Vanderbilt Clinical Trials

Eligibility

Eligible Ages

Over 18 Years

Eligible Genders

All

Accepts Healthy Volunteers

No

Criteria

Inclusion Criteria:

- Patient must be >= 18 years of age

- Patient must have a confirmed histopathologic diagnosis of undifferentiated
pleomorphic sarcoma (UPS) or a related poorly differentiated sarcoma. Because UPS
can sometimes exist in a spectrum among related diagnoses, the following additional
diagnostic will be allowed, but not limited to:

- Pleomorphic sarcoma with inflammation or with limited areas of differentiation

- Pleomorphic sarcoma with giant cells

- Malignant fibrous histiocytoma (including storiform-pleomorphic and
inflammatory subtypes)

- Myxofibrosarcoma, poorly differentiated sarcoma not otherwise specified (NOS)

- Undifferentiated spindle cell sarcoma

- Pleomorphic dermal sarcoma

- Poorly differentiated spindle cell sarcoma NOS Any of these subtypes may have
areas of focal myogenic differentiation

- Patient must have metastatic or unresectable sarcoma

- Patient must not be pregnant or breast-feeding due to the potential harm to an
unborn fetus and possible risk for adverse events in nursing infants with the
treatment regimens being used. All patients of childbearing potential must have a
blood test or urine study within 14 days prior to randomization to rule out
pregnancy. A patient of childbearing potential is defined as anyone, regardless of
sexual orientation or whether they have undergone tubal ligation, who meets the
following criteria:

- Has achieved menarche at some point

- Has not undergone a hysterectomy or bilateral oophorectomy; or

- Has not been naturally postmenopausal (amenorrhea following cancer therapy does
not rule out childbearing potential) for at least 24 consecutive months (i.e.,
has had menses at any time in the preceding 24 consecutive months)

- Patient must not expect to conceive or father children by using an accepted and
effective method(s) of contraception or by abstaining from sexual intercourse for
the duration of their participation in the study. Contraception measures must
continue for 6 months after the last dose of doxorubicin for patients of child
bearing potential and for 3 months after the last dose of doxorubicin for male
patients with partners of child bearing potential. Males with pregnant partners
should use condoms during doxorubicin treatment and for at least 10 days after the
last dose of doxorubicin. Contraception measures must also continue for 4 months
after the last dose of pembrolizumab for patients of child bearing potential

- Patient must have the ability to understand and the willingness to sign a written
informed consent document. Patients with impaired decision-making capacity (IDMC)
who have a legally authorized representative (LAR) or caregiver and/or family member
available will also be considered eligible

- Patient must have a left ventricular ejection fraction (LVEF) > 50% by either MUGA
scan or echocardiogram obtained within 28 days prior to randomization

- Absolute neutrophil count (ANC) ≥ 1,500 cells/m^3 (must be obtained ≤ 7 days prior
to protocol randomization)

- Platelets ≥ 75,000 cells/m^3 (must be obtained ≤ 7 days prior to protocol
randomization)

- Total bilirubin < 1.2 mg/dL (must be obtained ≤ 7 days prior to protocol
randomization)

- Aspartate aminotransferase (AST)(serum glutamic oxaloacetic transaminase [SGOT])/
Alanine aminotransferase (ALT) (serum glutamic pyruvic transaminase [SGPT]) ≤ 3.0 ×
institutional ULN (must be obtained ≤ 7 days prior to protocol randomization)

- Creatinine clearance ≥ 30 mL/min according to the Cockcroft-Gault formula (must be
obtained ≤ 7 days prior to protocol randomization)

- Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral
therapy with undetectable viral load within 6 months of randomization are eligible
for this trial

- For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV
viral load must be undetectable on suppressive therapy, if indicated

- Patients with a history of hepatitis C virus (HCV) infection must have been treated
and cured. For patients with HCV infection who are currently on treatment, they are
eligible if they have an undetectable HCV viral load

- Patients with treated brain metastases are eligible if follow-up brain imaging after
central nervous system (CNS)-directed therapy shows no evidence of progression

- Patients with new or progressive brain metastases (active brain metastases) or
leptomeningeal disease are eligible if the treating physician determines that
immediate CNS specific treatment is not required and is unlikely to be required
during the first cycle of therapy

- Patients with a prior or concurrent malignancy whose natural history or treatment
does not have the potential to interfere with the safety or efficacy assessment of
the investigational regimen are eligible for this trial

- 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 using the New York Heart Association Functional Classification. To be
eligible for this trial, patients should be class 2B or better

- Patient must not have a history of or active interstitial lung disease

- Patient must have measurable disease. Baseline imaging must include a chest CT.
Imaging should be inclusive of all measurable and non-measurable disease and must be
obtained within 28 days prior to randomization. Imaging must be available for
uploading to TRIAD

- NOTE: CT with (w/) contrast preferred, chest CT without contrast is acceptable,
CT portion of positron emission tomography (PET) may be acceptable. Magnetic
resonance imaging (MRI) is acceptable for measuring other sites of disease

- Patient must have an Eastern Cooperative Oncology Group (ECOG) performance status
0-1

- Patient must not have had prior treatment with an anthracycline

- Patient must not have a diagnosis of clinically significant immunodeficiency or an
autoimmune disorder requiring the patient to use systemic steroid chronically, or
systemic steroids within 7 days prior to randomization

- Patient must not have a known history of active TB (Bacillus Tuberculosis)

- Patient must not have a known hypersensitivity to doxorubicin or pembrolizumab or
any of their excipients

- Patients who have received prior chemotherapy, targeted small molecule therapy or
radiation therapy must have recovered from the prior therapy at the time of
randomization

- Patient must have recovered adequately from any prior major surgery prior to
randomization

- Patient must not have had prior pericardial or mediastinal radiation

- Patient must not have received prior therapy with an anti-PD-1, anti-PD-L1,
anti-PD-L2 or anti-CTLA4 agent

- Patient must not have an autoimmune or other disease that requires the use of daily
corticosteroids of > 10 mg of prednisone (or equivalent). Patients who are on an
active steroid taper at the time of randomization must finish prior to beginning
study treatment. Patients who require inhaled or topical steroids are eligible