Pembrolizumab + Epacadostat vs Pembrolizumab + Placebo in Recurrent or Progressive Metastatic Urothelial Carcinoma
- 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
- 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.
- 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
Group Intervention Description Pembrolizumab 200 mg + Epacadostat 100 mg BID Epacadostat Pembrolizumab + epacadostat Pembrolizumab 200 mg + placebo BID Placebo Pembrolizumab + placebo Pembrolizumab 200 mg + placebo BID Pembrolizumab Pembrolizumab + placebo Pembrolizumab 200 mg + Epacadostat 100 mg BID Pembrolizumab Pembrolizumab + epacadostat
- Primary Outcome Measures
Name Time Method Objective Response Rate (ORR) With Pembrolizumab + Epacadostat Versus Pembrolizumab + Placebo up 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
Name Time Method Safety and Tolerability of Pembrolizumab + Epacadostat Versus Pembrolizumab + Placebo as Measured by Number of Participants Discontinuing Study Treatment Due to AE 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.
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