Clinical Trial

SAINT:Trabectedin, Ipilimumab and Nivolumab for Previously Treated Advanced Soft Tissue Sarcoma

Recruiting Phase 1/2
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Summary
This is an open label, dose-seeking phase 1/2 study using escalating doses of TRABECTEDIN given intravenously with defined doses of IPILIMUMAB and NIVOLUMAB based on preliminary results of the Checkmate 012 trial for NSCLC (Hellman et al., 2016). For the Phase 1 Part of Study, only previously treated patients will be enrolled. For the Phase 2 Part of Study, previously treated patients will be enrolled.
Protocol Amendment History 11 amendments
This ClinicalTrials.gov record has been amended 11 times since 2017-04-28; most recent amendment 2025-02-21.
Status change: Active, Not Recruiting → Recruiting 2017-05-20
Trial Details
NCT Number NCT03138161
Lead Sponsor Sarcoma Oncology Research Center, LLC
Conditions Advanced Soft Tissue Sarcoma, Metastatic Soft Tissue Sarcoma
Enrollment 250 participants
Start Date 2017-04-13
Primary Completion 2030-12-31 (estimated)
Study Completion 2031-07-31 (estimated)
Updated on ClinicalTrials.gov 2025-02-24