RandomPhIIStudy CabozantinibIpilimumab&Nivolumab Pa w/SoftTissue Sarcoma

UCI Specialty Area: Orthopaedics

Principal Investigator: Warren A Chow

Official Title: Randomized Phase II Study of Cabozantinib, Ipilimumab, and Nivolumab in Patients with Soft Tissue Sarcoma

A Study On:

Bones and Joints

Soft Tissue

Study Description

The study is also being done to answer the following question:

Does the combination of cabozantinib, nivolumab, and ipilimumab cause your tumor to shrink more than, or stop growing for longer than, the combination of nivolumab and ipilimumab?

We are doing this study because we want to find out if this approach is better or worse than the usual approach for your soft tissue sarcoma. The usual approach is defined as care most people get for soft tissue sarcoma.

Eligibility

Patients must have histologically or cytologically confirmed metastatic STS,

specifically undifferentiated pleomorphic sarcoma (UPS), extraskeletal

myxoid chondrosarcoma (EMC), liposarcoma (LPS) or non-uterine

leiomyosarcoma (LMS) that are locally advanced and surgically

unresectable.

Patients must have measurable disease, defined as at least one lesion that can

be accurately measured in at least one dimension by clinical exam.

Patients with prior treatment with MET or VEGFR inhibitors are allowed.

However, prior cabozantinib-treated patients will not be allowed.

Patients must have adequate organ and marrow function.

For patients with evidence of chronic hepatitis B virus (HBV) infection, the

HBV viral load must be undetectable on suppressive therapy.

Patients with a history of hepatitis C virus (HCV) infection must have been

treated and undetectable HCV viral load 12 or more weeks after treatment

completion.

Patients with known history or current symptoms of cardiac disease, or

history of treatment with cardiotoxic agents, should have a clinical risk

assessment of cardiac function.

Patients must be willing to provide blood specimens and undergo biopsies for

research purposes.

Patients with baseline blood pressure (BP) lower than 140 mmHg and 90 mmHg

Human immunodeficiency virus (HIV)-infected patients on effective

combination antiretroviral therapy are eligible as long as HIV is wellcontrolled

and there is undetectable viral load within 6 months.

because other therapeutic

agents used in this trial are known to be teratogenic, women of child-bearing

potential (WOCBP) and men must agree to use adequate contraception

(hormonal or barrier method of birth control; abstinence) prior to study entry

and for the duration of study participation.

Ability to understand and the willingness to sign a written informed consent

document.

A female nurse attentively holds a tablet, ready to assist with patient care and medical information.

Interested in Participating in this Trial?

Thank you for your interest with our team.

One of our specialists will be in contact with you soon.

University of California, Irvine - Study Information Sheet

UCI Center for Clinical Research Potential Participant Database

Lead Researcher
Maheswari Senthil, MD
UCI Center for Clinical Research

In the instance of parental permission, “You” refers to “Your child.”

Please read the information below and ask questions about anything that you do not understand. A
researcher listed above will be available to answer your questions.

You are being asked to participate in a clinical research potential participant database to identify
potential clinical research studies you may be eligible for. Participation in this database is voluntary.
You may choose to skip any question. You may refuse to participate or discontinue your involvement
at any time without penalty or loss of benefits. You are free to withdraw from this database at any
time. If you decide to withdraw from this database you should notify the research team
immediately.

You are eligible to participate in this study if you may be interested in participating in a research trial at UCI Health

We would like to interview you to learn more about your eligibility for current clinical research studies at UCI. The interview will last about 5-30 minutes, depending on the extent of your medical history.

Possible risks/discomforts associated with the database are hearing about potential clinical research studies that may not be of interest to you, invasion of your privacy, or a potential breach of confidentiality.

There are no direct benefits from participation in the database. However, this database may help inform you on clinical research studies that you may be eligible for. Participation in UCI clinical research studies help us gain important data and knowledge that may lead to improved treatment options for people with similar conditions to you in the future.

There are no alternative procedures available. The only alternative is not to participate in this study.

There is no compensation for your participation in this database.

There is no cost to you for participation in this database.

All information collected will be stored confidentially in a world-class securely-hosted application, “RealTime CTMS,” with robust data protections and encryption. This application has HIPAA compliant architecture and application rules to ensure data privacy and regulatory compliance.

Researchers will use your information to assess your eligibility for current and future clinical research studies at UCI. You may opt out at any time.

The research team, authorized UCI personnel, and regulatory entities, may have access to your study records to protect your safety and welfare.

While the research team will make every effort to keep your personal information confidential, it is possible that an unauthorized person might see it. We cannot guarantee total privacy.

Future Research Use
Researchers will use your information to conduct this study. Once the study is done using your information, we may share them with other researchers so they can use them for other studies in the future. We will not share your name or any other private identifiable information that would let the researchers know who you are. We will not ask you for additional permission to share this de-identified information

Data Retention - In accordance with UC Office of the President policy, information will be retained for 10 years after the end of the calendar year in which the research is completed.

If, during the course of this study, significant new information becomes available that may relate to your willingness to continue to participate, this information will be provided to you by the research team listed at the top of the form.

If you have any comments, concerns, or questions regarding the conduct of this research please contact the researchers listed at the top of this form

Please contact the UCI Institutional Review Board by phone, (949) 824-8170, by e-mail at IRB@research.uci.edu or at 160 Aldrich Hall, Irvine, CA 92697-7600 if you are unable to reach the researchers listed at the top of the form and have general questions; have concerns or complaints about the research; have questions about your rights as a research subject; or have general comments or suggestions.

What is an IRB?