Description:
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.
Title
- Brief Title: Pembrolizumab in Combination With Epacadostat or Placebo in Cisplatin-ineligible Urothelial Carcinoma (KEYNOTE-672/ECHO-307)
- Official Title: A Phase 3 Randomized, Double-Blind Trial of Pembrolizumab (MK-3475) in Combination With Epacadostat (INCB024360) or Placebo in Participants With Cisplatin-ineligible Urothelial Carcinoma (KEYNOTE-672/ECHO-307)
Clinical Trial IDs
- ORG STUDY ID:
KEYNOTE-672/ECHO-307
- NCT ID:
NCT03361865
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 in participants with cisplatin-ineligible urothelial
carcinoma.
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 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.
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: | Week 9 |
Safety Issue: | |
Description: | ORR was defined as the percentage of participants who had a confirmed complete response (CR) or partial response (PR) per RECIST v1.1 by investigator determination.
Responses are based on Investigator assessments per RECIST 1.1 without confirmation using all scans up to the cutoff date. |
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 approximately 9 months at data cut-off 15-AUG-2018 |
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 approximately 9 months at data cut-off 15-AUG-2018 |
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 cancer, programmed cell death 1 (PD-1) inhibitor
- indoleamine 2,3-dioxygenase (IDO) inhibitor
Last Updated
September 14, 2020