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

NCT05594290 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 36

Last updated 2026-01-14

No results posted yet for this study

Summary

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.

Conditions

Interventions

DRUG

Retifanlimab

Retifanlimab i.v. 500 mg day 1

DRUG

Cisplatin

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)

DRUG

Etoposide

Etoposide 100 mg/sqm iv. day 1, 2, 3

Sponsors & Collaborators

  • Gruppo Oncologico del Nord-Ovest

    lead OTHER

Principal Investigators

  • Federica Morano, MD · Fondazione IRCCS Istituto Nazionale dei Tumori, Milano

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-12-07
Primary Completion
2025-11-15
Completion
2026-11-30

Countries

  • Italy

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05594290 on ClinicalTrials.gov