Randomized Phase II Study of Cabozantinib, Ipilimumab, and Nivolumab in Patients with Soft Tissue Sarcoma
Details
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
You can join if...
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.