Clinical trial · Interventional
Safety Study of BMS-986016 With or Without Nivolumab in Patients With Advanced Solid Tumors
A Phase 1 Study of the Safety, Tolerability, and Efficacy of Anti-LAG-3 Monoclonal Antibody (BMS-986016) Administered Alone and in Combination With Anti-PD-1 Monoclonal Antibody (Nivolumab, BMS-936558) in Advanced Solid Tumors
NCT02966548CI-TRIAL-00086078completedPhase 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)
This study will be used to determine the safety and tolerability of BMS-986016 administered alone and in combination with Nivolumab in subjects with advanced solid tumors.
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 |
|---|---|---|---|
| Cancer | Malignant Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Nivolumab | Drug | Nivolumab | ALIAS |
| Relatlimab | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Monotherapy
- description
- Relatlimab (BMS-986016) administered every 2 weeks as a single agent intravenous formulation
- interventionNames
- Drug: Relatlimab
- type
- EXPERIMENTAL
- label
- Combination Therapy
- description
- Relatlimab (BMS-986016) will be administered in combination with Nivolumab every 2 weeks or every 4 weeks as an intravenous formulation
- interventionNames
- Drug: Relatlimab
- Drug: Nivolumab
Primary outcomes (4)
- measure
- Number of adverse events (AE)
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 20 Years
Show eligibility criteria text
For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com Inclusion Criteria: * Must have histologic or cytologic confirmation of an incurable solid malignancy that is advanced (metastatic and/or unresectable) * Must have received, and then progressed or been intolerant to, standard treatment regimen in the advanced or metastatic setting, if such a therapy exists * Presence of at least one lesion with measurable disease as defined by RECIST v1.1 criteria for response assessment * Males and Females, ages 20 years or older, inclusive Exclusion Criteria: * Known or suspected CNS (central nervous system) metastases or with the CNS as the only site of active disease * Other concomitant malignancies (with some exceptions per protocol) * Any active autoimmune disease or history of known or suspected autoimmune disease * History of uncontrolled or significant cardiovascular disease Other protocol defined inclusion/exclusion criteria could apply
References
Publications (0)
Data not yet available
No reference posted for this study.