Trial Tests Immunotherapy Before Surgery
Baylor and Duke are testing immunotherapy before surgery for mesothelioma. Trial now enrolling operable patients.
Key Trial Information
| Detail | Information |
|---|---|
| Trial sites | Baylor St. Luke’s, Duke University |
| Treatment | Chemo + immunotherapy before surgery |
| Drugs | Durvalumab, tremelimumab, platinum/pemetrexed |
| Population | Operable mesothelioma |
| Status | Actively recruiting |
A major new clinical trial is investigating whether combining chemotherapy with immunotherapy before surgery can improve outcomes for patients with operable mesothelioma. The study, led by researchers at Baylor College of Medicine and Duke University, builds on earlier findings showing dual immunotherapy extended survival.
Why This Trial Matters
The Problem with Current Treatment
For patients with surgically removable mesothelioma, standard treatment typically involves:
- Surgery (pleurectomy/decortication or extrapleural pneumonectomy)
- Chemotherapy (before and/or after surgery)
- Sometimes radiation
Despite aggressive treatment, most patients eventually relapse. Median survival with surgery alone is approximately 18-24 months.
The Hypothesis
Adding immunotherapy to chemotherapy before surgery may:
- Shrink tumors more effectively than chemo alone
- Prime the immune system to recognize cancer cells
- Eliminate microscopic disease the surgeon can’t see
- Extend overall survival
Building on Earlier Success
This trial follows a completed Phase 2 study at Baylor (NCT02592551) that produced compelling results:
Prior Baylor Trial Results (2016-2019)
| Outcome | Durvalumab Alone | Durvalumab + Tremelimumab |
|---|---|---|
| Median OS | 14.0 months | Not reached |
| Surgical completion | 85% | 85% |
| Pathologic response | : | 35% |
Patients receiving dual immunotherapy (durvalumab + tremelimumab) had significantly longer survival than those receiving durvalumab alone, so much longer that the median wasn’t reached at data cutoff.
The New Trial Design
Treatment Arms
The new study compares two approaches:
| Arm | Before Surgery | After Surgery |
|---|---|---|
| Control | Chemotherapy | Durvalumab (12 months) |
| Experimental | Chemo + durvalumab + tremelimumab | Durvalumab (12 months) |
Treatment Protocol
Before surgery:
- Durvalumab (anti-PD-L1)
- Tremelimumab (anti-CTLA-4): experimental arm only
- Pemetrexed + platinum chemotherapy
- Multiple cycles
Surgery:
- Pleurectomy/decortication or extrapleural pneumonectomy
- Based on disease extent and patient factors
After surgery:
- Durvalumab maintenance for up to 12 months
- Tremelimumab for up to 5 cycles (experimental arm)
How the Drugs Work
| Drug | Target | Mechanism |
|---|---|---|
| Durvalumab | PD-L1 | Blocks cancer’s “off switch” on immune cells |
| Tremelimumab | CTLA-4 | Releases the “brake” on T-cell activation |
| Pemetrexed | Folate pathway | Kills rapidly dividing cells |
| Platinum (cisplatin/carboplatin) | DNA | Damages cancer cell DNA |
The combination attacks cancer through multiple pathways simultaneously.
Trial Locations
Baylor St. Luke’s Medical Center (Houston, TX)
- Lead investigator: R. Taylor Ripley, M.D.
- Director, Mesothelioma Treatment Center
- Nationally recognized thoracic surgeon
Duke University Health System (Durham, NC)
- Comprehensive mesothelioma program
- High-volume thoracic surgery center
- Strong immunotherapy research program
Both are designated mesothelioma centers of excellence with experienced multidisciplinary teams.
Who May Be Eligible
While specific criteria should be confirmed with the trial team, typical eligibility includes:
May qualify:
- Confirmed mesothelioma diagnosis
- Disease considered surgically removable
- Good overall health (performance status)
- Adequate organ function
- No prior systemic treatment for mesothelioma
May not qualify:
- Advanced/metastatic disease
- Prior immunotherapy or chemotherapy
- Significant heart or lung problems
- Active autoimmune disease
- Certain medical conditions
How to Enroll
If you’re interested in this trial, contact Baylor St. Luke’s Mesothelioma Treatment Center in Houston, Texas, or the Thoracic Oncology program at Duke in Durham, North Carolina. Search ClinicalTrials.gov for durvalumab and tremelimumab mesothelioma studies. Ask your oncologist to refer you to one of the participating sites.
Related Treatment Advances
This trial is part of a broader shift toward combining immunotherapy with surgery:
| Trial | Approach | Results |
|---|---|---|
| Hopkins perioperative trial | Nivo + Ipi before/after surgery | 28.6 mo median OS |
| Baylor Phase 2 (completed) | Durva + Treme before surgery | Median OS not reached |
| Baylor-Duke (recruiting) | Chemo + IO before surgery | Enrolling now |
What to Expect as a Participant
Potential Benefits for Participants
Participants gain access to combination therapy before it is widely available, care at specialized mesothelioma centers like Baylor St. Luke’s and Duke, close monitoring throughout treatment, and the ability to contribute to research that may help future patients.
