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
Location: See all (5) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 18 years of age or older

• UV-related stage I to IVa CSCC with an indication for extensive or disfiguring surgery

• Stage III-IVa CSCC (T3-4N0-3M0 or T0N1-3M0) or multi-focal stage I-II CSCC

• Primary tumour site: vermillion border lip (C00.0, C00.1, C00.2), skin of lip NOS (C44.0), external ear (C44.2), skin face unspecified (ao: external lip and vestibulum nasi) (C44.3), skin scalp and neck (C44.4), overlapping lesion of skin (C44.8), primary site eyelid (C44.1), other body sites: CSCC outside head and neck area, but not vulva, anus or penis.

• World Health Organisation (WHO) performance status of 0-2

• Indication for SOC surgery with curative intent ± RT

• Screening laboratory values must meet the following criteria: WBC ≥ 2.0x109/L, Neutrophils ≥1.5x109 /L, Platelets ≥100 x109 /L, Haemoglobin ≥5.5 mmol/L, Creatinine ≤1.5x upper limit of normal (ULN), AST ≤ 1.5 x ULN, ALT ≤ 1.5 x ULN, Bilirubin ≤1.5 X ULN (except patients with Gilbert Syndrome, who are eligible when total bilirubin \< 3.0 mg/dL).

• Women of child-bearing potential (WOCBP) must use appropriate method(s) of contraception. They should use an adequate method to avoid pregnancy for 23 weeks (30 days plus the time required time for nivolumab to undergo five x T1/2) after the last dose of the IMP.

• WOCBP must have a negative serum or urine pregnancy test (minimum sensitivity 25IU/L or equivalent units of HCG) prior to the start of ICB.

• Patients willing and able to understand the Dutch study information and protocol requirements and comply with the treatment/intervention schedule, scheduled visits, and other requirements of the study.

Locations
Other Locations
Netherlands
Amsterdam UMC
NOT_YET_RECRUITING
Amsterdam
Netherlands Cancer Institute - Antoni van Leeuwenhoek
RECRUITING
Amsterdam
Maastricht UMC
NOT_YET_RECRUITING
Maastricht
Erasmus MC
NOT_YET_RECRUITING
Rotterdam
UMC Utrecht
NOT_YET_RECRUITING
Utrecht
Contact Information
Primary
Lotje Zuur, Prof. Dr.
c.zuur@nki.nl
+31205129111
Backup
Stan W. van Dijk, MD
matisse2@nki.nl
+31205129111
Time Frame
Start Date: 2025-05-14
Estimated Completion Date: 2029-02
Participants
Target number of participants: 41
Treatments
Experimental: Neoadjuvant nivolumab + ipilimumab
Intravenous neoadjuvant nivolumab 3 mg/kg in week 0 and 2 in combination with intravenous neoadjuvant ipilimumab 1 m/kg in week 0.
Sponsors
Collaborators: UMC Utrecht, Amsterdam UMC, location VUmc, Maastricht University Medical Center, Erasmus Medical Center
Leads: The Netherlands Cancer Institute

This content was sourced from clinicaltrials.gov