Pembrolizumab + Defactinib In Pleural Mesothelioma

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
Raphael Bueno, MD
Study ID
NCT04201145
Phase
PHASE1
Status
Withdrawn

Conditions

  • Malignant Pleural Mesothelioma

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Pembrolizumab — DRUG
    IV, predetermined dosage, twice per cycle
  • Defactinib — DRUG
    Defactinib oral, twice daily, per predetermined dose and predetermined duration as defined by cohort

Study Details

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

Key Dates

Start date
Sep 30, 2020
Status verified
Nov 2020
Primary completion
Dec 31, 2021
Completion
Dec 31, 2022

Study Design

Enrollment
0 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Run in cohort: pembrolizumab only
    Treatment with pembrolizumab as a single agent for 56 days \- 2 doses during treatment cycle, intravenous, at predetermined protocol dose
  • Experimental: Cohort 1: pembrolizumab + defactinib 12 days
    Treatment with Defactinib in combination with Pembrolizumab for 12 days * Defactinib oral, twice daily, per predetermined dose for 12 days of treatment in combination * Pembrolizumab via infusion, twice per cycle, per predetermined dose
  • Experimental: Cohort 2: pembrolizumab + defactinib 35 days
    Treatment with defactinib in combination with pembrolizumab to 35 days * Defactinib oral, twice daily, per predetermined dose for 35 days of treatment in combination * Pembrolizumab via infusion, twice per cycle, per predetermined dose
  • Experimental: Expansion cohort
    Tolerated phase IA regimen will be administered in a phase IB expansion cohort

Primary Outcome Measure

Maximum Tolerated Duration (MTD) [ Time Frame: 56 days ]

Locations (2)

FacilityCityStateZIPSite coordinators
Brigham and Women's HospitalBostonMassachusetts02115-
Dana Farber Cancer InstituteBostonMassachusetts02115-

Find similar trials in Boston, MA

By research site
Brigham and Women's Hospital· Boston, MADana Farber Cancer Institute· Boston, MA

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