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.
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.
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
Single group
Nivolumab
Drug3 mg/kg
Ipilumimab
Drug1 mg/kg
Rate of clinical complete remission after only immunotherapy
The rate of patients with a clinical complete remission at 24 months of follow-up or at time of death prior to 24 months follow-up, whichever comes first, after only immunotherapy, without surgery, radiotherapy or maintenance immunotherapy.
Rate of clinical complete remission after only immunotherapy
The rate of patients with a clinical complete remission at 12 and 18 months of follow-up or at time of death prior to the specified time-point, whichever comes first, after only immunotherapy, without surgery, radiotherapy or maintenance immunotherapy
Immune-related adverse events
The rate and type of immune-related adverse events (CTCAE v5.0, Clavien-Dindo).
Health-related quality of life (EORTC QLQ-C30)
EORTC Core Quality of Life questionnaire. Rated on a Likert-type scale from one (never) to four (almost always), to evaluate different domains. Functional and global health status scales indicated towards better levels of functioning, whereas higher scores in the symptom scales demonstrated higher levels of symptoms.
Health-related quality of life (EORTC QLQ-H&N35)
EORTC Head and Neck Cancer Quality of Life Questionnaire. Rated on a Likert-type scale from one (never) to four (almost always). Multi-item scales (pain, swallowing, senses, speech, social eating, social contact, and sexuality), and six symptom items (dental problems, opening mouth, dry mouth, sticky saliva, coughing, and feeling ill). Higher scores in the symptom scales demonstrated higher levels of symptoms.
Tumor micro-environment (IHC)
Temporal and spatial analyses of the TME in the lymph nodes and primary tumours will be explored using immunohistochemistry (e.g. PD-L1 expression, CPS score).
Tumor micro-environment (RNAseq)
Temporal and spatial analyses of the TME in the lymph nodes and primary tumours will be explored using bulk and single-cell RNA-sequencing.
Tumor micro-environment (spatial mass cytometry)
Temporal and spatial analyses of the TME in the lymph nodes and primary tumours will be explored using spatial mass cytometry.
Immune dynamics (PBMC)
Temporal immune dynamics in peripheral blood will be investigated via peripheral blood mononuclear cells (PBMCs).
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The Netherlands Cancer Institute
Lead sponsor
UMC Utrecht
Collaborator
Erasmus Medical Center
Collaborator
Maastricht University Medical Center
Collaborator
Amsterdam UMC, location VUmc
Collaborator
