Description:
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.
Title
- Brief Title: Pembrolizumab + Epacadostat vs Pembrolizumab + Placebo in Recurrent or Progressive Metastatic Urothelial Carcinoma
- Official Title: A Phase 3 Randomized, Double-Blind Clinical Study 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 (KEYNOTE-698/ECHO-303)
Clinical Trial IDs
- ORG STUDY ID:
KEYNOTE-698/ECHO-303
- NCT ID:
NCT03374488
Conditions
Interventions
Drug | Synonyms | Arms |
---|
Pembrolizumab | MK-3475 | Pembrolizumab 200 mg + Epacadostat 100 mg BID |
Epacadostat | INCB024360 | Pembrolizumab 200 mg + Epacadostat 100 mg BID |
Placebo | | Pembrolizumab 200 mg + placebo BID |
Purpose
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.
Trial Arms
Name | Type | Description | Interventions |
---|
Pembrolizumab 200 mg + Epacadostat 100 mg BID | Experimental | Pembrolizumab + epacadostat | |
Pembrolizumab 200 mg + placebo BID | Active Comparator | Pembrolizumab + placebo | |
Eligibility Criteria
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.
Maximum Eligible Age: | N/A |
Minimum Eligible Age: | 18 Years |
Eligible Gender: | All |
Healthy Volunteers: | No |
Primary Outcome Measures
Measure: | Objective Response Rate (ORR) With Pembrolizumab + Epacadostat Versus Pembrolizumab + Placebo |
Time Frame: | up to 9 weeks +14 days |
Safety Issue: | |
Description: | 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
Measure: | Safety and Tolerability of Pembrolizumab + Epacadostat Versus Pembrolizumab + Placebo as Measured by Number of Participants Experiencing Adverse Events (AEs) |
Time Frame: | Up to 8 months |
Safety Issue: | |
Description: | 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. |
Measure: | Safety and Tolerability of Pembrolizumab + Epacadostat Versus Pembrolizumab + Placebo as Measured by Number of Participants Discontinuing Study Treatment Due to AE |
Time Frame: | Up to 8 months |
Safety Issue: | |
Description: | 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. |
Details
Phase: | Phase 3 |
Primary Purpose: | Interventional |
Overall Status: | Completed |
Lead Sponsor: | Incyte Corporation |
Trial Keywords
- Urothelial carcinoma
- programmed cell death protein 1 (PD-1) inhibitor
- indoleamine 2,3-dioxygenase (IDO) inhibitor
Last Updated
September 14, 2020