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

Abramson Cancer Center at Penn Medicine1 site in 1 country20 target enrollmentJanuary 10, 2023

ConditionsMesotheliomas Pleural

InterventionsPembrolizumab Indocyanine Green (ICG) Image-Guided Surgery Cisplatin Pemetrexed

DrugsPembrolizumab Cisplatin Pemetrexed

Overview

Phase: Phase 1
Intervention: Pembrolizumab
Conditions: Mesotheliomas Pleural
Sponsor: Abramson Cancer Center at Penn Medicine
Enrollment: 20
Locations: 1
Primary Endpoint: Study related adverse events (AEs)
Status: Recruiting
Last Updated: 4 months ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief 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).

Registry

clinicaltrials.gov

Start Date

January 10, 2023

End Date

February 1, 2027

Last Updated

4 months ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Abramson Cancer Center at Penn Medicine

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•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.
•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
•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.

Exclusion Criteria

•Is currently participating and receiving study therapy or has participated in a study of an investigational agent and received study therapy or used an investigational device within 4 weeks of the first dose of treatment.
•Has a diagnosis of immunodeficiency or is receiving any form of immunosuppressive therapy within 7 days prior to the first dose of trial treatment OR Is taking chronic systemic steroids (in doses exceeding 10 mg daily of prednisone equivalent) within 7 days prior to the first dose of trial treatment. (Note: Subjects with asthma or chronic obstructive pulmonary disease that require intermittent use of bronchodilators, inhaled steroids, or local steroid injections would not be excluded from the study.)
•Has a known history of active TB (Bacillus Tuberculosis)
•Hypersensitivity to ICG or pembrolizumab or any of their excipients.
•Has had a prior anti-cancer monoclonal antibody (mAb) within 4 weeks prior to study Day 1 or who has not recovered (i.e., ≤ Grade 1 or at baseline) from adverse events due to agents administered more than 4 weeks earlier.
•Has had prior chemotherapy, targeted small molecule therapy, or radiation therapy within 2 weeks prior to study Day 1 or who has not recovered (i.e., ≤ Grade 1 or at baseline) from adverse events due to a previously administered agent. Note: Subjects with ≤ Grade 2 neuropathy are an exception to this criterion and may qualify for the study. Note: If subject received major surgery, they must have recovered adequately from the toxicity and/or complications from the intervention prior to starting therapy.
•Has a known additional malignancy that is progressing or requires active treatment. Exceptions include basal cell carcinoma of the skin or squamous cell carcinoma of the skin that has undergone potentially curative therapy or in situ cervical cancer.
•Has known metastatic disease and/or disease that is otherwise determined to be unresectable.
•Has active autoimmune disease that has required systemic treatment in the past 2 years (i.e. with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (eg., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment.
•Has a history of (non-infectious) pneumonitis that required steroids or current pneumonitis.

Arms & Interventions

Pembrolizumab with image-guided surgery and chemotherapy

Intervention: Pembrolizumab

Pembrolizumab with image-guided surgery and chemotherapy

Intervention: Indocyanine Green (ICG) Image-Guided Surgery

Pembrolizumab with image-guided surgery and chemotherapy

Intervention: Cisplatin

Pembrolizumab with image-guided surgery and chemotherapy

Intervention: Pemetrexed

Outcomes

Primary Outcomes

Study related adverse events (AEs)

Time Frame: Each subjects will be assessed for AEs from the time of their first study treatment until 30 days after the end of their treatment for AEs and until 90 days after their last treatment for serious AEs (study treatment may last for up to 1 year)

Study related adverse events (AEs)

Secondary Outcomes

Progression-free survival (PFS)(Each subject will be assessed for PFS from the time of their first study treatment until the date when they have documented disease progression or death (whichever comes first), or until the study is completed (estimated 2 years for study completion))
Overall survival (OS)(Each subject will be assessed for OS from the time of their first study treatment until the date when they have documented disease progression or death (whichever comes first), or until the study is completed (estimated 2 years for study completion))