Towards Cure Via Only Ultra-short ICB in CSCC
- Sponsor
- The Netherlands Cancer Institute
- Study ID
- NCT06823479
- Phase
- PHASE2
- Status
- Recruiting
Conditions
- Cutaneous Squamous Cell Cancer
- Cutaneous Squamous Cell Carcinoma
- Cutaneous Squamous Cell Carcinoma (CSCC)
- Cutaneous Squamous Cell Carcinoma of the Head and Neck
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- Nivolumab — DRUG3 mg/kg
- Ipilumimab — DRUG1 mg/kg
Study Details
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.
Key Dates
- Start date
- May 14, 2025
- Status verified
- May 2025
- Primary completion
- Feb 28, 2029
- Completion
- Feb 28, 2029
Study Design
- Enrollment
- 41 participants (estimated)
- Allocation
- NA
- Intervention model
- SINGLE_GROUP
- Primary purpose
- TREATMENT
Arms
- Experimental: Neoadjuvant nivolumab + ipilimumabIntravenous neoadjuvant nivolumab 3 mg/kg in week 0 and 2 in combination with intravenous neoadjuvant ipilimumab 1 m/kg in week 0.
Primary Outcome Measure
Rate of clinical complete remission after only immunotherapy [ Time Frame: From the start of immunotherapy until 24 months of follow-up ]
Central Contacts
- Lotje Zuur, Prof. Dr.+31205129111
- Stan W. van Dijk, MD+31205129111
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