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NCT06823479: MATISSE 2
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
Phase 2 trial testing Nivolumab in Cutaneous Squamous Cell Carcinoma (CSCC) in 41 participants. Currently enrolling.
1 February 2029
Quick facts
| Lead sponsor | The Netherlands Cancer Institute |
|---|---|
| Phase | Phase 2 |
| Status | Recruiting now |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 41 |
| Start date | 14 May 2025 |
| Primary completion | 1 February 2029 |
| Estimated completion | 1 February 2029 |
| Sites | 5 locations across Netherlands |
Drugs / interventions tested
- Nivolumab (nivolumab) — full drug profile →
- Ipilumimab — full drug profile →
Conditions studied
- Cutaneous Squamous Cell Carcinoma (CSCC) — all drugs for Cutaneous Squamous Cell Carcinoma (CSCC) →
- Cutaneous Squamous Cell Cancer — all drugs for Cutaneous Squamous Cell Cancer →
- Cutaneous Squamous Cell Carcinoma of the Head and Neck — all drugs for Cutaneous Squamous Cell Carcinoma of the Head and Neck →
- Cutaneous Squamous Cell Carcinoma — all drugs for Cutaneous Squamous Cell Carcinoma →
Sponsor
The Netherlands Cancer Institute
Who can join
18 and older, any sex, with Cutaneous Squamous Cell Carcinoma (CSCC) or Cutaneous Squamous Cell Cancer. Patients with the condition only — healthy volunteers not accepted.
What's being measured
Primary outcomes are the specific endpoints the trial is designed to prove or disprove.
-
Rate of clinical complete remission after only immunotherapy
Time frame: From the start of immunotherapy until 24 months of follow-up
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.
Sponsor's own description
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.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
Divergent immuno-landscapes: comparing the tumor microenvironment of Indian and Western HNSCC patients.
Kumar Rai P, Choudhary B. · · 2026 · PMID 42111272 · DOI 10.3389/fcell.2026.1725978
Verify or expand the search:
- PubMed search for NCT06823479
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
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Trials testing the same drug.
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- NCT07420439 — Treatment in Patients With Advanced Non-Small Cell Lung Carcinoma and Interstitial Lung Disease · Phase 2 · not yet recruiting
- NCT07510334 — VSV-IFNβ-NIS With Ipilimumab and Nivolumab for the Treatment of Advanced or Metastatic Clear Cell Renal Cell Carcinoma · Phase 2 · not yet recruiting
Other recruiting trials for Cutaneous Squamous Cell Carcinoma (CSCC)
Currently open trials in the same condition.
- NCT06585410 — Study of Intralesional Cemiplimab in Adult Patients With Early Stage Cutaneous Squamous Cell Carcinoma · Phase 3 · recruiting
- NCT06664151 — A Phase 0 Window of Opportunity Trial of Intratumoral Seasonal Influenza Immunization in Cutaneous Squamous Cell Carcino · EARLY_PHASE1 · recruiting
- NCT06606028 — Tumor-Informed ctDNA Testing for MRD Following Treatment of Squamous Cell Carcinoma · recruiting
- NCT06444815 — A Study of VET3-TGI in Patients With Solid Tumors · Phase 1 · recruiting
- NCT05827614 — Study of the CHK1 Inhibitor BBI-355, an ecDNA-directed Therapy (ecDTx), and the RNR Inhibitor BBI-825, in Subjects With · Phase 1 · active not recruiting
Other The Netherlands Cancer Institute trials
Trials by the same sponsor.
- NCT07436858 — Whole Body HER2 Quantification With 89Zr-Trastuzumab PET/CT to Asses Zr-trastuzumab Accumulation in HER2-mutated and HER · Phase 1 · not yet recruiting
- NCT07071727 — Short Course of Radiotherapy Prior to Surgery of Soft Tissue Sarcomas · NA · recruiting
- NCT06931769 — TAO-Towards Optimal (Neo)Adjuvant Systemic Therapy of Stage III Triple-negative Breast Cancer · recruiting
- NCT06273800 — Chemosensitivity During Phases of the Menstrual Cycle in Breast Cancer Patients · NA · recruiting
- NCT07310758 — Contrast-enhanced Ultrasound for Sentinel Node Detection · Phase 2, PHASE3 · recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT06823479 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by The Netherlands Cancer Institute
- Last refreshed: 22 May 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06823479.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing