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

Sponsor

NYU Langone Health (Other)

Overall Status

Withdrawn

CT.gov ID

NCT03149120

Collaborator

Bristol-Myers Squibb (Industry)

Enrollment

Location

Arms

Anticipated Duration (Months)

Patients Per Site Per Month

Study Details

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

Condition or Disease	Intervention/Treatment	Phase
Soft Tissue Sarcomas	Biological: Nivolumab Drug: Pazopanib	Phase 2

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

0 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

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

Anticipated Study Start Date :

Aug 1, 2017

Actual Primary Completion Date :

Aug 17, 2017

Anticipated Study Completion Date :

Jun 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Nivolumab 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 will be given as an intravenous infusion at a dose of 240 mg every 2 weeks for at least 6 months. Other Names: Opdivo
Experimental: Nivolumab with Pazopanib Pazopanib at a dose of 800mg by mouth daily.	Biological: Nivolumab Nivolumab will be given as an intravenous infusion at a dose of 240 mg every 2 weeks for at least 6 months. Other Names: Opdivo Drug: Pazopanib Pazopanib given at a dose of 800 mg by mouth daily. Other Names: Votrient

Arm

Intervention/Treatment

Experimental: Nivolumab

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

Other Names:

Opdivo

Experimental: Nivolumab with Pazopanib

Pazopanib at a dose of 800mg by mouth daily.

Biological: Nivolumab

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

Other Names:

Opdivo

Drug: Pazopanib

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

Other Names:

Votrient

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

Measure of Tolerability [6 Months]
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 [6 Months]
Proportion of patients with reduction in tumor burden of a predefined amount
Median Progression Free Overall Survival (OS) [6 Months]
Time from randomization until death from any cause

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 100 Years

Sexes Eligible for Study:

All

Accepts 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.