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Clinical Trial NCT06823479 (MATISSE 2) for Cutaneous Squamous Cell Carcinoma (CSCC), Cutaneous Squamous Cell Cancer, Cutaneous Squamous Cell Carcinoma of the Head and Neck, Cutaneous Squamous Cell Carcinoma is recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here. | ||
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Towards Cure Via Only Ultra-short ICB in CSCC (MATISSE 2) Phase 2 41 Immunotherapy
Clinical Trial NCT06823479 (MATISSE 2) is designed to study Treatment for Cutaneous Squamous Cell Carcinoma (CSCC), Cutaneous Squamous Cell Cancer, Cutaneous Squamous Cell Carcinoma of the Head and Neck, Cutaneous Squamous Cell Carcinoma. It is a Phase 2 interventional study that is recruiting, having started on 14 May 2025, with plans to enroll 41 participants. Led by The Netherlands Cancer Institute, it is expected to complete by 1 February 2029. The latest data from ClinicalTrials.gov was last updated on 29 May 2025.
Brief 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 ...Show More
Official Title
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
Conditions
Cutaneous Squamous Cell Carcinoma (CSCC)Cutaneous Squamous Cell CancerCutaneous Squamous Cell Carcinoma of the Head and NeckCutaneous Squamous Cell CarcinomaOther Study IDs
- MATISSE 2
- M24MAT
- 2024-516152-17-00 (EU Study (CTIS) Number)
NCT ID Number
Start Date (Actual)
2025-05-14
Last Update Posted
2025-05-29
Completion Date (Estimated)
2029-02
Enrollment (Estimated)
41
Study Type
Interventional
PHASE
Phase 2
Status
Recruiting
Keywords
nivolumab
opdivo
ipilimumab
yervoy
immunotherapy
intravenous
checkpoint inhibitors
neoadjuvant
opdivo
ipilimumab
yervoy
immunotherapy
intravenous
checkpoint inhibitors
neoadjuvant
Primary Purpose
Treatment
Design Allocation
N/A
Interventional Model
Single Group
Masking
None (Open Label)
Arms / Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
ExperimentalNeoadjuvant 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. | Nivolumab 3 mg/kg Ipilumimab 1 mg/kg |
Primary Outcome Measures
Secondary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
Rate of clinical complete remission after only immunotherapy | The rate of patients with a clinical complete remission at 24 months of follow-up or at time of death prior to 24 months follow-up, whichever comes first, after only immunotherapy, without surgery, radiotherapy or maintenance immunotherapy. | From the start of immunotherapy until 24 months of follow-up |
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
Rate of clinical complete remission after only immunotherapy | The rate of patients with a clinical complete remission at 12 and 18 months of follow-up or at time of death prior to the specified time-point, whichever comes first, after only immunotherapy, without surgery, radiotherapy or maintenance immunotherapy | From the start of immunotherapy until 12 and 18 months of follow-up. |
Immune-related adverse events | The rate and type of immune-related adverse events (CTCAE v5.0, Clavien-Dindo). | From the start of immunotherapy until 100 days after the last course of immunotherapy. |
Health-related quality of life (EORTC QLQ-C30) | EORTC Core Quality of Life questionnaire. Rated on a Likert-type scale from one (never) to four (almost always), to evaluate different domains. Functional and global health status scales indicated towards better levels of functioning, whereas higher scores in the symptom scales demonstrated higher levels of symptoms. | From the start of immunotherapy until 24 months of follow-up. |
Health-related quality of life (EORTC QLQ-H&N35) | EORTC Head and Neck Cancer Quality of Life Questionnaire. Rated on a Likert-type scale from one (never) to four (almost always). Multi-item scales (pain, swallowing, senses, speech, social eating, social contact, and sexuality), and six symptom items (dental problems, opening mouth, dry mouth, sticky saliva, coughing, and feeling ill). Higher scores in the symptom scales demonstrated higher levels of symptoms. | From the start of immunotherapy until 24 months of follow-up. |
Health-related quality of life (EQ5D) | EuroQol Five Dimensions Health Questionnaire. Domains: mobility, self-care, usual activity, pain/discomfort, and anxiety/depression. It also includes a VAS regarding patients' "Health Today" scored between 0 and 100. Each domain will be converted into categorical values (problems vs no problems). | From the start of immunotherapy until 24 months of follow-up. |
Health-related quality of life (CWS) | Cancer worry scale. Rated on a Likert-type scale from one (never) to four (almost always), which were summed to produce a total CWS score ranging from 8 to 32, with higher scores indicating more frequent worries about cancer. | From the start of immunotherapy until 24 months of follow-up. |
Health-related quality of life (IT) | Immunotherapy questionnaire. Rated on a Likert-type scale from one (never) to four (almost always), to evaluate toxicity after immunotherapy treatment. | From the start of immunotherapy until 24 months of follow-up. |
Health-related quality of life (sexuality questionnaire) | Rated on a Likert-type scale from one (never) to four (almost always), to evaluate problems in sexual functioning. | From the start of immunotherapy until 24 months of follow-up. |
Treatment duration | Total duration of received treatment | From the start of immunotherapy until the end of treatment (average 6 weeks) |
Treatment stops | The amount of times and the length of time the immunotherapy, surgery or adjuvant radiotherapy had to be stopped. | From the start of immunotherapy until the end of treatment (average 6 weeks) |
Disease-specific survival | The length of time a patient survives without death due to disease. | From the start of immunotherapy until 2 years follow-up. |
Recurrence-free survival | The length of time a patient survives without recurrent disease. | From the start of immunotherapy until 2 years follow-up. |
Event-free survival | The length of time a patient survives without recurrent disease or death of any cause. | From the start of immunotherapy until 2 years follow-up. |
Overall survival | The length of time a patient survives after treatment. | From the start of immunotherapy until 2 years follow-up. |
Healthcare consumption | Healthcare consumption during the trial. | From the start of immunotherapy until 24 months of follow-up. |
Cost-effectiveness | The incremental cost-effectiveness ratio between quality-adjusted life years and the cost of trial-related healthcare. | From the start of immunotherapy until 24 months of follow-up. |
Participation Assistant
Eligibility Criteria
Eligible Ages
Adult, Older Adult
Minimum Age
18 Years
Eligible Sexes
All
- 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.
- 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)
- Patients who are pregnant or breastfeeding
- History of allergy to study drug components and/or history of severe hypersensitivity to any monoclonal antibody
- Use of other investigational drugs 30 days before study drug administration and 5 half times before study inclusion.
The Netherlands Cancer Institute- 🏛️UMC Utrecht
Study Central Contact
Contact: Lotje Zuur, Prof. Dr., +31205129111, [email protected]
Contact: Stan W. van Dijk, MD, +31205129111, [email protected]
5 Study Locations in 1 Countries
Limburg
Maastricht UMC, Maastricht, Limburg, 6229HX, Netherlands
Not yet recruiting
North Holland
Netherlands Cancer Institute - Antoni van Leeuwenhoek, Amsterdam, North Holland, 1066CX, Netherlands
Recruiting
Amsterdam UMC, Amsterdam, North Holland, 1105AZ, Netherlands
Not yet recruiting
South Holland
Erasmus MC, Rotterdam, South Holland, 3015GD, Netherlands
Not yet recruiting
Utrecht
UMC Utrecht, Utrecht, Utrecht, 3584CX, Netherlands
Not yet recruiting