Opdualag (nivolumab/relatlimab-rmbw) / BMS, Ono Pharmaceutical - LARVOL DELTA

Nivolumab plus relatlimab vs nivolumab alone for the adjuvant treatment of completely resected stage III–IV melanoma: Primary results from RELATIVITY-098. (ASCO 2025) - P3 | "NIVO + RELA did not result in significant RFS improvement vs NIVO alone as adjuvant treatment for pts after complete resection of stage III–IV melanoma. The safety profile of NIVO + RELA in this setting was generally consistent with results from RELATIVITY-047. A robust biomarker analysis for the study is currently underway."

Clinical • Late-breaking abstract • Melanoma • Oncology • Solid Tumor • RELA

Nivolumab (NIVO) plus relatlimab (RELA) vs NIVO in previously untreated metastatic or unresectable melanoma: 2-year subgroup analyses from RELATIVITY-047 (ESMO 2023) - P2/3 | "Additional analyses will be presented. Table: 1103P"

Metastases • Melanoma • Oncology • Solid Tumor • RELA

Nivolumab (NIVO) + relatlimab (RELA) versus NIVO in previously untreated metastatic or unresectable melanoma: OS and ORR by key subgroups from RELATIVITY-047. (ASCO 2022) - P2/3 | "NIVO + RELA was favored over NIVO across key subgroups for PFS, OS, and ORR, and findings appeared consistent with outcomes in the overall population. NIVO + RELA had a favorable benefit-risk profile."

IO biomarker • Melanoma • Oncology • Solid Tumor • BRAF • LAG3 • PD-L1 • RELA

Nivolumab (NIVO) plus relatlimab (RELA) vs NIVO in previously untreated metastatic or unresectable melanoma: 2-year results from RELATIVITY-047. (ASCO 2023) - P2/3 | "With 12.3 months of additional follow-up, a consistent benefit was observed with NIVO + RELA vs NIVO for PFS, OS and ORR in the ITT population, as well as in key patient subgroups. MSS was longer with NIVO + RELA compared with NIVO. The safety profile of NIVO + RELA remained consistent with previous reports, with no new or unexpected safety signals."

Metastases • Melanoma • Oncology • Solid Tumor • RELA

Radiation Therapy and Nivolumab with Relatlimab-rmbw Achieved a Complete Response in Metastatic Cutaneous Melanoma to the Orbit. (PubMed, Ophthalmic Plast Reconstr Surg) - "We present a patient with left orbital metastasis of cutaneous melanoma, treated with 30 Gy in 10 fraction radiation therapy followed by a combination of programmed death-1 inhibitor, nivolumab, and lymphocyte-activation gene inhibitor, relatlimab. The patient achieved a complete response to treatment, with no evidence of recurrence of the orbital mass, 17 months after treatment initiation."

Journal • Cutaneous Melanoma • Melanoma • Oncology • Solid Tumor

First-Line Nivolumab and Relatlimab Plus Chemotherapy for Gastric or Gastroesophageal Junction Adenocarcinoma: The Phase II RELATIVITY-060 Study. (PubMed, J Clin Oncol) - "RELATIVITY-060 did not meet its primary end point of improved ORR in patients with LAG-3 expression ≥1% when relatlimab was added to nivolumab + chemotherapy compared with nivolumab + chemotherapy. Further studies are needed to address whether adding anti-LAG-3 to anti-PD-1 plus chemotherapy can benefit specific GC/GEJC patient subgroups."

IO biomarker • Journal • P2 data • Esophageal Cancer • Gastric Cancer • Gastroesophageal Junction Adenocarcinoma • Gastrointestinal Cancer • Oncology • Solid Tumor

First-Line Nivolumab Plus Relatlimab Versus Nivolumab Plus Ipilimumab in Advanced Melanoma: An Indirect Treatment Comparison Using RELATIVITY-047 and CheckMate 067 Trial Data. (PubMed, J Clin Oncol) - "Nivolumab plus relatlimab demonstrated similar efficacy to nivolumab plus ipilimumab in the overall population, including most-but not all-subgroups, and improved safety in patients with untreated advanced melanoma. Results should be interpreted with caution."

