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

NCT05041062 | Completed Phase 2 Results FDA Drug

• 1 other identifier: IRB21-0672
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Mesothelioma; Peritoneal Mesothelioma

Keywords

chest cancer; abdominal cancer; lung cancer; cancer in lining of lungs

Outcome Measures

Primary Outcomes (1)

• 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.

  24 months

Secondary Outcomes (7)

• Rate of Participants Who Report Serious Side Effects to Nivolumab Combined With Ipilimumab Before Surgery (Neoadjuvant Treatment)

  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

  19 weeks

• Overall Survival of Participants Who Take Nivolumab Combined With Ipilimumab Before Surgery

  42 Months

• Progression-Free Survival of Participants Who Take Nivolumab Combined With Ipilimumab Before Surgery

  42 months

• Rate of Participants Who Report Serious Side Effects to Taking Nivolumab Combined With Ipilimumab After Surgery (Adjuvant Treatment)

  12 weeks

Study Arms (1)

All Participants in Study Who Have Mesothelioma

EXPERIMENTAL

Individuals in this group will receive a combination of two immunotherapy drugs (nivolumab and ipilimumab) before and after surgery to remove their cancer. There will also be a follow up period to determine how well the drugs and surgery worked to get rid of your cancer. Your overall participation in this study (including drug treatment, surgery and follow up visits) will last for roughly one and a half years. All eligible participant who enroll in the study will participate in this group.

Drug: Nivolumab; Drug: Ipilimumab

Interventions

Nivolumab DRUG

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.

Also known as: Opdivo, ONO-4538, BMS-936558, MDX1106

All Participants in Study Who Have Mesothelioma

Ipilimumab DRUG

Ipilimumab is a type of immunotherapy drug known as a checkpoint inhibitor, which helps your own immune system attack cancer cells.

Also known as: Yervoy

All Participants in Study Who Have Mesothelioma

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• Be willing and able to provide written informed consent for the trial

You may not qualify if:

• 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
• 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
• 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)
• 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
• Has an active infection requiring systemic therapy
• Has a known history of HIV, Hepatitis B, or Hepatitis C
• Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.
• 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
• 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.

Sponsors & Collaborators

• University of Chicago: lead

Study Sites (1)

The University of Chicago

Chicago, Illinois, 60637, United States

Location

MeSH Terms

Conditions

Mesothelioma; Lung Neoplasms

Interventions

Nivolumab; Ipilimumab

Condition Hierarchy (Ancestors)

Adenoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Mesothelial; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Results Point of Contact

• Title: Theodore Karrison (Research Professor)
• Organization: University of Chicago

tkarrison@health.bsd.uchicago.edu

773-702-9326

Study Officials

• Kiran Turaga, MD

  University of Chicago

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 7, 2021
• First Posted: September 10, 2021
• Study Start: December 1, 2021
• Primary Completion: April 13, 2023
• Study Completion: April 13, 2023
• Last Updated: January 3, 2024
• Results First Posted: January 3, 2024

Record last verified: 2023-12

Locations

US (1)