EV-302 : An Open-label, Randomized, Controlled Phase 3 Study of Enfortumab Vedotin in Combination With Pembrolizumab Versus Chemotherapy Alone in Previously Untreated Locally Advanced or Metastatic Urothelial Cancer

Male or<br/>FemaleGender Male or
Female

RecruitingStatus Recruiting

Systemic<br/>Therapy TrialTypeSystemic
Therapy Trial

ThreePhase Three

18+Age Over 18

Urinary System<br/>CancersCancer LocationUrinary System
Cancers

Systemic therapy,Treatment | Urinary systemUrothelial

Trial Overview Read MoreRead more

This phase III trial is trying to understand how well two targeted cancer drugs (enfortumab vedotin and pembrolizumab) work together to treat patients with urothelial cancer, compared to standard of care chemotherapy.
 

This trial is treating patients with urothelial cancer (a type of bladder cancer).

This is a systemic therapy trial.

You may be able to join this trial if:

  • Your cancer has spread to other parts of the body.

You may be excluded from this trial if:

  • You have a certain disease or psychological condition.
  • You have been diagnosed with a prior or secondary type of cancer.
  • You have had certain treatments, surgical procedures or drugs.

Clinical trials have complex eligibility criteria - talk to your doctor about your interest in this trial.

Clinical Summary Read MoreRead more

Trial Identifiers

Use the hyperlinks, where available to access additional clinical trial information.

Scientific Title

An Open-label, Randomized, Controlled Phase 3 Study of Enfortumab Vedotin in Combination With Pembrolizumab Versus Chemotherapy Alone in Previously Untreated Locally Advanced or Metastatic Urothelial Cancer

Commercial Sponsor

Astellas Pharma Inc.

Summary

Eligible patients will be randomised to Arm A, Arm B or Arm C of the trial. At this stage, only Arm A and Arm B are accepting patients. Patients will either receive intravenous Enfortumab vedotin and pembrolizumab (in Arm A of the trial) or standard of care chemotherapy (containing Gemcitabine and Cisplatin or Carboplatin, in Arm B of the trial) over a three-week cycle.

Recruiting Hospitals Read MoreRead more

Olivia Newton-John Cancer Wellness & Research Centre
Heidelberg
Ms Samantha Chakar
samantha.chakar@austin.org.au
03 9496 3088

Box Hill Hospital Medical Oncology
Box Hill
Lauren Mitchell
lauren.mitchell@monash.edu
03 9094 9544

Trial Overview: General information about a clinical trial. This section provides an overview of who might be able to join this trial and what type of treatment is involved.

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