Clinical Trials /

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

NCT03760575

Description:

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).

Related Conditions:
  • Malignant Pleural Mesothelioma
Recruiting Status:

Not yet recruiting

Phase:

Phase 1

Trial Eligibility

Document

Title

  • Brief Title: Pembrolizumab in Combination With Chemotherapy and Image-Guided Surgery for Malignant Pleural Mesothelioma (MPM)
  • Official Title: Pembrolizumab in Combination With Chemotherapy and Image-Guided Surgery for Malignant Pleural Mesothelioma (MPM)

Clinical Trial IDs

  • ORG STUDY ID: UPCC 07518
  • SECONDARY ID: 831466
  • NCT ID: NCT03760575

Conditions

  • Mesotheliomas Pleural

Interventions

DrugSynonymsArms
PembrolizumabMK-3475Pembrolizumab with image-guided surgery and chemotherapy
CisplatinPembrolizumab with image-guided surgery and chemotherapy
PemetrexedPembrolizumab with image-guided surgery and chemotherapy

Purpose

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).

Trial Arms

NameTypeDescriptionInterventions
Pembrolizumab with image-guided surgery and chemotherapyExperimental
  • Pembrolizumab
  • Cisplatin
  • Pemetrexed

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 1.1.

          -  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.

        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.

          -  Evidence of interstitial lung disease.

          -  Has an active infection requiring systemic therapy.

          -  Has a history or current evidence of any condition, therapy, or laboratory abnormality
             that might confound the results of the trial, interfere with the subject's
             participation for the full duration of the trial, or is not in the best interest of
             the subject to participate, in the opinion of the treating investigator.

          -  Has known psychiatric or substance abuse disorders that would interfere with
             cooperation with the requirements of the trial.

          -  Is pregnant or breastfeeding, or expecting to conceive or father children within the
             projected duration of the trial, starting with the pre-screening or screening visit
             through 120 days after the last dose of trial treatment.

          -  Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent.

          -  Has a known history of Human Immunodeficiency Virus (HIV) (HIV 1/2 antibodies).

          -  Has known active Hepatitis B (e.g., HBsAg reactive) or Hepatitis C (e.g., HCV RNA
             [qualitative] is detected).

          -  Has received a live vaccine within 30 days of planned start of study therapy. Note:
             Seasonal influenza vaccines for injection are generally inactivated flu vaccines and
             are allowed; however intranasal influenza vaccines (e.g., Flu-Mist®) are live
             attenuated vaccines, and are not allowed
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure: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)
Safety Issue:
Description:Study related adverse events (AEs)

Secondary Outcome Measures

Measure: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)
Safety Issue:
Description:Progression-free survival (PFS)
Measure: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)
Safety Issue:
Description:Overall survival (OS)

Details

Phase:Phase 1
Primary Purpose:Interventional
Overall Status:Not yet recruiting
Lead Sponsor:Abramson Cancer Center of the University of Pennsylvania

Last Updated

April 15, 2019