Towards Cure Via Only Ultra-short ICB in CSCC

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorThe Netherlands Cancer Institute

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

41 Participants
are divided into 1 treatment group

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