Opdualag (nivolumab/relatlimab-rmbw)

P2, N=90, Recruiting, H. Lee Moffitt Cancer Center and Research Institute | Trial completion date: Jul 2027 --> Nov 2028 | Trial primary completion date: Jul 2027 --> Nov 2028

P2, N=105, Recruiting, NYU Langone Health | N=69 --> 105 | Trial completion date: Dec 2025 --> Feb 2028 | Trial primary completion date: Jun 2025 --> Aug 2026

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.

P1/2, N=15, Not yet recruiting, University of Wisconsin, Madison

P1/2, N=24, Completed, Bristol-Myers Squibb | Active, not recruiting --> Completed

P2, N=20, Active, not recruiting, Melanoma Institute Australia | Recruiting --> Active, not recruiting

P2, N=43, Active, not recruiting, Memorial Sloan Kettering Cancer Center | Recruiting --> Active, not recruiting

P1, N=67, Terminated, TriSalus Life Sciences, Inc. | Active, not recruiting --> Terminated; The decision was made to terminate the study after the completion of Phase 1 enrollment and not proceed with Phase 2. Trial termination was not due to patient safety or data concerns.

The absence of macroscopic tumor and reduced peripheral LAG-3+ T cells may explain the lack of added benefit of nivolumab plus relatlimab over nivolumab in resected versus metastatic melanoma. ClinicalTrials.gov identifier: NCT05002569 .

Based on the hypothetical drug profile presented in the DCE, the fixed dose combination of nivolumab and relatlimab was the preferred regimen in the metastatic disease setting while either pembrolizumab or nivolumab were preferred in the adjuvant setting.Our study highlights the importance of considering patients' prioritization of treatment efficacy as the primary factor when making decisions about melanoma care, both in the adjuvant and metastatic settings. Although efficacy and safety were attributed to have relatively similar importance for treatment preference in the adjuvant setting, patients with more advanced disease or those carrying the BRAF mutation placed heightened emphasis on treatment efficacy.

P2, N=30, Recruiting, M.D. Anderson Cancer Center | Trial completion date: Dec 2026 --> Jul 2028 | Trial primary completion date: Jul 2025 --> Jul 2028

This analysis demonstrated TFS benefit during the 48 months since initiating nivolumab plus relatlimab compared with nivolumab alone in patients with advanced melanoma. A direct comparison between nivolumab plus relatlimab and nivolumab plus ipilimumab is needed to determine the differences between the regimens in TFS and those in traditional endpoints.