Study of Nivolumab With or Without Pazopanib in Metastatic or Unresectable Soft Tissue Sarcomas

• Status: Withdrawn
• Trial end date: 2022-06-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: New York University School of Medicine; NYU Langone Health
• Collaborator: Bristol-Myers Squibb
• Treatments: Antibodies, Monoclonal; Nivolumab

Criteria

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.