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Study of Sitravatinib With or Without Other Anticancer Therapies Receiving Clinical Benefit From Parent Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04887870
Recruitment Status : Enrolling by invitation
First Posted : May 14, 2021
Last Update Posted : February 6, 2023
Sponsor:
Information provided by (Responsible Party):
Mirati Therapeutics Inc.

Study Description
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Brief Summary:
A Study of Sitravatinib Alone or in Combination with Other Anticancer Therapies in Advanced or Metastatic Malignancies

Condition or disease Intervention/treatment Phase
Advanced or Metastatic Solid Malignancies Drug: Sitravatinib Drug: Nivolumab Drug: Pembrolizumab Drug: Enfortumab Vedotin-Ejfv Drug: Ipilimumab Phase 2 Phase 3

Detailed Description:

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Multicenter, Open-label Rollover Study of Sitravatinib Alone or in Combination With Other Anticancer Therapies in Patients With Advanced or Metastatic Solid Malignancies
Actual Study Start Date : June 30, 2021
Estimated Primary Completion Date : April 19, 2024
Estimated Study Completion Date : April 19, 2024
Arms and Interventions
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Arm Intervention/treatment
Experimental: 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.
 Drug: Sitravatinib
Sitravatinib is a small molecule inhibitor of receptor tyrosine kinases.
Other Name: MGCD516

Drug: Nivolumab
Nivolumab is a programmed death receptor-1 (PD-1) blocking antibody
Other Name: OPDIVO

Drug: Pembrolizumab
Pembrolizumab is a programmed death receptor-1 (PD-1) blocking antibody
Other Name: KEYTRUDA

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)
Other Name: PADCEV

Drug: Ipilimumab
Ipilimumab is a CTLA-4 (cytotoxic T-lymphocyte-associated protein 4) blocking antibody
Other Name: YERVOY


Outcome Measures
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Primary Outcome Measures :
  1. Frequency of subjects experiencing treatment-related AEs. [ Time Frame: 24 Months ]
    Frequency of subjects experiencing treatment-related AEs.


Secondary Outcome Measures :
  1. Time to clinical or radiographic progression on study. [ Time Frame: 24 Months ]
    Time to clinical or radiographic progression on study.


Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04887870


Locations
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United States, California
Beverly Hills Cancer Center
Beverly Hills, California, United States, 90211
United States, Colorado
Rocky Mountain Cancer Centers
Aurora, Colorado, United States, 90012
United States, Massachusetts
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02215
United States, Michigan
Karmanos Cancer Institute
Detroit, Michigan, United States, 48201
United States, Minnesota
University of Minnesota Health Clinics and Surgery Center
Minneapolis, Minnesota, United States, 55455
United States, Nebraska
GU Research Network/Urology Cancer Center
Omaha, Nebraska, United States, 68130
United States, New York
New York Oncology Hematology, P.C.
Clifton Park, New York, United States, 12065
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10065
United States, Ohio
The Ohio State University Wexner Medical Center - Thoracic Oncology Clinic
Columbus, Ohio, United States, 43210
United States, Texas
Texas Oncology - Denison Cancer Center
Denison, Texas, United States, 75020
UT MD Anderson Cancer Center
Houston, Texas, United States, 77030
NEXT Oncology
San Antonio, Texas, United States, 78229
United States, Virginia
NEXT Virginia
Fairfax, Virginia, United States, 22031
Sponsors and Collaborators
Mirati Therapeutics Inc.
Investigators
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Study Director: Ronald Shazer, MD Mirati Therapeutics Inc.
More Information
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Responsible Party: Mirati Therapeutics Inc.
ClinicalTrials.gov Identifier: NCT04887870    
Other Study ID Numbers: 516-014
First Posted: May 14, 2021    Key Record Dates
Last Update Posted: February 6, 2023
Last Verified: February 2023

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Neoplasms
Pembrolizumab
Nivolumab
Ipilimumab
 Antineoplastic Agents, Immunological
Antineoplastic Agents
Immune Checkpoint Inhibitors
Molecular Mechanisms of Pharmacological Action