Nivolumab + Relatlimab

DRUG11 trials

Sponsors

Bristol-Myers Squibb, Carlo Contreras, Exelixis, H. Lee Moffitt Cancer Center and Research Institute, Immunocore Ltd

Conditions

Advanced MelanomaCancerClear Cell Renal Cell Carcinoma (ccRCC)Clinical Stage I Cutaneous Melanoma AJCC v8Clinical Stage IA Cutaneous Melanoma AJCC v8Clinical Stage IB Cutaneous Melanoma AJCC v8Clinical Stage II Cutaneous Melanoma AJCC v8Clinical Stage IIA Cutaneous Melanoma AJCC v8

Early Phase 1

Pilot Study of Nivolumab w/Ipilimumab or Relatlimab in Surgically Resectable Melanoma Brain Metastases

CompletedNCT05704933

H. Lee Moffitt Cancer Center and Research InstituteMetastasis to Brain, Metastatic Melanoma

Start: 2023-06-06End: 2024-08-20Updated: 2025-10-20

Phase 1

Intralesional Influenza Vaccine for the Treatment of Stage I-IV Melanoma

RecruitingNCT04697576

Carlo ContrerasClinical Stage IA Cutaneous Melanoma AJCC v8, Clinical Stage IB Cutaneous Melanoma AJCC v8, Clinical Stage I Cutaneous Melanoma AJCC v8 +6

Start: 2021-10-20End: 2027-12-31Target: 36Updated: 2026-03-10

Study of Zanzalintinib in Combination With Immuno-Oncology Agents in Participants With Solid Tumors

RecruitingNCT05176483

ExelixisClear Cell Renal Cell Carcinoma (ccRCC), Colorectal Cancer (CRC), Head and Neck Squamous Cell Carcinoma (HNSCC) +7

Start: 2021-12-14End: 2030-06-28Target: 1314Updated: 2026-03-12

Phase 2

Pan Tumor Rollover Study

RecruitingNCT03899155

Bristol-Myers SquibbCancer

Start: 2019-08-09End: 2029-08-25Target: 1500Updated: 2026-04-01

Neoadjuvant and Adjuvant Anti-PD1 or Combinations for Locoregionally Advanced Melanoma

RecruitingNCT06295159

H. Lee Moffitt Cancer Center and Research InstituteAdvanced Melanoma, Melanoma, Melanoma Stage III +1

Start: 2024-05-17End: 2028-11-01Target: 90Updated: 2026-04-01

Phase 3

A Study of Subcutaneous Nivolumab + Relatlimab Fixed-dose Combination (FDC) in Previously Untreated Metastatic or Unresectable Melanoma

Active, not recruitingNCT05625399

Bristol-Myers SquibbMelanoma

Start: 2023-03-06End: 2027-11-18Updated: 2025-08-24

IMC-F106C Regimen Versus Nivolumab Regimens in Previously Untreated Advanced Melanoma (PRISM-MEL-301)

RecruitingNCT06112314

Immunocore LtdAdvanced Melanoma

Start: 2024-06-05End: 2027-10-16Target: 680Updated: 2026-02-25

VO and Nivolumab vs Physician's Choice in Advanced Melanoma That Progressed on Anti-PD-1 & Anti-CTLA-4 Drugs [IGNYTE-3]

RecruitingNCT06264180

Replimune Inc.Advanced Melanoma

Start: 2024-07-11End: 2034-08-31Target: 400Updated: 2026-03-13

Phase 4

A Study To Assess the Safety, and Tolerability of Nivolumab + Relatlimab Fixed-Dose Combination (FDC) In Untreated, Unresectable or Metastatic Melanoma Participants In India

Not yet recruitingNCT07459543

Bristol-Myers SquibbMetastatic Melanoma, Unresectable Melanoma, Untreated Melanoma

Start: 2026-11-15End: 2029-05-28Target: 30Updated: 2026-03-09

Unknown Phase

Outcomes of Nivolumab in Combination With Relatlimab in Patients With Advanced Melanoma in the Flatiron Database

