MSK Sacituzumab Govitecan Phase 2 Trial (NCT06477419)
Memorial Sloan Kettering Phase 2 trial of sacituzumab govitecan for previously treated diffuse pleural mesothelioma (NCT06477419) is recruiting.
Memorial Sloan Kettering Cancer Center is recruiting people with previously treated diffuse pleural mesothelioma for a Phase 2 clinical trial of sacituzumab govitecan, an antibody-drug conjugate targeting TROP-2.
The trial, designated NCT06477419, is enrolling at MSK sites across New York and New Jersey. Collaborators include the U.S. Department of Defense and Gilead Sciences.
About the Study
Participants receive sacituzumab govitecan-hziy until disease progression, intolerable side effects, or a decision by the participant or study doctor to stop treatment. Eligibility requires pathologically confirmed diffuse pleural mesothelioma, at least one prior systemic therapy (such as platinum and pemetrexed, immunotherapy, or a combination), measurable disease, and adequate organ function. The primary endpoint is overall response rate.
Treatment Approach
This trial does not test checkpoint inhibitor immunotherapy. Sacituzumab govitecan is an antibody-drug conjugate that targets TROP-2 on tumor cells and delivers a topoisomerase I inhibitor payload (SN-38).
Key trial details:
- Phase: Phase 2
- Sponsor: Memorial Sloan Kettering Cancer Center
- Intervention: Sacituzumab govitecan-hziy
- Status: Recruiting
Why This Trial Matters
Sacituzumab govitecan is already approved in other tumor types. Testing it in mesothelioma evaluates a different mechanism of action for people whose disease has progressed on standard chemotherapy and checkpoint inhibitors.
Memorial Sloan Kettering is one of the leading mesothelioma treatment centers in the United States.
Study Locations
The trial is recruiting at Memorial Sloan Kettering Cancer Center sites, including:
- MSK Main Campus, New York
- MSK Westchester, New York
- MSK Commack, New York
- MSK Basking Ridge, New Jersey
- MSK Monmouth, New Jersey
- MSK Bergen (Montvale), New Jersey
Refer to ClinicalTrials.gov for the full, current list of participating sites.
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 new drug trial for mesothelioma?
The HIT-MESO trial, launched in March 2026, is the first randomized UK clinical trial testing proton beam therapy (PBT) for people with mesothelioma to potentially raise two-year survival from 30% to 50%. The ATOMIC-Meso trial showed pegargiminase (ADI-PEG20) combined with chemotherapy extended three-year survival four times longer than chemotherapy alone in 2024 results. Other active trials include a National Cancer Institute study of mesothelin-targeted TNhYP218 CAR T-cell therapy and phase III testing of volrustomig (MEDI5752) with carboplatin plus pemetrexed. Over 80 trials are recruiting for emerging therapies like enzyme inhibitors and targeted drugs. Details on eligibility and locations appear on ClinicalTrials.gov.
Is sacituzumab govitecan approved?
Sacituzumab govitecan (Trodelvy) holds FDA accelerated approval for specific breast cancer indications, including metastatic triple-negative breast cancer after at least two prior therapies (April 2020) , and unresectable locally advanced or metastatic HR+/HER2- breast cancer after endocrine therapy and at least two additional systemic therapies (February 2023). The FDA fully withdrew approval for locally advanced or metastatic urothelial cancer on November 22, 2024. No approvals exist for mesothelioma [1-8].
How long does it take to get mesothelioma after asbestos exposure?
The latency period for mesothelioma, from initial asbestos exposure to diagnosis, typically ranges from 10 to 50 years, with a median of about 33-35 years across studies. Occupational exposure often correlates with shorter latencies (around 30 years median) compared to environmental or secondary exposure, which can exceed 50 years. Rare cases occur in under 10 years or over 70 years, but 96% of cases show at least 20 years. Factors like exposure intensity, duration, asbestos type, age at exposure, and sex influence variability, though no level of exposure is safe.
How much does sacituzumab govitecan cost?
Sacituzumab govitecan (Trodelvy) costs about $12,478 per 21-day cycle at the sponsor-submitted price of $1,478 per vial, assuming a 94% dose intensity. A U.S. modeling study for people with hormone receptor-positive/HER2-negative metastatic breast cancer estimated an incremental cost of $132,689 over chemotherapy, yielding an ICER of $612,772/QALY. Cost-effectiveness improves if the price drops below $3.997/mg or patient weight is under 19.88 kg. A Canadian analysis reported an ICER of $506,807/QALY with incremental costs of $101,369.