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

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 atumor lesion. Newly-obtained is defined as a specimen obtained up to 6 weeks (42days) prior to initiation of treatment on Day 1. Subjects for whom newly-obtainedsamples cannot be provided (e.g. inaccessible or subject safety concern) may submitan 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 serumpregnancy within 72 hours prior to receiving the first dose of study medication. Ifthe urine test is positive or cannot be confirmed as negative, a serum pregnancytest will be required.

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

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

Exclusion Criteria:

• Is currently participating and receiving study therapy or has participated in astudy of an investigational agent and received study therapy or used aninvestigational device within 4 weeks of the first dose of treatment.

• Has a diagnosis of immunodeficiency or is receiving any form of immunosuppressivetherapy within 7 days prior to the first dose of trial treatment OR Is takingchronic systemic steroids (in doses exceeding 10 mg daily of prednisone equivalent)within 7 days prior to the first dose of trial treatment. (Note: Subjects withasthma or chronic obstructive pulmonary disease that require intermittent use ofbronchodilators, inhaled steroids, or local steroid injections would not be excludedfrom 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 studyDay 1 or who has not recovered (i.e., ≤ Grade 1 or at baseline) from adverse eventsdue to agents administered more than 4 weeks earlier.

• Has had prior chemotherapy, targeted small molecule therapy, or radiation therapywithin 2 weeks prior to study Day 1 or who has not recovered (i.e., ≤ Grade 1 or atbaseline) from adverse events due to a previously administered agent. Note: Subjectswith ≤ Grade 2 neuropathy are an exception to this criterion and may qualify for thestudy. Note: If subject received major surgery, they must have recovered adequatelyfrom the toxicity and/or complications from the intervention prior to startingtherapy.

• Has a known additional malignancy that is progressing or requires active treatment.Exceptions include basal cell carcinoma of the skin or squamous cell carcinoma ofthe skin that has undergone potentially curative therapy or in situ cervical cancer.

• Has known metastatic disease and/or disease that is otherwise determined to beunresectable.

• Has active autoimmune disease that has required systemic treatment in the past 2years (i.e. with use of disease modifying agents, corticosteroids orimmunosuppressive drugs). Replacement therapy (eg., thyroxine, insulin, orphysiologic corticosteroid replacement therapy for adrenal or pituitaryinsufficiency, etc.) is not considered a form of systemic treatment.

• Has a history of (non-infectious) pneumonitis that required steroids or currentpneumonitis.

• Evidence of interstitial lung disease.

• Has an active infection requiring systemic therapy.

• Has a history or current evidence of any condition, therapy, or laboratoryabnormality that might confound the results of the trial, interfere with thesubject's participation for the full duration of the trial, or is not in the bestinterest of the subject to participate, in the opinion of the treating investigator.

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

• Is pregnant or breastfeeding, or expecting to conceive or father children within theprojected duration of the trial, starting with the pre-screening or screening visitthrough 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 andare allowed; however intranasal influenza vaccines (e.g., Flu-Mist®) are liveattenuated vaccines, and are not allowed