CompletedNCT07079644

Bristol-Myers SquibbAdvanced Melanoma

Start: 2024-11-29End: 2025-03-31Updated: 2025-07-23

Real-world Outcomes Among Patients With Melanoma Treated With Neoadjuvant Nivolumab+Relatlimab or Nivolumab+Ipilimumab

CompletedNCT07091695

Bristol-Myers SquibbMelanoma

Start: 2025-05-11End: 2025-11-06Updated: 2025-11-12

Related Papers

Zanzalintinib (zanza) + nivolumab (nivo) ± relatlimab (rela) in patients (pts) with previously untreated clear cell renal cell carcinoma (ccRCC): Results from an expansion cohort of the phase 1b STELLAR-002 study.

Journal of Clinical Oncology2025-05-281 citations

A randomized, controlled, multicenter, phase 3 study of vusolimogene oderparepvec combined with nivolumab vs treatment of physician’s choice in patients with advanced melanoma that has progressed on anti–PD-1 and anti–CTLA-4 therapy (IGNYTE-3).

Journal of Clinical Oncology2025-05-28

Zanzalintinib (zanza) + nivolumab (nivo) ± relatlimab (rela) in patients (pts) with advanced solid tumors: Results from two dose-escalation cohorts of the phase 1b STELLAR 002 study.

Journal of Clinical Oncology2025-05-28

STELLAR-304: a phase III study of zanzalintinib (XL092) plus nivolumab in advanced non-clear cell renal cell carcinoma

Future Oncology2025-02-261 citations

Recent Advancements in Cell-Based Therapies in Melanoma.

2024-09-124 citations

Neues vom ASCO 2024 zum Melanom

JDDG Journal der Deutschen Dermatologischen Gesellschaft2024-08-01

Phase 1 safety and efficacy of IMC-F106C, a PRAME × CD3 ImmTAC bispecific, in post-checkpoint cutaneous melanoma (CM).

Journal of Clinical Oncology2024-06-0112 citations

A phase 3 trial of IMC-F106C (PRAME x CD3) plus nivolumab versus standard nivolumab regimens in HLA-A*02:01+ patients with previously untreated advanced melanoma (PRISM-MEL-301).

Journal of Clinical Oncology2024-06-016 citations

A randomized, controlled, multicenter, phase 3 study of vusolimogene oderparepvec (VO) combined with nivolumab vs treatment of physician’s choice in patients with advanced melanoma that has progressed on anti–PD-1 and anti–CTLA-4 therapy (IGNYTE-3).

Journal of Clinical Oncology2024-06-016 citations

A phase 2, open-label, 2-cohort study to evaluate patient preference for nivolumab (NIVO) + relatlimab (RELA) fixed-dose combination (FDC) subcutaneous (SC) vs NIVO + RELA FDC intravenous (IV) and NIVO SC vs NIVO IV in participants with melanoma.

Journal of Clinical Oncology2024-06-011 citations

Zanzalintinib in combination with immune checkpoint inhibitors: Design of the renal cell carcinoma expansion stage cohorts in STELLAR-002

The Oncologist2023-08-232 citations

TIPS-04 A RANDOMIZED, MULTI-INSTITUTIONAL PILOT STUDY TO EVALUATE THE MOLECULAR AND CELLULAR RESPONSE TO TREATMENT WITH NIVOLUMAB WITH EITHER ADJUVANT IPILIMUMAB OR RELATLIMAB IN ADULT PATIENTS WITH SURGICALLY RESECTABLE MELANOMA BRAIN METASTASES: ONGOING TRIAL

Neuro-Oncology Advances2023-08-01

742 A multicohort phase 1b study (STELLAR-002) of XL092 in combination with immunotherapy in patients with advanced solid tumors

Regular and Young Investigator Award Abstracts2022-11-01

A phase 1b study (STELLAR-002) of XL092 administered in combination with nivolumab (NIVO) with or without ipilimumab (IPI) or bempegaldesleukin (BEMPEG) in patients (pts) with advanced solid tumors.

Journal of Clinical Oncology2022-06-015 citations