Neoadjuvant Merkel Cell Carcinoma Therapy (Tx) With the PD-1 Inhibitor Cemiplimab

Sponsor
Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest
Study ID
NCT07387198
Phase
PHASE2
Status
Recruiting
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Conditions

  • Merkel Cell Carcinoma, Stage I
  • Merkel Cell Carcinoma, Stage II
  • Neoadjuvant Immunotherapy

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Cemiplimab 350 mg i.v. on day 1 of every 21 days cycle for 2 cycles — DRUG
    Patients will receive Cemiplimab 350 mg i.v. on day 1 of every 21 days cycle for 2 cycles
  • Placebo NaCl 0.9% solution i.v. on day 1 of every 21 days cycle for 2 cycles. — DRUG
    Patients will receive NaCl 0.9% solution i.v. on day 1 of every 21 days cycle for 2 cycles.

Study Details

The study is a randomized, double blind, placebo-controlled, non-comparative phase II trial that investigates the efficacy of neoadjuvant anti-PD-1 antibody Cemiplimab treatment in patients with clinical stage I or II Merkel cell carcinoma who have have undergone primary tumour excision and are pending sentinel lymph node biopsy.

Key Dates

First listed
Feb 4, 2026
Start date
May 29, 2026
Status verified
Jun 2026
Primary completion
Dec 31, 2029
Completion
Jul 31, 2031

Study Design

Enrollment
135 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Arm A (Cemiplimab)
    2 cycles of Cemiplimab (350 mg, i.v., Q3W) followed by sentinel lymph node biopsy
  • Placebo Comparator: Arm B (placebo)
    2 cycles of placebo followed by sentinel lymph node biopsy

Primary Outcome Measure

Nodal micrometastases-free rate [ Time Frame: up to 36 months ]

Central Contacts