Clinical trial · Interventional
Safety and Efficacy Study of BMS-908662 in Combination With Ipilimumab in Subjects With Advanced Melanoma
A Phase 1 Study of a RAF Inhibitor (BMS-908662) Administered in Combination With Immunotherapy (Ipilimumab) in Subjects With Unresectable Stage III or Stage IV Melanoma
NCT01245556CI-TRIAL-00010689completedPhase 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)
The purpose of the study is to identify a safe and tolerable dose of BMS-908662 in combination with ipilimumab; and then to evaluate the anti-tumor response to BMS-908662 when administered in combination with ipilimumab.
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 |
|---|---|---|---|
| Melanoma | Melanoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| BMS-908662 | Drug | — | UNRESOLVED |
| Ipilimumab | Drug | Ipilimumab | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- BMS-908662 or Ipilimumab (A)
- interventionNames
- Drug: BMS-908662
- Drug: Ipilimumab
- type
- EXPERIMENTAL
- label
- BMS-908662 or Ipilimumab (B)
- interventionNames
- Drug: BMS-908662
- Drug: Ipilimumab
Primary outcomes (1)
- measure
- Toxicity will be evaluated according to the NCI Common Toxicity Criteria for Adverse Events (CTCAE) version 3
- timeFrame
- Assessments approximately every 3 weeks throughout the duration of the trial
Secondary outcomes (3)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion: * Male and female subjects ≥ 18 years of age with a histologic or cytologic diagnosis of Stage III or Stage IV (unresectable) melanoma * Enrollment to cohort expansion will be limited to only those subjects whose tumors demonstrate the B-Raf V600E mutation * ECOG ≤ 1 * Adequate organ \& marrow function Exclusion: * Uncontrolled or significant cardiovascular disease * Cohort expansion: Prior therapy with a RAF inhibitor
References
Publications (0)
Data not yet available
No reference posted for this study.