Pembrolizumab + Epacadostat vs Pembrolizumab + Placebo in Recurrent or Progressive Metastatic Urothelial Carcinoma

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 as a treatment for recurrent or progressive metastatic urothelial carcinoma in patients who have failed a first-line platinum-containing chemotherapy regimen for advanced/metastatic disease.

Key facts

Study ID

NCT03374488

Run by

Incyte Corporation

People needed

84

Starts

2017-12-22

Expected to finish

2020-07-23

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-confirmed diagnosis of urothelial carcinoma of the renal pelvis, ureter, bladder, or urethra, that is transitional cell, or mixed transitional/non-transitional (predominantly transitional) cell type.
• Progression or recurrence of urothelial carcinoma following one prior platinum containing chemotherapy regimen for metastatic or unresectable locally advanced disease. A participant who receives a neoadjuvant or adjuvant platinum-containing regimen following cystectomy for localized muscle-invasive urothelial carcinoma is acceptable (without further systemic treatment), if recurrence/progression occurs ≤ 12 months following completion of therapy.
• Measurable disease based on RECIST v1.1.
• Have provided an archival tumor tissue sample or newly obtained core or excisional biopsy of a tumor lesion not previously irradiated for PD-L1 analysis.
• Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
• Adequate organ function per protocol-defined criteria.

You may not qualify if…

• Urothelial carcinoma that is suitable for local therapy with curative intent.
• History or presence of an abnormal electrocardiogram (ECG) that, in the investigator's opinion, is clinically meaningful.
• 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.
• 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 (HBsAg reactive) or has active hepatitis C (HCV RNA). Note: Testing must be performed to determine eligibility.
• Use of protocol-defined prior/concomitant therapy.

Where it is running

• University of California Irvine Medical Center — Orange, California, United States
• UCSF Helen Diller Family Comprehensive Cancer Center — San Francisco, California, United States
• UCLA Hematology Oncology Santa Monica — Santa Monica, California, United States
• Smilow Cancer Center at Yale-New Haven — New Haven, Connecticut, United States
• Northside Hospital, Inc. - GCS/Annex — Atlanta, Georgia, United States
• University of Chicago — Chicago, Illinois, United States
• Quincy Medical Group — Quincy, Illinois, United States
• Johns Hopkins University — Baltimore, Maryland, United States
• Massachusetts General Hospital — Boston, Massachusetts, United States
• University of Michigan Health System — Ann Arbor, Michigan, United States
• NYU Clinical Cancer Center — New York, New York, United States
• Oklahoma Cancer Specialists & Research Institute — Tulsa, Oklahoma, United States
• Oregon Health & Science University — Portland, Oregon, United States
• University of Pennsylvania — Philadelphia, Pennsylvania, United States
• Thomas Jefferson University Hospital — 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
• University of Tennessee Medical Center Knoxville — Knoxville, Tennessee, United States
• Vanderbilt University Medical Center — Nashville, Tennessee, United States
• US Oncology and Research — Fort Worth, Texas, United States
• Virginia Cancer Specialists, PC — Fairfax, Virginia, United States
• Virginia Oncology Associates — Norfolk, Virginia, United States
• VCU Massey Cancer Center — Richmond, Virginia, United States
• Southern Medical Day Care Centre — Wollongong, New South Wales, Australia
• Ironwood Cancer & Research Centers — Chandler, Arizona, United States

Full record on ClinicalTrials.gov

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