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

NCT ID: NCT03149120

Last Updated: 2017-08-22

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE2
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-08-31
• Study Completion Date: 2022-06-30

Brief 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

Detailed Description

The investigators hypothesize that the nivolumab alone or nivolumab plus pazopanib will be associated with an improvement in progression free survival (PFS) at 6 months compared to historical controls of placebo and pazopanib alone respectively.

This is a randomized, Phase 2 study of nivolumab alone or nivolumab plus pazopanib in adult (≥ 18 years old) male and female subjects with unresectable or metastatic soft tissue sarcoma either ineligible to receive an anthracycline-based first line treatment or after one prior systemic therapy. Up to 33 and 46 subjects will be randomized (1:1) in the nivolumab and nivolumab plus pazopanib cohorts respectively, with a Simon two-stage design. Preliminary endpoint analysis will be performed when at least 18 subjects in the nivolumab cohort and 16 subjects in the nivolumab plus pazopanib cohort, have completed the first 12 cycles of nivolumab (6 months). Accrual duration is expected to be around 2 years.

Conditions

Soft Tissue Sarcomas

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Nivolumab

Nivolumab will be given as an intravenous infusion at a dose of 240 mg every 2 weeks for at least 6 months.

Group Type: EXPERIMENTAL

Nivolumab

Intervention Type: BIOLOGICAL

Nivolumab will be given as an intravenous infusion at a dose of 240 mg every 2 weeks for at least 6 months.

Nivolumab with Pazopanib

Pazopanib at a dose of 800mg by mouth daily.

Group Type: EXPERIMENTAL

Nivolumab

Intervention Type: BIOLOGICAL

Nivolumab will be given as an intravenous infusion at a dose of 240 mg every 2 weeks for at least 6 months.

Pazopanib

Intervention Type: DRUG

Pazopanib given at a dose of 800 mg by mouth daily.

Interventions

Nivolumab

Nivolumab will be given as an intravenous infusion at a dose of 240 mg every 2 weeks for at least 6 months.

Intervention Type: BIOLOGICAL

Pazopanib

Pazopanib given at a dose of 800 mg by mouth daily.

Intervention Type: DRUG

Other Intervention Names

Opdivo; Votrient

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 100 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Bristol-Myers Squibb

INDUSTRY

Sponsor Role: collaborator

NYU Langone Health

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Luca Paoluzzi

Role: PRINCIPAL_INVESTIGATOR

NYU Langone Health

Locations

New York University School of Medicine

New York, New York, United States

Countries

United States

Other Identifiers

16-02078

Identifier Type: -

Identifier Source: org_study_id