Health TrialsbyHealthPanel

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

ConditionMesotheliomas Pleural
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorAbramson Cancer Center at Penn Medicine

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Single group

Treatments tested in this trial

  • Pembrolizumab

    Drug

    Pembrolizumab 200mg via IV infusion every 3 weeks for 2 cycles 3 pre-surgery, for 4 cycles post-surgery and then every 3 weeks during maintenance.

  • Indocyanine Green (ICG) Image-Guided Surgery

    Procedure/Surgery

    Standard surgery with image guided resection.

  • Cisplatin

    Drug

    75 mg/m2 every 3 weeks via IV infusion for 4 cycles post-surgery.

  • Pemetrexed

    Drug

    500 mg/m2 every 3 weeks via IV infusion for 4 cycles post-surgery.

Treatment groups

20 Participants
are divided into 1 treatment group
Group A: Pembrolizumab with image-guided surgery and chemotherapyExperimental treatment 4 interventions

Trial outcomes

Primary outcomes

1

Study related adverse events (AEs)

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)

Secondary outcomes

1

Progression-free survival (PFS)

Progression-free survival (PFS)

Time frame
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)
2

Overall survival (OS)

Overall survival (OS)

Time frame
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)

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Abramson Cancer Center at Penn Medicine

Lead sponsor

Source ClinicalTrials.gov
Apply now