Chemo-immunotherapy in Patients With Resectable Merkel Cell Carcinoma Prior to Surgery

Sponsor
Gruppo Oncologico del Nord-Ovest
Study ID
NCT05594290
Phase
PHASE2
Status
Active Not Recruiting

Conditions

  • Merkel Cell Carcinoma

Eligibility Criteria

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

Interventions

  • Retifanlimab — DRUG
    Retifanlimab i.v. 500 mg day 1
  • Cisplatin — DRUG
    Cisplatin 25 mg/sqm i.v. day 1, 2 (recommended platinum agent) or carboplatin AUC 4 i.v., day 1 (in patients unsuited or unfit for cisplatin)
  • Etoposide — DRUG
    Etoposide 100 mg/sqm iv. day 1, 2, 3

Study Details

This is a window-of-opportunity study for patients with resectable Merkel Cell Carcinoma. The aim of this study is to test the activity of a course of chemo-immunotherapy followed by surgery in patients with operable Merkel cell carcinoma. Participants will receive one cycle of retifanlimab plus platinum-etoposide chemotherapy prior to their scheduled surgery.

Key Dates

Start date
Dec 7, 2022
Status verified
Jan 2026
Primary completion
Nov 15, 2025
Completion
Nov 30, 2026

Study Design

Enrollment
36 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Preoperative arm
    Patients will be treated with one cycle of chemo-immunotherapy with retifanlimab (500 mg day 1), cisplatin (25 mg/sqm i.v. day 1, 2 ) or carboplatin (AUC 4 i.v., day 1 - in patients unsuited or unfit for cisplatin) and etoposide (100 mg/sqm iv. day 1, 2, 3). After receiving the short-course preoperative chemo-immunotherapy study regimen, patients will undergo standard radical surgery. After surgery, patients will receive adjuvant radiation therapy if indicated

Primary Outcome Measure

Pathological complete response rate (pCR rate) [ Time Frame: 5 weeks ]

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