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New treatment option for Advanced Soft Tissue Sarcoma
Official title SAINT:Trabectedin, Ipilimumab and Nivolumab for Previously Treated Advanced Soft Tissue Sarcoma
ClinicalTrials.gov ID: NCT03138161
What this study is testing
What is Trabectedin?
Trabectedin is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for advanced soft tissue sarcoma.
Also referred to as Yondelis.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Individuals must meet all of the 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...
- 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...
You likely can't join if
- All individuals meeting any of the exclusion criteria at baseline will be excluded from study participation, as follows:
- people with untreated CNS metastases. people are eligible if CNS metastases have been adequately treated and have neurologically returned to baseline...
- people with carcinomatous meningitis
- Anticancer treatment with radiation therapy, chemotherapy, targeted therapy or other antitumor treatment within 2 weeks prior to study entry
- people who participated in an investigational drug or device study within 14 days prior to study entry
- Females who are pregnant or breast-feeding
See the full eligibility criteria
- Individuals must meet all of the 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 people with Gilbert Syndrome who must have a total bilirubin level ≤ 3.0 ULN);AST (SGOT), ALT (SGPT) and alkaline phosphatase ≤ 3 x ULN...
- 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 people must agree to use highly effective means of contraception (surgical sterilization or the use of barrier contraception with either a...
- All individuals meeting any of the exclusion criteria at baseline will be excluded from study participation, as follows:
- people with untreated CNS metastases. people 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)...
- people with carcinomatous meningitis
- Anticancer treatment with radiation therapy, chemotherapy, targeted therapy or other antitumor treatment within 2 weeks prior to study entry
- people 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...
- 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...
- 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...
- Current, active or previous history of heavy alcohol abuse
- Pituitary endocrinopathy
- Adrenal insufficiency or excess
The study team makes the final eligibility decision.
Where it's taking place
- Santa Monica, California, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Santa Monica, California, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.