SAINT: Trabectedin, Ipilimumab, and Nivolumab for Advanced Soft Tissue Sarcoma
This study is testing a combination of three drugs – Trabectedin, Ipilimumab, and Nivolumab – for people with advanced soft tissue sarcoma that has already been treated. Trabectedin is a drug that works by damaging cancer cells. Ipilimumab and Nivolumab are immunotherapy drugs that help your body's immune system fight cancer. The main goal of this study is to find the highest safe dose of Trabectedin when given with set doses of Ipilimumab and Nivolumab. You may be able to join if you are 18 or older, have a confirmed diagnosis of advanced soft tissue sarcoma, and have received prior treatment for your cancer. The study is currently unclear about its recruitment status.
- Study design
- This is an open-label, dose-seeking Phase 1/2 study. It will enroll up to 250 participants to find the maximum tolerated dose of the drug combination.
- What's involved
- Participants in the dose escalation part of the study may receive treatment for up to 9 six-week cycles (one year), or until their disease gets worse or side effects are too severe. Trabectedin is given every 3 weeks, Ipilimumab every 12 weeks, and Nivolumab every 2 weeks.
- Compensation
- Not stated in the trial record.
- Follow-up
- The maximum tolerated dose is measured at 6 months.
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NCT03138161
SAINT:Trabectedin, Ipilimumab and Nivolumab for Previously Treated Advanced Soft Tissue Sarcoma
Recruiting
PHASE1Ages 18+InterventionalTreatmentSarcoma Oncology Research Center, LLCInvestigator-initiated
~250 participants
Updated 2025-02-24 on ClinicalTrials.gov
What's tested:TrabectedinIpilimumabNivolumab
At a glance
Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Maximum tolerated dose
Measured over 6 months
Conditions
Where it's being run
1 sites across 1 statesCalifornia1
Study leadership
- Erlinda M Gordon, MD · PRINCIPAL_INVESTIGATOR · Sarcoma Oncology Research Center
Who to contact
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Do you actually qualify for this trial?
Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.
Eligibility criteria
Inclusion
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 enrolled.
Ability to understand the purposes and risks of the study and has signed and dated a written informed consent form approved by the investigator's IRB/Ethics Committee
Willingness to comply with all study procedures and availability for the duration of the study.
Measurable disease by RECIST v1.1
ECOG performance status ≤1
Life expectancy of at least 3 months
Acceptable liver function: Bilirubin ≤ 1.5 times upper limit of normal (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
All women of childbearing potential must have a negative pregnancy test and all subjects must agree to use highly effective means of contraception (surgical sterilization or the use of barrier contraception with either a condom or diaphragm in conjunction with spermicidal gel or an IUD) with their partner from entry into the study through 5 months for women and 7 months for men after the last dose.
Exclusion
Subjects with untreated CNS metastases. Subjects are eligible if CNS metastases have been adequately treated and have neurologically returned to baseline (except for residual signs or symptoms related to the CNS treatment) for at least 2 weeks prior to treatment initiation. In addition, subjects must be either off corticosteroids, or on a stable or decreasing dose of ≤10 mg daily prednisone (or equivalent) for at least 2 weeks prior to treatment initiation.
Subjects with carcinomatous meningitis
Anticancer treatment with radiation therapy, chemotherapy, targeted therapy or other antitumor treatment within 2 weeks prior to study entry
Subjects who participated in an investigational drug or device study within 14 days prior to study entry
Females who are pregnant or breast-feeding
Unwillingness or inability to comply with the study protocol for any reason
Non-oncology vaccine therapy used for prevention of infectious disease within 4 weeks of trial enrollment
• History of or known or suspected autoimmune disease (exception(s): patients with vitiligo, Type I diabetes, resolved childhood atopic dermatitis, hypothyroidism, or hyperthyroidism that is clinically euthyroid at Screening are allowed). Other exceptions may be allowed following discussion with the Sponsor Medical Monitor for patients who have not received treatment for their autoimmune disorder in the past 3 years.
Systemic immunosuppression, including HIV positive status with or without AIDS
Skin rash (psoriasis, eczema) affecting ≥ 25% body surface area
Inflammatory bowel disease (Crohn's or ulcerative colitis)
Ongoing or uncontrolled diarrhea within 4 weeks of trial enrollment
Recent history of acute diverticulitis, intraabdominal abscess or gastrointestinal obstruction within 6 months of trial enrollment, which are known risk factors for bowel perforation
Patients with congestive heart failure or recent cardiac event
Evidence of severe or uncontrolled systemic disease or any other concurrent condition, including psychiatric, which in the principal investigator's opinion makes it undesirable for the patient to participate in the trial or which would jeopardize compliance with the trial
Any positive test for hepatitis B virus or hepatitis C virus indicating acute or chronic infection
Known history of testing positive for human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome (AIDS).
Inadequate hematologic, renal or hepatic function defined by any of the following screening laboratory values: WBC ≤2000/µL; Neutrophils ≤1500/µL; Platelets ≤ 100,000/µL; hemoglobin ≤9.0 g/dL; Serum creatinine ≥1.5 x ULN or creatinine clearance ≤ 60 mL/min (using the Cockcroft Gault formula); AST/ALT ≥3 x ULN (≥ 5 x ULN if liver metastases); Total Bilirubin ≥1.5 x ULN (except subjects with Gilbert Syndrome who must have a total bilirubin level ≥ 3.0 ULN)
Current, active or previous history of heavy alcohol abuse
Pituitary endocrinopathy
Adrenal insufficiency or excess
What this trial measures
- Maximum tolerated dose6 months
Dose escalation study, determination of maximum tolerated dose (MTD) in previoiusly treated patients with soft tissue sarcoma followed by expansion to previously untreated patients with advanced STS