NCT04201145

Pembrolizumab + Defactinib In Pleural Mesothelioma

Phase IA-IB Open-label, Non-randomized, Neoadjuvant Treatment With Combination Pembrolizumab and Defactinib for Patients With Surgically Resectable Malignant Pleural Mesothelioma

• Status: Withdrawn
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Raphael Bueno, MD · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This research study is studying a new drug combination of Pembrolizumab and Defactinib followed by surgical resection possible treatment for resectable Malignant Pleural Mesothelioma (MPM). The names of the study drugs involved in this study are: * Pembrolizumab * Defactinib

Detailed description

The research study procedures include screening for eligibility and study treatment including evaluations and follow up visits. The names of the study drugs involved in this study are: * Pembrolizumab * Defactinib The Investigators are looking for the highest dose of the study drug that can be administered safely without severe or unmanageable side effects in participants that have Malignant Pleural Mesothelioma (MPM), not everyone who participates in this research study will receive the same dose of the study drug. The dose given will depend on the number of participants who have been enrolled prior and how well the dose was tolerated. The dose of the study drug, pembrolizumab, will not change no matter when the participant is enrolled into the study. The order in which the participant is enrolled to the study will determine the cohort assigned to: * Run-In Cohort: Pembrolizumab only followed by surgery * Cohort 1: Pembrolizumab and defactinib followed by surgery * Cohort 2: Pembrolizumab and defactinib followed by surgery * Expansion Cohort: Pembrolizumab and defactinib at the maximum dose as determined from the previous cohorts (Cohorts 1 and 2) * The U.S. Food and Drug Administration (FDA) has not approved defactinib as a treatment for any disease. * The U.S. Food and Drug Administration (FDA) has not approved pembrolizumab for this specific disease but it has been approved for other uses.

Conditions

• Malignant Pleural Mesothelioma

Interventions

Type	Name	Description
DRUG	Pembrolizumab	IV, predetermined dosage, twice per cycle
DRUG	Defactinib	Defactinib oral, twice daily, per predetermined dose and predetermined duration as defined by cohort

Timeline

• Start date: 2020-09-01
• Primary completion: 2021-12-31
• Completion: 2022-12-31
• First posted: 2019-12-17
• Last updated: 2020-11-17

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study