Clinical Trials

🔬 Clinical Trials Quick Facts
January 2026 Trial Landscape
Active US Trials	53 Recruiting
Patient Participation	Only 8%
CAR-T 1-Year Survival	83%
Best Response Rate	51.6% (BNT327)
Phase III Opening	H1 2026 (VT3989)
New US Cases/Year	~3,000
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Mesothelioma Clinical Trials represent the cutting edge of treatment research, offering patients access to breakthrough therapies before they become widely available. As of January 2026, fifty-three mesothelioma clinical trials are actively recruiting patients across the United States, including revolutionary CAR-T cell therapies achieving 83% one-year survival, the first-ever Phase III trial of a TEAD inhibitor, and AI-designed drugs now in human testing.

Executive Summary

The mesothelioma clinical trial landscape has transformed dramatically, yet patient participation remains critically low at just 8%—a significant drop from 14% in 2023. This gap exists despite proven survival benefits from trial participation. In January 2026, patients have access to immunotherapy combinations extending median survival beyond 18 months, targeted therapies achieving 32% response rates in previously untreatable disease, and cellular therapies demonstrating unprecedented durability. The FDA approved pembrolizumab plus chemotherapy in September 2024 as a new first-line standard, with subcutaneous Keytruda QLEX following in January 2026. VT3989, the first TEAD inhibitor, will advance to Phase III registration trials in the first half of 2026, representing a major milestone for targeted therapy in this disease. For patients and families navigating treatment decisions alongside legal compensation, specialized mesothelioma attorneys can help coordinate both processes simultaneously.

Key Facts: Mesothelioma Clinical Trials January 2026

53 actively recruiting mesothelioma clinical trials in the United States as of January 2026 8% patient participation rate—down from 14% in 2023 despite expanded options CAR-T cell therapy at Memorial Sloan Kettering achieves 83% one-year survival VT3989 TEAD inhibitor advancing to Phase III in H1 2026 with 32% response rate ISM6331—first AI-designed mesothelioma drug—dosed first patient January 22, 2025 Pembrolizumab + chemotherapy FDA approved September 2024; median survival 16.9 months Keytruda QLEX (subcutaneous) approved January 11, 2026 for all indications BNT327/PM8002 achieves 51.6% overall response rate; 75% in peritoneal mesothelioma CheckMate 743 shows 23.2% three-year survival with nivolumab plus ipilimumab Approximately 3,000 new US cases diagnosed annually; 72,779 total cases 1999-2021

What Phase III Trials Are Currently Recruiting?

Phase III trials represent the final stage before FDA approval and offer patients access to therapies that have already demonstrated efficacy in earlier studies.

eVOLVE-Meso Trial (NCT06097728)

The eVOLVE-Meso trial is a Phase III, randomized, open-label, multicenter study testing volrustomig (MEDI5752), a novel PD-1/CTLA-4 bispecific antibody, in combination with carboplatin and pemetrexed.

Trial Specifications:

• Status: Actively recruiting globally
• Sponsor: AstraZeneca
• Enrollment Target: 825 patients worldwide
• Mechanism: PD-1/CTLA-4 bispecific antibody providing selective CTLA-4 blockade on activated T cells
• Comparator Arms: Platinum-based chemotherapy or nivolumab plus ipilimumab
• Eligibility: Unresectable pleural mesothelioma with no prior systemic therapy
• Locations: United States, Canada, Brazil, China, Europe, Japan
• Expected Completion: Data anticipated post-2026

ATOMIC-Meso Results (Pegargiminase/ADI-PEG20)

The ATOMIC-Meso trial has completed, with practice-changing results published in JAMA Oncology in March 2024.

Published Results (249 patients with non-epithelioid pleural mesothelioma):

• Median overall survival: 9.3 months versus 7.7 months with placebo plus chemotherapy
• Three-year survival: Quadrupled compared to placebo arm
• Progression-free survival: 6.2 months versus 5.6 months (HR 0.65; p=0.02)
• Risk reduction: 35% reduction in progression risk
• Mechanism: Arginine depletion therapy targeting ASS1-deficient tumors

"The ATOMIC-Meso results represent a breakthrough for patients with non-epithelioid mesothelioma, a subtype that historically had very limited treatment options. Quadrupling three-year survival changes the outlook for these patients and their families."

— Rod De Llano, Founding Partner, Danziger & De Llano

What CAR-T Cell Therapies Are Available for Mesothelioma?

CAR-T (Chimeric Antigen Receptor T-cell) therapy represents one of the most promising frontiers in mesothelioma treatment, with multiple trials demonstrating unprecedented survival outcomes.

