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Towards Cure Via Only Ultra-short ICB in CSCC | Clinical Trials | Clareo Health

RECRUITINGPHASE2

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

NCT06823479•The Netherlands Cancer Institute

View on ClinicalTrials.gov

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).

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•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.

Exclusion Criteria

•Distantly metastasized (stadium IVb) CSCC
•SCC localized in a mucosal surface (i.e. anus, vulva, penis or mucosal portion of lip)
•Patients for whom standard of care treatment consists of definitive (brachy)radiotherapy
•Primary or recurrent CSCC appearing in an area that has been previously irradiated
•Prior systemic therapy or immunotherapy.
•Active human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome (AIDS)
•Positive test for hepatitis B virus surface antigen (HBsAg) or hepatitis C antibody (HCV Ab)
•Subjects with any active autoimmune disease or a documented history of autoimmune disease, except: subjects with vitiligo, resolved childhood asthma/atopy, residual hypothyroidism due to an autoimmune condition requiring only hormone replacement, psoriasis not requiring systemic treatment, any condition not expected to recur in the absence of an external trigger.
•Underlying medical conditions that, in the investigator's opinion, will make the administration of the study drug hazardous or obscure the interpretation of toxicity or AEs
•Concurrent medical condition requiring the use of immunosuppressive medications, or immunosuppressive doses of systemic or absorbable topical corticosteroids (up to 5 mg of prednisone per day is allowed)
+3 more criteria

Locations (5)

Maastricht UMC

Maastricht, Limburg, Netherlands

Netherlands Cancer Institute - Antoni van Leeuwenhoek

Amsterdam, North Holland, Netherlands

Amsterdam UMC

Amsterdam, North Holland, Netherlands

Erasmus MC

Rotterdam, South Holland, Netherlands

UMC Utrecht

Utrecht, Utrecht, Netherlands

Key Dates

Start Date

May 14, 2025

Primary Completion Date

February 1, 2029

Completion Date

February 1, 2029

Last Updated

May 29, 2025

Enrollment

ESTIMATED participants

Conditions

Cutaneous Squamous Cell Carcinoma (CSCC)Cutaneous Squamous Cell CancerCutaneous Squamous Cell Carcinoma of the Head and NeckCutaneous Squamous Cell Carcinoma

Interventions

Nivolumab

DRUG

Ipilumimab

DRUG

Contacts

Lotje Zuur, Prof. Dr.

CONTACT

+31205129111 c.zuur@nki.nl

Stan W. van Dijk, MD

CONTACT

+31205129111 matisse2@nki.nl

Intensity Modulated Proton or X-Ray Therapy After Surgery for Treatment of Head and Neck Cancer, the HEADLIGHT Study

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RECRUITINGPHASE2

Neoadjuvant Pembrolizumab in Cutaneous Squamous Cell Carcinoma

NCT05025813

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: May 29, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Towards Cure Via Only Ultra-short ICB in CSCC

Inclusion Criteria

Exclusion Criteria

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