Photodynamic Therapy + Nivolumab Phase 2 Trial (NCT04400539)
Phase 2 trial (NCT04400539) at University Hospital Lille testing intrapleural photodynamic therapy followed by nivolumab for mesothelioma. Now recruiting.
University Hospital, Lille is recruiting patients for a PHASE2 clinical trial testing intrapleural photodynamic therapy followed by the immunotherapy drug nivolumab for mesothelioma.
The trial, designated NCT04400539, aims to enroll up to 20 participants at 1 site.
About the Study
Pilot study of the feasibility of an innovative multimodal treatment combining intrapleural photodynamic therapy with videothoracoscopy followed by adjuvant immunotherapy with anti-PD-1 Nivolumab antibodies in patients with malignant pleural mesothelioma
Treatment Approach
This trial pairs a local and a systemic therapy. First, surgeons deliver intrapleural photodynamic therapy during a videothoracoscopy, using a light-activated agent to target tumor cells lining the chest. After surgery, patients receive the anti-PD-1 checkpoint inhibitor nivolumab as adjuvant immunotherapy.
Key trial details:
- Phase: PHASE2
- Sponsor: University Hospital, Lille
- Enrollment target: 20
- Status: RECRUITING
Why This Trial Matters
Most pleural mesothelioma treatment leans on either local control or systemic therapy, rarely both in one coordinated plan. This trial tests whether combining the two helps. Photodynamic therapy goes after tumor cells the surgeon can reach during the operation, while nivolumab works through the immune system to address disease that surgery cannot clear. If the approach proves feasible and safe in this small group, it could shape larger studies of multimodal treatment for the disease.
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 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.
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.