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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

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


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


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)



Facility Status Contact
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