Pre-Surgery Immunotherapy for Mesothelioma
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests if giving immunotherapy drugs can better control disease in patients with a specific type of mesothelioma. The drugs help the immune system attack cancer cells, which may stop the cancer from growing and spreading.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications. However, it mentions that you cannot have treatment with hormones or other chemotherapeutic agents, except for hormones used for non-disease-related conditions like insulin for diabetes.
Is the combination of nivolumab and ipilimumab safe for humans?
The combination of nivolumab (Opdivo) and ipilimumab (Yervoy) has been approved by the FDA for treating malignant pleural mesothelioma, and skin-related side effects are the most common. While these drugs are generally considered safe, they can cause immune-related side effects, so it's important to discuss potential risks with your doctor.12345
How is the drug combination of Ipilimumab and Nivolumab unique for treating mesothelioma?
What data supports the effectiveness of the drugs Ipilimumab, Yervoy, Nivolumab, and Opdivo for treating mesothelioma?
The combination of nivolumab (Opdivo) and ipilimumab (Yervoy) has been shown to improve overall survival in patients with unresectable malignant pleural mesothelioma, as demonstrated in the CheckMate 743 trial. Patients receiving these drugs lived longer compared to those receiving standard chemotherapy.14689
Are You a Good Fit for This Trial?
This trial is for adults with stage I-IIIa sarcomatoid mesothelioma who haven't had prior treatments affecting the primary tumor. Candidates must have a stable HIV, no active infections or autoimmune diseases (with some exceptions), and an ECOG performance status of <=2 or Karnofsky >=60%. Pregnant or nursing women are excluded, as well as those with certain heart conditions or other health issues that could interfere with surgery.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Neoadjuvant Immunotherapy
Participants receive nivolumab and ipilimumab intravenously before surgery
Surgery
Participants may undergo surgery after neoadjuvant immunotherapy
Follow-up
Participants are monitored for safety, effectiveness, and time to recurrence after surgery
What Are the Treatments Tested in This Trial?
Interventions
- Ipilimumab
- Nivolumab
- Surgical Procedure
Ipilimumab is already approved in United States, European Union for the following indications:
- Advanced melanoma
- Stage III unresectable melanoma
- Stage IV metastatic melanoma
- Advanced melanoma
- Stage III unresectable melanoma
- Stage IV metastatic melanoma
Find a Clinic Near You
Who Is Running the Clinical Trial?
Alliance for Clinical Trials in Oncology
Lead Sponsor
National Cancer Institute (NCI)
Collaborator