Nivolumab (NIVO), a programmed death-1 immune checkpoint inhibitor, is approved globally as an effective treatment across multiple cancer types. Several studies are investigating subcutaneous (SC) NIVO, co-formulated with recombinant human hyaluronidase PH20 (rHuPH20), as it may benefit patients, clinicians, and the healthcare system. Patients with cancer often prefer SC over IV administration. SC dosing may alleviate the need for IV vein ports, lower the risk of dosing errors, allow more patient flexibility, and reduce dose preparation and administration times, thereby optimizing occupancy in infusion centres. In CheckMate 8KX, SC NIVO + rHuPH20 was well tolerated in patients with different solid tumours and exposures were comparable to IV NIVO 3 mg/kg Q2W (from historical data). Investigations of SC NIVO vs IV NIVO in patients with clear cell renal cell carcinoma (phase 3 CheckMate 67T study) or melanoma following complete resection are ongoing. CheckMate 6GE is a multicentre, randomized, open-label, phase 3 study evaluating the pharmacokinetic (PK) noninferiority of SC NIVO + rHuPH20 vs IV NIVO in patients with melanoma following complete resection. Inclusion criteria are stage IIIA/B/C/D or stage IV melanoma, complete resection ≤ 12 weeks before randomization or treatment assignment, and ECOG performance status ≤ 1. Key exclusion criteria include a history of uveal/mucosal melanoma, untreated/unresected CNS metastases, concurrent malignancy or history of prior malignancy active ≤ 2 years before randomization or treatment assignment, known or suspected autoimmune disease, serious/uncontrolled medical disorder 4 weeks before screening, and prior immunotherapy. Patients (N ≈ 286) are randomized (1:1) to receive SC NIVO or IV NIVO in part 1 (stratified by stage [IIIA/B vs IIIC/D/IV] and weight [< 80 kg vs ≥ 80 kg]) or enrolled in the part 2 PK cohort. PK, safety, efficacy, immunogenicity, and cancer treatment satisfaction will be evaluated (Table).Table: 882TiPPrimary endpointsTime-averaged NIVO serum concentration over the first 28 daysCmin at steady stateSecondary endpointsSafety and tolerability, eg, AEs, serious AEs, immune-mediated AEs, death, administration-related reactions, laboratory abnormalitiesRecurrence-free survivalOverall survivalAdditional PK parameters: Cmin on Day 28, Cmax after the first dose, time to Cmax after the first dose, Cmax at steady state, time-averaged NIVO serum concentration at steady stateImmunogenicity (anti-NIVO and neutralizing antibodies)Cancer Treatment Satisfaction QuestionnaireAE, adverse event; Cmax, maximum NIVO serum concentration; Cmin, minimum NIVO serum concentration. Open table in a new tab AE, adverse event; Cmax, maximum NIVO serum concentration; Cmin, minimum NIVO serum concentration. NCT05297565. Professional medical writing and editorial assistance was provided by George Hsu, PhD, and Matthew Weddig, BA, of Spark Medica Inc., funded by Bristol Myers Squibb. Bristol Myers Squibb.