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

Incyte

Status and phase

Completed

Phase 3

Conditions

UC (Urothelial Cancer)

Treatments

Drug: Epacadostat

Drug: Pembrolizumab

Drug: Placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT03374488

2017-002310-31 (EudraCT Number)

KEYNOTE-698/ECHO-303

Details and patient eligibility

About

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.

Enrollment

84 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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 criteria

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.