Study of Nivolumab With or Without Pazopanib in Metastatic or Unresectable Soft Tissue Sarcomas
Withdrawn before enrolling · Phase 2
Conditions studied: Soft Tissue Sarcomas
In brief
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
Key facts
- Study ID
- NCT03149120
- Run by
- NYU Langone Health
- People needed
- 0
- Starts
- 2017-08-01
- Expected to finish
- 2022-06-01
- Last updated by the study team
- 2017-08-22
Who can join
Age: 18 and older, up to 100. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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.
Where it is running
- New York University School of Medicine — New York, New York, United States
Full record on ClinicalTrials.gov
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