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Combination of IDE196 and Crizotinib for Metastatic Uveal Melanoma

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)

PHASE2; PHASE3 · IDEAYA Biosciences · NCT05987332

This study is testing if a new combination of two drugs, IDE196 and crizotinib, can be a better first treatment option for people with metastatic uveal melanoma compared to standard treatments.

Quick facts

PhasePHASE2; PHASE3
Study typeInterventional
Enrollment420 (estimated)
Ages18 Years and up
SexAll
SponsorIDEAYA Biosciences (industry)
Drugs / interventionspembrolizumab, ipilimumab, nivolumab, crizotinib
Locations66 sites (Scottsdale, Arizona and 65 other locations)
Trial IDNCT05987332 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the safety and effectiveness of IDE196 in combination with crizotinib as a first-line treatment for patients with metastatic uveal melanoma. Participants will be randomized to receive either the combination therapy or an investigator's choice of standard treatments. The study includes a multi-stage design to optimize the dosing of IDE196 before proceeding to larger Phase 3 evaluations. The trial aims to assess the anti-tumor activity and pharmacokinetics of the treatment regimen.

Who should consider this trial

Good fit: Ideal candidates are adults with histologically confirmed metastatic uveal melanoma who are HLA-A*02:01 negative and have not received prior systemic therapy.

Not a fit: Patients with previous treatments involving PKC inhibitors or those with concurrent malignant diseases may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new effective option for patients with metastatic uveal melanoma.

How similar studies have performed: Other studies have shown promise with similar combination therapies in melanoma, but this specific combination is being evaluated for the first time.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion 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

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
* 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

Where this trial is running

Scottsdale, Arizona and 65 other locations

+16 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.

View on ClinicalTrials.gov →

Conditions: Metastatic Uveal Melanoma, IDE196, Darovasertib, Protein Kinase C, Melanoma, Ocular Oncology, Ophthalmology, Crizotinib

Last reviewed 2026-05-15 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.