About this trial
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.
Eligibility criteria
Qualifiers
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.
Disqualifiers
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
Trial design
Treatments tested in this trial
- Nivolumab
- Ipilumimab
Treatment groups
Sponsors and collaborators
The Netherlands Cancer Institute
Lead sponsor
UMC Utrecht
Collaborator
Erasmus Medical Center
Collaborator
Maastricht University Medical Center
Collaborator
Amsterdam UMC, location VUmc
Collaborator