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ACTIVE NOT RECRUITING
NCT06155279
PHASE2

Induction Chemo+Immunotherapy in Resectable Epithelioid and Biphasic Pleural Mesothelioma (CHIMERA Study)

Sponsor: Istituto Oncologico Veneto IRCCS

View on ClinicalTrials.gov

Summary

This is a prospective, open-label, multi-site Phase II trial of pembrolizumab in combination with pemetrexed and cisplatin or carboplatin as neo-adjuvant therapy followed by surgery and adjuvant pembrolizumab in patients affected by resectable stage I-IIIa chemonaïve epithelioid/biphasic pleural mesothelioma.

Official title: Phase II Study of Pembrolizumab in Combination With Cisplatin or Carboplatin and Pemetrexed as Induction Chemo+Immunotherapy in Resectable Epithelioid and Biphasic Pleural Mesothelioma (CHIMERA Study)

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

41

Start Date

2024-11-06

Completion Date

2027-03

Last Updated

2026-01-13

Healthy Volunteers

No

Interventions

DRUG

Carboplatin/Cisplatin - Pemetrexed - Pembrolizumab

The neoadjuvant systemic treatment will be based on three cycles of pembrolizumab 200 mg flat dose in combination with standard doses of cisplatin (75 mg/sm) or carboplatin (AUC 5) and pemetrexed (500 mg/sm) administered intra-venous every 3 weeks. The surgical intervention of pleurectomy/decortication will be planned to occur within 6 weeks after the completion of neoadjuvant treatment. The adjuvant systemic treatment will be based on 14 cycles of pembrolizumab 200 mg flat dose administered intra-venous every 3 weeks. Patients should be able to start pembrolizumab following surgery as soon as clinically feasible and within 10 weeks from surgery.

Locations (8)

Humanitas Gavazzeni

Bergamo, Italia/Bergamo, Italy

IFO - Istituto Tumori Regina Elena, Roma

Roma, Italia/Roma, Italy

Istituto Clinico Humanitas

Rozzano, Milano, Italy

Centro di Riferimento Oncologico (CRO) IRCCS

Aviano, Pordenone, Italy

Azienda Ospedaliera SS Antonio e Biagio e Cesare Arrigo

Alessandria, Italy

Azienda Ospedaliero-Universitaria S. Anna

Ferrara, Italy

Istituto Oncologico Veneto IRCCS

Padova, Italy

Azienda Ospedaliera-Universitaria di Parma

Parma, Italy