Phase 2
Completed N=1,482
An Investigational Immuno-therapy Study to Assess the Safety, Tolerability and Effectiveness of Anti-LAG-3 With and Without Anti-PD-1 in the Treatment of Solid Tumors
Neoplasms by Site
Source: ClinicalTrials.gov NCT01968109 ↗
Enrolled (actual)
1,482
Serious AEs
66.7%
Results posted
Jan 2026
Primary outcomePrimary: Number of Participants With Adverse Events, Deaths and Clinically Relevant Laboratory Abnormalities — 5; 4; 4; 12 Participants
Summary
The purpose of the study is to assess the safety, tolerability and effectiveness of experimental medication BMS-986016 administered alone and in combination with nivolumab in patients with solid tumors that have spread and/or cannot be removed by surgery.
The following tumor types are included in this study:
Non-Small Cell Lung Cancer (NSCLC), gastric cancer, hepatocellular carcinoma, renal cell carcinoma, bladder cancer, squamous cell carcinoma of the head and neck, and melanoma, that have NOT previously been treated with immunotherapy. NSCLC and melanoma that HAVE previously been treated with immunotherapy.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Adverse Events, Deaths and Clinically Relevant Laboratory Abnormalities |
5; 4; 4; 12; 7; 9 | — |
| PRIMARY Part C, D1, D2, E - Objective Response Rate Per BICR |
29.2; 47.0; 15.4; 15.4; 15.9; 8.6 | — |
| PRIMARY Part C, D1, D2, E - Disease Control Rate (DCR) Per BICR |
50.0; 59.1; 46.2; 49.2; 50.8; 25.8 | — |
| PRIMARY Part C, D1, D2, E - Duration of Response (DOR) Per BICR |
40.4; NA; NA; 27.9; 54.6; 35.1 | — |
| PRIMARY Part D1: Number of Participants With Adverse Events in the Broad Scope Standardized MedDRA (SMQ) Anaphylactic Reaction Occurring Within 2 Days of Any Doses of Study Therapy |
14; 2; 2; 11; 3; 4 | — |
| PRIMARY Part C, D1, D2, E - Objective Response Rate Per BICR |
29.2; 47.0; 15.4; 15.4; 15.9; 8.6 | — |
| SECONDARY Part C, D1 and D2: Progression-Free Survival (PFS) Rate Per BICR |
0.28; 0.48; 0.29; 0.17; 0.24; 0.09 | — |
| SECONDARY Part D1 and D2: Overall Survival (OS) at 12 and 24 Months |
0.56; 0.51; 0.57; 0.59; 0.30; 0.31 | — |
| SECONDARY Part C, D1, D2, E - Objective Response Rate Per Investigator |
41.7; 50.0; 11.5; 15.4; 15.9; 15.1 | — |
| SECONDARY Part C, D1, D2, E - Disease Control Rate (DCR) Per Investigator |
62.5; 62.1; 46.2; 50.8; 54.0; 32.3 | — |
| SECONDARY Part C, D1, D2, E - Duration of Response (DOR) Per Investigator |
15.3; NA; NA; 14.0; 53.4; 5.7 | — |
| SECONDARY Part C, D1 and D2: Progression-Free Survival (PFS) Rate Per Investigator |
0.29; 0.47; 0.33; 0.20; 0.18; 0.06 | — |
| SECONDARY Number of Participants With Positive Anti Drug Antibodies |
0; 0; 0; 0; 2; 2 | — |
| SECONDARY Part A, A/A1, and B: Number of Participants With Clinically Relevant QT Prolongation |
0; 0; 0; 0; 0; 0 | — |
| SECONDARY Maximum Observed Concentration (Cmax) of BMS-986016 (Relatlimab) |
5.501; 27.528; 69.761; 272.554; 5.762; 7.038 | — |
| SECONDARY Time to Maximum Observed Concentration (Tmax) of BMS-986016 (Relatlimab) |
3.173; 1.709; 9.700; 2.041; 2.988; 3.391 | — |
| SECONDARY Area Under the Concentration-time Curve in One Dosing Interval (AUCtau) of BMS-986016 (Relatlimab) |
686.264; 3308.767; 11848.262; 38183.302; 700.840; 756.154 | — |
| SECONDARY Part A/A1, B, C, D1, D2 and E: Trough Observed Concentration (Ctrough) of BMS-986016 (Relatlimab) |
215.000; 1.283; 1.597; 14.176; 38.174; 46.600 | — |
| SECONDARY Part A/A1, B, CTotal Body Clearance (CLT) of BMS-986016 (Relatlimab) |
7.580; 19.943; 12.387; 12.892; 8.932; 11.330 | — |
| SECONDARY Part A/A1, B, C AUC Accumulation Index AI_AUC of BMS-986016 (Relatlimab) |
2.433; NA; 1.825; 1.985; 3.143; NA | — |
Eligibility Criteria
Inclusion Criteria
- For Dose escalation: subjects with cervical, ovarian, bladder and colorectal cancer (CRC), head and neck, gastric and hepatocellular cancer naive to immuno-oncology agents; 1st line melanoma and 1st line/2nd line NSCLC; Renal Cell Carcinoma naive to IO; NSCLC progressing while on or after therapy with anti-PD1/anti-PDL-1 and melanoma subjects progressed while-on or after treatment with anti-PD1 or anti-PDL1 with or without anti-CTLA-4.
- For Dose Expansion: all of the above in escalation except for cervical, ovarian, and CRC
- Progressed, or been intolerant to, at least one standard treatment regimen, except for participants in 1st line cohorts.
- ECOG performance status between 0 and 2
- At least 1 lesion with measurable disease at baseline
- Availability of an existing tumor biopsy sample (and consent to allow pre-treatment tumor biopsy)
Exclusion Criteria
- Primary central nervous system (CNS) tumors or solid tumors with CNS metastases as the only site of active disease
- Autoimmune disease
- Encephalitis, meningitis, or uncontrolled seizures in the year prior to informed consent
- Uncontrolled CNS metastases
Other protocol defined inclusion/exclusion criteria could apply
Data sourced from ClinicalTrials.gov (NCT01968109). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.