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

Soft Tissue Sarcomas Clinical Trial

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03149120
• Other study ID #: 16-02078
• Status: Withdrawn
• Phase: Phase 2
• First received: April 27, 2017
• Last updated: August 17, 2017
• Start date: August 2017
• Est. completion date: June 2022

Study information

• Verified date: August 2017
• Source: New York University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: June 2022
• Est. primary completion date: August 17, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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.

Related Conditions & MeSH terms

• Sarcoma
• Soft Tissue Sarcomas

Intervention

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

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

Locations

Country	Name	City	State
United States	New York University School of Medicine	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
New York University School of Medicine	Bristol-Myers Squibb

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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)	6 Months
Secondary	Overall Response Rate	Proportion of patients with reduction in tumor burden of a predefined amount	6 Months
Secondary	Median Progression Free Overall Survival (OS)	Time from randomization until death from any cause	6 Months