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.
This is an investigator-initiated phase 2 clinical trial consisting of 41 patients with stage I-IVa CSCC and an indication for morbid/extensive curative surgery. All patients will receive two courses of nivolumab 3 mg/kg in week 0 and week 2, and one course of ipilimumab 1 mg/kg in week 0. In week 5 response to immunotherapy will be evaluated using clinical examination, \[18F\]FDG-PET/CT imaging, regional lymph node ultrasound with FNAC (if applicable) and a multicentre multidisciplinary meeting. Non-responders will receive standard of care surgery (w/wo radiotherapy). Responders will enter a wait-and-monitor follow-up schedule in which response will be monitored every 3 months for a total of 2 years. If a patient is no longer responding to immunotherapy during follow-up they will receive standard of care surgery (w/wo radiotherapy).
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
41
3 mg/kg
1 mg/kg
Maastricht UMC
Maastricht, Limburg, Netherlands
NOT_YET_RECRUITINGNetherlands Cancer Institute - Antoni van Leeuwenhoek
Amsterdam, North Holland, Netherlands
RECRUITINGAmsterdam UMC
Amsterdam, North Holland, Netherlands
NOT_YET_RECRUITINGRate 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.
Time frame: From the start of immunotherapy until 24 months of follow-up
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
Time frame: From the start of immunotherapy until 12 and 18 months of follow-up.
Immune-related adverse events
The rate and type of immune-related adverse events (CTCAE v5.0, Clavien-Dindo).
Time frame: From the start of immunotherapy until 100 days after the last course of immunotherapy.
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.
Time frame: From the start of immunotherapy until 24 months of follow-up.
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.
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Erasmus MC
Rotterdam, South Holland, Netherlands
NOT_YET_RECRUITINGUMC Utrecht
Utrecht, Utrecht, Netherlands
NOT_YET_RECRUITINGTime frame: From the start of immunotherapy until 24 months of follow-up.
Health-related quality of life (EQ5D)
EuroQol Five Dimensions Health Questionnaire. Domains: mobility, self-care, usual activity, pain/discomfort, and anxiety/depression. It also includes a VAS regarding patients' "Health Today" scored between 0 and 100. Each domain will be converted into categorical values (problems vs no problems).
Time frame: From the start of immunotherapy until 24 months of follow-up.
Health-related quality of life (CWS)
Cancer worry scale. Rated on a Likert-type scale from one (never) to four (almost always), which were summed to produce a total CWS score ranging from 8 to 32, with higher scores indicating more frequent worries about cancer.
Time frame: From the start of immunotherapy until 24 months of follow-up.
Health-related quality of life (IT)
Immunotherapy questionnaire. Rated on a Likert-type scale from one (never) to four (almost always), to evaluate toxicity after immunotherapy treatment.
Time frame: From the start of immunotherapy until 24 months of follow-up.
Health-related quality of life (sexuality questionnaire)
Rated on a Likert-type scale from one (never) to four (almost always), to evaluate problems in sexual functioning.
Time frame: From the start of immunotherapy until 24 months of follow-up.
Treatment duration
Total duration of received treatment
Time frame: From the start of immunotherapy until the end of treatment (average 6 weeks)
Treatment stops
The amount of times and the length of time the immunotherapy, surgery or adjuvant radiotherapy had to be stopped.
Time frame: From the start of immunotherapy until the end of treatment (average 6 weeks)
Disease-specific survival
The length of time a patient survives without death due to disease.
Time frame: From the start of immunotherapy until 2 years follow-up.
Recurrence-free survival
The length of time a patient survives without recurrent disease.
Time frame: From the start of immunotherapy until 2 years follow-up.
Event-free survival
The length of time a patient survives without recurrent disease or death of any cause.
Time frame: From the start of immunotherapy until 2 years follow-up.
Overall survival
The length of time a patient survives after treatment.
Time frame: From the start of immunotherapy until 2 years follow-up.
Healthcare consumption
Healthcare consumption during the trial.
Time frame: From the start of immunotherapy until 24 months of follow-up.
Cost-effectiveness
The incremental cost-effectiveness ratio between quality-adjusted life years and the cost of trial-related healthcare.
Time frame: From the start of immunotherapy until 24 months of follow-up.