Trial results for a Phase 2 study (NCT06101134) evaluating patient preference for subcutaneous (SC) versus intravenous (IV) administration of Nivolumab and Nivolumab + Relatlimab fixed-dose combinations in melanoma were posted on ClinicalTrials.gov on 2026-04-09. The study found that 78.0% of participants with metastatic melanoma and 70.8% of those with resected melanoma preferred the subcutaneous route of administration.
Background
Nivolumab is an immunotherapy used in the treatment of various cancers, including melanoma. This study focused on assessing patient preference for different routes of administration for nivolumab, alone or in combination with relatlimab, for melanoma patients.
Trial design
The study (NCT06101134) was a Phase 2 trial with an enrollment of 100 participants diagnosed with melanoma. The trial's primary objective was to evaluate patient preference for subcutaneous (SC) administration of nivolumab or nivolumab + relatlimab fixed-dose combination (FDC) compared to intravenous (IV) administration. The study also aimed to gather patient experience data by route of administration and characterize the safety profile of patients switching administration routes. Interventions included nivolumab, nivolumab + rhuph20, relatlimab + nivolumab, and relatlimab + nivolumab + rhuph20.
Key results
The key results focused on patient preference for the subcutaneous (SC) route of administration, as measured by the Patient Experience and Preference Questionnaire (PEPQ) after Cycle 4 Day 1 dose.
- Among evaluable participants with metastatic melanoma (Cohort 1), 78.0% preferred the SC route of administration.
- Among evaluable participants with resected melanoma (Cohort 2), 70.8% preferred the SC route of administration.
Regarding safety, 47 participants in Cohort 1 (Metastatic Melanoma) and 47 participants in Cohort 2 (Resected Melanoma) experienced adverse events or deaths.
What this means
These results indicate a strong patient preference for subcutaneous administration of nivolumab and nivolumab + relatlimab in both metastatic and resected melanoma populations. This preference for a less invasive and potentially more convenient administration route could improve patient experience and adherence to treatment. The collection of safety data during the switch from intravenous to subcutaneous administration also provides important information for future clinical practice.
Source
The information regarding these trial results was obtained from ClinicalTrials.gov, a public database of clinical studies. The results for study NCT06101134, titled 'A Study to Evaluate Whether Participants With Melanoma Prefer Subcutaneous vs Intravenous Administration of Nivolumab and Nivolumab + Relatlimab Fixed-dose Combinations', were posted on 2026-04-09 on clinicaltrials.gov.