Study of Sitravatinib With or Without Other Anticancer Therapies Receiving Clinical Benefit From Parent Study
A Multicenter, Open-label Rollover Study of Sitravatinib Alone or in Combination With Other Anticancer Therapies in Patients With Advanced or Metastatic Solid Malignancies
2 other identifiers
interventional
52
1 country
13
Brief Summary
A Study of Sitravatinib Alone or in Combination with Other Anticancer Therapies in Advanced or Metastatic Malignancies
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Jun 2021
Typical duration for phase_2
13 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 28, 2021
CompletedFirst Posted
Study publicly available on registry
May 14, 2021
CompletedStudy Start
First participant enrolled
June 29, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 21, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
September 25, 2025
CompletedOctober 10, 2025
October 1, 2025
3.8 years
April 28, 2021
October 8, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
Frequency of subjects experiencing treatment-related AEs.
Frequency of subjects experiencing treatment-related AEs.
24 Months
Secondary Outcomes (1)
Time to clinical or radiographic progression on study.
24 Months
Study Arms (1)
Phase 2/3: Open label extension of parent study
EXPERIMENTALThe 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.
Interventions
Sitravatinib is a small molecule inhibitor of receptor tyrosine kinases.
Nivolumab is a programmed death receptor-1 (PD-1) blocking antibody
Pembrolizumab is a programmed death receptor-1 (PD-1) blocking antibody
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 is a CTLA-4 (cytotoxic T-lymphocyte-associated protein 4) blocking antibody
Eligibility Criteria
You may qualify if:
- Currently receiving sitravatinib single- agent or in combination with other therapeutic agent(s) in another Mirati- sponsored protocol
- 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
You may not qualify if:
- Known or suspected presence of other cancer
- Other life- threatening illness or organ system dysfunction compromising safety evaluation
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (13)
Rocky Mountain Cancer Centers - Littleton
Littleton, Colorado, 80218, United States
Local Institution - 516-014-029
Goshen, Indiana, 46526, United States
Local Institution - 516-014-002
Boston, Massachusetts, 02215, United States
Barbara Ann Karmanos Cancer Institute
Detroit, Michigan, 48201, United States
Local Institution - 516-014-005
Minneapolis, Minnesota, 55455, United States
Urology Cancer Center and GU Research Network
Omaha, Nebraska, 68130, United States
Local Institution - 516-014-011
Albany, New York, 12208, United States
Memorial Sloan Kettering Cancer Center - Arnold and Marie Schwartz Cancer Research Building
New York, New York, 10065, United States
Local Institution - 516-014-004
Columbus, Ohio, 43210, United States
Local Institution - 516-014-001
Austin, Texas, 78758, United States
USOR - Texas Oncology Northeast Texas - Denison
Denison, Texas, 75020, United States
Local Institution - 516-014-013
Houston, Texas, 77030, United States
NEXT Virginia
Fairfax, Virginia, 22031, United States
Related Links
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Bristol-Myers Squibb
Bristol-Myers Squibb
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 28, 2021
First Posted
May 14, 2021
Study Start
June 29, 2021
Primary Completion
April 21, 2025
Study Completion
September 25, 2025
Last Updated
October 10, 2025
Record last verified: 2025-10