Clinical Trials: Difference between revisions
Internal linking: added 5 wiki links |
Convert exec summary to lead, add listicle, fix dark mode |
||
| Line 1: | Line 1: | ||
/Users/charlesfletcher/Library/Python/3.9/lib/python/site-packages/urllib3/__init__.py:35: NotOpenSSLWarning: urllib3 v2 only supports OpenSSL 1.1.1+, currently the 'ssl' module is compiled with 'LibreSSL 2.8.3'. See: https://github.com/urllib3/urllib3/issues/3020 | |||
warnings.warn( | |||
Connecting to wikimesothelioma.com... | |||
Logging in as MesotheliomaSupport@Claude... | |||
Successfully logged in! | |||
--- Page Content --- | |||
{{#seo: | {{#seo: | ||
|title=Mesothelioma Clinical Trials 2026: 53 Active Trials, CAR-T, TEAD Inhibitors | |title=Mesothelioma Clinical Trials 2026: 53 Active Trials, CAR-T, TEAD Inhibitors | ||
| Line 29: | Line 36: | ||
| style="padding:10px; border-bottom:1px solid #dee2e6;" | H1 2026 (VT3989) | | style="padding:10px; border-bottom:1px solid #dee2e6;" | H1 2026 (VT3989) | ||
|- | |- | ||
| style="padding:10px; font-weight:bold; " | New US Cases/Year | | style="padding:10px; font-weight:bold;" | New US Cases/Year | ||
| style="padding:10px;" | ~3,000 | | style="padding:10px;" | ~3,000 | ||
|- | |- | ||
| Line 35: | Line 42: | ||
|} | |} | ||
''' | '''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.<ref>[https://dandell.com/malignant-mesothelioma/ Malignant Mesothelioma Lawyers], Danziger & De Llano</ref> | ||
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. | |||
'''Mesothelioma clinical trials at a glance:''' | |||
* '''53 actively recruiting trials''' — the number of mesothelioma clinical trials open to patients across the United States as of January 2026 | |||
* '''8% participation rate''' — patient enrollment has dropped from 14% in 2023 despite expanded trial options and proven survival benefits | |||
* '''83% one-year survival''' — Memorial Sloan Kettering's intrapleural CAR-T program achieves dramatically higher survival than standard therapy | |||
* '''32% response rate''' — VT3989 TEAD inhibitor advancing to Phase III in H1 2026 after demonstrating durable responses in relapsed patients | |||
* '''51.6% overall response''' — BNT327/PM8002 bispecific antibody achieves exceptional results, with 75% response in peritoneal mesothelioma | |||
* '''16.9 months median survival''' — pembrolizumab plus chemotherapy FDA approved September 2024 with 52% confirmed response rate | |||
* '''23.2% three-year survival''' — CheckMate 743 nivolumab plus ipilimumab demonstrates sustained long-term benefit versus chemotherapy | |||
* '''First AI-designed drug''' — ISM6331 pan-TEAD inhibitor dosed its first patient January 22, 2025 after AI-accelerated development | |||
* '''Approximately 3,000 new cases''' — annual U.S. mesothelioma diagnoses with 72,779 total cases documented from 1999 to 2021 | |||
* '''90-day first payment''' — patients can pursue trust fund compensation simultaneously with clinical trial participation | |||
{| style="width:100%; border:2px solid #1a5276; border-radius:8px; margin:1em 0;" | {| style="width:100%; border:2px solid #1a5276; border-radius:8px; margin:1em 0;" | ||
|- | |- | ||
! style="background:#1a5276; color:white; padding:12px; font-size:1.1em; text-align:left; border-radius:6px 6px 0 0;" | Key Facts: | ! style="background:#1a5276; color:white; padding:12px; font-size:1.1em; text-align:left; border-radius:6px 6px 0 0;" | Key Facts: Mesothelioma Clinical Trials January 2026 | ||
|- | |- | ||
