Pembrolizumab in Combination With Epacadostat or Placebo in Cisplatin-ineligible Urothelial Carcinoma (KEYNOTE-672/ECHO-307)

Completed · Phase 3 · Has a placebo group

Conditions studied: UC (Urothelial Cancer)

In brief

The purpose of this study was to evaluate the efficacy and safety of pembrolizumab + epacadostat vs pembrolizumab + placebo in participants with cisplatin-ineligible urothelial carcinoma.

Key facts

Study ID

NCT03361865

Run by

Incyte Corporation

People needed

93

Starts

2017-12-04

Expected to finish

2020-08-04

Last updated by the study team

2025-08-22

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Histologically or cytologically-confirmed diagnosis of advanced/unresectable (inoperable) or metastatic urothelial cancer of the renal pelvis, ureter, bladder, or urethra.
• Measurable disease based on RECIST v1.1.
• Be considered ineligible to receive cisplatin-based combination therapy, based on protocol-defined criteria.
• Have provided tissue for PD-L1 analysis from an archival tissue sample or newly obtained core or excisional biopsy of a tumor lesion not previously irradiated.
• Have received no prior systemic chemotherapy for advanced/unresectable (inoperable) or metastatic urothelial cancer.
• Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2 within 14 days prior to randomization.
• Adequate organ function per protocol-defined criteria.

You may not qualify if…

• Disease that is suitable for local therapy administered with curative intent.
• Known additional malignancy that is progressing or has required active treatment within the past 3 years.
• Known active central nervous system (CNS) metastases and/or carcinomatous meningitis. Participants with previously treated brain metastases may participate provided they are radiologically stable, ie, without evidence of progression for at least 4 weeks by repeat imaging, clinically stable and without requirement of steroid treatment for at least 14 days prior to first dose of study treatment.
• Active autoimmune disease that has required systemic treatment in past 2 years.
• Known history of human immunodeficiency virus (HIV) infection. HIV testing is not required unless mandated by local health authority.
• Known history of or is positive for active hepatitis B (hepatitis B surface antigen [HBsAg] reactive) or has active hepatitis C (HCV RNA). Note: Testing must be performed to determine eligibility.
• History of a gastrointestinal condition that in the opinion of the Investigator may affect oral drug absorption.
• History or presence of an abnormal electrocardiogram (ECG) that, in the investigator's opinion, is clinically meaningful.
• Use of protocol-defined prior/concomitant therapy.

Where it is running

• University of California Irvine Medical Center — Orange, California, United States
• Yale Cancer Center — New Haven, Connecticut, United States
• Woodlands Medical Specialists, PA — Pensacola, Florida, United States
• Rush University Medical Center — Chicago, Illinois, United States
• Quincy Medical Group — Quincy, Illinois, United States
• Massachusetts General Hospital — Boston, Massachusetts, United States
• GU Research Network-Urology Cancer Center — Omaha, Nebraska, United States
• Comprehensive Cancer Centers of Nevada — Las Vegas, Nevada, United States
• Laura and Isaac Perlmutter Cancer Center at NYU Langone — New York, New York, United States
• Levine Cancer Institute — Charlotte, North Carolina, United States
• Willamette Valley Cancer Institute and Research Center — Eugene, Oregon, United States
• Abramson Cancer Center of the University of Pennsylvania — Philadelphia, Pennsylvania, United States
• Fox Chase Cancer Center — Philadelphia, Pennsylvania, United States
• Medical University of South Carolina-Hollings Cancer Center — Charleston, South Carolina, United States
• Tennessee Oncology, PLLC/The Sarah Cannon Research Institute — Chattanooga, Tennessee, United States
• University of Tennessee Medical Center Knoxville — Knoxville, Tennessee, United States
• Sarah Cannon Research Institute — Nashville, Tennessee, United States
• Tennessee Oncology Nashville — Nashville, Tennessee, United States
• Vanderbilt-Ingram Cancer Center — Nashville, Tennessee, United States
• Texas Oncology-Memorial City — Houston, Texas, United States
• University of Washington — Seattle, Washington, United States
• Calvary Mater Newcastle — Waratah, New South Wales, Australia
• Southern Medical Day Care Centre — Wollongong, New South Wales, Australia
• Austin Health-Austin Hospital — Heidelberg, Victoria, Australia
• Arizona Oncology Associates PC- HOPE — Tucson, Arizona, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.