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Study of the Combination of ACP-196 and Pembrolizumab in Subjects With Platinum Resistant Urothelial Bladder Cancer (KEYNOTE143)

Primary Purpose

Metastatic Urothelial Carcinoma

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
pembrolizumab
ACP-196 in combination with pembrolizumab
Sponsored by
Acerta Pharma BV
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Metastatic Urothelial Carcinoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Men and women ≥ 18 years of age
  • Histologically or cytologically confirmed urothelial carcinoma of the bladder or mixed histology bladder cancer
  • Metastatic bladder cancer with disease progression on or after platinum-based chemotherapy
  • Any primary site of urothelial carcinoma including upper tract, renal pelvis, bladder, and ureters
  • Prior therapy with ≥ 1 systemic chemotherapy regimens for urothelial carcinoma
  • Presence of radiographically measurable disease (defined as the presence of ≥ 1 lesion that measures ≥ 10 mm [≥ 15 mm for lymph nodes]
  • ECOG performance status of 0 or 1

Exclusion Criteria:

  • Prior malignancy (other than bladder cancer), except for adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, or other cancer from which the subject has been disease free for ≥ 2 years of which will not limit survival to < 2 years.
  • Known central nervous system metastases and/or carcinomatous meningitis
  • Malabsorption syndrome, disease significantly affecting gastrointestinal function
  • Significant cardiovascular disease such as uncontrolled or symptomatic arrhythmias, congestive heart failure, or myocardial infarction within 6 months of screening

Sites / Locations

  • University of Chicago
  • University of Michigan
  • James Cancer Hospital
  • Oregon Health and Science University
  • University of Pittsburgh
  • Carolina Urologic Research Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

Pembrolizumab

ACP-196 in combination with pembrolizumab

Arm Description

Arm 1: pembrolizumab monotherapy

Arm 2: ACP-196 in combination with pembrolizumab

Outcomes

Primary Outcome Measures

Number of Participants With Overall Response
Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR

Secondary Outcome Measures

Full Information

First Posted
January 28, 2015
Last Updated
August 22, 2019
Sponsor
Acerta Pharma BV
Collaborators
Merck Sharp & Dohme LLC
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1. Study Identification

Unique Protocol Identification Number
NCT02351739
Brief Title
Study of the Combination of ACP-196 and Pembrolizumab in Subjects With Platinum Resistant Urothelial Bladder Cancer
Acronym
KEYNOTE143
Official Title
Randomized Phase 2 Trial of ACP-196 and Pembrolizumab Immunotherapy Dual CHECKpoint Inhibition In Platinum Resistant Metastatic Urothelial Carcinoma (RAPID CHECK Study)
Study Type
Interventional

2. Study Status

Record Verification Date
August 2019
Overall Recruitment Status
Completed
Study Start Date
April 2015 (Actual)
Primary Completion Date
February 2018 (Actual)
Study Completion Date
April 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Acerta Pharma BV
Collaborators
Merck Sharp & Dohme LLC

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Study of the Combination of ACP-196 and Pembrolizumab in Subjects With Platinum Resistant Metastatic Urothelial Cancer

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metastatic Urothelial Carcinoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
78 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Pembrolizumab
Arm Type
Other
Arm Description
Arm 1: pembrolizumab monotherapy
Arm Title
ACP-196 in combination with pembrolizumab
Arm Type
Other
Arm Description
Arm 2: ACP-196 in combination with pembrolizumab
Intervention Type
Drug
Intervention Name(s)
pembrolizumab
Intervention Type
Drug
Intervention Name(s)
ACP-196 in combination with pembrolizumab
Primary Outcome Measure Information:
Title
Number of Participants With Overall Response
Description
Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR
Time Frame
Every 12 weeks for up to 2 years.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Men and women ≥ 18 years of age Histologically or cytologically confirmed urothelial carcinoma of the bladder or mixed histology bladder cancer Metastatic bladder cancer with disease progression on or after platinum-based chemotherapy Any primary site of urothelial carcinoma including upper tract, renal pelvis, bladder, and ureters Prior therapy with ≥ 1 systemic chemotherapy regimens for urothelial carcinoma Presence of radiographically measurable disease (defined as the presence of ≥ 1 lesion that measures ≥ 10 mm [≥ 15 mm for lymph nodes] ECOG performance status of 0 or 1 Exclusion Criteria: Prior malignancy (other than bladder cancer), except for adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, or other cancer from which the subject has been disease free for ≥ 2 years of which will not limit survival to < 2 years. Known central nervous system metastases and/or carcinomatous meningitis Malabsorption syndrome, disease significantly affecting gastrointestinal function Significant cardiovascular disease such as uncontrolled or symptomatic arrhythmias, congestive heart failure, or myocardial infarction within 6 months of screening
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Acerta Clinical Trials
Organizational Affiliation
1-888-292-9613; acertamc@dlss.com
Official's Role
Study Director
Facility Information:
Facility Name
University of Chicago
City
Chicago
State/Province
Illinois
Country
United States
Facility Name
University of Michigan
City
Ann Arbor
State/Province
Michigan
Country
United States
City
Durham
State/Province
North Carolina
Country
United States
Facility Name
James Cancer Hospital
City
Columbus
State/Province
Ohio
Country
United States
Facility Name
Oregon Health and Science University
City
Portland
State/Province
Oregon
Country
United States
Facility Name
University of Pittsburgh
City
Pittsburgh
State/Province
Pennsylvania
Country
United States
Facility Name
Carolina Urologic Research Center
City
Myrtle Beach
State/Province
South Carolina
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Study of the Combination of ACP-196 and Pembrolizumab in Subjects With Platinum Resistant Urothelial Bladder Cancer

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