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A Study of Enfortumab Vedotin Alone or With Other Therapies for Treatment of Urothelial Cancer

NCT03288545 · Status: TERMINATED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 348

Last updated 2026-03-24

No results posted yet for this study

Summary

This study will test an experimental drug (enfortumab vedotin) alone and with different combinations of anticancer therapies. Pembrolizumab is an immune checkpoint inhibitor (CPI) that is used to treat patients with cancer of the urinary system (urothelial cancer). This type of cancer includes cancer of the bladder, renal pelvis, ureter or urethra. Some parts of the study will look at locally advanced or metastatic urothelial cancer (la/mUC), which means the cancer has spread to nearby tissues or to other areas of the body. Other parts of the study will look at muscle-invasive bladder cancer (MIBC), which is cancer at an earlier stage that has spread into the muscle wall of the bladder. This study will look at the side effects of enfortumab vedotin alone and with other anticancer therapies. A side effect is a response to a drug that is not part of the treatment effect. This study will also test if the cancer shrinks with the different treatment combinations.

Conditions

  • Carcinoma, Transitional Cell
  • Urinary Bladder Neoplasms
  • Urologic Neoplasms
  • Renal Pelvis Neoplasms
  • Urothelial Cancer
  • Ureteral Neoplasms
  • Urethral Neoplasms

Interventions

DRUG

enfortumab vedotin (EV)

Intravenous (IV) infusion on days 1 and 8 every 21 days

DRUG

pembrolizumab

IV infusion on day 1 every 21 days

DRUG

cisplatin

IV infusion on day 1 every 21 days

DRUG

carboplatin

IV infusion on day 1 every 21 days

DRUG

gemcitabine

IV infusion on days 1 and 8 every 21 days

Sponsors & Collaborators

  • Merck Sharp & Dohme LLC

    collaborator INDUSTRY

  • Seagen Inc.

    collaborator INDUSTRY

  • Astellas Pharma Global Development, Inc.

    lead INDUSTRY

Principal Investigators

  • Changting Meng, MD · Seagen Inc.

  • Jason Lukas, MD, PhD · Seagen Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-10-11
Primary Completion
2026-02-20
Completion
2026-02-20
FDA Drug
Yes

Countries

  • United States
  • Canada
  • France
  • Italy
  • Puerto Rico
  • Spain

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

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 NCT03288545 on ClinicalTrials.gov