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

NCT03149120 | Withdrawn Phase 2 DMC FDA Drug

• 1 other identifier: 16-02078
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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

Conditions

Soft Tissue Sarcomas

Keywords

Metastatic; Unresectable; anthracycline; chemotherapy; systemic therapy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Measure of Tolerability

  6 Months

• Overall Response Rate

  6 Months

• Median Progression Free Overall Survival (OS)

  6 Months

Study Arms (2)

Nivolumab

EXPERIMENTAL

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

Biological: Nivolumab

Nivolumab with Pazopanib

EXPERIMENTAL

Pazopanib at a dose of 800mg by mouth daily.

Biological: Nivolumab; Drug: Pazopanib

Interventions

Nivolumab BIOLOGICAL

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

Also known as: Opdivo

Nivolumab; Nivolumab with Pazopanib

Pazopanib DRUG

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

Also known as: Votrient

Nivolumab with Pazopanib

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• NYU Langone Health: lead
• Bristol-Myers Squibb: collaborator

Study Sites (1)

New York University School of Medicine

New York, New York, 10016, United States

Location

MeSH Terms

Conditions

Sarcoma; Neoplasm Metastasis

Interventions

Nivolumab; pazopanib

Condition Hierarchy (Ancestors)

Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Luca Paoluzzi

  NYU Langone Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 27, 2017
• First Posted: May 11, 2017
• Study Start: August 1, 2017
• Primary Completion: August 17, 2017
• Study Completion: June 1, 2022
• Last Updated: August 22, 2017

Record last verified: 2017-08

Locations

US (1)