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

• Status: Completed
• Trial end date: 2020-08-04
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Incyte Corporation
• Collaborator: Merck Sharp & Dohme Corp.
• Treatments: Cisplatin; Pembrolizumab

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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.