| style="padding:15px;" | | | style="padding:15px;" | | ||
* '''53 actively recruiting''' mesothelioma clinical trials in the United States as of 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 | * '''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''' | * '''CAR-T cell therapy''' at Memorial Sloan Kettering achieves '''83% one-year survival''' | ||
| Line 53: | Line 71: | ||
* '''Pembrolizumab + chemotherapy''' FDA approved September 2024; median survival 16.9 months | * '''Pembrolizumab + chemotherapy''' FDA approved September 2024; median survival 16.9 months | ||
* '''Keytruda QLEX''' (subcutaneous) approved January 11, 2026 for all indications | * '''Keytruda QLEX''' (subcutaneous) approved January 11, 2026 for all indications | ||
* '''BNT327/PM8002''' achieves 51.6% overall response rate; 75% in | * '''BNT327/PM8002''' achieves 51.6% overall response rate; 75% in peritoneal mesothelioma | ||
* '''CheckMate 743''' shows 23.2% three-year survival with nivolumab plus ipilimumab | * '''CheckMate 743''' shows 23.2% three-year survival with nivolumab plus ipilimumab | ||
* '''Approximately 3,000 new US cases''' diagnosed annually | * '''Approximately 3,000 new US cases''' diagnosed annually; 72,779 total cases 1999-2021 | ||
|} | |} | ||
| Line 64: | Line 82: | ||
=== eVOLVE-Meso Trial (NCT06097728) === | === 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.<ref>[https:// | 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.<ref>[https://dandell.com/mesothelioma-compensation/ Mesothelioma Compensation], Danziger & De Llano</ref> | ||
'''Trial Specifications:''' | '''Trial Specifications:''' | ||
| Line 72: | Line 90: | ||
* '''Mechanism:''' PD-1/CTLA-4 bispecific antibody providing selective CTLA-4 blockade on activated T cells | * '''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 | * '''Comparator Arms:''' Platinum-based chemotherapy or nivolumab plus ipilimumab | ||
* '''Eligibility:''' Unresectable | * '''Eligibility:''' Unresectable pleural mesothelioma with no prior systemic therapy | ||
* '''Locations:''' United States, Canada, Brazil, China, Europe, Japan | * '''Locations:''' United States, Canada, Brazil, China, Europe, Japan | ||
* '''Expected Completion:''' Data anticipated post-2026 | * '''Expected Completion:''' Data anticipated post-2026 | ||
| Line 80: | Line 98: | ||
The ATOMIC-Meso trial has completed, with practice-changing results published in JAMA Oncology in March 2024.<ref>[https://mesothelioma.net/mesothelioma-emerging-treatments-research/ New Mesothelioma Treatments and Research], Mesothelioma.net</ref> | The ATOMIC-Meso trial has completed, with practice-changing results published in JAMA Oncology in March 2024.<ref>[https://mesothelioma.net/mesothelioma-emerging-treatments-research/ New Mesothelioma Treatments and Research], Mesothelioma.net</ref> | ||
'''Published Results (249 patients with non-epithelioid | '''Published Results (249 patients with non-epithelioid pleural mesothelioma):''' | ||
* '''Median overall survival:''' 9.3 months versus 7.7 months with placebo plus chemotherapy | * '''Median overall survival:''' 9.3 months versus 7.7 months with placebo plus chemotherapy | ||
* '''Three-year survival:''' Quadrupled compared to placebo arm | * '''Three-year survival:''' Quadrupled compared to placebo arm | ||
| Line 89: | Line 107: | ||
{| style="width:90%; margin:1.5em auto; border-left:4px solid #1a5276; border-radius:0 4px 4px 0;" | {| style="width:90%; margin:1.5em auto; border-left:4px solid #1a5276; border-radius:0 4px 4px 0;" | ||
