987332 2. Data on file. Ideaya Biosciences, 2025.