A Study of Immunotherapy Drugs Nivolumab and Ipilimumab in Patients w/Resectable Malignant Perito… (NCT05041062) | Clinical Trial Compass
CompletedPhase 2
A Study of Immunotherapy Drugs Nivolumab and Ipilimumab in Patients w/Resectable Malignant Peritoneal Mesothelioma
United States2 participantsStarted 2021-12-01
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Have a diagnosis of histologically or cytologically confirmed peritoneal mesothelioma, of epithelial, biphasic, or sarcomatoid subtypes
✓. Have disease burden amenable to cytoreduction and hyperthermic intraperitoneal chemotherapy (HIPEC), as determined by a surgeon specializing in mesothelioma
✓. Have measurable or evaluable disease based on RECIST 1.1 or on laparoscopy
✓. Have no definitive evidence of visceral metastases by best staging
✓. Be willing to undergo laparoscopy or mini-laparotomy for peritoneal staging
✓. Adequate organ function as determined by screening labs,
✓. Have an ECOG performance status of \< 2
✓. Be 18 years of age on day of signing informed consent
Exclusion criteria
✕. 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
What they're measuring
1
Major Pathologic (Disease) Response of Tumor to Nivolumab Combined With Ipilimumab Before Surgery
✕. Has received any immunotherapy agents outside of this protocol within 4 weeks of the first dose of treatment on this protocol
✕. 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.
✕. Has a known history of active TB infection (Bacillus tuberculosis)
✕. Has active COVID-19 infection
✕. Has known history of, or any evidence of active, non-infectious pneumonitis that required steroids, or active pneumonitis
✕. Has a severe hypersensitivity to nivolumab or any of its excipients
✕. Has a severe hypersensitivity to ipilimumab or any of its excipients