Trial Outcomes & Findings for A Study of Immunotherapy Drugs Nivolumab and Ipilimumab in Patients w/Resectable Malignant Peritoneal Mesothelioma (NCT NCT05041062)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

2 participants

Primary outcome timeframe

24 months

Results posted on

2024-01-03

Participant Flow

Participant milestones

Participant milestones
Measure	All Participants in Study Who Have Mesothelioma Individuals in this group will receive a combination of two immunotherapy drugs (nivolumab and ipilimumab) before and after surgery to remove their cancer. Nivolumab: Nivolumab is an immunotherapy drug (a type of drug that helps the 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: Ipilimumab is a type of immunotherapy drug known as a checkpoint inhibitor, which helps the immune system attack cancer cells.
Overall Study STARTED	2
Overall Study COMPLETED	0
Overall Study NOT COMPLETED	2

Reasons for withdrawal

Reasons for withdrawal
Measure	All Participants in Study Who Have Mesothelioma Individuals in this group will receive a combination of two immunotherapy drugs (nivolumab and ipilimumab) before and after surgery to remove their cancer. Nivolumab: Nivolumab is an immunotherapy drug (a type of drug that helps the 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: Ipilimumab is a type of immunotherapy drug known as a checkpoint inhibitor, which helps the immune system attack cancer cells.
Overall Study Adverse Event	2

Baseline Characteristics

A Study of Immunotherapy Drugs Nivolumab and Ipilimumab in Patients w/Resectable Malignant Peritoneal Mesothelioma

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	All Participants in Study Who Have Mesothelioma n=2 Participants Individuals in this group will receive a combination of two immunotherapy drugs (nivolumab and ipilimumab) before and after surgery to remove their cancer. Nivolumab: Nivolumab is an immunotherapy drug (a type of drug that helps the 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: Ipilimumab is a type of immunotherapy drug known as a checkpoint inhibitor, which helps the immune system attack cancer cells.
Age, Continuous	54.0 years n=39 Participants
Sex: Female, Male Female	1 Participants n=39 Participants
Sex: Female, Male Male	1 Participants n=39 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=39 Participants
Race (NIH/OMB) Asian	0 Participants n=39 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=39 Participants
Race (NIH/OMB) Black or African American	0 Participants n=39 Participants
Race (NIH/OMB) White	2 Participants n=39 Participants
Race (NIH/OMB) More than one race	0 Participants n=39 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=39 Participants
Region of Enrollment United States	2 participants n=39 Participants

PRIMARY outcome

Timeframe: 24 months

Population: Data not collected.

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.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 3 weeks (timeframe for surgery ) + 30 days (timeframe for assessing side effects after surgery)

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.

Outcome measures

Outcome measures
Measure	All Participants in Study Who Have Mesothelioma n=2 Participants Individuals in this group will receive a combination of two immunotherapy drugs (nivolumab and ipilimumab) before and after surgery to remove their cancer. Nivolumab: Nivolumab is an immunotherapy drug (a type of drug that helps the 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: Ipilimumab is a type of immunotherapy drug known as a checkpoint inhibitor, which helps the immune system attack cancer cells.
Rate of Participants Who Report Serious Side Effects to Nivolumab Combined With Ipilimumab Before Surgery (Neoadjuvant Treatment)	2 Participants

SECONDARY outcome

Timeframe: 19 weeks

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.

Outcome measures

Outcome measures
Measure	All Participants in Study Who Have Mesothelioma n=2 Participants Individuals in this group will receive a combination of two immunotherapy drugs (nivolumab and ipilimumab) before and after surgery to remove their cancer. Nivolumab: Nivolumab is an immunotherapy drug (a type of drug that helps the 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: Ipilimumab is a type of immunotherapy drug known as a checkpoint inhibitor, which helps the immune system attack cancer cells.
Number of Participants Who Proceed to Surgery Without Delays After Receiving Nivolumab Combined With Ipilimumab	1 Participants

SECONDARY outcome

Timeframe: 42 Months

Population: Data not collected.

Overall survival of participants who receive neoadjuvant nivolumab combined with ipilimumab, defined as time from enrollment on study to death from any cause.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 42 months

Population: Data not collected.

Progression-free survival of participants who receive neoadjuvant nivolumab combined with ipilimumab, defined as time from enrollment on study to death from any cause.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 12 weeks

Population: Neither of the two enrolled patients received study drug (nivolumab/ipilimumab) after surgery.

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.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 24 months

Population: Data not collected.

Radiologic response to nivolumab and ipilimumab before surgery using radiology images of tumor pre- and post-treatment.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 12 weeks

Population: Data not collected.

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.

Outcome measures

Outcome data not reported

Adverse Events

All Participants in Study Who Have Mesothelioma

Serious events: 2 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	All Participants in Study Who Have Mesothelioma n=2 participants at risk Individuals in this group will receive a combination of two immunotherapy drugs (nivolumab and ipilimumab) before and after surgery to remove their cancer. Nivolumab: Nivolumab is an immunotherapy drug (a type of drug that helps the 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: Ipilimumab is a type of immunotherapy drug known as a checkpoint inhibitor, which helps the immune system attack cancer cells.
Renal and urinary disorders Acute kidney injury	100.0% 2/2 • 12 weeks
Gastrointestinal disorders Abdominal pain	50.0% 1/2 • 12 weeks
Nervous system disorders Encephalopathy	50.0% 1/2 • 12 weeks

Other adverse events

Other adverse events
Measure	All Participants in Study Who Have Mesothelioma n=2 participants at risk Individuals in this group will receive a combination of two immunotherapy drugs (nivolumab and ipilimumab) before and after surgery to remove their cancer. Nivolumab: Nivolumab is an immunotherapy drug (a type of drug that helps the 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: Ipilimumab is a type of immunotherapy drug known as a checkpoint inhibitor, which helps the immune system attack cancer cells.
General disorders Pain	50.0% 1/2 • 12 weeks
Gastrointestinal disorders Nausea	100.0% 2/2 • 12 weeks
Gastrointestinal disorders Constipation	50.0% 1/2 • 12 weeks
Respiratory, thoracic and mediastinal disorders Respiratory, thoracic and mediastinal disorders-Other	50.0% 1/2 • 12 weeks
Gastrointestinal disorders Dry mouth	50.0% 1/2 • 12 weeks
General disorders Fatigue	50.0% 1/2 • 12 weeks
Infections and infestations Rash	50.0% 1/2 • 12 weeks
Gastrointestinal disorders Vomiting	50.0% 1/2 • 12 weeks
Metabolism and nutrition disorders Anorexia	50.0% 1/2 • 12 weeks
Gastrointestinal disorders Diarrhea	50.0% 1/2 • 12 weeks

Additional Information

Theodore Karrison (Research Professor)

University of Chicago

Phone: 773-702-9326

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place