Evaluation of Administration Route Preference for Nivolumab and Relatlimab in Melanoma Patients: Subcutaneous Versus Intravenous Delivery

The primary objective of this Phase 2 open-label study is to evaluate **patient preference** for the route of administration of a fixed-dose combination of nivolumab and relatlimab, comparing subcutaneous (SC) administration to intravenous (IV) administration in participants with **melanoma**. This objective is clinically relevant as it may influence treatment adherence and patient satisfaction, potentially impacting overall treatment outcomes.

The secondary objective is to assess the **safety** of the drug when participants switch from intravenous to subcutaneous administration. This evaluation is crucial to ensure that the alternative route of administration does not compromise patient safety, thereby supporting broader clinical application if proven safe.

The clinical trial involves a total of **63 participants** diagnosed with **melanoma**. The study population comprises both male and female subjects, aged 18 years and older, who are not pregnant or breastfeeding. Participants include individuals with either metastatic melanoma who have not received prior treatment for their cancer, or those with resected melanoma who have undergone complete surgical removal of the cancer no more than 12 weeks before the commencement of treatment, with a confirmed disease-free status. The participants are required to have a low level of disability and present with cancer that is either advanced in the case of metastatic melanoma or at risk of becoming advanced (intermediate) or advanced for resected melanoma. The trial population was selected based on these criteria, ensuring a focus on individuals with advanced or potentially advancing melanoma. Lifestyle considerations such as diet, physical activity, or habits are not specified in the available data.

The clinical trial is designed as a **Phase II**, open-label, two-cohort study to evaluate patient preference for the route of administration of **nivolumab** and **relatlimab** in participants with **melanoma**. The trial will compare subcutaneous (SC) administration versus intravenous (IV) administration of these drugs. The study is expected to commence recruitment on January 6, 2024, and conclude by September 28, 2027. Participants will be randomly assigned to receive either the SC or IV formulation, with the primary endpoint being the percentage of participants who prefer the SC route over the IV route. Secondary endpoints include the assessment of side effects and abnormal laboratory tests during the study.

Participants will undergo a series of study visits, beginning with an inclusion (screening) visit to confirm eligibility based on criteria such as age, cancer status, and health condition. Eligible participants are adults aged 18 years or older with either metastatic melanoma or resected melanoma. The screening visit will ensure that participants have a low level of disability and are free of disease if they have undergone surgery. Following the screening, participants will attend regular follow-up visits to monitor their response to treatment and any adverse effects. The end-of-study visit will conclude the trial, where final assessments will be conducted.

The expected length of participant involvement in the trial is determined by the treatment period, which may vary depending on individual response and tolerance to the medication. Conditions that may lead to early termination from the study include significant adverse reactions, withdrawal of consent, or any medical condition that contraindicates continued participation. The trial is not classified as low intervention, and it is conducted under the sponsorship of Bristol-Myers Squibb International Corporation, utilizing their products in the study.

The clinical trial involves the administration of **Nivolumab/Relatlimab**, a **solution for infusion** developed by Bristol-Myers Squibb International Corporation. This experimental medication is administered via **intravenous infusion**. The specific dosage and frequency of administration are not detailed in the provided data. The formulation is not a pediatric formulation, and it is not classified as an orphan drug. The maximum treatment period is indicated as 9999 days, suggesting an extended duration of administration, although specific dosing schedules are not provided.

Another treatment in the trial is **OPDIVO 10 mg/mL**, a concentrate for solution for infusion containing **nivolumab**. This product is also administered intravenously. The maximum daily dose is 480 mg, with a total maximum dose of 960 mg over a treatment period of 8 weeks. This product is authorized for use in the European Union and is manufactured by Bristol-Myers Squibb Pharma EEIG. The formulation is not intended for pediatric use and is not designated as an orphan drug.

The trial also includes the administration of **FDC Nivolumab + Relatlimab + rHuPH20 Injection**, a **solution for injection**. This formulation is administered via the **subcutaneous route**. The specific dosage and frequency of administration are not provided, and the maximum treatment period is indicated as 9999 days. This product is developed by Bristol-Myers Squibb International Corporation and is not a pediatric formulation or an orphan drug.

Lastly, the trial involves **Nivolumab Subcutaneous**, a **solution for injection** administered subcutaneously. The specific dosage and frequency of administration are not detailed, and the maximum treatment period is also indicated as 9999 days. This product is manufactured by Bristol-Myers Squibb International Corporation and is not intended for pediatric use or classified as an orphan drug.

Efficacy in this clinical trial will be assessed primarily through the evaluation of participant preference for the administration route of the treatment. The primary endpoint is the percentage of participants who prefer the subcutaneous (SC) administration of the **nivolumab** and **relatlimab** fixed-dose combination over the intravenous (IV) route. This preference will be measured and collected through participant feedback during the study.

Secondary endpoints include the assessment of side effects and any abnormal laboratory test results that occur during the trial. These will be monitored to ensure the safety and tolerability of the treatment regimens. The trial is designed to compare the SC and IV administration routes in participants with melanoma, focusing on both metastatic and resected cases. The study will involve a systematic collection of data at specified intervals to analyze the efficacy and safety outcomes effectively.