Clinical trial · Interventional
A Phase 1b/2a Study Evaluating AMG 232 in Metastatic Melanoma
A Phase 1b/2a Study Evaluating the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Efficacy of AMG 232 Combined With Trametinib and Dabrafenib or Trametinib in Adult Subjects With Metastatic Cutaneous Melanoma
NCT02110355CI-TRIAL-00050910completedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- 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)
Phase 1b/2a, open-label, sequential dose escalation and expansion study of AMG 232 in combination with trametinib and dabrafenib in subjects with metastatic melanoma followed by a direct comparison of AMG 232 combined with trametinib and dabrafenib versus trametinib combined with dabrafenib alone.
Conditions
Conditions (7)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Advanced Malignancy | Malignant Neoplasm | CURATED_BROADER | 0.78 |
| Advanced Solid Tumors | Solid Neoplasm | CURATED_BROADER | 0.80 |
| Cancer | Malignant Neoplasm | ALIAS | 0.90 |
| Melanoma | Melanoma | ONTOLOGY_EXACT | 0.98 |
| Oncology | — | UNRESOLVED | — |
| Oncology Patients | — | UNRESOLVED | — |
| Tumors | Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| AMG 232 | Drug | Navtemadlin | ALIAS |
| Dabrafenib | Drug | Dabrafenib | ALIAS |
| Trametinib | Drug | Trametinib | ALIAS |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- AMG 232 with Trametinib and Dabrabenib
- description
- Arm 1 of Part 1 and 2 and Part 3
- interventionNames
- Drug: AMG 232
- Drug: Trametinib
- Drug: Dabrafenib
- type
- EXPERIMENTAL
- label
- AMG 232 with Trametinib
- description
- Arm 2 of Part 1 and 2
- interventionNames
- Drug: AMG 232
- Drug: Trametinib
- type
- ACTIVE_COMPARATOR
- label
- Trametinib and Dabrafenib
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: Subjects must have histologically or cytologically confirmed metastatic cutaneous or mucosal melanoma, Able to swallow and retain orally administered medication, Adequate hematological, renal, hepatic, and coagulation laboratory assessments Exclusion Criteria: Clinically significant bleeding within 4 weeks of screening, Current use of warfarin, factor Xa inhibitors, and direct thrombin inhibitors, Infection requiring anti-infective treatments within 1 week of study enrollment, Anti-tumor therapy, Major surgery within 28 days
References
Publications (0)
Data not yet available
No reference posted for this study.