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

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

52 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-06-29

Study Completion Date

2025-09-25

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

A Study of Sitravatinib Alone or in Combination with Other Anticancer Therapies in Advanced or Metastatic Malignancies

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Sitravatinib is a spectrum-selective receptor tyrosine kinase (RTK) inhibitor that inhibits several closely related RTKs including the TAM family (Tyro3/Axl/MERTK), VEGFR2, KIT, and MET.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Advanced or Metastatic Solid Malignancies

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Group Type EXPERIMENTAL

Sitravatinib

Intervention Type DRUG

Sitravatinib is a small molecule inhibitor of receptor tyrosine kinases.

Nivolumab

Intervention Type DRUG

Nivolumab is a programmed death receptor-1 (PD-1) blocking antibody

Pembrolizumab

Intervention Type DRUG

Pembrolizumab is a programmed death receptor-1 (PD-1) blocking antibody

Enfortumab Vedotin-Ejfv

Intervention Type DRUG

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

Intervention Type DRUG

Ipilimumab is a CTLA-4 (cytotoxic T-lymphocyte-associated protein 4) blocking antibody

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Sitravatinib

Sitravatinib is a small molecule inhibitor of receptor tyrosine kinases.

Intervention Type DRUG

Nivolumab

Nivolumab is a programmed death receptor-1 (PD-1) blocking antibody

Intervention Type DRUG

Pembrolizumab

Pembrolizumab is a programmed death receptor-1 (PD-1) blocking antibody

Intervention Type DRUG

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)

Intervention Type DRUG

Ipilimumab

Ipilimumab is a CTLA-4 (cytotoxic T-lymphocyte-associated protein 4) blocking antibody

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

MGCD516 OPDIVO KEYTRUDA PADCEV YERVOY

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* 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

Exclusion Criteria

* Known or suspected presence of other cancer
* Other life- threatening illness or organ system dysfunction compromising safety evaluation
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Mirati Therapeutics Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Bristol-Myers Squibb

Role: STUDY_DIRECTOR

Bristol-Myers Squibb

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Rocky Mountain Cancer Centers - Littleton

Littleton, Colorado, United States

Site Status

Local Institution - 516-014-029

Goshen, Indiana, United States

Site Status

Local Institution - 516-014-002

Boston, Massachusetts, United States

Site Status

Barbara Ann Karmanos Cancer Institute

Detroit, Michigan, United States

Site Status

Local Institution - 516-014-005

Minneapolis, Minnesota, United States

Site Status

Urology Cancer Center and GU Research Network

Omaha, Nebraska, United States

Site Status

Local Institution - 516-014-011

Albany, New York, United States

Site Status

Memorial Sloan Kettering Cancer Center - Arnold and Marie Schwartz Cancer Research Building

New York, New York, United States

Site Status

Local Institution - 516-014-004

Columbus, Ohio, United States

Site Status

Local Institution - 516-014-001

Austin, Texas, United States

Site Status

USOR - Texas Oncology Northeast Texas - Denison

Denison, Texas, United States

Site Status

Local Institution - 516-014-013

Houston, Texas, United States

Site Status

NEXT Virginia

Fairfax, Virginia, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Related Links

Access external resources that provide additional context or updates about the study.

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

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

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.