NCT04620200

Neo-adjuvant Nivolumab or Nivolumab With Ipilimumab in Advanced Cutaneous Squamous Cell Carcinoma Prior to Surgery

Neo-adjuvant Nivolumab or Nivolumab With Ipilimumab in Advanced Cutaneous Squamous Cell Carcinoma Patients Prior to Standard of Care Surgery; the MATISSE Trial

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 50 (actual)
• Sponsor: The Netherlands Cancer Institute · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

To determine the histopathological response rate to neo-adjuvant nivolumab and nivolumab plus ipilimumab at time of standard of care(surgery ± radiotherapy).in patients with cutaneous squamous cell carcinoma.

Detailed description

This is an investigator-initiated randomized non-comparative phase II trial consisting of 40 patients with resectable stage III-IVa CSCC randomized 1:1 to ARM A: 2 courses of nivolumab 3 mg/kg in week 0 and 2, or ARM B: 2 courses of nivolumab 3 mg/kg in week 0 and 2 plus 1 course of ipilimumab 1mg/kg in week 0. Both treatment arms are neo-adjuvant and applied prior to standard of care (consisting of surgery at week 4 with or without adjuvant radiotherapy).

Conditions

• Cutaneous Squamous Cell Carcinoma

Interventions

Type	Name	Description
DRUG	Nivolumab	3mg/kg
DRUG	Ipilimumab	1mg/kg

Timeline

• Start date: 2020-08-11
• Primary completion: 2025-01-07
• Completion: 2025-01-07
• First posted: 2020-11-06
• Last updated: 2025-08-11

Locations

1 site across 1 country: Netherlands

Regulatory

• FDA-regulated drug study