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Clinical Trial Detail

Avelumab and Trabectedin in Treating Patients With Liposarcoma or Leiomyosarcoma That is Metastatic or Cannot Be Removed by Surgery

Complete title: A Phase I/II Trial Combining Avelumab and Trabectedin for Advanced Liposarcoma and Leiomyosarcoma

Research Study Number 9717
Principal Investigator Seth Pollack
Phase I/II

Research Study Description

This phase I/II studies the side effects of avelumab and trabectedin and how well they work in treating patients with leiomyosarcoma or liposarcoma that has spread to other places in the body or cannot be removed by surgery. Monoclonal antibodies, such as avelumab, may block tumor growth in different ways by targeting certain cells. Drugs used in chemotherapy, such as trabectedin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving avelumab and trabectedin may work better in treating patients with liposarcoma or leiomyosarcoma.

Eligibility Criteria (must meet the following to participate in this study)

Ages Eligible for Study: 18 Years and older (Adult, Older Adult)

Sexes Eligible for Study: All

- Diagnosed with advanced (metastatic or unresectable) leiomyosarcoma or liposarcoma

- Being considered for trabectedin as standard of care

- Absolute neutrophil count (ANC) >= 1.5 x 10^9/L

- Platelet count >= 100 x 10^9/L

- Hemoglobin >= 9 g/dL (may have been transfused)

- Total bilirubin level =< 1.5 x the upper limit of normal (ULN) range

- Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) levels =< 2.5 x ULN for all subjects

- Creatinine clearance >= 30 mL/min according to the Cockcroft-Gault formula

- Ejection fraction > 45%

- Negative serum pregnancy test at screening for women of childbearing potential

- Effective contraception for both male and female subjects if the risk of conception exists; women of childbearing potential and men able to father a child must agree to use a method of effective contraception; effective contraception is required throughout the study and for at least 1 month after avelumab treatment, 2 months after last dose of trabectedin for women of reproductive potential, and 5 months following the last dose of trabectedin for males with female partners of reproductive potential

- Eastern Cooperative Oncology Group (ECOG) performance status =< 1 or Karnofsky performance scale >= 70

Other eligibility criteria may apply.

Exclusions (conditions that would prevent participation in this study)

- All subjects with brain metastases, except those meeting the following criteria:

-- * Brain metastases that have been treated locally and are clinically stable for at least 2 weeks prior to enrollment

-- * No ongoing neurological symptoms that are related to the brain localization of the disease (sequelae that are a consequence of the treatment of the brain metastases are acceptable)

-- * Subjects must be either off steroids or on a stable or decreasing dose of =< 10 mg daily prednisone (or equivalent)

- Prior organ transplantation, including allogeneic stem cell transplantation

- Prior treatment with trabectedin

- Significant acute or chronic infections including, among others:

-- * Known history of testing positive test for human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome (AIDS)

-- * Positive test for hepatitis B virus (HBV) surface antigen and/or confirmatory hepatitis C virus (HCV) ribonucleic acid (RNA) (if anti-HCV antibody tested positive)

- Active autoimmune disease that might deteriorate when receiving an immunostimulatory agent:

-- * Subjects with diabetes type I, vitiligo, psoriasis, hypo- or hyperthyroid disease not requiring immunosuppressive treatment are eligible

-- * Subjects requiring hormone replacement with corticosteroids are eligible if the steroids are administered only for the purpose of hormonal replacement and at doses =< 10 mg or 10 mg equivalent prednisone per day

-- * Administration of steroids through a route known to result in a minimal systemic exposure (topical, intranasal, intro-ocular, or inhalation) are acceptable

- Known severe hypersensitivity reactions to monoclonal antibodies (grade >= 3 National Cancer Institute [NCI] Common Terminology Criteria for Adverse Events [CTCAE] version [v] 4.03), any history of anaphylaxis, or uncontrolled asthma (that is, 3 or more features of partially controlled asthma)

- Persisting toxicity related to prior therapy of grade > 1 NCI-CTCAE v 4.03; however, alopecia and sensory neuropathy grade =< 2 is acceptable

- Pregnancy or lactation

- Known alcohol or drug abuse

- All other significant diseases (for example, inflammatory bowel disease, uncontrolled asthma), which, in the opinion of the investigator, might impair the subject's tolerance of trial treatment

- Any psychiatric condition that would prohibit the understanding or rendering of informed consent

- Any vaccination within 4 weeks of the first dose of avelumab, with the following exceptions:

-- * Administration of inactivated vaccines, including inactivated flu vaccines, are allowable; however, they should not be given within 2 weeks prior to starting study treatment

- Clinically significant cardiovascular disease including cerebral vascular accident/stroke (< 6 months prior to enrollment), myocardial infarction (< 6 months prior to enrollment), congestive heart failure with New York Heart Association (NYHA) class II or greater or serious cardiac arrhythmia requiring medication

- Severe (requiring active treatment) acute or chronic medical conditions including: colitis, inflammatory bowel disease, pneumonitis, or pulmonary fibrosis

- Recent (within the past year) or active suicidal ideation or behavior

Other exclusion criteria may apply.

Research Study Number 9717
Contact Seattle Cancer Care Alliance Intake Office
Telephone 800-804-8824 / 206-606-1024

Keywords: Sarcoma; Solid Tumors; Liposarcoma; Neoplasms, Connective and Soft Tissue; Neoplasms, Adipose Tissue; Neoplasms, Muscle Tissue; Leiomyosarcoma

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Please remember:

  • Talk to your health care providers first before making decisions about your health care.
  • Whether you are eligible for a research study depends on many things. There are specific requirements to be in research studies. These requirements are different for each study.

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