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A Phase 2 Study of Sitravatinib in Combination With PD-(L)1 Checkpoint Inhibitor Regimens in Patients With Advanced or Metastatic Urothelial Carcinoma

NCT03606174 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 260

Last updated 2023-08-24

Study results available
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Summary

The study will evaluate the clinical activity of PD-(L)1 Checkpoint Inhibitor regimens in combination with the investigational agent sitravatinib in patients with advanced or metastatic urothelial carcinoma.

Conditions

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

Interventions

DRUG

Sitravatinib

Sitravatinib is a small molecule inhibitor of receptor tyrosine kinases

DRUG

Nivolumab

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

DRUG

Pembrolizumab

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

DRUG

Enfortumab vedotin

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)

Sponsors & Collaborators

  • Mirati Therapeutics Inc.

    lead INDUSTRY

Principal Investigators

  • Hirak Der-Torossian, MD · Mirati Therapeutics Inc.

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-09-11
Primary Completion
2022-08-03
Completion
2022-08-22
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03606174 on ClinicalTrials.gov