Neoadjuvant Immunotherapy for Mesothelioma
Trial Summary
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications. However, if you are on systemic corticosteroids or other immunosuppressive medications, you may need to stop them at least 14 days before starting the study drugs. It's best to discuss your specific medications with the study team.
What data supports the effectiveness of the drug combination of nivolumab and ipilimumab for treating mesothelioma?
What safety data exists for neoadjuvant immunotherapy using nivolumab and ipilimumab in humans?
Nivolumab and ipilimumab, used together, have been approved for treating malignant pleural mesothelioma, and studies show they can cause immune-related side effects, including skin issues. These treatments have been evaluated in various conditions, and while they can improve survival, they may also lead to adverse events like small vessel vasculitis (inflammation of blood vessels) and dry gangrene (tissue death due to lack of blood flow).13678
How does neoadjuvant immunotherapy for mesothelioma differ from other treatments?
Neoadjuvant immunotherapy for mesothelioma, using nivolumab and ipilimumab, is unique because it leverages the body's immune system to fight cancer, unlike traditional chemotherapy. This combination has shown improved survival rates compared to standard chemotherapy and represents a new approach for treating this aggressive cancer.13589
What is the purpose of this trial?
The proposed study will evaluate the safety and feasibility of neoadjuvant nivolumab +/- ipilimumab in resectable MPM. In addition, maintenance nivolumab will be administered for 1 year following completion of standard bi-/tri-modality therapy.
Research Team
Julie Brahmer, MD
Principal Investigator
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Eligibility Criteria
This trial is for adults with resectable malignant pleural mesothelioma (MPM), specifically epithelial or biphasic types, who are in good physical condition and have not received prior cancer therapy. They must be able to undergo a biopsy, have adequate organ function, and agree to use contraception. People with unresectable disease, sarcomatoid histology, interstitial lung disease, autoimmune diseases, infections like HIV/AIDS or hepatitis B/C, recent immunosuppressant use or allergies to study drugs cannot join.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Neoadjuvant Treatment
Participants receive preoperative nivolumab +/- ipilimumab prior to planned surgery
Surgery
Participants undergo planned surgery for resectable MPM
Maintenance Therapy
Participants receive maintenance nivolumab for 1 year following standard therapy
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- Ipilimumab
- Nivolumab
Find a Clinic Near You
Who Is Running the Clinical Trial?
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Lead Sponsor
Bristol-Myers Squibb
Industry Sponsor
Christopher Boerner
Bristol-Myers Squibb
Chief Executive Officer since 2023
PhD in Business Administration from the Haas School of Business, University of California, Berkeley; BA in Economics and History from Washington University in St. Louis
Deepak L. Bhatt
Bristol-Myers Squibb
Chief Medical Officer since 2024
MD from Yale University; MSc in Clinical Epidemiology from the University of Pennsylvania