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

Conditions

• Metastatic Uveal Melanoma

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• IDE196 — DRUG
  Dosed orally, twice daily
• Crizotinib — DRUG
  Dosed orally, twice daily
• Pembrolizumab — DRUG
  IV administration every 3 weeks
• Ipilimumab — DRUG
  IV administration every 3 weeks for 4 Cycles
• Nivolumab — DRUG
  IV administration every 3 Weeks for 4 Cycles, thereafter every 4 Weeks maintenance
• Dacarbazine — DRUG
  IV administration every 3 Weeks

Study Details

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).

Key Dates

Start date

Oct 31, 2023

Status verified

Feb 2026

Primary completion

Jan 15, 2027

Completion

Jan 15, 2028

Study Design

Enrollment

420 participants (estimated)

Allocation

RANDOMIZED

Intervention model

SEQUENTIAL

Primary purpose

TREATMENT

Arms

• Experimental: Phase 2a Dose Optimization of IDE196 + crizotinib
  Multiple doses of IDE196 will be tested in combination with fixed dose of crizotinib to identify the optimal combination dose.
• Experimental: Phase 2b / 3 Chosen Combination dose of IDE196 + crizotinib
  Chosen combination dose of IDE196 + crizotinib will be tested in additional participants.
• Active Comparator: Phase 2a / 2b / 3 Comparator Arm
  Participants will receive investigator's choice of Pembrolizumab, Ipilimumab + Nivolumab, or Dacarbazine.

Primary Outcome Measure

Phase 2a: To determine the optimal dose of IDE196 + Crizotinib combination for Phase 2B and Phase 3 by evaluating the following: [ Time Frame: Approximately 5 months ]

Locations (31)

Find similar trials in Scottsdale, AZ

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