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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06086288
Other study ID # 2022-500988-12-00
Secondary ID
Status Not yet recruiting
Phase Phase 2
First received
Last updated
Start date November 2023
Est. completion date December 2027

Study information

Verified date September 2023
Source Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
Contact Sara Pusceddu
Phone +390223903251
Email sara.pusceddu@istitutotumori.mi.it
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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Study Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
Italy Fondazione IRCCS Istituto Nazionale dei Tumori Milano
Italy AOUS Policlinico Le Scotte Siena
Italy Azienda Ospedaliera Universitaria Integrata (AOUI) Verona

Sponsors (1)

Lead Sponsor Collaborator
Fondazione IRCCS Istituto Nazionale dei Tumori, Milano

Country where clinical trial is conducted

Italy, 

Outcome

Type Measure Description Time frame Safety issue
Primary To assess the safety and antitumor activity of pembrolizumab combined with cisplatin/carboplatin and etoposide as first line treatment in MCC. ORR, that will be defined as the percentage of patients achieving complete response (CR) or partial response (PR) according to RECIST 1.1 criteria 48 months
Secondary To assess safety and efficacy of pembrolizumab combined with chemotherapy as first line treatment in patients with MCC Incidence of Serius Adverse Events (SAE) 48 months
Secondary To assess safety and efficacy of pembrolizumab combined with chemotherapy as first line treatment in patients with MCC Incidence and severity of Adverse Events (AEs) according to NCI Common Terminology criteria Adverse Event (CTCAE), version 5.0 48 months
Secondary To assess safety and efficacy of pembrolizumab combined with chemotherapy as first line treatment in patients with MCC Incidence and severity of Immune-mediated Adverse Events (imAE) 48 months
Secondary To assess safety and efficacy of pembrolizumab combined with chemotherapy as first line treatment in patients with MCC Overall Survival (OS) that will be measured from the date of starting therapy to the date of death by any cause 48 months
Secondary To assess safety and efficacy of pembrolizumab combined with chemotherapy as first line treatment in patients with MCC Progression Free Survival (PFS) that will be measured from the date of starting therapy to the date of disease progression or death. 48 months
Secondary To assess safety and efficacy of pembrolizumab combined with chemotherapy as first line treatment in patients with MCC Duration of Response (DOR) that will be measured from the date of the first response to disease progression or death in those patients who achieved a CR o PR during study treatment. 48 months
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