Is NCT03138161 recruiting in Santa Monica, CA?

Yes, NCT03138161 is currently recruiting participants at its Santa Monica, CA location. This advanced soft tissue sarcoma clinical trial is actively enrolling qualified participants.

How do I join the advanced soft tissue sarcoma clinical trial in Santa Monica?

To join this clinical trial in Santa Monica, complete the eligibility form on this page. A study coordinator will contact you to discuss next steps and determine if you qualify.

Is participation in this Santa Monica clinical trial free?

Yes, all study-related care is provided at no cost to qualified participants. Many studies also offer compensation for time and travel expenses.

Advanced Soft Tissue Sarcoma Clinical Trial in Santa Monica, CA

About This Advanced Soft Tissue Sarcoma Study in Santa Monica

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.

Sponsor: Sarcoma Oncology Research Center, LLC

Who Can Participate

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

Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility.

Frequently Asked Questions

Q:Is this study available in Santa Monica?

Yes, this clinical trial (NCT03138161) has an active research site in Santa Monica, CA that is currently enrolling participants.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. This study has been reviewed and approved, and participants are closely monitored by medical professionals. You can withdraw at any time.

Q:Will I be compensated?

Many clinical trials offer compensation for your time and travel expenses. Specific compensation details will be discussed during the screening process. All study-related medical care is provided at no cost.

Q:Can I leave the trial if I change my mind?

Absolutely. Participation is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty.

Still have questions? Our study coordinators are here to help.

Advanced Soft Tissue Sarcoma Treatment Options in Santa Monica, CA

If you're searching for advanced soft tissue sarcoma treatment options in Santa Monica, CA, this clinical trial (NCT03138161) may be an excellent opportunity. Clinical trials provide access to cutting-edge treatments that aren't yet available to the general public, often at no cost to participants.

Our Santa Monica research site is actively enrolling participants for this clinical trial. You'll receive care from experienced advanced soft tissue sarcoma specialists who are at the forefront of medical research. All study-related care, including examinations, treatments, and monitoring, is provided at no cost to qualified participants.

Looking for more options? Browse all advanced soft tissue sarcoma clinical trials near you to find additional studies recruiting in your area.

Advanced Soft Tissue Sarcoma Clinical Trial in Santa Monica, CA

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