|- | |- | ||
| style="padding:20px 25px 15px; font-style:italic; font-size:1.05em; line-height:1.6;" | "The ATOMIC-Meso results represent a breakthrough for patients with non-epithelioid mesothelioma, a subtype that historically had very limited | | style="padding:20px 25px 15px; font-style:italic; font-size:1.05em; line-height:1.6;" | "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." | ||
|- | |- | ||
| style="padding:5px 25px 20px; text-align:right;" | '''— Rod De Llano,''' Founding Partner, Danziger & De Llano | | style="padding:5px 25px 20px; text-align:right;" | '''— Rod De Llano,''' Founding Partner, Danziger & De Llano | ||
| Line 96: | Line 114: | ||
== What CAR-T Cell Therapies Are Available for Mesothelioma? == | == 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.<ref>[https://www. | 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.<ref>[https://www.mesotheliomalawyercenter.org/financial-compensation-form/ Financial Compensation Form], Mesothelioma Lawyer Center</ref> | ||
=== TNhYP218 Trial at National Cancer Institute (NCT06885697) === | === 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. | This Phase I dose-escalation study evaluates anti-mesothelin TNaive/SCM hYP218 CAR T cells, designed for enhanced tumor infiltration and persistence. | ||
'''Trial Details:''' | '''Trial Details:''' | ||
| Line 112: | Line 130: | ||
=== Memorial Sloan Kettering Intrapleural CAR-T Program (NCT04577326) === | === 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.<ref>[https:// | This groundbreaking program pioneered regional delivery of CAR-T cells directly into the pleural space, minimizing systemic toxicity while maximizing tumor contact.<ref>[https://dandell.com/mesothelioma-lawyer/new-york/ New York Mesothelioma Lawyers], Danziger & De Llano</ref> | ||
{| style="width:100%; border:1px solid #28a745; border-left:5px solid #28a745; border-radius:4px; margin:1em 0;" | {| style="width:100%; border:1px solid #28a745; border-left:5px solid #28a745; border-radius:4px; margin:1em 0;" | ||
|- | |- | ||
| style="padding:15px; " | ''' | | style="padding:15px;" | '''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. | ||
|} | |} | ||
| Line 128: | Line 146: | ||
=== SynKIR-110 Trial (STAR-101, NCT05568680) === | === SynKIR-110 Trial (STAR-101, NCT05568680) === | ||
This novel approach uses KIR-CAR T cells targeting mesothelin across multiple tumor types including mesothelioma.<ref>[https:// | This novel approach uses KIR-CAR T cells targeting mesothelin across multiple tumor types including mesothelioma.<ref>[https://mesothelioma.net/immunotherapy/ Immunotherapy for Mesothelioma], Mesothelioma.net</ref> | ||
* '''Status:''' Completed enrollment of Cohorts 1-3 without dose-limiting toxicities as of May 2025 | * '''Status:''' Completed enrollment of Cohorts 1-3 without dose-limiting toxicities as of May 2025 | ||
| Line 150: | Line 168: | ||
'''Regulatory Designations:''' | '''Regulatory Designations:''' | ||
* FDA Orphan Drug Designation | * FDA Orphan Drug Designation | ||
* FDA Fast Track Designation | * FDA Fast Track Designation | ||
{| style="width:100%; border:1px solid #007bff; border-left:5px solid #007bff; border-radius:4px; margin:1em 0;" | {| style="width:100%; border:1px solid #007bff; border-left:5px solid #007bff; border-radius:4px; margin:1em 0;" | ||
|- | |- | ||
