Using immunotherapy to treat cutaneous squamous cell carcinoma without surgery

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This phase 2 clinical trial aims to evaluate the effectiveness of immunotherapy in curing patients with cutaneous squamous cell carcinoma (CSCC) without the need for surgery or radiotherapy. A total of 41 patients with stage I-IVa CSCC will receive two doses of nivolumab and one dose of ipilimumab. The patients' responses to the treatment will be assessed through clinical examinations and imaging techniques at week 5. Those who respond positively will be monitored for two years, while non-responders will receive standard surgical treatment.

Why it matters

Who can join: the full rules

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.

Where it's running

• Netherlands Cancer Institute - Antoni van Leeuwenhoek
  Amsterdam, North Holland, Netherlands Recruiting
• Maastricht UMC
  Maastricht, Limburg, Netherlands Not yet recruiting
• Amsterdam UMC
  Amsterdam, North Holland, Netherlands Not yet recruiting
• Erasmus MC
  Rotterdam, South Holland, Netherlands Not yet recruiting
• UMC Utrecht
  Utrecht, Utrecht, Netherlands Not yet recruiting

Study contacts

• Principal investigator: Lotje Zuur, Prof. Dr. — The Netherlands Cancer Institute
• Study coordinator: Lotje Zuur, Prof. Dr.
• Email: c.zuur@nki.nl
• Phone: +31205129111

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.