Journal • Metastases • Melanoma • Oncology • Solid Tumor • BRAF

Neo ReNi II: A Phase 2 Clinical Trial of Neoadjuvant Relatlimab and Nivolumab in High Risk, Clinical Stage II Cutaneous Melanoma (clinicaltrials.gov) - P2 | N=20 | Active, not recruiting | Sponsor: Melanoma Institute Australia | Trial completion date: Jan 2036 ➔ Oct 2035

Trial completion date • Cutaneous Melanoma • Melanoma • Oncology • Solid Tumor • BRAF

Nivolumab and Relatlimab in Patients With Advanced Melanoma That Had Progressed on Anti-Programmed Death-1/Programmed Death Ligand 1 Therapy: Results From the Phase I/IIa RELATIVITY-020 Trial. (PubMed, J Clin Oncol) - "Nivolumab and relatlimab had a manageable safety profile and demonstrated durable clinical activity in a proportion of patients with heavily pretreated advanced melanoma with prior progression on anti-PD-(L)1-containing regimens."

Journal • Metastases • P1/2 data • Cardiovascular • Melanoma • Oncology • Solid Tumor • LAG3

Hepzato Kit and Opdualag for Metastatic Melanoma and Liver Metastasis (clinicaltrials.gov) - P1/2 | N=15 | Recruiting | Sponsor: University of Wisconsin, Madison | Not yet recruiting ➔ Recruiting

Enrollment open • Melanoma • Oncology • Solid Tumor • BRAF

Nivolumab plus relatlimab in advanced melanoma: RELATIVITY-047 4-year update. (PubMed, Eur J Cancer) - P2/3 | "With 4 years of follow-up, nivolumab plus relatlimab demonstrated durable improvement in outcomes versus nivolumab monotherapy for patients with previously untreated advanced melanoma. The durable benefit observed comes at a lower toxicity cost compared with other immuno-oncology combinations."

Journal • Melanoma • Oncology • Solid Tumor

Neoadjuvant relatlimab and nivolumab in resectable melanoma. (PubMed, Nature) - P2 | "Safety during neoadjuvant therapy is favourable compared to other combination immunotherapy regimens. These data, in combination with the results of the RELATIVITY-047 trial, provide further confirmation of the efficacy and safety of this new immunotherapy regimen."

Journal • Melanoma • Oncology • Solid Tumor

Three-Year Overall Survival With Nivolumab Plus Relatlimab in Advanced Melanoma From RELATIVITY-047. (PubMed, J Clin Oncol) - P2/3 | "Overall, at 3-year follow-up, the benefit observed with nivolumab plus relatlimab compared with nivolumab in patients with advanced melanoma was sustained, with the OS HR 95% CI upper bound now <1. This benefit is accompanied by a safety profile consistent with previous reports."

Journal • Metastases • Melanoma • Oncology • Solid Tumor

Nivolumab (NIVO) + relatlimab (RELA) vs NIVO in previously untreated metastatic or unresectable melanoma: Additional response outcomes from RELATIVITY-047 (ESMO 2022) - P2/3 | "In both arms, pts who responded to treatment had substantially improved PFS and OS vs nonresponders. Table: 817P Responder: complete or partial response; Nonresponder: stable disease, progressive disease, noncomplete response or nonprogressive disease.CI, confidence interval; NR, not reached."

Melanoma • Oncology • Solid Tumor • RELA

Relatlimab and Nivolumab versus Nivolumab in Untreated Advanced Melanoma. (PubMed, N Engl J Med) - P2/3 | "The inhibition of two immune checkpoints, LAG-3 and PD-1, provided a greater benefit with regard to progression-free survival than inhibition of PD-1 alone in patients with previously untreated metastatic or unresectable melanoma. Relatlimab and nivolumab in combination showed no new safety signals. (Funded by Bristol Myers Squibb; RELATIVITY-047 ClinicalTrials.gov number, NCT03470922.)."

Journal • Immune Modulation • Inflammation • Melanoma • Oncology • Solid Tumor • LAG3

PRAC adopted an extension of indication for OPDUALAG for first-line treatment of advanced melanoma (unresectable or metastatic) in patients ≥12 years with PD-L1 ≥1%, based on 4-year CA224047 data. The SmPC sections 4.1, 4.2, 4.4, 4.8, and 5.1 and the Package Leaflet were updated, including removal of Annex IV. (European Medicines Agency) - Pharmacovigilance Risk Assessment Committee (PRAC)-Draft agenda for the meeting on 12 – 15 Jan 2026: [AI generated summary]

PRAC • Hematological Malignancies • Melanoma • Oncology

Neoadjuvant and Adjuvant Anti-PD1 or Combinations for Locoregionally Advanced Melanoma (clinicaltrials.gov) - P2 | N=90 | Recruiting | Sponsor: H. Lee Moffitt Cancer Center and Research Institute | Trial completion date: Jul 2027 ➔ Nov 2028 | Trial primary completion date: Jul 2027 ➔ Nov 2028

IO biomarker • Trial completion date • Trial primary completion date • Melanoma • Oncology • Solid Tumor • BRAF • PD-L1

