Clinical trial · Interventional
Study of Adjuvant Darovasertib and Crizotinib in Participants With Primary Non-metastatic Uveal Melanoma
A Randomized, Phase 3, Open-label Study of Adjuvant Darovasertib and Crizotinib in Participants With Primary Non-metastatic Uveal Melanoma
NCT07804186CI-TRIAL-00125954recruitingPhase 3ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 16, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260916-000001
Summary
Brief summary (as posted)
This is a randomized, multi-center, open-label study of adjuvant darovasertib in participants with non-metastatic uveal melanoma (OptimUM-11)
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Uveal Melanoma | Uveal Melanoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Crizotinib (Xalkori) | Drug | Crizotinib | ALIAS |
| Darovasertib | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Treatment
- description
- Participant Group/Arm: Treatment combination dose of IDE196 + crizotinib will be tested
- interventionNames
- Drug: Darovasertib
- Drug: Crizotinib (Xalkori)
- type
- NO_INTERVENTION
- label
- Observation
- description
- Participant Group/Arm: Observation Standard of care observation \& follow-up (no treatment)
Primary outcomes (1)
- measure
- Median relapse-free survival
- timeFrame
- Approximately 5 years
- description
- Time to local recurrence or metastatic disease per Blinded Independent Central Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Primary Uveal Melanoma, classified as high-risk of relapse (AJCC Stage II or Stage 3) * Completed primary local therapy (enucleation, proton beam therapy, plaque brachytherapy) * ECOG performance status of 0 or 1 * Adequate organ function * Age 18 or older * Written informed consent and ability to comply * Primary local therapy completed within 120 days before C1D1/randomization. * Contraception requirements Exclusion Criteria: * Previous systemic treatment for Uveal Melanoma * Clinical or radiological evidence of metastatic UM * Concurrent malignant disease with the following exceptions: malignancies that were treated curatively and have not recurred within 2 years prior to randomization, completely resected basal cell and squamous cell skin cancers, any malignancy considered to be indolent and never required systemic therapy, and any type of carcinoma in situ receiving curative therapy (resection) * Known AIDS related illness * History of interstitial lung disease, active pneumonitis, or history of noninfectious pneumonitis requiring steroids * History of syncope may be exclusionary, but will be reviewed on a case-by-case basis * Active Hepatitis B or C infection * Any gastrointestinal condition (eg, inflammatory bowel disease, major gastric or intestinal surgery) that could affect absorption or ability to swallow * Females who are pregnant or breastfeeding * Impaired cardiac function * History of stroke within the last 6 months of randomization * Ongoing use of medication use for infections, other antineoplastic therapies, or other prohibited medications, including medications that interact with the metabolism of darovasertib+crizotinib * allergy to mammalian meat products or gelatin
References
Publications (0)
Data not yet available
No reference posted for this study.