TNhYP218 Trial at National Cancer Institute (NCT06885697)

This Phase I dose-escalation study evaluates anti-mesothelin TNaive/SCM hYP218 CAR T cells, designed for enhanced tumor infiltration and persistence.

Trial Details:

• Status: Recruiting since 2025
• Location: National Cancer Institute, Bethesda, Maryland
• Innovation: Targets membrane-proximal epitope of mesothelin, showing 2-4 fold better tumor killing than membrane-distal approaches in preclinical studies
• Eligibility: Age 18 or older, mesothelin expression greater than 50% of tumor cells, ECOG 0-1
• Monitoring: Patients must remain within 2 hours of NIH for 30 days post-infusion
• Follow-up: 15 years per FDA requirement

Memorial Sloan Kettering Intrapleural CAR-T Program (NCT04577326)

This groundbreaking program pioneered regional delivery of CAR-T cells directly into the pleural space, minimizing systemic toxicity while maximizing tumor contact.

✓ Breakthrough Results: Memorial Sloan Kettering's intrapleural CAR-T program achieved 83% one-year survival for malignant pleural mesothelioma patients—dramatically exceeding historical outcomes of 12-16 months median survival with standard therapy.

Published Results:

• One-year survival: 83% for malignant pleural mesothelioma patients
• CAR-T persistence: Cells detected in peripheral blood for more than 100 days in 39% of patients
• Durable responses: One patient achieved partial response lasting 26 months
• Safety profile: Intrapleural administration was safe and well tolerated
• Combination approach: 18 patients received CAR-T with pembrolizumab, demonstrating enhanced function

SynKIR-110 Trial (STAR-101, NCT05568680)

This novel approach uses KIR-CAR T cells targeting mesothelin across multiple tumor types including mesothelioma.

• Status: Completed enrollment of Cohorts 1-3 without dose-limiting toxicities as of May 2025
• Sites: Multiple US locations including Penn Medicine
• Safety: No dose-limiting toxicities in completed cohorts

What Targeted Therapies Are Showing Promise?

VT3989 TEAD Inhibitor — Advancing to Phase III

VT3989 represents a breakthrough in targeting the previously "undruggable" Hippo/YAP/TEAD pathway, which is dysregulated in the majority of mesotheliomas.

ESMO 2025 Results (Published Nature Medicine December 2025):

• Objective response rate: 32% in 22 mesothelioma patients at optimized dose
• Disease control rate: 86% when incorporating optimal dose and UACR threshold
• Median progression-free survival: 10 months
• Duration of response: 8 patients on treatment more than 1 year; one approaching 2 years
• Selected dose: 100 mg two-weeks-on/two-weeks-off for Phase III
• Safety: Favorable profile with mostly grade 1-2 toxicities; proteinuria reversible with dose adjustment
• Tumor types: Activity demonstrated in both NF2-mutant and wild-type tumors

Regulatory Designations:

• FDA Orphan Drug Designation
• FDA Fast Track Designation

ℹ️ Historic Milestone: VT3989 will become the first TEAD inhibitor to reach a registrational Phase III trial in mesothelioma when it opens in the first half of 2026, representing a major advance for targeted therapy in this disease.

ISM6331 — First AI-Designed Drug for Mesothelioma (NCT06566079)

This pan-TEAD inhibitor was designed using Insilico Medicine's Chemistry42 AI platform, representing the first AI-designed drug to enter clinical testing for mesothelioma.

Development Timeline:

• September 2020: AI platform launched
• June 2023: Recommended for preclinical studies
• April 2024: AACR presentation showing broad cancer-killing effects
• June 2024: FDA Orphan Drug Designation granted
• August 2024: IND clearance received
• January 22, 2025: First patient dosed in China
• 2026: US enrollment expected

Mechanism: Pan-TEAD inhibitor blocking the palmitoylation site, disrupting YAP/TAZ-TEAD transcriptional activity

IAG933 TEAD Inhibitor — Development Discontinued

Novartis discontinued development of IAG933 in October 2025 following underwhelming ESMO 2025 data showing only 13% objective response rate in 30 pleural mesothelioma patients. QTc prolongation dose-limiting toxicities in 4 patients contributed to the decision.

What Are the Latest Immunotherapy Results?

Pembrolizumab Plus Chemotherapy — FDA Approved September 2024

The KEYNOTE-483 trial led to FDA approval for first-line treatment of unresectable advanced or metastatic malignant pleural mesothelioma on September 17, 2024.

