Actively Recruiting
SAINT:Trabectedin, Ipilimumab and Nivolumab for Previously Treated Advanced Soft Tissue Sarcoma
Led by Sarcoma Oncology Research Center, LLC · Updated on 2025-02-24
250
Participants Needed
1
Research Sites
746 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
SAINT:Trabectedin, Ipilimumab and Nivolumab for Previously Treated Advanced Soft Tissue Sarcoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female 18 years of age or older
- Pathologically confirmed locally advanced unresectable or metastatic soft tissue sarcoma
- Previously treated for soft tissue sarcoma
- Ability to understand study risks and purposes and sign informed consent
- Willingness to follow all study procedures and availability for study duration
- Measurable disease by RECIST v1.1 criteria
- ECOG performance status of 0 or 1
- Life expectancy of at least 3 months
- Acceptable liver function: Bilirubin 1.5 times upper limit of normal (ULN), AST, ALT, and alkaline phosphatase 3 times ULN ( 5 times ULN if liver metastases)
- Acceptable kidney function: Creatinine 1.5 times ULN or creatinine clearance 60 mL/min
- Acceptable blood counts without support: WBC 2000/�b5L, ANC 1500/�b5L, Platelets 100,000/�b5L, Hemoglobin 9.0 g/dL, Normal clotting tests
- Women of childbearing potential must have a negative pregnancy test and agree to use effective contraception during and after the study
You will not qualify if you...
- Untreated central nervous system metastases or carcinomatous meningitis
- Recent anticancer treatment within 2 weeks before study entry
- Participation in another investigational study within 14 days before enrollment
- Pregnant or breastfeeding females
- Inability or unwillingness to follow study protocol
- Recent use of non-oncology vaccines within 4 weeks
- History or suspected autoimmune disease except certain controlled conditions
- Systemic immunosuppression or HIV infection
- Skin rash affecting 25% or more of body surface
- Inflammatory bowel disease or recent uncontrolled diarrhea
- Recent history of bowel conditions increasing risk of perforation
- Congestive heart failure or recent cardiac events
- Severe uncontrolled systemic or psychiatric diseases
- Positive tests for hepatitis B or C infections
- Known HIV/AIDS diagnosis
- Inadequate blood, kidney, or liver function based on lab tests
- History of heavy alcohol abuse
- Pituitary or adrenal gland disorders
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Sarcoma Oncology Research Center
Santa Monica, California, United States, 90403
Actively Recruiting
Research Team
E
Erlinda M Gordon, MD
CONTACT
V
Victoria Chua-Alcala, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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