Actively Recruiting
Towards Cure Via Only Ultra-short ICB in CSCC
Led by The Netherlands Cancer Institute · Updated on 2025-05-29
41
Participants Needed
5
Research Sites
194 weeks
Total Duration
On this page
Sponsors
T
The Netherlands Cancer Institute
Lead Sponsor
U
UMC Utrecht
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Towards Cure Via Only Ultra-short ICB in CSCC
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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, skin of lip NOS, external ear, skin face unspecified, skin scalp and neck, overlapping lesion of skin, primary site eyelid, or other body sites excluding vulva, anus, or penis
- World Health Organisation (WHO) performance status of 0-2
- Indication for standard of care surgery with curative intent with or without radiotherapy
- Screening laboratory values meeting specified minimum levels for white blood cells, neutrophils, platelets, haemoglobin, creatinine, AST, ALT, and bilirubin
- Women of child-bearing potential must use effective contraception for 23 weeks after last dose and have a negative pregnancy test before immunotherapy
- Ability and willingness to understand the study information and comply with treatment and visit schedules
You will not qualify if you...
- Distantly metastasized (stage IVb) CSCC
- Squamous cell carcinoma located on mucosal surfaces such as anus, vulva, penis, or mucosal lip
- Patients whose standard care consists of definitive brachytherapy or radiotherapy
- Primary or recurrent CSCC in previously irradiated areas
- Prior systemic therapy or immunotherapy
- Active HIV infection or AIDS
- Positive test for hepatitis B surface antigen or hepatitis C antibody
- Active autoimmune disease or certain autoimmune histories not listed as exceptions
- Medical conditions that increase risk or interfere with study drug safety or results
- Use of immunosuppressive medications or high-dose corticosteroids (above 5 mg prednisone daily)
- Pregnancy or breastfeeding
- Known allergy or severe reaction to study drugs or monoclonal antibodies
- Use of other investigational drugs within 30 days before study drug administration and five half-lives before inclusion
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 5 locations
1
Maastricht UMC
Maastricht, Limburg, Netherlands, 6229HX
Not Yet Recruiting
2
Netherlands Cancer Institute - Antoni van Leeuwenhoek
Amsterdam, North Holland, Netherlands, 1066CX
Actively Recruiting
3
Amsterdam UMC
Amsterdam, North Holland, Netherlands, 1105AZ
Not Yet Recruiting
4
Erasmus MC
Rotterdam, South Holland, Netherlands, 3015GD
Not Yet Recruiting
5
UMC Utrecht
Utrecht, Utrecht, Netherlands, 3584CX
Not Yet Recruiting
Research Team
L
Lotje Zuur, Prof. Dr.
CONTACT
S
Stan W. van Dijk, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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