A Phase 2 Study of Sitravatinib in Combination with Nivolumab in Patients with Advanced or Metastatic Urothelial Carcinoma (516-003)

  • STATUS
    Recruiting
Updated on 2 June 2021
cancer
carcinoma
tumor cells
nivolumab
platinum-based chemotherapy
advanced urothelial carcinoma
metastatic urothelial carcinoma
urothelial carcinoma
advanced urothelial cancer

Summary

This is a study involving an investigational (experimental) drug called sitravatinib, given in combination with the immunotherapy nivolumab (also known as OPDIVO®). 
Sitravatinib is designed to block specific proteins that are thought to cause tumors to grow and to prevent growth of new blood vessels that help cancer tumors to grow and spread.   In addition, research indicates that sitravatinib may help stimulate a patient’s immune system, improving its ability to recognize and attack cancer cells.  
Nivolumab is an FDA approved, prescription drug that belongs to a class of drugs known as checkpoint inhibitors; specifically, nivolumab is an inhibitor of the Programmed Cell Death (or PD 1).  Cancers can have extra signal molecules (PD-L1 molecules) on their surface that make the immune system accept them as normal, helping the cancer cells avoid attack by the immune system.  Nivolumab can block these signal molecules, allowing the immune system to recognize and attack cancer cells.  
This study will evaluate whether the combination of immune system stimulation caused by sitravatinib and improved recognition of tumor cells caused by nivolumab results in more anti tumor activity (tumor shrinkage) than would be expected with either agent used alone.
Patients will be grouped into cohorts based upon the following:
  • Whether or not patients were previously treated with or were ineligible for platinum-based chemotherapy 
  • Whether or not patients were previously treated with a checkpoint inhibitor or another type of immunotherapy
  • Whether or not patients were treated with an antibody-drug conjugate (ADC)
Study cohorts may include 9 - 45 patients depending on the cohort assignment and on how much anti-tumor activity is seen in a cohort.  Up to a maximum of 330 patients across approximately 27 study sites in the United States are expected to participate in this study.  
 

Description

Sitravatinib oral capsules administered daily in combination with nivolumab administered as 240 mg IV every 2 weeks or 480 mg IV every 4 weeks.
Several laboratory tests will be performed using samples of tumor tissue (archival tissue may be submitted and/or having tumor biopsy performed prior to the study and at 1 timepoint on-study) or blood to understand how and why the drugs may work together in the treatment of urothelial carcinoma.
For further information, please contact Mirati Therapeutic Study Locator Services via e-mail at miratistudylocator@emergingmed.com or via phone 1-844-893-5530 (toll free).

Details
Condition Urothelial Cancer, Urothelial Tract Cancer, Urothelial Carcinoma
Clinical Study IdentifierTX225018
Last Modified on2 June 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Diagnosis of urothelial carcinoma
Adequate bone marrow and organ function

Exclusion Criteria

Uncontrolled tumor in the brain
Unacceptable toxicity with prior checkpoint inhibitor
Impaired heart function
Clear my responses

How to participate?

Step 1 Connect with a site
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar
Name

Primary Contact

site
Name

0/250
Preferred Language
Other Language
Please verify that you are not a bot.

Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

Learn more

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

Learn more

Similar trials to consider

Loading...

Browse trials for

Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer

user name

Added by • 

 • 

Private

Reply by • Private
Loading...

Lorem ipsum dolor sit amet consectetur, adipisicing elit. Ipsa vel nobis alias. Quae eveniet velit voluptate quo doloribus maxime et dicta in sequi, corporis quod. Ea, dolor eius? Dolore, vel!

  The passcode will expire in None.
Loading...

No annotations made yet

Add a private note
  • abc Select a piece of text from the left.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.
Add a private note