Status:
COMPLETED
Pembrolizumab + Epacadostat vs Pembrolizumab + Placebo in Recurrent or Progressive Metastatic Urothelial Carcinoma
Lead Sponsor:
Incyte Corporation
Collaborating Sponsors:
Merck Sharp & Dohme LLC
Conditions:
UC (Urothelial Cancer)
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
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 ...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
December 22 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 23 2020
Estimated Enrollment :
84 Patients enrolled
Trial Details
Trial ID
NCT03374488
Start Date
December 22 2017
End Date
July 23 2020
Last Update
August 22 2025
Active Locations (135)
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1
Ironwood Cancer & Research Centers
Chandler, Arizona, United States, 85224
2
University of California Irvine Medical Center
Orange, California, United States, 92868
3
UCSF Helen Diller Family Comprehensive Cancer Center
San Francisco, California, United States, 94158
4
UCLA Hematology Oncology Santa Monica
Santa Monica, California, United States, 90404