Prostate Cancer

CONTACT-02

A Phase 3, Randomized, Open-Label, Controlled Study of Cabozantinib (XL184) in Combination with Atezolizumab vs Second Novel Hormonal Therapy (NHT) in Subjects with Metastatic Castration-Resistant Pro

Trial overview

Topic

CONTACT-02

Description

A Phase 3, Randomized, Open-Label, Controlled Study of Cabozantinib (XL184) in Combination with Atezolizumab vs Second Novel Hormonal Therapy (NHT) in Subjects with Metastatic Castration-Resistant Prostate Cancer

Eligibility criteria:

  • Men with histologically or cytologically confirmed adenocarcinoma of the prostate
  • Surgical or medical castration, with serum testosterone = 50 ng/dL (= 1.73 nmol/L) at screening
  • Measurable (extrapelvic soft tissue) metastatic disease per Investigator assessment defined by at least one of the following: measurable visceral disease (eg, adrenal, kidney, liver, lung, pancreas, spleen) per RECIST 1.1; OR measurable extrapelvic adenopathy (ie, adenopathy above the aortic bifurcation)
  • Progressive disease at study entry as defined by specific criteria for prostate specific antigen (PSA) progression OR soft tissue disease progression in the opinion of the Investigator (Note: subjects with bone disease progression alone are not eligible)
  • Age = 18 years old or meeting country definition of adult, whichever is older, on the day of consent
  • ECOG performance status of 0 or 1
  • Recovery to baseline or = Grade 1 per Common Terminology Criteria for Adverse Events (CTCAE) v5 from toxicities related to any prior treatments, unless AE(s) are clinically nonsignificant and/or stable on supportive therapy in the opinion of the Investigator
  • Adequate organ and marrow function based upon specific laboratory assessments obtained within 21 days prior to randomization

Study details:

This multicountry, multicenter, retrospective, non-interventional study involving patients diagnosed with HER2-positive unresectable or metastatic breast cancer mBC will be conducted to understand the demographic and clinico-pathological profile of the patients, diagnostic practices for human epidermal growth factor receptor 2 (HER2) status, current treatment landscape and sequencing of therapies, associated burden of toxicities with all lines of
treatment (LOTs), and survival outcomes in the real-world setting.

Further information:

Please click here for more information

Thank you for submitting.

We will be in touch within 24 hours

An unexpected error has occurred.

You will need to complete the form again, sorry for the inconvenience.

How can we help?

If you have a medical emergency please call 000. If you have an urgent request and would like to speak to our staff, please contact one of our centres directly.

* Indicates a required field.