Pembrolizumab in Combination With Chemotherapy and Image-Guided Surgery for Malignant Pleural Mesothelioma (MPM)

Who is this study for? Patients with malignant pleural mesothelioma
What treatments are being studied? Pembrolizumab+Indocyanine Green Image-Guided Surgery+Cisplatin+Pemetrexed
Status: Recruiting
Location: See location...
Intervention Type: Drug, Procedure
Study Type: Interventional
Study Phase: Phase 1
SUMMARY

The study is a single-arm phase I trial to evaluate the safety, feasibility, and preliminary efficacy of the addition of pembrolizumab and image-guided resection to surgical therapy and chemotherapy for malignant pleural mesothelioma (MPM).

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Be willing and able to provide written informed consent for the trial.

• Be 18 years of age on day of signing informed consent.

• Have measurable disease based on RECIST 1.1.

• Be willing to provide tissue from a newly obtained core or excisional biopsy of a tumor lesion. Newly-obtained is defined as a specimen obtained up to 6 weeks (42 days) prior to initiation of treatment on Day 1. Subjects for whom newly-obtained samples cannot be provided (e.g. inaccessible or subject safety concern) may submit an archived specimen only upon agreement from the Sponsor.

• Have a performance status of 0 or 1 on the ECOG Performance Scale.

• Demonstrate adequate organ function, all screening labs should be performed within 10 days of treatment initiation.

• Female subject of childbearing potential should have a negative urine or serum pregnancy within 72 hours prior to receiving the first dose of study medication. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required.

• Female subjects of childbearing potential must be willing to use an adequate method of contraception for the course of the study through 120 days after the last dose of study medication. Note: Abstinence is acceptable if this is the usual lifestyle and preferred contraception for the subject.

• Male subjects of childbearing potential must agree to use an adequate method of contraception starting with the first dose of study therapy through 120 days after the last dose of study therapy. Note: Abstinence is acceptable if this is the usual lifestyle and preferred contraception for the subject.

Locations
United States
Pennsylvania
Abramson Cancer Center of the University of Pennsylvania
RECRUITING
Philadelphia
Contact Information
Primary
Corey Langer, MD
Corey.Langer@uphs.upenn.edu
2156623914
Time Frame
Start Date: 2023-01-10
Estimated Completion Date: 2025-12-31
Participants
Target number of participants: 20
Treatments
Experimental: Pembrolizumab with image-guided surgery and chemotherapy
Related Therapeutic Areas
Sponsors
Leads: Abramson Cancer Center at Penn Medicine

This content was sourced from clinicaltrials.gov