Status:
COMPLETED
Pembrolizumab in Combination With Epacadostat or Placebo in Cisplatin-ineligible Urothelial Carcinoma (KEYNOTE-672/ECHO-307)
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 in participants with cisplatin-ineligible urothelial carcinoma.
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
December 4 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 4 2020
Estimated Enrollment :
93 Patients enrolled
Trial Details
Trial ID
NCT03361865
Start Date
December 4 2017
End Date
August 4 2020
Last Update
August 22 2025
Active Locations (143)
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1
Arizona Oncology Associates PC- HOPE
Tucson, Arizona, United States, 85704
2
University of California Irvine Medical Center
Orange, California, United States, 92868
3
Yale Cancer Center
New Haven, Connecticut, United States, 06511
4
Woodlands Medical Specialists, PA
Pensacola, Florida, United States, 32503