Towards Cure Via Only Ultra-short ICB in CSCC

Launched by THE NETHERLANDS CANCER INSTITUTE · Feb 6, 2025

Keywords

ClinConnect Summary

This clinical trial, titled "Towards Cure Via Only Ultra-short ICB in CSCC," is exploring whether patients with cutaneous squamous cell carcinoma (CSCC) can be treated effectively using only immunotherapy, which is a type of treatment that helps the body's immune system fight cancer, without the need for surgery or radiation. The trial is currently not recruiting participants, but it aims to find out if this approach can lead to a cure for patients who have stage I to IVa CSCC, particularly those facing extensive or disfiguring surgeries.

To be eligible for this trial, participants need to be at least 18 years old and have specific types of CSCC that may require significant surgery. They should also be able to understand the study instructions and meet certain health criteria. For example, they must have a good overall health status and certain acceptable laboratory test results. Additionally, women who can become pregnant must agree to use contraception during the study. Participants will receive immunotherapy treatment and will be monitored throughout the trial to assess its effectiveness and any side effects. This study represents a hopeful step towards finding less invasive treatment options for skin cancer.

Gender

ALL

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.