Clinical Trials /

Pembrolizumab in Combination With Epacadostat or Placebo in Cisplatin-ineligible Urothelial Carcinoma (KEYNOTE-672/ECHO-307)

NCT03361865

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.

Related Conditions:
  • Urothelial Carcinoma
Recruiting Status:

Completed

Phase:

Phase 3

Trial Eligibility

Document

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

  • UC (Urothelial Cancer)

Interventions

DrugSynonymsArms
PembrolizumabMK-3475Pembrolizumab 200 mg + epacadostat 100 mg BID
EpacadostatINCB024360Pembrolizumab 200 mg + epacadostat 100 mg BID
PlaceboPembrolizumab 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

NameTypeDescriptionInterventions
Pembrolizumab 200 mg + epacadostat 100 mg BIDExperimentalPembrolizumab + epacadostat
  • Pembrolizumab
  • Epacadostat
Pembrolizumab 200 mg + placebo BIDActive ComparatorPembrolizumab + placebo
  • 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