OncoMatch/Clinical Trials/NCT03138161
SAINT:Trabectedin, Ipilimumab and Nivolumab for Previously Treated Advanced Soft Tissue Sarcoma
Is NCT03138161 recruiting? Yes, currently enrolling (May 2026). This Phase 1/2 trial studies multiple treatments including Trabectedin and Ipilimumab for advanced soft tissue sarcoma.
Treatment: Trabectedin · Ipilimumab · Nivolumab — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Sarcoma
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Must have received: any prior anticancer therapy
previously treated patients will be enrolled
Cannot have received: anticancer treatment (radiation therapy, chemotherapy, targeted therapy or other antitumor treatment)
Anticancer treatment with radiation therapy, chemotherapy, targeted therapy or other antitumor treatment within 2 weeks prior to study entry
Cannot have received: investigational drug or device
Subjects who participated in an investigational drug or device study within 14 days prior to study entry
Lab requirements
Blood counts
WBC ≥2000/µL; ANC ≥ 1500 cells/μL; Platelet count ≥ 100,000/µL; Hemoglobin ≥ 9.0 g/dL; Normal PT, PTT, INR
Kidney function
Creatinine ≤1.5 times ULN or ≥ 60 mL/min (using the Cockcroft Gault formula)
Liver function
Bilirubin ≤ 1.5 times ULN (except subjects with Gilbert Syndrome who must have a total bilirubin level ≤ 3.0 ULN); AST (SGOT), ALT (SGPT) and alkaline phosphatase ≤ 3 x ULN (≤ 5 x ULN if liver metastases)
Acceptable liver function: Bilirubin ≤ 1.5 times ULN (except subjects with Gilbert Syndrome who must have a total bilirubin level ≤ 3.0 ULN); AST (SGOT), ALT (SGPT) and alkaline phosphatase ≤ 3 x ULN (≤ 5 x ULN if liver metastases); Acceptable renal function: Creatinine ≤1.5 times ULN or ≥ 60 mL/min (using the Cockcroft Gault formula); Acceptable hematologic status (without hematologic support): WBC ≥2000/µL; ANC ≥ 1500 cells/μL; Platelet count ≥ 100,000/µL; Hemoglobin ≥ 9.0 g/dL; Normal PT, PTT, INR
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Sarcoma Oncology Research Center · Santa Monica, California
Showing up to 5 US sites. See all sites on ClinicalTrials.gov →
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