Nivolumab + Ipilimumab Phase 2 Trial for Mesothelioma
Alliance phase 2 trial testing nivolumab + ipilimumab for mesothelioma. NCT05647265 is now recruiting patients.
Alliance for Clinical Trials in Oncology is recruiting patients for a PHASE2 clinical trial testing nivolumab plus ipilimumab for mesothelioma.
The trial, designated NCT05647265, aims to enroll up to 26 participants at 126 sites, including locations in Alaska, Arizona, California.
About the Study
This phase II trial evaluates the safety and effectiveness of giving immunotherapy (nivolumab and ipilimumab) before surgery for controlling disease in patients with stage I-IIIa sarcomatoid mesothelioma. Immunotherapy with monoclonal antibodies, such as nivolumab and ipilimumab, may help the body’s immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving immunotherapy before surgery may be more effective at controlling disease in patients with sarcomatoid mesothelioma than giving immunotherapy alone.
Treatment Approach
This trial uses a combination of checkpoint inhibitors that was FDA-approved for mesothelioma in 2020.
Key trial details:
- Phase: PHASE2
- Sponsor: Alliance for Clinical Trials in Oncology
- Enrollment target: 26
- Status: RECRUITING
Why This Trial Matters
Study Locations
The trial is recruiting at:
- Anchorage Associates in Radiation Medicine, Alaska
- Anchorage Radiation Therapy Center, Alaska
- Alaska Breast Care and Surgery LLC, Alaska
- Alaska Oncology and Hematology LLC, Alaska
- Alaska Women’s Cancer Care, Alaska
How to Enroll
Patients interested in this trial should:
- Discuss eligibility with their oncologist
- Review the full eligibility criteria on ClinicalTrials.gov
- Contact the study coordinator for screening
Reader Q&A
Frequently Asked Questions
What is the life expectancy of someone with immunotherapy for mesothelioma?
People with mesothelioma treated with immunotherapy, such as Opdivo plus Yervoy, have a median survival of 18.1 months, compared to 14.1 months with chemotherapy alone, per the CheckMate 743 trial. Keytruda combined with chemotherapy yields a median survival of 17.3-19.8 months. The DREAM trial reported 20.4 months median overall survival with durvalumab plus chemotherapy, rising to 24.3 months for epithelioid pleural mesothelioma. Overall, 3-year survival rates reach 23-25% with these treatments.
What cancer is linked to asbestos?
Asbestos exposure causes most mesotheliomas, a rare cancer of the thin membranes lining the chest and abdomen, and also causes lung, larynx, and ovarian cancers. Evidence further links it to pharyngeal, stomach, and colorectal cancers, though associations are less strong for these. All forms of asbestos increase these risks, with greater exposure linked to higher cancer incidence. Approximately 80% of mesothelioma cases are pleural, 20% peritoneal, and less than 1% pericardial or testicular.
Where does mesothelioma cancer usually start?
Mesothelioma most commonly starts in the pleura, the thin membrane lining the lungs, accounting for the majority of cases. The cancer can also develop in the peritoneum, the lining of the abdominal cavity, or more rarely in the pericardium (heart lining) or tunica vaginalis testis. Asbestos fibers that are inhaled travel to the ends of small air passages and reach the pleura, where they can cause inflammation, scarring, and DNA damage that leads to uncontrolled cell growth. If asbestos fibers are swallowed, they can reach the abdominal lining and contribute to peritoneal mesothelioma.
Is there a cure for cancer caused by asbestos?
No cure exists for mesothelioma, the cancer caused by asbestos exposure. Evidence shows 1-year survival rates of 79.6% for people with pleural mesothelioma receiving multimodal treatment, with 11% of surveyed individuals achieving remission through chemotherapy, surgery, or immunotherapy. The NERO trial demonstrated niraparib, a PARP inhibitor, reduced progression or death risk by 27% and delayed worsening by 1.5 months on average in recurrent cases. Ongoing research explores preventive agents like sulforaphane and therapies such as tumor treating fields, which extend survival by 4-6 months with chemotherapy. Standard options include surgery, radiation, chemotherapy, immunotherapy (nivolumab plus ipilimumab), and targeted therapy.