Combination treatment for advanced soft tissue sarcoma
SAINT: A Phase 1/2 Study of Safe Amounts of IPLIMUMAB, NIVOLUMAB and TRABECTEDIN for Previously Treated Advanced Soft Tissue Sarcoma (STS)
This study is testing a new combination of treatments using Trabectedin, Ipilimumab, and Nivolumab to see if it can help people with advanced soft tissue sarcoma who have already received other treatments.
Quick facts
| Phase | Phase1; Phase2 |
|---|---|
| Study type | Interventional |
| Enrollment | 250 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Sarcoma Oncology Research Center, LLC Academic / other |
| Drugs / interventions | chemotherapy, radiation, prednisone, IPILIMUMAB, NIVOLUMAB |
| Locations | 1 site (Santa Monica, California) |
| Trial ID | NCT03138161 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the safety and efficacy of a combination therapy using Trabectedin, Ipilimumab, and Nivolumab in patients with previously treated advanced soft tissue sarcoma. The study is divided into two phases: a dose escalation phase to determine the maximum tolerated dose of Trabectedin, followed by an expansion phase to evaluate the treatment's effectiveness. Participants will receive escalating doses of Trabectedin along with fixed doses of Ipilimumab and Nivolumab, with treatment continuing until disease progression or unacceptable toxicity occurs. The trial aims to provide insights into the potential benefits of combining chemotherapy and immunotherapy for this challenging cancer type.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with a pathologically confirmed diagnosis of locally advanced unresectable or metastatic soft tissue sarcoma who have previously received treatment.
Not a fit: Patients with untreated advanced soft tissue sarcoma or those with significant comorbidities that may affect treatment tolerance may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could improve outcomes for patients with advanced soft tissue sarcoma by offering a new therapeutic option.
How similar studies have performed: Other studies have shown promise in using similar combinations of immunotherapy and chemotherapy for various cancers, suggesting potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion 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 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 Criteria: * All individuals meeting any of the exclusion criteria at baseline will be excluded from study participation, as follows: * 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
Where this trial is running
Santa Monica, California
- Sarcoma Oncology Research Center — Santa Monica, California, United States (Recruiting)
Study contacts
- Principal investigator: Erlinda M Gordon, MD — Sarcoma Oncology Research Center
- Study coordinator: Erlinda M Gordon, MD
- Email: egordon@sarcomaoncology.com
- Phone: 310-552-9999
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.