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

NCT05987332 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 420

Last updated 2026-02-17

No results posted yet for this 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).

Conditions

  • Metastatic Uveal Melanoma

Interventions

DRUG

IDE196

Dosed orally, twice daily

DRUG

Crizotinib

Dosed orally, twice daily

DRUG

Pembrolizumab

IV administration every 3 weeks

DRUG

Ipilimumab

IV administration every 3 weeks for 4 Cycles

DRUG

Nivolumab

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

DRUG

Dacarbazine

IV administration every 3 Weeks

Sponsors & Collaborators

  • IDEAYA Biosciences

    lead INDUSTRY

Principal Investigators

  • Hetal Patel, MD, MSHS, CHCQM · IDEAYA Biosciences

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-10-31
Primary Completion
2027-01-15
Completion
2028-01-15
FDA Drug
Yes

Countries

  • United States
  • Australia
  • Belgium
  • Canada
  • France
  • Germany
  • Israel
  • Italy
  • Netherlands
  • Poland
  • Spain
  • Switzerland
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05987332 on ClinicalTrials.gov