Clinical trial · Interventional
A Study to Assess Safety of Relatlimab With Ipilimumab in Participants With Advanced Melanoma Who Progressed on Anti-Programmed Cell Death Protein 1 (Anti-PD-1) Treatment
A Phase 1/2a Study to Evaluate the Safety, Tolerability, and Efficacy of Relatlimab Administered in Combination With Ipilimumab or Ipilimumab Alone in Participants With Unresectable or Metastatic Melanoma Who Have Progressed on Anti-PD-1 Therapy
NCT03978611CI-TRIAL-00079097terminatedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Business objectives have changed.
Summary
Brief summary (as posted)
The primary purpose of this study is to characterize the safety, tolerability, and dose-limiting toxicities (DLTs) of relatlimab 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 |
|---|---|---|---|
| Ipilimumab | Drug | Ipilimumab | ALIAS |
| Relatlimab | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Part 1: Dose Escalation Phase
- interventionNames
- Drug: Relatlimab
- Drug: Ipilimumab
Primary outcomes (6)
- measure
- Number of Participants with Adverse Events (AEs)
- timeFrame
- Up to Follow-up Period (100 days after 34 cycles [1 cycle is of 3 weeks])
- measure
- Number of Participants with Serious Adverse Events (SAEs)
- timeFrame
- Up to Follow-up Period (100 days after 34 cycles [1 cycle is of 3 weeks])
- measure
- Number of Participants With Adverse Events Including Dose Limiting Toxicity
- timeFrame
- Up to 28 days after last study drug dose (approximately up to 2 years)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Must have documented progression while on a prior anti-programmed cell death protein 1 (PD-1) containing regimen limited to Nivolumab or Pembrolizumab * Must have histologically confirmed advanced unresectable (Stage III) or metastatic (Stage IV) melanoma, as per (AJCC) staging system * Tumor tissue from an unresectable or metastatic site of disease must be provided for biomarker analyses * Eastern Cooperative Oncology Group (ECOG) 0-1 Exclusion Criteria: * History of uveal melanoma * Known history of positive test for human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome * Prior treatment with ipilimumab, relatlimab, or any other cytotoxic T-lymphocyte-associated antigen 4 (CTLA-4) or lymphocyte-activation gene 3 (LAG-3) targeted agents
References
Publications (0)
Data not yet available
No reference posted for this study.