Trial Results:

• Median overall survival: 16.9 months versus 14.1 months with chemotherapy alone
• Hazard ratio: 0.79 (95% CI: 0.63-0.99; p=0.0209)
• Confirmed objective response rate: 52% versus 29%
• Median duration of response: 6.9 versus 6.8 months
• Regimen: Pembrolizumab with pemetrexed and platinum chemotherapy

January 2026 Update: FDA approved Keytruda QLEX (subcutaneous pembrolizumab) on January 11, 2026, offering a 1-minute injection every 3 weeks as an alternative to IV infusion for all 38 pembrolizumab indications including mesothelioma.

Nivolumab Plus Ipilimumab — CheckMate 743 Long-term Data

CheckMate 743 remains the only Phase 3 trial demonstrating survival improvement sustained over 3 years with first-line immunotherapy in unresectable malignant pleural mesothelioma.

Three-Year Follow-up Results:

• Three-year overall survival: 23.2% versus 15.4% with chemotherapy
• Sustained benefit: Observed regardless of histology
• Duration of response: Longer with dual immunotherapy at 3 years
• Safety: Consistent profile with no new signals at long-term follow-up

"Clinical trials represent the cutting edge of mesothelioma treatment. We encourage every patient to explore trial options because tomorrow's standard treatments are available today through these programs. The survival improvements we're seeing with newer therapies are remarkable."

— Paul Danziger, Founding Partner, Danziger & De Llano

BNT327/PM8002 — Exceptional Peritoneal Mesothelioma Results

This PD-L1/VEGF-A bispecific antibody demonstrated remarkable activity at ASCO 2025, particularly in peritoneal mesothelioma.

Phase 2 Trial Results (31 patients with unresectable mesothelioma):

• Confirmed overall response rate: 51.6%
• Peritoneal mesothelioma cohort (8 patients): 75% ORR, 100% disease control rate
• Median exposure: 16.0 months (95% CI 8.1-19.5)
• Median follow-up: 19.3 months
• Safety: 93.5% experienced grade 3/4 adverse events; no treatment-related deaths

Phase 3 trial planning is underway (NCT07133750 registered July 2025).

UV1 Vaccine Plus Checkpoint Inhibitors

The NIPU trial (Phase II, NCT04300244) demonstrated statistically significant survival improvement when UV1 telomerase vaccine was added to nivolumab plus ipilimumab.

Results (118 patients randomized):

• Median overall survival: 15.4 months with UV1 versus 11.1 months without—statistically significant
• Median progression-free survival: 4.2 months versus 2.9 months
• Objective response rate: 31% versus 16%
• Safety: Comparable adverse event rates between groups
• Regulatory Status: FDA Fast Track Designation granted February 2024

What Are the Eligibility Requirements for Most Trials?

Performance Status Requirements

Most mesothelioma clinical trials require patients to meet specific baseline criteria:

ECOG Performance Status:

• ECOG 0: Fully active, able to carry on all pre-disease activities without restriction
• ECOG 1: Restricted in physically strenuous activity but ambulatory and able to carry out light work
• ECOG 2: Some trials accept for exceptional cases
• Alternative measure: Karnofsky score 70% or higher

Typical Laboratory Value Requirements

• Absolute neutrophil count 1,500/μL or higher
• Platelet count 100,000/μL or higher
• Hemoglobin 9.0 g/dL or higher
• Creatinine clearance 45 mL/min or higher
• Bilirubin 1.5x upper limit of normal or lower

Disease Requirements

• Histologically confirmed mesothelioma (pathology report required)
• Measurable disease by modified RECIST criteria
• No untreated brain metastases
• Specific histology requirements vary by trial
• Some trials require specific biomarker expression (mesothelin greater than 50% for certain CAR-T trials)

⚠️ Important: Eligibility requirements vary significantly between trials. A patient who does not qualify for one trial may be eligible for others. Work with a mesothelioma specialist to identify all available options.

Where Are Major Clinical Trials Located?

National Cancer Institute (Bethesda, Maryland)

• TNhYP218 CAR-T trial (NCT06885697)
• Multiple additional mesothelioma studies
• Travel assistance programs available

MD Anderson Cancer Center (Houston, Texas)

• 16+ active mesothelioma trials
• VT3989 TEAD inhibitor trial (lead investigator: Dr. Timothy Yap)
• Specialized mesothelioma program
• Telemedicine consultations offered

Memorial Sloan Kettering Cancer Center (New York)

• Intrapleural CAR-T program (NCT04577326)
• International patient services
• Dedicated mesothelioma team

University of Chicago

• ISM6331 trial site
• ICARuS II peritoneal trial (NCT06057935)
• Multiple systemic therapy trials

Princess Margaret Cancer Centre (Toronto)

• SMARTER trial headquarters
• International enrollment accepted
• Modified surgical protocols

What Are the Financial Considerations for Trial Participation?

