Trial results for Nivolumab and relatlimab in patients with solid tumors were posted on ClinicalTrials.gov on 2026-01-06. The Phase 1/Phase 2 study, which assessed the safety, tolerability, and effectiveness of these immunotherapies, reported the number of participants experiencing adverse events across various monotherapy and combination arms.
Background
Nivolumab is an anti-PD-1 immunotherapy, and relatlimab is an anti-LAG-3 immunotherapy. Both are used in the treatment of various cancers. This study investigated their use in patients with solid tumors, including non-small cell lung cancer, gastric cancer, hepatocellular carcinoma, renal cell carcinoma, bladder cancer, squamous cell carcinoma of the head and neck, and melanoma, both immunotherapy-naive and previously treated (for NSCLC and melanoma).
Trial design
This completed Phase 1/Phase 2 trial (NCT01968109) enrolled 1482 participants with solid tumors, including non-small cell lung cancer, gastric cancer, hepatocellular carcinoma, renal cell carcinoma, bladder cancer, squamous cell carcinoma of the head and neck, and melanoma. The study assessed the safety, tolerability, and effectiveness of BMS-986016 (relatlimab) administered alone and in combination with nivolumab. It included patients who had not previously been treated with immunotherapy, as well as those with NSCLC and melanoma who had received prior immunotherapy.
Key results
The key results posted focused on safety, specifically the number of participants experiencing adverse events, deaths, and clinically relevant laboratory abnormalities. The findings across different treatment arms were:
- In the BMS-986016 (Relatlimab) Monotherapy 20 Milligram (mg) (Part A) group, 5 Participants experienced these events.
- In the BMS-986016 (Relatlimab) Monotherapy 80 Milligram (mg) (Part A) group, 4 Participants experienced these events.
- In the BMS-986016 (Relatlimab) Monotherapy 240 Milligram (mg) (Part A) group, 4 Participants experienced these events.
- In the BMS-986016 (Relatlimab) Monotherapy 800 Milligram (mg) (Part A/A1) group, 12 Participants experienced these events.
- In the Combination-Escalation-BMS-986016 (Relatlimab)/Nivolumab (20 mg/80 mg) (Part B) group, 7 Participants experienced these events.
- In the Combo-esc--BMS-986016 (Relatlimab)/Nivolumab (20 mg/240 mg (Part B) group, 9 Participants experienced these events.
- In the Combo-esc--BMS-986016 (Relatlimab)/Nivolumab (80 mg/240 mg) (Part B) group, 8 Participants experienced these events.
- In the Combo-esc--BMS-986016 (Relatlimab)/Nivolumab (160 mg/240 mg) (Part B) group, 8 Participants experienced these events.
- In the Combo-esc--BMS-986016 (Relatlimab)/Nivolumab (240 mg/240 mg) (Part B) group, 8 Participants experienced these events.
- In the Combo-esc--BMS-986016 (Relatlimab)/Nivolumab (160 mg/480 mg) (Part B) group, 7 Participants experienced these events.
- In the Combo-esc--BMS-986016 (Relatlimab)/Nivolumab (240 mg/480 mg) (Part B) group, 8 Participants experienced these events.
- In the Combo-esc--BMS-986016 (Relatlimab)/Nivolumab (320 mg/480 mg) (Part B) group, 8 Participants experienced these events.
What this means
The posted results provide initial safety and tolerability data for relatlimab as monotherapy and in combination with nivolumab across various dose levels in patients with solid tumors. The reported numbers of participants experiencing adverse events, deaths, and clinically relevant laboratory abnormalities offer insights into the safety profile of these investigational treatments. These findings are crucial for further development and understanding of the combination therapy in oncology, particularly for determining appropriate dosing and identifying potential safety concerns.
Source
The information regarding these trial results was obtained from ClinicalTrials.gov, a public database of clinical studies. The results for study NCT01968109, titled '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,' were posted on 2026-01-06 on clinicaltrials.gov.