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BRIEF TITLE: A Phase 2 Study of Sitravatinib in Combination With Nivolumab in Patients With Advanced or Metastatic Urothelial Carcinoma

A Phase 2 Study of Sitravatinib in Combination With Nivolumab in Patients With Advanced or Metastatic Urothelial Carcinoma


  • Org Study ID: 516-003
  • Secondary ID:
  • NCT ID: NCT03606174
  • NCT Alias:
  • Sponsor: Mirati Therapeutics Inc. - Industry
  • Source: 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.

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.

Overal Status Start Date Phase Study Type
Recruiting September 11, 2018 Phase 2 Interventional

Primary Outcomes:

Primary Outcome 1 - Measure: Number of patients experiencing tumor size reduction

Primary Outcome 1 - Time Frame: up to 3 months

Condition:

  • Urothelial Carcinoma
  • Urothelial Carcinoma Bladder
  • Urothelial Carcinoma Ureter
  • Urothelial Carcinoma of the Renal Pelvis and Ureter
  • Urothelial Carcinoma Urethra

Eligibility

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
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Gender: All

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: No

Official Information

Name: Isan Chen, MD

Role: Study Director

Affiliation: Mirati Therapeutics Inc.

Overall Contact

Name: Mirati Therapeutics Study Locator Services

Phone: 1-844-893-5530 (toll free)

Email: Mirati516003@mirati.com

Locations

Facility Status Contact
Rocky Mountain Cancer Centers-Aurora
Aurora, Colorado 80012
United States
Recruiting
SCRI - Florida Cancer Specialists- North Region
Saint Petersburg, Florida 33705
United States
Recruiting
Florida Cancer Specialist-West Palm Beach
West Palm Beach, Florida 33401
United States
Recruiting
Washington University in St Louis
Saint Louis, Missouri 63110
United States
Recruiting
GU Research Network/Urology Cancer Center
Omaha, Nebraska 68130
United States
Recruiting
Comprehensive Cancer Centers of Nevada
Las Vegas, Nevada 89169
United States
Recruiting
New York Oncology Hematology
Albany, New York 12206
United States
Recruiting
The Ohio State University
Columbus, Ohio 43202
United States
Not yet recruiting
Allegheny Singer Research Institute
Pittsburgh, Pennsylvania 15212
United States
Not yet recruiting
Texas Oncology-Austin Central
Austin, Texas 78731
United States
Recruiting
Texas Oncology- Memorial City
Houston, Texas 77024
United States
Recruiting
MD Anderson Cancer Center
Houston, Texas 77030
United States
Recruiting
Texas Oncology - Tyler
Tyler, Texas 75702
United States
Recruiting
Virginia Cancer Specialists- Fairfax
Fairfax, Virginia 22031
United States
Recruiting