Costs Covered by Trial Sponsors

• Study drug or intervention
• Trial-specific tests and procedures
• Additional monitoring visits required by protocol
• Some travel expenses (varies by trial)

Patient/Insurance Responsibility

• Standard of care treatments
• Routine doctor visits
• Hospital stays if not trial-related
• Most travel and lodging expenses

Insurance Coverage

The Affordable Care Act requires most health plans to cover routine patient costs in clinical trials.

• Medicare: Covers qualifying trials for Medicare beneficiaries
• Private insurance: 44 states require coverage; check your state's mandates
• Medicaid: Coverage depends on state regulations
• VA benefits: VA covers trial participation at approved facilities for eligible veterans

"Many families don't realize that pursuing legal compensation and participating in clinical trials can happen simultaneously. The two processes are completely separate, and pursuing one doesn't affect the other. We help families navigate both paths at once."

— Michelle Whitman, Attorney, Danziger & De Llano

What Survival Outcomes Can Patients Expect?

Current Survival Data by Treatment Type

Treatment Approach	Median Overall Survival	Notable Outcomes
Pembrolizumab + Chemotherapy	16.9 months	FDA approved September 2024; 52% response rate
Nivolumab + Ipilimumab	18.1 months	23.2% three-year survival
MSK Intrapleural CAR-T	Data maturing	83% one-year survival
VT3989 (Relapsed)	Data maturing	10 months PFS; 32% response rate
CRS-HIPEC (Peritoneal)	53 months	47% five-year survival

What Trials Are Expected in 2026?

Confirmed Q1-Q2 2026 Trial Openings

VT3989 Phase III:

• First registrational trial of a TEAD inhibitor in mesothelioma
• Based on ESMO 2025 data showing 32% ORR
• Third-line indication

BNT327/PM8002 Phase III:

• NCT07133750 registered July 2025
• Building on exceptional Phase 2 results

ISM6331 US Enrollment:

• Expected to open following January 2025 China enrollment
• First AI-designed mesothelioma drug

MVdeltaC First-in-Human:

• Measles virus-based immunotherapy
• FDA Orphan Drug Designation June 2025
• Clinical trial planned for 2026

Pipeline Developments

Antibody-Drug Conjugates (ADCs):

• SGN-MesoC2 recruiting (updated November 2025)
• Rinatabart Sesutecan (GEN1184/PRO1184) recruiting (updated December 2025)

How Do I Find and Enroll in a Clinical Trial?

Primary Trial Resources

• ClinicalTrials.gov: Official NIH database with all registered trials
• NCI Cancer Information Service: 1-800-4-CANCER
• EmergingMed Navigator: Free matching service
• Lazarex Cancer Foundation: Financial assistance for trial costs

Questions to Ask Before Enrolling

1. What phase is the trial? (Phase I = safety focus, Phase II = efficacy, Phase III = comparison)
2. What are the specific eligibility requirements?
3. How many visits are required and where?
4. What costs will I be responsible for?
5. Can I leave the trial if needed?
6. How will this affect my other treatment options?
7. What are the known risks and potential benefits?
8. What happens if the treatment works—can I continue receiving it?

"When my father was diagnosed with mesothelioma, we didn't know about clinical trials or the compensation available to us. Now I help families understand all their options—both medical and legal—so they can make informed decisions during an incredibly difficult time."

— David Foster, Client Advocate, Danziger & De Llano

Key NCT Numbers for Trial Verification

Trial Name	NCT Number	Status
eVOLVE-Meso (Volrustomig)	NCT06097728	Recruiting
TNhYP218 CAR-T (NCI)	NCT06885697	Recruiting
ISM6331 TEAD Inhibitor	NCT06566079	Recruiting
MSK Intrapleural CAR-T	NCT04577326	Recruiting
SynKIR-110	NCT05568680	Recruiting
ICARuS II (Peritoneal)	NCT06057935	Recruiting
NERO (Niraparib)	NCT05455424	Completed
NIPU (UV1 Vaccine)	NCT04300244	Completed

Getting Legal Help During Trial Participation

Patients participating in clinical trials can simultaneously pursue legal compensation from asbestos trust funds and responsible companies. This compensation is entirely separate from trial participation and can help cover expenses not covered by the trial, including travel, lodging, lost wages, and care for family members.

🛡️ Free Clinical Trial & Compensation Consultation Our team helps families navigate both treatment options and legal rights. Call (866) 222-9990 →

Related Resources

• Trust Funds — Access $30+ billion in asbestos trust fund compensation
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• Choosing an Attorney — What to look for in mesothelioma legal representation
• Treatment Centers — Specialized mesothelioma treatment facilities nationwide
• Understanding Your Diagnosis — Medical information for newly diagnosed patients