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

Phase 3
Completed
Conditions
UC (Urothelial Cancer)
Interventions
Registration Number
NCT03374488
Lead Sponsor
Incyte Corporation
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 in patients who have failed a first-line platinum-containing chemotherapy regimen for advanced/metastatic disease.

Detailed Description

Not available

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
84
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.

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Pembrolizumab 200 mg + Epacadostat 100 mg BIDEpacadostatPembrolizumab + epacadostat
Pembrolizumab 200 mg + placebo BIDPlaceboPembrolizumab + placebo
Pembrolizumab 200 mg + placebo BIDPembrolizumabPembrolizumab + placebo
Pembrolizumab 200 mg + Epacadostat 100 mg BIDPembrolizumabPembrolizumab + epacadostat
Primary Outcome Measures
NameTimeMethod
Objective Response Rate (ORR) With Pembrolizumab + Epacadostat Versus Pembrolizumab + Placeboup to 9 weeks +14 days

ORR was defined as the percentage of participants who had a complete response (CR), disappearance of all target lesions or partial response (PR), \>=30% decrease in the sum of the longest diameter of target lesions per RECIST v1.1 by investigator determination.

Secondary Outcome Measures
NameTimeMethod
Safety and Tolerability of Pembrolizumab + Epacadostat Versus Pembrolizumab + Placebo as Measured by Number of Participants Discontinuing Study Treatment Due to AEUp to 8 months

AE is defined as any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment.

Safety and Tolerability of Pembrolizumab + Epacadostat Versus Pembrolizumab + Placebo as Measured by Number of Participants Experiencing Adverse Events (AEs)Up to 8 months

AE is defined as any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment.

Trial Locations

Locations (135)

Ironwood Cancer & Research Centers

🇺🇸

Chandler, Arizona, United States

University of California Irvine Medical Center

🇺🇸

Orange, California, United States

UCSF Helen Diller Family Comprehensive Cancer Center

🇺🇸

San Francisco, California, United States

UCLA Hematology Oncology Santa Monica

🇺🇸

Santa Monica, California, United States

Smilow Cancer Center at Yale-New Haven

🇺🇸

New Haven, Connecticut, United States

Northside Hospital, Inc. - GCS/Annex

🇺🇸

Atlanta, Georgia, United States

University of Chicago

🇺🇸

Chicago, Illinois, United States

Quincy Medical Group

🇺🇸

Quincy, Illinois, United States

Johns Hopkins University

🇺🇸

Baltimore, Maryland, United States

Massachusetts General Hospital

🇺🇸

Boston, Massachusetts, United States

Scroll for more (125 remaining)
Ironwood Cancer & Research Centers
🇺🇸Chandler, Arizona, United States

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