A Study of Immunotherapy Drugs Nivolumab and Ipilimumab in Patients w/Resectable Malignant Peritoneal Mesothelioma
Condition: Mesothelioma; Peritoneal Mesothelioma
MeSH terms: Mesothelioma; Mesothelioma, Malignant
Intervention: Nivolumab; Ipilimumab
Intervention description: Nivolumab is an immunotherapy drug (a type of drug that helps your immune system fight cancer) that is often used with ipilimumab as the first treatment in adults with mesothelioma whose disease cannot be removed by surgery. The drug will be given as an IV infusion.; Ipilimumab is a type of immunotherapy drug known as a checkpoint inhibitor, which helps your own immune system attack cancer cells.
Intervention MeSH terms: Nivolumab; Ipilimumab
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 2.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: chest cancer; abdominal cancer; lung cancer; cancer in lining of lungs

Summary:

      This study is for individuals who have peritoneal mesothelioma, a cancer of the lining of
      your abdominal wall and organs (the peritoneum). Doctors leading the study would like to
      determine the effects of treating this cancer with immunotherapy drugs (nivolumab and
      ipilimumab - the two study drugs that will be used in this study) before and after surgery.

      Doctors hope to learn if giving these two drugs before surgery will decrease the amount of
      viable (live) cancer cells that remain at the time of surgery and whether it will delay the
      time it could take for the cancer to regrow.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Have a diagnosis of histologically or cytologically confirmed peritoneal mesothelioma,
             of epithelial, biphasic, or sarcomatoid subtypes

          2. Have disease burden amenable to cytoreduction and hyperthermic intraperitoneal
             chemotherapy (HIPEC), as determined by a surgeon specializing in mesothelioma

          3. Have measurable or evaluable disease based on RECIST 1.1 or on laparoscopy

          4. Have no definitive evidence of visceral metastases by best staging

          5. Be willing to undergo laparoscopy or mini-laparotomy for peritoneal staging

          6. Adequate organ function as determined by screening labs,

          7. Have an ECOG performance status of < 2

          8. Be 18 years of age on day of signing informed consent

          9. Be willing and able to provide written informed consent for the trial

        Exclusion Criteria:

          1. Is currently participating in a study of an investigational agent and received an
             investigational agent within 4 weeks of the first dose of treatment on this protocol

          2. Has received any immunotherapy agents outside of this protocol within 4 weeks of the
             first dose of treatment on this protocol

          3. Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy
             (>10 mg of prednisone daily or equivalent) or any other form of immunosuppressive
             therapy within 14 days prior to the first dose of study drug.

          4. Has a known history of active TB infection (Bacillus tuberculosis)

          5. Has active COVID-19 infection

          6. Has known history of, or any evidence of active, non-infectious pneumonitis that
             required steroids, or active pneumonitis

          7. Has a severe hypersensitivity to nivolumab or any of its excipients

          8. Has a severe hypersensitivity to ipilimumab or any of its excipients

          9. Has an 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)

         10. Has a known additional malignancy that is progressing or required active treatment
             within the 3 years prior to enrollment - 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 or other tumors that will not affect life
             expectancy

         11. Has an active infection requiring systemic therapy

         12. Has a known history of HIV, Hepatitis B, or Hepatitis C

         13. Has known psychiatric or substance abuse disorders that would interfere with
             cooperation with the requirements of the trial.

         14. Is pregnant or breastfeeding, or expecting to conceive or father children within the
             projected duration of the trial, starting with the screening visit through 120 days
             after the last dose of trial treatment

               1. Female subjects 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.

               2. Female subjects of childbearing potential should be willing to use 2 methods of
                  birth control or be surgically sterile, or abstain from heterosexual activity for
                  the course of the study through 120 days after the last dose of study medication
                  (Reference Section 5.8.2). Subjects of childbearing potential are those who have
                  not been surgically sterilized or have not been free from menses for > 1 year.

               3. Male subjects should 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.

         15. Is on anticoagulation that cannot be discontinued in the perioperative period

         16. Has received a live vaccine within 30 days of planned start of study therapy