NCT04153565

A Study of Pembrolizumab in Combination With Cisplatin and Pemetrexed in Advanced Malignant Pleural Mesothelioma (MPM) (MK-3475-A17)

A Phase Ib Clinical Study to Evaluate the Safety and Efficacy of Pembrolizumab (MK-3475) in Combination With Cisplatin and Pemetrexed in Treatment-naive Participants With Advanced Malignant Pleural Mesothelioma (KEYNOTE-A17).

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 19 (actual)
• Sponsor: Merck Sharp & Dohme LLC · Industry
• Sex: All
• Age: 20 Years
• Healthy volunteers: Not accepted

Summary

This is a multicenter, open-label, non-randomized, study of pembrolizumab in combination with cisplatin and pemetrexed in treatment of naïve participants with a histologically confirmed diagnosis of advanced/unresectable malignant pleural mesothelioma (MPM) in Japanese participants. This study will evaluate the safety, tolerability, and preliminary efficacy of pembrolizumab in combination with cisplatin and pemetrexed. The primary objective is to evaluate the safety and tolerability of treatment with pembrolizumab in combination with cisplatin and pemetrexed.

Conditions

• Mesothelioma

Interventions

Type	Name	Description
DRUG	Pembrolizumab	Participants will receive Pembrolizumab 200 mg IV every 3 weeks (Q3W) until disease progression, or until participant has received 35 administrations of Pembrolizumab (approximately 2 years).
DRUG	Pemetrexed	Participants will receive Pemetrexed 500 mg/m\^2 IV on Day 1 of each cycle up to 4-6 cycles where each cycle = 3 weeks
DRUG	Cisplatin	Participants will receive Cisplatin 75 mg/m\^2 IV on Day 1 of each cycle up to 4-6 cycles where each cycle = 3 weeks

Timeline

• Start date: 2019-12-09
• Primary completion: 2022-09-21
• Completion: 2022-09-21
• First posted: 2019-11-06
• Last updated: 2025-07-17
• Results posted: 2024-03-22

Locations

4 sites across 1 country: Japan