Study to Identify the Optimal Adjuvant Combination Scheme of Ipilimumab and Nivolumab in Melanoma Patients
- Sponsor
- The Netherlands Cancer Institute
- Study ID
- NCT02437279
- Phase
- PHASE1
- Status
- Unknown
Conditions
- Stage III Skin Melanoma
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- Surgery of the tumor — PROCEDURE
- Infusion with ipilimumab 3 mg/kg q3wks — DRUG
- Infusion with nivolumab 1 mg/kg q3wks — DRUG
Study Details
This is a two-arm Phase 1b feasibility trial consisting of 20 patients receiving the combination of ipilimumab+nivolumab, either adjuvant, or split neo-adjuvant and adjuvant.
Key Dates
- Start date
- Nov 24, 2016
- Status verified
- Apr 2022
- Primary completion
- Jun 28, 2018
- Completion
- Jun 30, 2025
Study Design
- Enrollment
- 20 participants (actual)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- TREATMENT
Arms
- Active Comparator: Arm APost-surgery infusion for 12 weeks with the combination of ipilimumab+nivolumab
- Active Comparator: Arm BA split design 6 weeks upfront surgery and 6 weeks post-surgery infusion with the combination of ipilimumab+nivolumab
Primary Outcome Measure
The alteration in magnitude of the neo-antigen specific T cell response in the time interval pre- to post-adjuvant therapy in peripheral blood [ Time Frame: 12 weeks from baseline ]