Enfortumab Vedotin and Pembrolizumab vs. Chemotherapy Alone in Untreated Locally Advanced or Metastatic Urothelial Cancer

Conditions

• Urothelial Cancer

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Enfortumab vedotin — DRUG
  Enfortumab vedotin administered as an IV infusion on Days 1 and 8 of every 3-week cycle
• Pembrolizumab — DRUG
  IV infusion on Day 1 of every 3-week cycle
• Cisplatin — DRUG
  administered as IV infusion on Day 1 of each 3-week cycle
• Carboplatin — DRUG
  Dosed according to local guidelines and will be administered as IV infusion on Day 1 of each 3-week cycle
• Gemcitabine — DRUG
  IV infusion on Days 1 and 8 of every 3 week cycle

Study Details

This study is being done to see how well two drugs (enfortumab vedotin and pembrolizumab) work together to treat patients with urothelial cancer. The study will compare these drugs to other drugs that are usually used to treat this cancer (standard of care). The patients in this study will have cancer that has spread from their urinary system to other parts of their body.

Key Dates

Start date

Mar 30, 2020

Status verified

May 2026

Primary completion

Aug 8, 2023

Completion

Mar 1, 2028

Study Design

Enrollment

886 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Arm A
  Enfortumab vedotin + pembrolizumab
• Active Comparator: Arm B
  Gemcitabine + cisplatin or carboplatin

Primary Outcome Measure

Progression-Free Survival (PFS) Per Response Evaluation Criteria in Solid Tumors (RECIST) Version (v) 1.1 by Blinded Independent Central Review (BICR) [ Time Frame: From the date of randomization to first documentation of PD or death due to any cause, whichever occurred first (maximum exposure to treatment was up to 39.2 months) ]

Locations (34)

Related coverage on Hipa.ai

• Pembrolizumab Combination Significantly Improves Survival in Urothelial Cancer
  Pembrolizumab · Aug 8, 2023 · ClinicalTrials.gov

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