30 Participants Needed

Neoadjuvant Immunotherapy for Mesothelioma

Recruiting at 2 trial locations
HS
PF
JB
Overseen ByJasmine Brooks, BA
Age: 18+
Sex: Any
Trial Phase: Phase 2
Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Stay on Your Current MedsYou can continue your current medications while participating
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial
Breakthrough TherapyThis drug has been fast-tracked for approval by the FDA given its high promise

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?

The combination of nivolumab and ipilimumab was shown to improve overall survival in patients with unresectable malignant pleural mesothelioma, with patients living a median of 18.1 months compared to 14.1 months for those receiving standard chemotherapy, according to the CheckMate 743 study.12345

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

JB

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

My organs are functioning well.
Women of child-bearing potential (WOCBP) and men must agree to use adequate contraception
I am fully active or can carry out light work.
See 6 more

Exclusion Criteria

I may need to start medications that affect my immune system during the study.
You have an ongoing autoimmune disease, except for certain specific conditions.
Underlying medical conditions that, in the Investigator's opinion, will make the administration of study drug hazardous or obscure the interpretation of toxicity or adverse events
See 13 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Neoadjuvant Treatment

Participants receive preoperative nivolumab +/- ipilimumab prior to planned surgery

6 weeks
3 visits (in-person)

Surgery

Participants undergo planned surgery for resectable MPM

1 week
1 visit (in-person)

Maintenance Therapy

Participants receive maintenance nivolumab for 1 year following standard therapy

52 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

up to 5 years

Treatment Details

Interventions

  • Ipilimumab
  • Nivolumab
Trial Overview The trial tests the safety of using Nivolumab alone or combined with Ipilimumab before surgery in MPM patients. After standard treatments post-surgery, maintenance doses of Nivolumab will continue for one year to see if it helps keep the cancer from coming back.
Participant Groups
2Treatment groups
Experimental Treatment
Group I: Arm B Nivolumab + IpilimumabExperimental Treatment2 Interventions
Receive preoperative nivolumab, 3mg/kg IV, on Day -42, -28 and Day -14 (+/- two days for each timepoint) + ipilimumab 1mg/kg IV on Day -42 prior to planned surgery on Day 0 (to allow for scheduling surgery may take place between Day -3 and Day +10).
Group II: Arm A Nivolumab OnlyExperimental Treatment1 Intervention
Receive preoperative nivolumab, 240mg IV, on Day -42, -28 and Day -14 (+/- two days for each timepoint) prior to planned surgery on Day 0 (to allow for scheduling surgery may take place between Day -3 and Day +10).

Find a Clinic Near You

Who Is Running the Clinical Trial?

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Lead Sponsor

Trials
578
Recruited
33,600+

Bristol-Myers Squibb

Industry Sponsor

Trials
2,731
Recruited
4,127,000+
Headquarters
New York City, USA
Known For
Oncology & Cardiovascular
Top Products
Eliquis, Opdivo, Revlimid, Orencia
Christopher Boerner profile image

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 profile image

Deepak L. Bhatt

Bristol-Myers Squibb

Chief Medical Officer since 2024

MD from Yale University; MSc in Clinical Epidemiology from the University of Pennsylvania

Findings from Research

Nivolumab (Opdivo) combined with ipilimumab (Yervoy) has been approved by the FDA as a first-line treatment for adults with unresectable malignant pleural mesothelioma, based on promising results from the CHECKMATE 743 trial.
The approval was supported by an interim analysis comparing the combination therapy to standard chemotherapy, indicating that this new treatment option may offer better outcomes for patients with this challenging cancer.
FDA Approves Nivolumab Plus Ipilimumab for Previously Untreated Unresectable Malignant Pleural Mesothelioma.Wright, K.[2021]
In the CheckMate 743 trial involving 605 patients with unresectable malignant pleural mesothelioma, the combination of nivolumab and ipilimumab significantly improved overall survival compared to chemotherapy.
Patient-reported outcomes indicated that nivolumab and ipilimumab not only delayed deterioration in health-related quality of life and disease-related symptoms but also maintained quality of life over time, with improvements noted in various symptom scales.
First-line nivolumab plus ipilimumab versus chemotherapy for the treatment of unresectable malignant pleural mesothelioma: patient-reported outcomes in CheckMate 743.Scherpereel, A., Antonia, S., Bautista, Y., et al.[2022]
Nivolumab combined with ipilimumab has been approved by the FDA as the first-line treatment for unresectable malignant pleural mesothelioma (MPM), showing improved overall survival (OS) of 18.1 months compared to 14.1 months for chemotherapy, based on a study of 605 patients.
The treatment was particularly more beneficial for patients with non-epithelioid histology, and the approval process involved collaboration with multiple international health agencies, marking the first new drug regimen for MPM since 2004.
FDA Approval Summary: Nivolumab in Combination with Ipilimumab for the Treatment of Unresectable Malignant Pleural Mesothelioma.Nakajima, EC., Vellanki, PJ., Larkins, E., et al.[2022]

References

FDA Approves Nivolumab Plus Ipilimumab for Previously Untreated Unresectable Malignant Pleural Mesothelioma. [2021]
First-line nivolumab plus ipilimumab versus chemotherapy for the treatment of unresectable malignant pleural mesothelioma: patient-reported outcomes in CheckMate 743. [2022]
FDA Approval Summary: Nivolumab in Combination with Ipilimumab for the Treatment of Unresectable Malignant Pleural Mesothelioma. [2022]
The Immune Microenvironment, Genome-wide Copy Number Aberrations, and Survival in Mesothelioma. [2018]
First-line nivolumab plus ipilimumab versus chemotherapy in patients with unresectable malignant pleural mesothelioma: 3-year outcomes from CheckMate 743. [2022]
Correlation between immune-related adverse events and therapeutic effects of nivolumab in patients with malignant pleural mesothelioma. [2022]
Small vessel vasculitis and dry gangrene secondary to combined CTLA-4 and PD-1 blockade in malignant mesothelioma. [2022]
Ipilimumab and nivolumab in the treatment of recurrent malignant pleural mesothelioma (INITIATE): results of a prospective, single-arm, phase 2 trial. [2020]
Nivolumab Immunotherapy in Malignant Mesothelioma: A Case Report Highlighting a New Opportunity for Exceptional Outcomes. [2019]
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top
Terms of Service·Privacy Policy·Cookies·Security