Nivolumab + Ipilimumab Phase 1/2 Trial (NCT07121374)
University Hospital, Antwerp PHASE1/PHASE2 clinical trial testing nivolumab plus ipilimumab for people with mesothelioma. Trial NCT07121374 is now recruiting.
University Hospital, Antwerp is recruiting patients for a PHASE1/PHASE2 clinical trial testing nivolumab plus ipilimumab for mesothelioma.
The trial, designated NCT07121374, aims to enroll up to 37 participants at 1 sites.
About the Study
The goal of this clinical trial is to evaluate whether a combination of chemotherapy and immunotherapy can make surgery possible in adults with inoperable pleural mesothelioma (a type of cancer affecting the lung lining). The main questions it aims to answer are:
Can two cycles of neoadjuvant chemotherapy and dual immunotherapy, followed by surgery, be completed safely and effectively?
Does this treatment allow previously inoperable patients to become eligible for surgery and improve survival outcomes?
Participants will:
Receive two cycles of chemotherapy (cisplatin or carboplatin and pemetrexed)
Receive dual immunotherapy (nivolumab and ipilimumab)
Undergo evaluation by a multidisciplinary team to determine if surgery is possible
If operable, undergo extended pleurectomy/decortication surgery
Be followed for one year to assess side effects, quality of life, and survival
Treatment Approach
This trial uses a combination of checkpoint inhibitors that was FDA-approved for mesothelioma in 2020.
Key trial details:
- Phase: PHASE1/PHASE2
- Sponsor: University Hospital, Antwerp
- Enrollment target: 37
- Status: RECRUITING
Why This Trial Matters
Study Locations
Contact the trial sponsor for information about participating sites.
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 on immunotherapy for mesothelioma?
People with mesothelioma treated with immunotherapy regimens like nivolumab (Opdivo) plus ipilimumab (Yervoy) have a median survival of 18.1 months, based on the phase 3 CheckMate 743 trial. In the KEYNOTE-483 trial, pembrolizumab (Keytruda) combined with chemotherapy yielded a median survival of 17.3 months, compared to 16.1 months with chemotherapy alone. Overall, FDA-approved immunotherapies extend median life expectancy to 17-18 months for people with unresectable pleural mesothelioma across stages. Survival varies by factors like cell type and treatment sequence, with 1-year rates around 68% and 2-year rates at 41% for Opdivo plus Yervoy.
Is cancer from asbestos curable?
No, cancers linked to asbestos exposure, including mesothelioma and lung cancer, are not curable in most cases. For pleural mesothelioma, treatments like surgery, chemotherapy, radiation, and immunotherapy can extend survival, with a 1-year survival rate of 79.6% for multimodal therapy, but most diagnoses occur at advanced stages where cure is not possible. Asbestos-related lung cancer has a 5-year survival rate of 28% for non-small cell types, using similar treatments including carboplatin, pemetrexed, and immune checkpoint inhibitors, though prognosis remains poor overall. No preventive treatments exist for at-risk individuals.
What is the best immunotherapy for mesothelioma?
FDA-approved immunotherapies for unresectable pleural mesothelioma include nivolumab (Opdivo) plus ipilimumab (Yervoy), with median overall survival of 18.1 months versus 12-14 months for chemotherapy alone in the CheckMate 743 trial, and pembrolizumab (Keytruda) plus pemetrexed and platinum chemotherapy, with approximately 18 months median survival in the KEYNOTE-483 trial. The Opdivo-Yervoy combination shows particular effectiveness for people with non-epithelioid (sarcomatoid or biphasic) mesothelioma, nearly doubling survival compared to chemotherapy. The PrE0505 trial reported 20.4 months median overall survival with durvalumab plus chemotherapy, higher for epithelioid subtypes at 24.3 months. No single immunotherapy is designated as best across all cases, as outcomes vary by histology and trial data.
What is the name of the cancer caused by asbestos?
Asbestos exposure causes multiple cancers, with mesothelioma being the primary one. Mesothelioma is a rare cancer of the thin membranes lining the chest, abdomen, and other organs, and asbestos is responsible for more than 80% of cases. Asbestos also causes lung cancer, laryngeal cancer, and ovarian cancer. The International Agency for Research on Cancer and the U.S. Environmental Protection Agency classify all types of asbestos as carcinogens.