6/29/23, 1:09 AM RELATIVITY-047 Pathway Feedback Search Clinical Topics Home Studies RELATIVITY 047 RELATIVITY 047 Disease Cutaneous melanoma Trial question Is relatlimab-nivolumab combination therapy superior to nivolumab monotherapy in patients with untreated advanced melanoma? Study design Multi-center Double blinded RCT Population Characteristics of study participants 42.0% female N = 714 58.0% male 714 patients (298 female, 416 male) Inclusion criteria: patients with previously untreated metastatic or unresectable melanoma Key exclusion criteria: uveal melanoma and active, untreated brain or leptomeningeal metastases Interventions N=355 relatlimab-nivolumab (intravenous infusion of 160 mg relatlimab and 480 mg nivolumab in a fixed-dose combination every 4 weeks) N=359 nivolumab (intravenous infusion of 480 mg every 4 weeks) Primary outcome Median progression-free survival https://web.pathway.md/studies/rec1UylQmvwqScDQn 1/2 6/29/23, 1:09 AM RELATIVITY-047 Pathway 10.1 months 10.1 7.6 months 5.0 months 4.6 2.5 months Significant increase 0.0 months Relatlimab-nivolumab Nivolumab Significant increase in median progression-free survival (10.1 months vs. 4.6 months; HR 1.33, 95% CI 1.09 to 1.61) Secondary outcomes Borderline significant increase in progression-free survival for 1% lymphocyte-activation gene 3 expression (12.6 months vs. 4.8 months; HR 1.33, 95% CI 1.05 to 1.69) No significant difference in progression-free survival for 1% programmed death ligand 1 expression (15.7 months vs. 14.7 months; HR 1.05, 95% CI 0.75 to 1.47) No significant difference in progression-free survival with BRAF mutation (10.1 months vs. 4.6 months; HR 1.35, 95% CI 0.97 to 1.85) Safety outcomes No significant difference in health-related quality of life. Conclusion In patients with previously untreated metastatic or unresectable melanoma, relatlimab-nivolumab was superior to nivolumab with respect to median progression-free survival. Reference Hussein A Tawbi, Dirk Schadendorf, Evan J Lipson et al. Relatlimab and Nivolumab versus Nivolumab in Untreated Advanced Melanoma. N Engl J Med. 2022 Jan 6;386(1):24-34. Open reference URL https://web.pathway.md/studies/rec1UylQmvwqScDQn 2/2