Pembrolizumab, Chemo and Lenvatinib Phase 2 Trial for Pleural Mesothelioma
Phase 2 trial NCT06318286 (PENINSULA) at Hyogo Medical University: pembrolizumab plus platinum chemotherapy and lenvatinib for pleural mesothelioma. Recruiting.
Hyogo Medical University is recruiting patients for a PHASE2 clinical trial testing pembrolizumab (Keytruda) combined with platinum doublet chemotherapy and lenvatinib for pleural mesothelioma.
The trial, designated NCT06318286, aims to enroll up to 25 participants at 1 sites.
About the Study
In this Phase-II study, the investigators will investigate the efficacy and safety of lenvatinib in combination with pembrolizumab and chemotherapy in patients with malignant pleural mesothelioma.
Treatment Approach
This trial pairs a PD-1 checkpoint inhibitor, which helps the immune system recognize and attack cancer cells, with platinum doublet chemotherapy and lenvatinib, a tyrosine kinase inhibitor that targets tumor blood vessel growth. It’s a four-drug, single-arm regimen of pembrolizumab, pemetrexed, cisplatin or carboplatin, and lenvatinib.
Key trial details:
- Phase: PHASE2
- Sponsor: Hyogo Medical University
- Enrollment target: 25
- 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.
What cancer has been linked to asbestos?
Asbestos exposure causes mesothelioma, lung cancer, laryngeal cancer, and ovarian cancer. Mesothelioma accounts for more than 80% of cases linked to asbestos, while about 4% of lung cancer cases and a 40% increased risk of laryngeal cancer stem from exposure. Evidence also shows positive associations with pharyngeal, stomach, and colorectal cancers, though causation is less definitively established. Ongoing research by IARC explores these links further.
Can you cure cancer caused by asbestos?
No cure exists for mesothelioma, the cancer most commonly caused by asbestos exposure. The NERO trial showed niraparib, a PARP inhibitor, reduced progression or death risk by 27% and delayed worsening by 1.5 months on average in people with relapsed mesothelioma. Multimodal treatments, including immunotherapy and surgery, achieve 1-year survival of 79.6% for pleural mesothelioma and remission in 11% of surveyed cases, though 5-year survival remains around 5%. Ongoing research explores prevention with sulforaphane and gene therapies targeting tumor growth.
What drugs are FDA approved for mesothelioma?
The FDA has approved several drugs for malignant mesothelioma, including pemetrexed disodium (Alimta), nivolumab (Opdivo), ipilimumab (Yervoy), and pembrolizumab (Keytruda). Ipilimumab and nivolumab received accelerated approval in 2020 as first-line combination therapy for unresectable pleural mesothelioma in people with no prior treatment. Pembrolizumab gained full approval in 2024 combined with pemetrexed and platinum chemotherapy for first-line treatment of unresectable advanced or metastatic malignant pleural mesothelioma.