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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT03361865




Registration number
NCT03361865
Ethics application status
Date submitted
29/11/2017
Date registered
5/12/2017
Date last updated
14/09/2020

Titles & IDs
Public title
Pembrolizumab in Combination With Epacadostat or Placebo in Cisplatin-ineligible Urothelial Carcinoma (KEYNOTE-672/ECHO-307)
Scientific 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)
Secondary ID [1] 0 0
KEYNOTE-672/ECHO-307
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
UC (Urothelial Cancer) 0 0
Condition category
Condition code
Cancer 0 0 0 0
Kidney
Cancer 0 0 0 0
Bladder - transitional cell cancer

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Pembrolizumab
Treatment: Drugs - Epacadostat
Treatment: Drugs - Placebo

Experimental: Pembrolizumab 200 mg + epacadostat 100 mg BID - Pembrolizumab + epacadostat

Active Comparator: Pembrolizumab 200 mg + placebo BID - Pembrolizumab + placebo


Treatment: Drugs: Pembrolizumab
Pembrolizumab administered intravenously every 3 weeks.

Treatment: Drugs: Epacadostat
Epacadostat administered orally twice daily.

Treatment: Drugs: Placebo
Matching placebo administered orally twice daily.

Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Objective Response Rate (ORR) With Pembrolizumab + Epacadostat Versus Pembrolizumab + Placebo - 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.
Timepoint [1] 0 0
Week 9
Secondary outcome [1] 0 0
Safety and Tolerability of Pembrolizumab + Epacadostat Versus Pembrolizumab + Placebo as Measured by Number of Participants Experiencing Adverse Events (AEs) - 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.
Timepoint [1] 0 0
Up to approximately 9 months at data cut-off 15-AUG-2018
Secondary outcome [2] 0 0
Safety and Tolerability of Pembrolizumab + Epacadostat Versus Pembrolizumab + Placebo as Measured by Number of Participants Discontinuing Study Treatment Due to AE - 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.
Timepoint [2] 0 0
Up to approximately 9 months at data cut-off 15-AUG-2018

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,VIC
Recruitment hospital [1] 0 0
Calvary Mater Newcastle - Waratah
Recruitment hospital [2] 0 0
Southern Medical Day Care Centre - Wollongong
Recruitment hospital [3] 0 0
Austin Health-Austin Hospital - Heidelberg
Recruitment hospital [4] 0 0
Adelaide Cancer Centre - Kurralta Park
Recruitment hospital [5] 0 0
Macquarie University Hospital - Macquarie Park
Recruitment postcode(s) [1] 0 0
2298 - Waratah
Recruitment postcode(s) [2] 0 0
2500 - Wollongong
Recruitment postcode(s) [3] 0 0
3084 - Heidelberg
Recruitment postcode(s) [4] 0 0
5037 - Kurralta Park
Recruitment postcode(s) [5] 0 0
2109 - Macquarie Park
Recruitment outside Australia
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Plymouth
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Incyte Corporation
Address
Country
Other collaborator category [1] 0 0
Commercial sector/Industry
Name [1] 0 0
Merck Sharp & Dohme Corp.
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
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 website
https://clinicaltrials.gov/show/NCT03361865
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Mark Jones, MD
Address 0 0
Incyte Corporation
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
Other publications