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New treatment option for Cutaneous Squamous Cell Carcinoma (CSCC)
Official title Towards Cure Via Only Ultra-short ICB in CSCC
ClinicalTrials.gov ID: NCT06823479
What this study is testing
What is Nivolumab?
Nivolumab is an investigational medicine, being studied as a potential treatment for cutaneous squamous cell carcinoma (cscc).
Also referred to as Immunotherapy.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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...
- World Health Organisation (WHO) performance status of 0-2
You likely can't join if
- 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)
See the full eligibility 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)...
- 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...
- 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...
- 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.
- 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)
- people with any active autoimmune disease or a documented history of autoimmune disease, except: people with vitiligo, resolved childhood asthma/atopy, residual hypothyroidism due to an autoimmune condition requiring...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Maastricht, Limburg, Netherlands
- Amsterdam, North Holland, Netherlands
- Rotterdam, South Holland, Netherlands
- Utrecht, Utrecht, Netherlands
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, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Maastricht, Limburg, Netherlands; Amsterdam, North Holland, Netherlands; Rotterdam, South Holland, Netherlands; Utrecht, Utrecht, Netherlands. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.