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Towards organ preservation and cure via immunotherapy in cutaneous squamous cell carcinoma patients, normally undergoing morbid curative surgery and radiotherapy
EU CTIS ID: 2024-516152-17-00
What this study is testing
To determine the rate of patients with a clinical complete remission at 12, 18 and 24 months of FU after only immunotherapy, without surgery, radiotherapy or maintenance immunotherapy.
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 18 years of age or older
- 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.
- 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 (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 nasal vestibulum) (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
You likely can't join if
- Distantly metastasized (stadium IVb) CSCC
- 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
- SCC localized in a mucosal surface (i.e. anus, vulva, penis or mucosal portion of lip)
See the full eligibility criteria
Who can join
- 18 years of age or older
- 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.
- 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 (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 nasal vestibulum) (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.
- Women of child-bearing potential must have a negative serum or urine pregnancy test (minimum sensitivity 25IU/L or equivalent units of HCG) prior to the start of ICB.
- Men who are sexually active with WOCBP must use a contraceptive method with a failure rate of less than 1% per year and will be instructed to adhere to contraception for a period of 31 weeks after the last dose of ICB. Surgically sterile or azoospermic men do not require aforementioned contraception.
What rules you out
- Distantly metastasized (stadium IVb) CSCC
- 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
- SCC localized in a mucosal surface (i.e. anus, vulva, penis or mucosal portion of lip)
- Patients for whom SOC 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
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.