Study of PembrolizumAb combiNeD With Cisplatin or carbOplatin and Etoposide in Treatment naïve Advanced meRkel Cell cArcinoma (MCC)
NCT06086288 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 35
Last updated 2023-10-17
Summary
This is an open label, multicenter, phase II study evaluating the activity and safety of pembrolizumab combined with cisplatin/carboplatin and etoposide as first line treatment in patients with advanced MCC.
Conditions
Interventions
- DRUG
-
Pembrolizumab, Etoposide, Cisplatin or Carboplatin
Induction Phase (4 cycles, 1Cycle=3W): Pembrolizumab 200 mg + Etoposide + Cisplatin or Carboplatin; Maintenance Phase (16 Cycles, 1Cycle=6W): Pembrolizumab 400 mg
Sponsors & Collaborators
-
Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
lead OTHER
Principal Investigators
-
Sara Pusceddu, MD · Fondazione IRCCS Istituto Nazionale 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
- 2023-11-30
- Primary Completion
- 2027-12-31
- Completion
- 2027-12-31
Countries
- Italy
Study Locations
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