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Neoadjuvant Cemiplimab in Merkel Cell Carcinoma
NCT07387198Phase 2
Key facts
- Status
- Recruiting
- Start
- May 2026
- Primary completion
- Dec 2029
- Countries
- 1
- Modality
- Immune Checkpoint Inhibitors, Antibody Conjugates, Engineered Antibody Formats
- Drugs
- cemiplimab
- Conditions
- Merkel cell carcinoma (MCC)
01
Overview
Phase 2, randomised, double-blind trial in Merkel cell carcinoma (MCC) comparing Arm A (Cemiplimab) with Arm B (placebo) (2 arms). Primary endpoint: Nodal micrometastases-free rate at 36 months. Started May 2026; status: recruiting.
02
Design
2 arms- Study design
- RandomizedDouble-blind
Arm A (Cemiplimab)
2 cycles of Cemiplimab (350 mg, i.v., Q3W) followed by sentinel lymph node biopsy
Arm B (placebo)
2 cycles of placebo followed by sentinel lymph node biopsy
03
Who it enrols
Adult patients with clinical stage I or II Merkel cell carcinoma who have undergone primary tumor excision and are pending sentinel lymph node biopsy, with adequate organ function and no prior systemic anti-tumor therapy.
04
Endpoints
Primary
Nodal micrometastases-free rate
Secondary
Recurrence-free survival
Overall survival
Disease specific survival
Quality of life using FCRI-SF questionnaire
Safety (AEs and SAEs)
Quality of life using the mFACT-M questionnaire
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