Study of Sitravatinib With or Without Other Anticancer Therapies Receiving Clinical Benefit From Parent Study
NCT ID: NCT04887870
Last Updated: 2025-10-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2/PHASE3
52 participants
INTERVENTIONAL
2021-06-29
2025-09-25
Brief Summary
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Detailed Description
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The current study is designed to allow continued access to sitravatinib and to evaluate the safety and tolerability of sitravatinib alone or in combination with other anticancer therapies in patients who are deriving clinical benefit in a previous parent clinical trial.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Phase 2/3: Open label extension of parent study
The current study is designed to allow continued access to sitravatinib and to evaluate the safety and tolerability of sitravatinib alone or in combination with other anticancer therapies in patients who are deriving clinical benefit in a previous parent clinical trial.
Sitravatinib
Sitravatinib is a small molecule inhibitor of receptor tyrosine kinases.
Nivolumab
Nivolumab is a programmed death receptor-1 (PD-1) blocking antibody
Pembrolizumab
Pembrolizumab is a programmed death receptor-1 (PD-1) blocking antibody
Enfortumab Vedotin-Ejfv
Enfortumab is a Nectin-4 directed antibody-drug conjugate (ADC) comprised of a monoclonal antibody conjugated to the small molecule microtubule disrupting agent, monomethyl auristatin E (MMAE)
Ipilimumab
Ipilimumab is a CTLA-4 (cytotoxic T-lymphocyte-associated protein 4) blocking antibody
Interventions
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Sitravatinib
Sitravatinib is a small molecule inhibitor of receptor tyrosine kinases.
Nivolumab
Nivolumab is a programmed death receptor-1 (PD-1) blocking antibody
Pembrolizumab
Pembrolizumab is a programmed death receptor-1 (PD-1) blocking antibody
Enfortumab Vedotin-Ejfv
Enfortumab is a Nectin-4 directed antibody-drug conjugate (ADC) comprised of a monoclonal antibody conjugated to the small molecule microtubule disrupting agent, monomethyl auristatin E (MMAE)
Ipilimumab
Ipilimumab is a CTLA-4 (cytotoxic T-lymphocyte-associated protein 4) blocking antibody
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Currently tolerating the treatment regimen in the parent protocol
* Experiencing clinical benefit with or without prior radiographic progression from the treatment regimen in the parent protocol in the opinion of the investigator and the investigator determines that continuing treatment is in the patient's best interest
Exclusion Criteria
* Other life- threatening illness or organ system dysfunction compromising safety evaluation
18 Years
ALL
No
Sponsors
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Mirati Therapeutics Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Bristol-Myers Squibb
Role: STUDY_DIRECTOR
Bristol-Myers Squibb
Locations
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Rocky Mountain Cancer Centers - Littleton
Littleton, Colorado, United States
Local Institution - 516-014-029
Goshen, Indiana, United States
Local Institution - 516-014-002
Boston, Massachusetts, United States
Barbara Ann Karmanos Cancer Institute
Detroit, Michigan, United States
Local Institution - 516-014-005
Minneapolis, Minnesota, United States
Urology Cancer Center and GU Research Network
Omaha, Nebraska, United States
Local Institution - 516-014-011
Albany, New York, United States
Memorial Sloan Kettering Cancer Center - Arnold and Marie Schwartz Cancer Research Building
New York, New York, United States
Local Institution - 516-014-004
Columbus, Ohio, United States
Local Institution - 516-014-001
Austin, Texas, United States
USOR - Texas Oncology Northeast Texas - Denison
Denison, Texas, United States
Local Institution - 516-014-013
Houston, Texas, United States
NEXT Virginia
Fairfax, Virginia, United States
Countries
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Related Links
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BMS Clinical Trial Information
BMS Clinical Trial Patient Recruiting
Other Identifiers
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CA248-0003
Identifier Type: OTHER
Identifier Source: secondary_id
516-014
Identifier Type: OTHER
Identifier Source: secondary_id
CA248-0003
Identifier Type: -
Identifier Source: org_study_id
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