Potential Risks to Weigh
Participation carries side effects from immunotherapy (fatigue, rash, immune reactions that can affect the lungs, colon, liver, or thyroid), side effects from chemotherapy (nausea, low blood counts, fatigue), standard surgical risks, and a substantial time commitment for visits and monitoring.
Time Commitment
Expect multiple visits over 12+ months, including:
- Pre-treatment evaluation
- Treatment cycles (every 3 weeks)
- Surgery and recovery
- Post-surgery maintenance
- Follow-up visits
If you have operable mesothelioma and haven’t received prior treatment, you may be eligible. Contact Baylor St. Luke’s Mesothelioma Treatment Center in Houston or Duke’s Thoracic Oncology program in Durham. You can also search ClinicalTrials.gov for durvalumab/tremelimumab mesothelioma studies.
Reader Q&A
Frequently Asked Questions
What is neoadjuvant immunotherapy?
Neoadjuvant therapy is treatment given before surgery. This trial tests whether giving immunotherapy (durvalumab and tremelimumab) combined with chemotherapy before surgery can shrink tumors, prime the immune system to recognize cancer cells, and eliminate microscopic disease the surgeon can’t see.
Who is eligible for this trial?
Typical eligibility includes: confirmed mesothelioma diagnosis, disease considered surgically removable, good overall health, adequate organ function, and no prior systemic treatment for mesothelioma. Patients with advanced/metastatic disease, prior immunotherapy or chemotherapy, or significant heart/lung problems may not qualify.
What happened in the earlier Baylor trial?
The completed Phase 2 Baylor study (2016-2019) showed that patients receiving dual immunotherapy (durvalumab + tremelimumab) before surgery had significantly longer survival than those receiving durvalumab alone. Median overall survival was not reached at data cutoff, a very positive sign.
How do I enroll in this trial?
Contact Baylor St. Luke’s Mesothelioma Treatment Center in Houston, TX, or Duke’s Thoracic Oncology program in Durham, NC. You can also ask your oncologist for a referral or search ClinicalTrials.gov for current studies.
What is the best hospital for mesothelioma?
No single hospital is designated as the best for people with mesothelioma, as effectiveness depends on factors like cancer type, location, and individual needs. Multiple sources rank University of Texas MD Anderson Cancer Center (Houston, TX) as the top U.S. cancer hospital overall, with specialized mesothelioma programs treating more cases than most centers. Other frequently cited centers include Brigham and Women’s Hospital (Boston, MA), Mayo Clinic (Rochester, MN), Mount Sinai Hospital (New York, NY), and Massachusetts General Hospital (Boston, MA). These facilities often participate in clinical trials and multidisciplinary care listed on ClinicalTrials.gov [1-3].
What is the life expectancy of a person with mesothelioma?
People with mesothelioma have an average life expectancy of 4-12 months without treatment and 12-21 months with treatment, primarily for pleural mesothelioma. Peritoneal mesothelioma shows longer survival, averaging 53 months with cytoreductive surgery and heated intraperitoneal chemotherapy (HIPEC). Life expectancy varies by stage for pleural cases (21 months at stage 1, 19 months at stage 2, 16 months at stage 3, 12 months at stage 4) and cell type, with epithelioid offering better outcomes. Five-year relative survival rates for pleural mesothelioma are 23% for localized, 15% for regional, and 11% for distant disease.
Is mesothelioma one of the worst cancers?
Mesothelioma ranks among the deadliest cancers due to its low 5-year survival rate of 7.2-12% across stages, lower than most others except pancreatic cancer at 7.3%. Localized pleural mesothelioma, the most common type affecting over 75-80% of people with the disease, has a 20% 5-year survival rate, dropping to 8% for distant spread. Median life expectancy after diagnosis ranges from 12-21 months with treatment, often shorter without it, reflecting its aggressive nature linked to asbestos exposure. Factors like stage at diagnosis and treatment access influence individual outcomes.
Can I have surgery while on immunotherapy?
Research across several cancers indicates that many people can safely undergo surgery while receiving immunotherapy, particularly immune checkpoint inhibitors such as pembrolizumab. Small retrospective studies and newer perioperative guidelines report no major increase in serious surgical complications or 30 day readmissions, and some breast surgery guidance notes that checkpoint inhibitors can often continue through the perioperative period. In several cancers, using immunotherapy before surgery (neoadjuvant) and then again afterward (adjuvant) has improved outcomes, including higher cure rates and lower recurrence risks. However, immune related side effects like inflammation of the lungs, gut, liver, or endocrine glands can complicate anesthesia and recovery, so teams often use extra preoperative testing and monitoring. Evidence is still evolving, and approaches vary by cancer type, drug, and individual health status.