NCT02437279

Study to Identify the Optimal Adjuvant Combination Scheme of Ipilimumab and Nivolumab in Melanoma Patients

Feasibility Study to Identify the Optimal Adjuvant Combination Scheme of Ipilimumab and Nivolumab in Stage III Melanoma Patients

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: The Netherlands Cancer Institute · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

Patients with stage III melanoma with palpable disease, naïve for CTLA-4/PD-1/PD-L1 immunotherapy, will be treated either post-surgery for 12 weeks with the combination of ipilimumab+nivolumab or in a split design for 6 weeks upfront surgery and for 6 weeks postsurgery. It is a two-arm Phase 1b feasibility trial consisting of 20 patients, 10 in each arm. At different timepoints tumor biopsies and blood for PBMCs will be taken for translational research. Also scans will be done on specific timepoints. The study will be held to determine safety, feasibility, and the immune-activating capacity of short-term combined neo-adjuvant and adjuvant ipilimumab + nivolumab. And to determine relapse free survival (RFS), any late adverse events, pharmacokinetics/pharmacodynamics, and the correlation between RFS and changes in neo-antigen specific T cell response.

Conditions

• Stage III Skin Melanoma

Interventions

Type	Name	Description
PROCEDURE	Surgery of the tumor
DRUG	Infusion with ipilimumab 3 mg/kg q3wks
DRUG	Infusion with nivolumab 1 mg/kg q3wks

Timeline

• Start date: 2016-11-24
• Primary completion: 2018-06-28
• Completion: 2025-06-01
• First posted: 2015-05-07
• Last updated: 2022-04-15

Locations

1 site across 1 country: Netherlands