Soft Tissue SarcomasPhase 2NCT03149120
Study of Nivolumab With or Without Pazopanib in Metastatic or Unresectable Soft Tissue Sarcomas
A Phase 2 study testing Nivolumab and Pazopanib in people with Soft Tissue Sarcomas, run by NYU Langone Health at 1 site in United States.
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 Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Soft Tissue Sarcomas
- What is being tested?
- Nivolumab and Pazopanib
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2017to Jun 2022
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
New York University School of Medicine
New York, New York, 10016
About this study
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
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
Read the 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
- Being tested
- Nivolumab, Pazopanib
- Keywords
- Metastatic, Unresectable, anthracycline, chemotherapy, systemic therapy
- Medical subject headings
- Sarcoma, Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NivolumabBiological
Also called Opdivo
Nivolumab will be given as an intravenous infusion at a dose of 240 mg every 2 weeks for at least 6 months.
PazopanibDrug
Also called Votrient
Pazopanib given at a dose of 800 mg by mouth daily.
| Study group | Role | What they receive |
|---|---|---|
| Nivolumab | Experimental | Nivolumab will be given as an intravenous infusion at a dose of 240 mg every 2 weeks for at least 6 months. Receives: Biological: Nivolumab |
| Nivolumab with Pazopanib | Experimental | Pazopanib at a dose of 800mg by mouth daily. Receives: Biological: Nivolumab; Drug: Pazopanib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-free survival (PFS) at 6 months for nivolumab alone or nivolumab in combination with pazopanib
Time from randomization until disease progression or death
Measured: 6 Months
Secondary outcomes (3)
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)
Measured: 6 Months
Overall Response Rate
Proportion of patients with reduction in tumor burden of a predefined amount
Measured: 6 Months
Median Progression Free Overall Survival (OS)
Time from randomization until death from any cause
Measured: 6 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2017
- Study startAug 2017 (estimated)
- Primary completion17 Aug 2017
- Study completionJun 2022 (estimated)
Why it stopped: No patient enrolled as new similar study will be in system within 3 months
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Soft Tissue SarcomasStudies of the same condition, open and under way.
- More trials run by NYU Langone HealthThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Collaborators
- Bristol-Myers Squibb
- Responsible party
- Sponsor
- Investigators
- Luca Paoluzzi, Principal investigator, NYU Langone Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03149120
- Sponsor's protocol ID
- 16-02078
- Status last verified
- Aug 2017
- First submitted
- 27 Apr 2017
- Last updated
- 22 Aug 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03149120
- Acronym / sponsor ID
- 16-02078
- Conditions
- Soft Tissue Sarcomas
- Keywords
- Metastatic, Unresectable, anthracycline, chemotherapy, systemic therapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: No patient enrolled as new similar study will be in system within 3 months
- Enrolment
- 0 participants (actual)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Collaborators
- Bristol-Myers Squibb
- Study start
- Aug 2017 (estimated)
- Primary completion
- 17 Aug 2017 (actual)
- Study completion
- Jun 2022 (estimated)
- First posted
- 11 May 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Nivolumab | Experimental | Biological: NivolumabNivolumab will be given as an intravenous infusion at a dose of 240 mg every 2 weeks for at least 6 months. |
| Nivolumab with Pazopanib | Experimental | Biological: Nivolumab, Drug: PazopanibPazopanib at a dose of 800mg by mouth daily. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NivolumabAlso: OpdivoNivolumab 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 |
| PazopanibAlso: VotrientPazopanib given at a dose of 800 mg by mouth daily. | Drug | Nivolumab with Pazopanib |
Primary outcome
Progression-free survival (PFS) at 6 months for nivolumab alone or nivolumab in combination with pazopanib
Time frame: 6 Months
Time from randomization until disease progression or death
3 secondary outcomes
Measure of Tolerability
Time frame: 6 Months
Overall Response Rate
Time frame: 6 Months
Median Progression Free Overall Survival (OS)
Time frame: 6 Months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Aug 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Luca Paoluzzi principal investigator
NYU Langone Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Nivolumab and Pazopanib in people with Soft Tissue Sarcomas, run by NYU Langone Health at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 22 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression-free survival (PFS) at 6 months for nivolumab alone or nivolumab in combination with pazopanib (time frame: 6 Months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Aug 2017.