Trial Tests Immunotherapy Before Surgery

Key Trial Information

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:

1. Surgery (pleurectomy/decortication or extrapleural pneumonectomy)
2. Chemotherapy (before and/or after surgery)
3. 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)

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:

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

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:

1. Contact Baylor St. Luke’s: Mesothelioma Treatment Center, Houston, TX
2. Contact Duke: Thoracic Oncology program, Durham, NC
3. Search ClinicalTrials.gov: Look for durvalumab/tremelimumab mesothelioma studies
4. Ask your oncologist: They can refer you to participating sites

Related Treatment Advances

This trial is part of a broader shift toward combining immunotherapy with surgery:

What to Expect as a Participant

Potential Benefits

• Access to cutting-edge combination therapy
• Care at specialized mesothelioma centers
• Close monitoring throughout treatment
• Contributing to research that may help future patients

Potential Risks

• Side effects from immunotherapy (fatigue, rash, immune reactions)
• Side effects from chemotherapy (nausea, low blood counts, fatigue)
• Surgical risks
• 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