Pre-Surgery Immunotherapy for Mesothelioma
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores whether using immunotherapy drugs, nivolumab and ipilimumab, before surgery can better control sarcomatoid mesothelioma, a type of lung cancer. These drugs boost the immune system to attack cancer cells and may help stop the cancer from growing and spreading. The trial targets individuals with stage I-IIIa sarcomatoid mesothelioma who haven't received prior treatments for their cancer. Participants will receive the drugs through an IV and may undergo surgery, with several scans (such as CT or MRI) to monitor progress.
As a Phase 2 trial, this research focuses on measuring how well the treatment works in an initial, smaller group of people, offering participants a chance to contribute to important advancements in cancer treatment.
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 there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that the combination of nivolumab and ipilimumab has been tested for safety in people with pleural mesothelioma. In one study, 135 patients received this treatment, and researchers monitored their safety. The results showed that most patients tolerated the treatment well. However, like any treatment, some side effects occurred, such as tiredness, skin rash, and diarrhea. Most patients found these side effects manageable. Another study found that the response to this treatment was similar to traditional chemotherapy but with different side effects. Overall, these studies suggest that the nivolumab and ipilimumab combination is safe, with side effects that are usually manageable.12345
Why are researchers excited about this trial's treatments?
Researchers are excited about the combination of Ipilimumab and Nivolumab for mesothelioma because it represents a shift from traditional chemotherapy-based treatments to immunotherapy. Unlike standard treatments that typically attack cancer cells directly, these drugs work by boosting the body's immune system to recognize and destroy cancer cells more effectively. Ipilimumab and Nivolumab are both checkpoint inhibitors, which help to unleash the immune system by blocking proteins that prevent immune cells from attacking cancer. This innovative approach has the potential to improve outcomes for patients by enhancing the body's natural defenses against cancer, possibly leading to better survival rates and quality of life.
What evidence suggests that this treatment might be an effective treatment for mesothelioma?
Research has shown that using the drugs nivolumab and ipilimumab together can help treat mesothelioma, a type of cancer. In a study with patients who had malignant pleural mesothelioma, those who received these two drugs had a 26% lower chance of dying compared to those who received standard chemotherapy. This suggests the drug combination may help the immune system fight cancer cells more effectively. In this trial, participants will receive nivolumab and ipilimumab before surgery. The results indicate that using these drugs before surgery might better control a specific type of mesothelioma called sarcomatoid mesothelioma.14678
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