Clinical trial · Interventional
IDE196 (Darovasertib) in Combination With Crizotinib as First-line Therapy in 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)
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
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 |
|---|---|---|---|
| Metastatic Uveal Melanoma | Uveal Melanoma | CURATED_BROADER | 0.78 |
Interventions
Interventions (6)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Crizotinib | Drug | Crizotinib | ALIAS |
| Dacarbazine | Drug | Dacarbazine | ALIAS |
| IDE196 | Drug | — | UNRESOLVED |
| Ipilimumab | Drug | Ipilimumab | ALIAS |
| Nivolumab | Drug | Nivolumab | ALIAS |
| Pembrolizumab | Drug | Pembrolizumab | ALIAS |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- Phase 2a Dose Optimization of IDE196 + crizotinib
- description
- Multiple doses of IDE196 will be tested in combination with fixed dose of crizotinib to identify the optimal combination dose.
- interventionNames
- Drug: IDE196
- Drug: Crizotinib
- type
- EXPERIMENTAL
- label
- Phase 2b / 3 Chosen Combination dose of IDE196 + crizotinib
- description
- Chosen combination dose of IDE196 + crizotinib will be tested in additional participants.
- interventionNames
- Drug: IDE196
- Drug: Crizotinib
- type
- ACTIVE_COMPARATOR
- label
- Phase 2a / 2b / 3 Comparator Arm
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Histological or cytological confirmed Metastatic Uveal Melanoma * HLA-A\*02:01 negative * No prior systemic therapy in the metastatic or advanced setting 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 or falls * Known AIDS related illness * Active adrenal insufficiency, active colitis, or active inflammatory bowel disease * History of interstitial lung disease, active pneumonitis, or history of pneumonitis requiring steroids * Active infection requiring systemic antibiotic therapy or active Hepatitis B/C * Major surgery, radiotherapy, or use of hematopoietic colony-stimulating factors (CSF) within 2 weeks 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 * Impaired Cardiac function or clinically significant cardiac diseases, including angina pectoris or acute myocardial infarction \<= 6 months prior to start of study treatment * 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
References
Publications (0)
Data not yet available