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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
2
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.
The University of Chicago
Chicago, Illinois, United States
Major Pathologic (Disease) Response of Tumor to Nivolumab Combined With Ipilimumab Before Surgery
The response of participant's tumor to treatment with nivolumab and ipilimumab before surgery by analyzing tissue samples collected from participant during surgery for the presence of cancerous tumour cells. Major pathologic response will be defined as tissue samples containing less than or equal to 10% of residual (leftover) tumor/cancer in the tissue after surgery.
Time frame: 24 months
Rate of Participants Who Report Serious Side Effects to Nivolumab Combined With Ipilimumab Before Surgery (Neoadjuvant Treatment)
The rate of participants who report Grade 3 or 4 serious adverse events (side effects) after taking nivolumab combined with ipilimumab before surgery. These side effects will be measured according to Common Terminology Criteria for Adverse Events v5.0 for up to 30 days after surgery.
Time frame: 3 weeks (timeframe for surgery ) + 30 days (timeframe for assessing side effects after surgery)
Number of Participants Who Proceed to Surgery Without Delays After Receiving Nivolumab Combined With Ipilimumab
Number of participants who complete treatment with nivolumab and ipilimumab before surgery and proceed to surgery without extended treatment-related delays or progression precluding surgery as assessed by clinical /study records.
Time frame: 19 weeks
Overall Survival of Participants Who Take Nivolumab Combined With Ipilimumab Before Surgery
Overall survival of participants who receive neoadjuvant nivolumab combined with ipilimumab, defined as time from enrollment on study to death from any cause.
Time frame: 42 Months
Progression-Free Survival of Participants Who Take Nivolumab Combined With Ipilimumab Before Surgery
Progression-free survival of participants who receive neoadjuvant nivolumab combined with ipilimumab, defined as time from enrollment on study to death from any cause.
Time frame: 42 months
Rate of Participants Who Report Serious Side Effects to Taking Nivolumab Combined With Ipilimumab After Surgery (Adjuvant Treatment)
The rate of participants who report Grade 3 or 4 serious adverse events (side effects) after taking nivolumab combined with ipilimumab after surgery. These side effects will be measured according to Common Terminology Criteria for Adverse Events v5.0.
Time frame: 12 weeks
Radiologic Response to Nivolumab and Ipilimumab Before Surgery
Radiologic response to nivolumab and ipilimumab before surgery using radiology images of tumor pre- and post-treatment.
Time frame: 24 months
Peritoneal Carcinomatosis Index (PCI) of Participants Who Taking Nivolumab Combined With Ipilimumab Before Surgery
The effect of nivolumab and ipilimumab on participant's tumor as assessed by a peritoneal carcinomatosis index (PCI) score, a score determined based on the size of participant's tumor after abdominal surgery. The Peritoneal Cancer Index (PCI) scoring system is a diagnostic and prognostic tool. The PCI score is calculated by dividing the peritoneal (abdominal) cavity into 13 regions and assigning a score to each of the 13 regions. Each region receives a score of 0-3 based on the largest tumor size in each region. The total sum of all 13 regions is the PCI score. PCI scores can range from 0 to 39. Higher scores indicate more widespread and/or larger tumors in the peritoneal cavity.
Time frame: 12 weeks
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