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

Primary Purpose

Soft Tissue Sarcomas

Status
Withdrawn
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Nivolumab
Pazopanib
Sponsored by
NYU Langone Health
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Soft Tissue Sarcomas focused on measuring Metastatic, Unresectable, anthracycline, chemotherapy, systemic therapy

Eligibility Criteria

18 Years - 100 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • New York University School of Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Nivolumab

Nivolumab with Pazopanib

Arm Description

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

Pazopanib at a dose of 800mg by mouth daily.

Outcomes

Primary Outcome Measures

Progression-free survival (PFS) at 6 months for nivolumab alone or nivolumab in combination with pazopanib
Time from randomization until disease progression or death

Secondary Outcome Measures

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)
Overall Response Rate
Proportion of patients with reduction in tumor burden of a predefined amount
Median Progression Free Overall Survival (OS)
Time from randomization until death from any cause

Full Information

First Posted
April 27, 2017
Last Updated
August 17, 2017
Sponsor
NYU Langone Health
Collaborators
Bristol-Myers Squibb
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1. Study Identification

Unique Protocol Identification Number
NCT03149120
Brief Title
Study of Nivolumab With or Without Pazopanib in Metastatic or Unresectable Soft Tissue Sarcomas
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
Study Type
Interventional

2. Study Status

Record Verification Date
August 2017
Overall Recruitment Status
Withdrawn
Why Stopped
No patient enrolled as new similar study will be in system within 3 months
Study Start Date
August 2017 (Anticipated)
Primary Completion Date
August 17, 2017 (Actual)
Study Completion Date
June 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
NYU Langone Health
Collaborators
Bristol-Myers Squibb

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Soft Tissue Sarcomas
Keywords
Metastatic, Unresectable, anthracycline, chemotherapy, systemic therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Nivolumab
Arm Type
Experimental
Arm Description
Nivolumab will be given as an intravenous infusion at a dose of 240 mg every 2 weeks for at least 6 months.
Arm Title
Nivolumab with Pazopanib
Arm Type
Experimental
Arm Description
Pazopanib at a dose of 800mg by mouth daily.
Intervention Type
Biological
Intervention Name(s)
Nivolumab
Other Intervention Name(s)
Opdivo
Intervention Description
Nivolumab will be given as an intravenous infusion at a dose of 240 mg every 2 weeks for at least 6 months.
Intervention Type
Drug
Intervention Name(s)
Pazopanib
Other Intervention Name(s)
Votrient
Intervention Description
Pazopanib given at a dose of 800 mg by mouth daily.
Primary Outcome Measure Information:
Title
Progression-free survival (PFS) at 6 months for nivolumab alone or nivolumab in combination with pazopanib
Description
Time from randomization until disease progression or death
Time Frame
6 Months
Secondary Outcome Measure Information:
Title
Measure of Tolerability
Description
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)
Time Frame
6 Months
Title
Overall Response Rate
Description
Proportion of patients with reduction in tumor burden of a predefined amount
Time Frame
6 Months
Title
Median Progression Free Overall Survival (OS)
Description
Time from randomization until death from any cause
Time Frame
6 Months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Luca Paoluzzi
Organizational Affiliation
NYU Langone Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
New York University School of Medicine
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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