NCT06823479

Towards Cure Via Only Ultra-short ICB in CSCC

Towards Organ Preservation and Cure Via Immunotherapy in Cutaneous Squamous Cell Carcinoma Patients, Normally Undergoing Morbid Curative Surgery and Radiotherapy. The MATISSE 2 Trial, an Investigator-initiated Multicentre Phase 2 Trial

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 41 (estimated)
• Sponsor: The Netherlands Cancer Institute · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The goal of this clinical trial is to determine whether cutaneous squamous cell carcinoma patients can be cured using only immunotherapy, without surgery or radiotherapy.

Detailed description

This is an investigator-initiated phase 2 clinical trial consisting of 41 patients with stage I-IVa CSCC and an indication for morbid/extensive curative surgery. All patients will receive two courses of nivolumab 3 mg/kg in week 0 and week 2, and one course of ipilimumab 1 mg/kg in week 0. In week 5 response to immunotherapy will be evaluated using clinical examination, \[18F\]FDG-PET/CT imaging, regional lymph node ultrasound with FNAC (if applicable) and a multicentre multidisciplinary meeting. Non-responders will receive standard of care surgery (w/wo radiotherapy). Responders will enter a wait-and-monitor follow-up schedule in which response will be monitored every 3 months for a total of 2 years. If a patient is no longer responding to immunotherapy during follow-up they will receive standard of care surgery (w/wo radiotherapy).

Conditions

• Cutaneous Squamous Cell Carcinoma (CSCC)
• Cutaneous Squamous Cell Cancer
• Cutaneous Squamous Cell Carcinoma of the Head and Neck
• Cutaneous Squamous Cell Carcinoma

Interventions

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

Timeline

• Start date: 2025-05-14
• Primary completion: 2029-02-01
• Completion: 2029-02-01
• First posted: 2025-02-12
• Last updated: 2025-05-29

Locations

5 sites across 1 country: Netherlands