TIL Cell Therapy Phase 2 Trial (NCT03935893)
UPMC Hillman Cancer Center Phase 2 clinical trial testing autologous TIL cell therapy for people with mesothelioma. Trial NCT03935893 is recruiting.
UPMC Hillman Cancer Center is recruiting people with mesothelioma for a Phase 2 clinical trial testing autologous tumor infiltrating lymphocyte (TIL) cell therapy, led by principal investigator Udai S. Kammula.
The trial, designated NCT03935893, is enrolling at one site in Pennsylvania.
About the Study
This is a Phase 2 study evaluating a non-myeloablative lymphodepleting preparative regimen followed by infusion of autologous TIL and high-dose aldesleukin in people with locally advanced, recurrent, or metastatic cancer, including mesothelioma. Other eligible cancer types include gastric or esophagogastric, colorectal, pancreatic, sarcoma, neuroendocrine, squamous cell, Merkel cell, and mismatch repair deficient or microsatellite unstable cancers. The primary endpoint is objective response rate (ORR).
Treatment Approach
This trial uses adoptive cell therapy with autologous tumor infiltrating lymphocytes (TIL) plus high-dose aldesleukin (IL-2), not checkpoint inhibitor immunotherapy.
Key trial details:
- Phase: Phase 2
- Sponsor: UPMC Hillman Cancer Center (PI: Udai S. Kammula)
- Intervention: Autologous TIL cell therapy with high-dose aldesleukin
- Status: Recruiting
Why This Trial Matters
Adoptive cell therapy with tumor infiltrating lymphocytes is an active area of research for solid tumors, including mesothelioma. This trial tests whether a patient’s own expanded T cells, combined with high-dose aldesleukin, can produce measurable responses in cancers that have exhausted standard therapy.
Study Locations
The trial is recruiting at:
- UPMC Hillman Cancer Center, Pittsburgh, Pennsylvania
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 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.
Is cancer caused by asbestos curable?
There is no known cure for asbestos-related cancers, including lung cancer and mesothelioma. However, treatment can extend survival and improve quality of life, particularly when cancer is detected early. For non-small cell lung cancer treated with surgery in early stages, people with asbestos-related lung cancer lived an average of 35 months. Recent clinical trials show that combining immunotherapy with chemotherapy extended median overall survival to 15 months compared to less than 13 months with chemotherapy alone. Some people with asbestos-related lung cancer have achieved remission, and individual outcomes vary based on factors like stage at diagnosis, treatment type, and overall health.
What are good signs immunotherapy is working?
Good signs that immunotherapy is working for people with mesothelioma include tumor shrinkage or stabilization on imaging scans, improvement in cancer-related symptoms such as reduced pain or fatigue, and stable or declining tumor markers like CEA or LDH. Laboratory changes, including decreased circulating tumor DNA (ctDNA) levels or shifts in immune biomarkers like IL-8, also indicate positive responses, as shown in studies of lung cancers responsive to immunotherapy. These signs often appear within 8-12 weeks and correlate with better outcomes, though no FDA-approved blood tests specifically monitor immunotherapy effectiveness.