| style="padding:15px; " | ''' | | style="padding:15px;" | '''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) === | === 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.<ref>[https:// | 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.<ref>[https://www.mesotheliomalawyercenter.org/mesothelioma/treatment/ Mesothelioma Treatment Options], Mesothelioma Lawyer Center</ref> | ||
'''Development Timeline:''' | '''Development Timeline:''' | ||
| Line 181: | Line 199: | ||
=== Pembrolizumab Plus Chemotherapy — FDA Approved September 2024 === | === 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.<ref>[https://www. | The KEYNOTE-483 trial led to FDA approval for first-line treatment of unresectable advanced or metastatic malignant pleural mesothelioma on September 17, 2024.<ref>[https://www.mesotheliomalawyercenter.org/mesothelioma/prognosis/ Mesothelioma Prognosis], Mesothelioma Lawyer Center</ref> | ||
'''Trial Results:''' | '''Trial Results:''' | ||
| Line 194: | Line 212: | ||
=== Nivolumab Plus Ipilimumab — CheckMate 743 Long-term Data === | === 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.<ref>[https:// | CheckMate 743 remains the only Phase 3 trial demonstrating survival improvement sustained over 3 years with first-line immunotherapy in unresectable malignant pleural mesothelioma.<ref>[https://mesothelioma.net/treatment-for-mesothelioma/ Mesothelioma Treatment Options], Mesothelioma.net</ref> | ||
'''Three-Year Follow-up Results:''' | '''Three-Year Follow-up Results:''' | ||
| Line 211: | Line 229: | ||
=== BNT327/PM8002 — Exceptional Peritoneal Mesothelioma Results === | === BNT327/PM8002 — Exceptional Peritoneal Mesothelioma Results === | ||
This PD-L1/VEGF-A bispecific antibody demonstrated remarkable activity at ASCO 2025, particularly in | This PD-L1/VEGF-A bispecific antibody demonstrated remarkable activity at ASCO 2025, particularly in peritoneal mesothelioma.<ref>[https://mesotheliomaattorney.com/mesothelioma/types/peritoneal/ Peritoneal Mesothelioma], MesotheliomaAttorney.com</ref> | ||
'''Phase 2 Trial Results (31 patients with unresectable mesothelioma):''' | '''Phase 2 Trial Results (31 patients with unresectable mesothelioma):''' | ||
| Line 224: | Line 242: | ||
=== UV1 Vaccine Plus Checkpoint Inhibitors === | === 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.<ref>[https:// | The NIPU trial (Phase II, NCT04300244) demonstrated statistically significant survival improvement when UV1 telomerase vaccine was added to nivolumab plus ipilimumab.<ref>[https://www.mesotheliomalawyercenter.org/blog/cancer-vaccine-presents-promising-new-treatment-for-mesothelioma/ Cancer Vaccine for Mesothelioma], Mesothelioma Lawyer Center</ref> | ||
'''Results (118 patients randomized):''' | '''Results (118 patients randomized):''' | ||
| Line 237: | Line 255: | ||
=== Performance Status Requirements === | === Performance Status Requirements === | ||
Most mesothelioma clinical trials require patients to meet specific baseline criteria | Most mesothelioma clinical trials require patients to meet specific baseline criteria:<ref>[https://mesothelioma.net/mesothelioma-diagnosis/ Mesothelioma Diagnosis], Mesothelioma.net</ref> | ||
'''ECOG Performance Status:''' | '''ECOG Performance Status:''' | ||
| Line 263: | Line 281: | ||
{| style="width:100%; border:1px solid #ffc107; border-left:5px solid #ffc107; border-radius:4px; margin:1em 0;" | {| style="width:100%; border:1px solid #ffc107; border-left:5px solid #ffc107; border-radius:4px; margin:1em 0;" | ||
|- | |- | ||
