NCT06823479 Towards Cure Via Only Ultra-short ICB in CSCC
| NCT ID | NCT06823479 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | The Netherlands Cancer Institute |
| Condition | Cutaneous Squamous Cell Carcinoma (CSCC) |
| Study Type | INTERVENTIONAL |
| Enrollment | 41 participants |
| Start Date | 2025-05-14 |
| Primary Completion | 2029-02 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 41 participants in total. It began in 2025-05-14 with a primary completion date of 2029-02.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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) * 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.
Contact & Investigator
Lotje Zuur, Prof. Dr.
PRINCIPAL INVESTIGATOR
The Netherlands Cancer Institute
Frequently Asked Questions
Who can join the NCT06823479 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Cutaneous Squamous Cell Carcinoma (CSCC). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06823479 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT06823479 currently recruiting?
Yes, NCT06823479 is actively recruiting participants. Contact the research team at c.zuur@nki.nl for enrollment information.
Where is the NCT06823479 trial being conducted?
This trial is being conducted at Maastricht, Netherlands, Amsterdam, Netherlands, Amsterdam, Netherlands, Rotterdam, Netherlands and 1 additional location.
Who is sponsoring the NCT06823479 clinical trial?
NCT06823479 is sponsored by The Netherlands Cancer Institute. The principal investigator is Lotje Zuur, Prof. Dr. at The Netherlands Cancer Institute. The trial plans to enroll 41 participants.