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

Incyte

Status and phase

Completed

Phase 3

Conditions

UC (Urothelial Cancer)

Treatments

Drug: Pembrolizumab

Drug: Epacadostat

Drug: Placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT03361865

2017-002311-34 (EudraCT Number)

KEYNOTE-672/ECHO-307

Details and patient eligibility

About

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.

Enrollment

93 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.