| style="padding:15px; " | ''' | | style="padding:15px;" | '''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. | ||
|} | |} | ||
| Line 271: | Line 289: | ||
* TNhYP218 CAR-T trial (NCT06885697) | * TNhYP218 CAR-T trial (NCT06885697) | ||
* Multiple additional mesothelioma studies | * Multiple additional mesothelioma studies | ||
* Travel assistance programs available | * Travel assistance programs available<ref>[https://www.mesotheliomalawyercenter.org/mesothelioma-lawyer/maryland/ Maryland Mesothelioma Lawyers], Mesothelioma Lawyer Center</ref> | ||
=== MD Anderson Cancer Center (Houston, Texas) === | === MD Anderson Cancer Center (Houston, Texas) === | ||
| Line 278: | Line 295: | ||
* VT3989 TEAD inhibitor trial (lead investigator: Dr. Timothy Yap) | * VT3989 TEAD inhibitor trial (lead investigator: Dr. Timothy Yap) | ||
* Specialized mesothelioma program | * Specialized mesothelioma program | ||
* Telemedicine consultations offered<ref>[https:// | * Telemedicine consultations offered<ref>[https://dandell.com/mesothelioma-lawyer/texas/houston/ Houston Mesothelioma Lawyer], Danziger & De Llano</ref> | ||
=== Memorial Sloan Kettering Cancer Center (New York) === | === Memorial Sloan Kettering Cancer Center (New York) === | ||
* Intrapleural CAR-T program (NCT04577326) | * Intrapleural CAR-T program (NCT04577326) | ||
* International patient services | * International patient services | ||
* Dedicated mesothelioma team | * Dedicated mesothelioma team | ||
=== University of Chicago === | === University of Chicago === | ||
| Line 311: | Line 328: | ||
=== Insurance Coverage === | === Insurance Coverage === | ||
The Affordable Care Act requires most health plans to cover routine patient costs in clinical trials.<ref>[https:// | The Affordable Care Act requires most health plans to cover routine patient costs in clinical trials.<ref>[https://dandell.com/mesothelioma/va-mesothelioma-claims/ VA Mesothelioma Claims], Danziger & De Llano</ref> | ||
* '''Medicare:''' Covers qualifying trials for Medicare beneficiaries | * '''Medicare:''' Covers qualifying trials for Medicare beneficiaries | ||
| Line 335: | Line 352: | ||
! style="background:#1a5276; color:white; padding:12px; text-align:left;" | Notable Outcomes | ! style="background:#1a5276; color:white; padding:12px; text-align:left;" | Notable Outcomes | ||
|- | |- | ||
| style="padding:12px; font-weight:bold; " | Pembrolizumab + Chemotherapy | | style="padding:12px; font-weight:bold;" | Pembrolizumab + Chemotherapy | ||
| style="padding:12px; " | 16.9 months | | style="padding:12px;" | 16.9 months | ||
| style="padding:12px; " | FDA approved September 2024; 52% response rate | | style="padding:12px;" | FDA approved September 2024; 52% response rate | ||
|- | |- | ||
| style="padding:12px; font-weight:bold;" | Nivolumab + Ipilimumab | | style="padding:12px; font-weight:bold;" | Nivolumab + Ipilimumab | ||
| Line 343: | Line 360: | ||
| style="padding:12px;" | 23.2% three-year survival | | style="padding:12px;" | 23.2% three-year survival | ||
|- | |- | ||
| style="padding:12px; font-weight:bold; " | MSK Intrapleural CAR-T | | style="padding:12px; font-weight:bold;" | MSK Intrapleural CAR-T | ||
| style="padding:12px; " | Data maturing | | style="padding:12px;" | Data maturing | ||
| style="padding:12px; " | 83% one-year survival | | style="padding:12px;" | 83% one-year survival | ||
|- | |- | ||
| style="padding:12px; font-weight:bold;" | VT3989 (Relapsed) | | style="padding:12px; font-weight:bold;" | VT3989 (Relapsed) | ||