Interleukin-6 Receptor Inhibitor Sarilumab in Combination With Ipilimumab, Nivolumab and Relatlimab in Patients With Unresectable Stage III or Stage IV Melanoma (clinicaltrials.gov) - P2 | N=105 | Recruiting | Sponsor: NYU Langone Health | N=69 ➔ 105 | Trial completion date: Dec 2025 ➔ Feb 2028 | Trial primary completion date: Jun 2025 ➔ Aug 2026

Enrollment change • Trial completion date • Trial primary completion date • Mucosal Melanoma • Oncology • Solid Tumor

Drug-Induced Bullous Pemphigoid Triggered by Immune Checkpoint Inhibitor Opdualag in an Elderly Patient With Recurrent Metastatic Melanoma: A Case Report and Treatment Course With Dupilumab. (PubMed, Cureus) - "We present the case of an 81-year-old male with a history of recurrent metastatic melanoma previously treated with nivolumab and relatlimab (Opdualag), who developed a persistent pruritic eruption following initiation of dual PD-1/LAG-3 blockade. Despite discontinuation of immunotherapy six months before dermatologic evaluation and use of multiple topical corticosteroids and oral antihistamines, symptoms persisted...At follow-up, the patient reported persistent activity, receiving intramuscular triamcinolone acetonide and adjunctive therapies, including hydroxyzine, hydrocortisone 2.5% cream (for groin), and triamcinolone 0.1% ointment...This case illustrates the diagnostic and therapeutic challenges in managing ICI-induced BP and highlights the early course of dupilumab therapy, which had not yet produced clinical improvement at the time of last follow-up. Continued therapy was planned, and no adverse effects were reported."

Checkpoint inhibition • Journal • Bullous Pemphigoid • Dermatology • Dermatopathology • Immunology • Melanoma • Oncology • Solid Tumor • Urticaria • LAG3

Opdualag vs. Cemiplimab/Fianlimab in Relation to the Immunological Response in Tumor and Peripheral Blood in Unresectable or Metastatic Melanoma (clinicaltrials.gov) - P=N/A | N=20 | Recruiting | Sponsor: John Kirkwood | Not yet recruiting ➔ Recruiting

Enrollment open • Hepatocellular Cancer • Melanoma • Oncology • Solid Tumor

Hepzato Kit and Opdualag for Metastatic Melanoma and Liver Metastasis (clinicaltrials.gov) - P1/2 | N=15 | Not yet recruiting | Sponsor: University of Wisconsin, Madison

New P1/2 trial • Melanoma • Oncology • Solid Tumor

A Study of IO102/IO103, Nivolumab, and Relatlimab in People With Melanoma (clinicaltrials.gov) - P2 | N=43 | Active, not recruiting | Sponsor: Memorial Sloan Kettering Cancer Center | Recruiting ➔ Active, not recruiting

Enrollment closed • Melanoma • Oncology • Solid Tumor • BRAF

RELATIVITY 059: A Study to Assess Relatlimab and Nivolumab Fixed-dose Combination in Chinese Participants With Advanced Solid Tumors (clinicaltrials.gov) - P1/2 | N=24 | Completed | Sponsor: Bristol-Myers Squibb | Active, not recruiting ➔ Completed

Trial completion • Solid Tumor

Neo ReNi II: A Phase 2 Clinical Trial of Neoadjuvant Relatlimab and Nivolumab in High Risk, Clinical Stage II Cutaneous Melanoma (clinicaltrials.gov) - P2 | N=20 | Active, not recruiting | Sponsor: Melanoma Institute Australia | Recruiting ➔ Active, not recruiting

Enrollment closed • Cutaneous Melanoma • Melanoma • Oncology • Solid Tumor • BRAF

Favezelimab in Combination with Pembrolizumab in Patients with Anti–PD-1–Naive Relapsed or Refractory Classical Hodgkin Lymphoma: Updated Analysis of an Open-Label Phase 1/2 Study (ASH 2023) - P1/2 | "With additional follow-up, the combination of favezelimab and pembrolizumab continued to demonstrate sustained antitumor activity and manageable safety in patients with anti–PD-1–naive R/R cHL. Analyses are underway to identify biomarkers predictive of response to the combination of favezelimab and pembrolizumab. Further studies to investigate this combination are warranted."

Clinical • Combination therapy • IO biomarker • P1/2 data • Classical Hodgkin Lymphoma • Endocrine Disorders • Fatigue • Gastroenterology • Gastrointestinal Disorder • Hematological Malignancies • Hepatology • Hodgkin Lymphoma • Immunology • Lymphoma • Melanoma • Oncology • Pneumonia • Solid Tumor • LAG3