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Sitravatinib and Nivolumab in Urothelial Carcinoma Study

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ClinicalTrials.gov Identifier: NCT03606174
Recruitment Status : Recruiting
First Posted : July 30, 2018
Last Update Posted : September 30, 2019
Sponsor:
Information provided by (Responsible Party):
Mirati Therapeutics Inc.

Brief Summary:
The study will evaluate the clinical activity of nivolumab in combination with the investigational agent sitravatinib in patients with advanced or metastatic urothelial carcinoma.

Condition or disease Intervention/treatment Phase
Urothelial Carcinoma Urothelial Carcinoma Bladder Urothelial Carcinoma Ureter Urothelial Carcinoma of the Renal Pelvis and Ureter Urothelial Carcinoma Urethra Drug: Sitravatinib Drug: Nivolumab Phase 2

Detailed Description:
Sitravatinib is an orally-available, potent small molecule inhibitor of a closely related spectrum of receptor tyrosine kinases (RTKs) including MET, Axl, MERTK, VEGFR family, PDGFR family, KIT, FLT3, Trk family, RET, DDR2 and selected Eph family members. Nivolumab is a human IgG monoclonal antibody that binds to the programmed cell death-1(PD-1) receptor and blocks its interaction with programmed cell death ligand-1 (PD-L1) and PD-L2, releasing PD-1 pathway-mediated inhibition of the immune response including anti-tumor immune response. Combining an immunotherapeutic PD-L1 checkpoint inhibitor with an agent that has both immune modulatory and antitumor properties could enhance the antitumor efficacy observed with either agent alone. Sitravatinib selectively inhibits key molecular and cellular pathways strongly implicated in checkpoint inhibitor resistance and therefore represents a rational strategy to enhance or restore anti-tumor immunity when combined with nivolumab, a checkpoint inhibitor therapy.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 2 Study of Sitravatinib in Combination With Nivolumab in Patients With Advanced or Metastatic Urothelial Carcinoma
Actual Study Start Date : September 11, 2018
Estimated Primary Completion Date : December 31, 2019
Estimated Study Completion Date : September 30, 2020

Resource links provided by the National Library of Medicine

Drug Information available for: Nivolumab

Arm Intervention/treatment
Experimental: Sitravatinib and Nivolumab
Sitravatinib oral capsule administered daily in combination with nivolumab administered as 240 mg IV every 2 weeks
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




Primary Outcome Measures :
  1. Number of patients experiencing tumor size reduction [ Time Frame: up to 3 months ]

Secondary Outcome Measures :
  1. Number of patients experiencing adverse events [ Time Frame: up to 12 months ]
  2. Blood plasma concentration of the investigational agent [ Time Frame: up to 20 weeks ]


Information from the National Library of Medicine

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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:

  • Diagnosis of urothelial carcinoma
  • Most recent treatment must have included a checkpoint inhibitor
  • Adequate bone marrow and organ function

Exclusion Criteria:

  • Uncontrolled tumor in the brain
  • Unacceptable toxicity with prior checkpoint inhibitor
  • Impaired heart function

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): NCT03606174


Contacts
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Contact: Mirati Therapeutics Study Locator Services 1-844-893-5530 (toll free) miratistudylocator@emergingmed.com

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Locations
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United States, Colorado
Rocky Mountain Cancer Centers Recruiting
Aurora, Colorado, United States, 80012
United States, Connecticut
Yale School of Medicine Not yet recruiting
New Haven, Connecticut, United States, 06510
United States, Florida
SCRI - Florida Cancer Specialists- North Region Recruiting
Saint Petersburg, Florida, United States, 33705
SCRI - Florida Cancer Specialists - West Palm Beach Recruiting
West Palm Beach, Florida, United States, 33401
United States, Illinois
The University of Chicago Recruiting
Chicago, Illinois, United States, 60637
United States, Indiana
Indiana University - Melvin & Bren Simon Cancer Center Recruiting
Indianapolis, Indiana, United States, 46202
United States, Kentucky
Norton Cancer Institute - Broadway Recruiting
Louisville, Kentucky, United States, 40202
United States, Louisiana
Ochsner Cancer Institute Recruiting
New Orleans, Louisiana, United States, 70121
United States, Michigan
Barbara Ann Karmanos Cancer Institute Recruiting
Detroit, Michigan, United States, 48201
United States, Missouri
Washington University School of Medicine - Siteman Cancer Center Recruiting
Saint Louis, Missouri, United States, 63110
United States, Nebraska
GU Research Network/Urology Cancer Center Recruiting
Omaha, Nebraska, United States, 68130
United States, Nevada
Comprehensive Cancer Centers of Nevada - Southwest Recruiting
Las Vegas, Nevada, United States, 89169
United States, New York
New York Oncology Hematology - Albany Medical Center Recruiting
Albany, New York, United States, 12206
Roswell Park Cancer Institute Recruiting
Buffalo, New York, United States, 14263
Northwell Health Monter Cancer Center Recruiting
Lake Success, New York, United States, 11042
Memorial Sloan-Kettering Cancer Center Recruiting
New York, New York, United States, 10065
United States, North Carolina
University of North Carolina - Lineberger Comprehensive Cancer Center Recruiting
Chapel Hill, North Carolina, United States, 27599
Duke University Hospital Recruiting
Durham, North Carolina, United States, 27710
United States, Ohio
The Ohio State University College of Medicine Recruiting
Columbus, Ohio, United States, 43202
United States, Pennsylvania
Allegheny General Hoospital Recruiting
Pittsburgh, Pennsylvania, United States, 15212
United States, Tennessee
Vanderbilt University - Ingram Cancer Center Recruiting
Nashville, Tennessee, United States, 37232
United States, Texas
Texas Oncology-Austin Central Recruiting
Austin, Texas, United States, 78731
Texas Oncology- Memorial City Recruiting
Houston, Texas, United States, 77024
University of Texas - MD Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
Texas Oncology - Tyler Recruiting
Tyler, Texas, United States, 75702
United States, Virginia
Virginia Cancer Specialists- Fairfax Recruiting
Fairfax, Virginia, United States, 22031
Sponsors and Collaborators
Mirati Therapeutics Inc.
Investigators
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Study Director: Isan Chen, MD Mirati Therapeutics Inc.

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Responsible Party: Mirati Therapeutics Inc.
ClinicalTrials.gov Identifier: NCT03606174     History of Changes
Other Study ID Numbers: 516-003
First Posted: July 30, 2018    Key Record Dates
Last Update Posted: September 30, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Mirati Therapeutics Inc.:
MGCD516
Antineoplastic Agents
Immunologic Factors
Nivolumab
Tyrosine Kinase Inhibitor
VEGFR
TAM RTKs
PD-1
PD-L1
Additional relevant MeSH terms:
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Carcinoma
Carcinoma, Transitional Cell
Urinary Bladder Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Urologic Diseases
Urinary Bladder Diseases
Nivolumab
Antineoplastic Agents, Immunological
Antineoplastic Agents