| Line 351: | Line 368: | ||
| style="padding:12px;" | 10 months PFS; 32% response rate | | style="padding:12px;" | 10 months PFS; 32% response rate | ||
|- | |- | ||
| style="padding:12px; font-weight:bold; " | CRS-HIPEC (Peritoneal) | | style="padding:12px; font-weight:bold;" | CRS-HIPEC (Peritoneal) | ||
| style="padding:12px; " | 53 months | | style="padding:12px;" | 53 months | ||
| style="padding:12px; " | 47% five-year survival | | style="padding:12px;" | 47% five-year survival | ||
|} | |} | ||
| Line 390: | Line 407: | ||
=== Primary Trial Resources === | === Primary Trial Resources === | ||
* '''ClinicalTrials.gov:''' Official NIH database with all registered trials | * '''ClinicalTrials.gov:''' Official NIH database with all registered trials | ||
* '''NCI Cancer Information Service:''' 1-800-4-CANCER | * '''NCI Cancer Information Service:''' 1-800-4-CANCER | ||
* '''EmergingMed Navigator:''' Free matching service | * '''EmergingMed Navigator:''' Free matching service | ||
| Line 402: | Line 419: | ||
# What costs will I be responsible for? | # What costs will I be responsible for? | ||
# Can I leave the trial if needed? | # Can I leave the trial if needed? | ||
# How will this affect my other | # How will this affect my other treatment options? | ||
# What are the known risks and potential benefits? | # What are the known risks and potential benefits? | ||
# What happens if the treatment works—can I continue receiving it? | # What happens if the treatment works—can I continue receiving it? | ||
| Line 421: | Line 438: | ||
! style="background:#1a5276; color:white; padding:10px;" | Status | ! style="background:#1a5276; color:white; padding:10px;" | Status | ||
|- | |- | ||
| eVOLVE-Meso (Volrustomig) || | | eVOLVE-Meso (Volrustomig) || NCT06097728 || Recruiting | ||
|- | |- | ||
| TNhYP218 CAR-T (NCI) || | | TNhYP218 CAR-T (NCI) || NCT06885697 || Recruiting | ||
|- | |- | ||
| ISM6331 TEAD Inhibitor || | | ISM6331 TEAD Inhibitor || NCT06566079 || Recruiting | ||
|- | |- | ||
| MSK Intrapleural CAR-T || | | MSK Intrapleural CAR-T || NCT04577326 || Recruiting | ||
|- | |- | ||
| SynKIR-110 || | | SynKIR-110 || NCT05568680 || Recruiting | ||
|- | |- | ||
| ICARuS II (Peritoneal) || | | ICARuS II (Peritoneal) || NCT06057935 || Recruiting | ||
|- | |- | ||
| NERO (Niraparib) || | | NERO (Niraparib) || NCT05455424 || Completed | ||
|- | |- | ||
| NIPU (UV1 Vaccine) || | | NIPU (UV1 Vaccine) || NCT04300244 || Completed | ||
|} | |} | ||
| Line 456: | Line 473: | ||
== Related Resources == | == Related Resources == | ||
* [[ | * [[Trust Funds]] — Access $30+ billion in asbestos trust fund compensation | ||
* [[ | * [[VA Benefits]] — Veterans disability claims and healthcare coverage | ||
* [[Choosing | * [[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 | * [[Understanding Your Diagnosis]] — Medical information for newly diagnosed patients | ||
Revision as of 06:41, 24 February 2026
/Users/charlesfletcher/Library/Python/3.9/lib/python/site-packages/urllib3/__init__.py:35: NotOpenSSLWarning: urllib3 v2 only supports OpenSSL 1.1.1+, currently the 'ssl' module is compiled with 'LibreSSL 2.8.3'. See: https://github.com/urllib3/urllib3/issues/3020
warnings.warn(
Connecting to wikimesothelioma.com... Logging in as MesotheliomaSupport@Claude... Successfully logged in!
--- Page Content ---
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.[1]
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.
