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

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.

Trial Details

NCT ID
NCT03138161
Phase
PHASE1 / PHASE2
Sponsor
Sarcoma Oncology Research Center, LLC
Status
RECRUITING
Cancer Type
Liposarcoma Sarcoma
Interventions
  • Trabectedin
  • Ipilimumab
  • Nivolumab
Locations (sample)
  • Santa Monica, California, United States|34.01949,-118.49138

Key Eligibility Criteria

  • Individuals must meet all of the inclusion criteria in order to be eligible to participate in the study, as follows:
  • Male or Female ≥ 18 years of age
  • Pathologically confirmed diagnosis of locally advanced unresectable or metastatic soft tissue sarcoma
  • For the Phase 1 Part of Study, previously treated patients will be enrolled. For the Phase 2 Part of Study, previously treated patients will be enr…

For full eligibility, visit ClinicalTrials.gov.

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