A Trial Evaluating the Safety & Efficacy of Intra-Tumoral Ipilimumab in Combination With Intra-venous Nivolumab in Patients With Metastatic Melanoma
- Sponsor
- Gustave Roussy, Cancer Campus, Grand Paris
- Study ID
- NCT02857569
- Phase
- PHASE1/PHASE2
- Status
- Completed
Conditions
- Stage III/IV Melanoma
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- Ipilimumab IT — DRUG
- Ipilimumab IV — DRUG
- Nivolumab IV — DRUG
Study Details
The study aims to evaluate the 6 month-treatment tolerance defined as the immune related grade 3-4 adverse event-free survival of the combination therapy IT ipilimumab + IV nivolumab. The IV ipilimumab + IV nivolumab (same doses than in Phase I) arm will be used as an internal control to interpret the results obtained in the IT ipilimumab arm.
Key Dates
- Start date
- Dec 5, 2016
- Status verified
- Feb 2023
- Primary completion
- Jan 31, 2021
- Completion
- May 20, 2022
Study Design
- Enrollment
- 90 participants (actual)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- TREATMENT
Arms
- Experimental: Experimental IT Arm* ipilimumab: 0.3mg/kg IT injection every 3 weeks until complete response, eradication of all injectable sites, disease progression or toxicity, for a maximum of 4 doses (to compare back to back to IV standard of care and marketing authorization). * nivolumab: 1mg/kg, IV injection every 3 weeks during IT ipilimumab treatment period and 3mg/kg, IV injection every 2 weeks after IT ipilimumab treatment interruption. Treatment should be continued as long as clinical benefit is observed or until treatment is no longer tolerated by the patient for a maximum of 12 months.
- Active Comparator: Standard Arm* ipilimumab: 3mg/kg, IV injection every 3 weeks for a maximum of 4 doses as per standard of care and marketing authorization. * nivolumab: 1mg/kg, IV injection every 3 weeks during IV ipilimumab treatment period and 3mg/kg, IV injection every 2 weeks after IV ipilimumab treatment interruption. Treatment should be continued as long as clinical benefit is observed or until treatment is no longer tolerated by the patient for a maximum of 12 months.
Primary Outcome Measure
6-months treatment-related grade 3-4 toxicity event-free survival (EFS). [ Time Frame: Assessed every 28 days after randomization up to 6 months ]