Mesothelioma clinical trials at a glance:
- 53 actively recruiting trials — the number of mesothelioma clinical trials open to patients across the United States as of January 2026
- 8% participation rate — patient enrollment has dropped from 14% in 2023 despite expanded trial options and proven survival benefits
- 83% one-year survival — Memorial Sloan Kettering's intrapleural CAR-T program achieves dramatically higher survival than standard therapy
- 32% response rate — VT3989 TEAD inhibitor advancing to Phase III in H1 2026 after demonstrating durable responses in relapsed patients
- 51.6% overall response — BNT327/PM8002 bispecific antibody achieves exceptional results, with 75% response in peritoneal mesothelioma
- 16.9 months median survival — pembrolizumab plus chemotherapy FDA approved September 2024 with 52% confirmed response rate
- 23.2% three-year survival — CheckMate 743 nivolumab plus ipilimumab demonstrates sustained long-term benefit versus chemotherapy
- First AI-designed drug — ISM6331 pan-TEAD inhibitor dosed its first patient January 22, 2025 after AI-accelerated development
- Approximately 3,000 new cases — annual U.S. mesothelioma diagnoses with 72,779 total cases documented from 1999 to 2021
- 90-day first payment — patients can pursue trust fund compensation simultaneously with clinical trial participation
| Key Facts: Mesothelioma Clinical Trials January 2026 |
|---|
|
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.[2]
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.[3]
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.[4]
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.[5]
| 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.[6]
- 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.[7]
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
| 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.[8]
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.[9]
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.[10]
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.[11]
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.[12]
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.[13]
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:[14]
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[15]
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[16]
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.[17]
- 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[19]
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)[20]
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[21]
Questions to Ask Before Enrolling
- What phase is the trial? (Phase I = safety focus, Phase II = efficacy, Phase III = comparison)
- What are the specific eligibility requirements?
- How many visits are required and where?
- What costs will I be responsible for?
- Can I leave the trial if needed?
- How will this affect my other treatment options?
- What are the known risks and potential benefits?
- 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.[23]
|
🛡️ Free Clinical Trial & Compensation Consultation Our team helps families navigate both treatment options and legal rights. |
Related Resources
- Trust Funds — Access $30+ billion in asbestos trust fund compensation
- VA Benefits — Veterans disability claims and healthcare coverage
- 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
References
- ↑ Malignant Mesothelioma Lawyers, Danziger & De Llano
- ↑ Mesothelioma Compensation, Danziger & De Llano
- ↑ New Mesothelioma Treatments and Research, Mesothelioma.net
- ↑ Financial Compensation Form, Mesothelioma Lawyer Center
- ↑ New York Mesothelioma Lawyers, Danziger & De Llano
- ↑ Immunotherapy for Mesothelioma, Mesothelioma.net
- ↑ New Mesothelioma Treatments, MesotheliomaAttorney.com
- ↑ Mesothelioma Treatment Options, Mesothelioma Lawyer Center
- ↑ Mesothelioma Diagnosis, Mesothelioma Lawyer Center
- ↑ Mesothelioma Prognosis, Mesothelioma Lawyer Center
- ↑ Mesothelioma Treatment Options, Mesothelioma.net
- ↑ Peritoneal Mesothelioma, MesotheliomaAttorney.com
- ↑ Cancer Vaccine for Mesothelioma, Mesothelioma Lawyer Center
- ↑ Mesothelioma Diagnosis, Mesothelioma.net
- ↑ Maryland Mesothelioma Lawyers, Mesothelioma Lawyer Center
- ↑ Houston Mesothelioma Lawyer, Danziger & De Llano
- ↑ VA Mesothelioma Claims, Danziger & De Llano
- ↑ Multimodal Therapy for Mesothelioma, Mesothelioma.net
- ↑ Top Mesothelioma Treatment Centers, MesotheliomaAttorney.com
- ↑ Latest Mesothelioma Research, Mesothelioma.net
- ↑ Clinical Trials for Mesothelioma, Mesothelioma.net
- ↑ Mesothelioma Lawyers, Mesothelioma Lawyer Center
- ↑ Mesothelioma Settlements, Danziger & De Llano