Soft Tissue Sarcomas Clinical Trial
Official title:
Phase II Randomized Study of Nivolumab With or Without Pazopanib in Metastatic or Unresectable Soft Tissue Sarcomas After One Prior Line of Systemic Therapy or Ineligible to Receive an Anthracycline-based Treatment
Verified date | August 2017 |
Source | New York University School of Medicine |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This trial will assess whether nivolumab alone or nivolumab combined with pazopanib will be associated with an improvement in progression free survival (PFS) at 6 months
Status | Withdrawn |
Enrollment | 0 |
Est. completion date | June 2022 |
Est. primary completion date | August 17, 2017 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 100 Years |
Eligibility |
Inclusion Criteria: - Histologic diagnosis of metastatic or unresectable soft tissue or bone sarcoma - No prior therapy with nivolumab in either cohorts or with pazopanib in the combination cohort - At least one line of systemic therapy or ineligibility for an anthracycline based chemotherapy - At least 2 distinct measurable metastatic sites - Adequate organ and marrow function as defined by initial laboratory tests - Life expectancy > 3 months - Stable brain metastases for at least 4 weeks and no steroid dependence Exclusion Criteria: - Autoimmune disease Any underlying medical or psychiatric condition, which in the opinion of the Investigator, will make the administration of study drugs hazardous or obscure the interpretation of adverse events - Concomitant therapy with any non-study immunotherapy regimens, cytotoxic chemotherapy, immunosuppressive agents, other investigation therapies Chronic use of systemic corticosteroids greater than prednisone 10 mg daily or its equivalent - Women of childbearing potential who are unwilling or unable to use an acceptable method to avoid pregnancy for the entire study period and for at least 5 months after cessation of study drug, or have a positive pregnancy test at baseline, or are pregnant or breastfeeding; - Prisoners or subjects who are compulsorily detained (involuntarily incarcerated) for treatment of either a psychiatric or physical illness. |
Country | Name | City | State |
---|---|---|---|
United States | New York University School of Medicine | New York | New York |
Lead Sponsor | Collaborator |
---|---|
New York University School of Medicine | Bristol-Myers Squibb |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Progression-free survival (PFS) at 6 months for nivolumab alone or nivolumab in combination with pazopanib | Time from randomization until disease progression or death | 6 Months | |
Secondary | Measure of Tolerability | Time from randomization to disease progression, death, or discontinuation of treatment for any reason (eg, toxicity, patient preference, or initiation of a new treatment without documented progression) | 6 Months | |
Secondary | Overall Response Rate | Proportion of patients with reduction in tumor burden of a predefined amount | 6 Months | |
Secondary | Median Progression Free Overall Survival (OS) | Time from randomization until death from any cause | 6 Months |
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