COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC:

Get the latest research information from NIH: Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02351739
Recruitment Status : Completed
First Posted : January 30, 2015
Results First Posted : September 10, 2019
Last Update Posted : September 10, 2019
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
Acerta Pharma BV

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

Condition or disease Intervention/treatment Phase
Metastatic Urothelial Carcinoma Drug: pembrolizumab Drug: ACP-196 in combination with pembrolizumab Phase 2

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 78 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Randomized Phase 2 Trial of ACP-196 and Pembrolizumab Immunotherapy Dual CHECKpoint Inhibition In Platinum Resistant Metastatic Urothelial Carcinoma (RAPID CHECK Study)
Actual Study Start Date : April 2015
Actual Primary Completion Date : February 2018
Actual Study Completion Date : April 2018

Arm Intervention/treatment
Arm 1: pembrolizumab monotherapy
Drug: pembrolizumab
ACP-196 in combination with pembrolizumab
Arm 2: ACP-196 in combination with pembrolizumab
Drug: ACP-196 in combination with pembrolizumab

Primary Outcome Measures :
  1. Number of Participants With Overall Response [ Time Frame: Every 12 weeks for up to 2 years. ]
    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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02351739

Layout table for location information
United States, Illinois
University of Chicago
Chicago, Illinois, United States
United States, Michigan
University of Michigan
Ann Arbor, Michigan, United States
United States, North Carolina
Durham, North Carolina, United States
United States, Ohio
James Cancer Hospital
Columbus, Ohio, United States
United States, Oregon
Oregon Health and Science University
Portland, Oregon, United States
United States, Pennsylvania
University of Pittsburgh
Pittsburgh, Pennsylvania, United States
United States, South Carolina
Carolina Urologic Research Center
Myrtle Beach, South Carolina, United States
Sponsors and Collaborators
Acerta Pharma BV
Merck Sharp & Dohme Corp.
Layout table for investigator information
Study Director: Acerta Clinical Trials 1-888-292-9613;
  Study Documents (Full-Text)

Documents provided by Acerta Pharma BV:
Study Protocol  [PDF] May 23, 2016
Statistical Analysis Plan  [PDF] January 30, 2018

Layout table for additonal information
Responsible Party: Acerta Pharma BV Identifier: NCT02351739    
Other Study ID Numbers: ACE-ST-005
First Posted: January 30, 2015    Key Record Dates
Results First Posted: September 10, 2019
Last Update Posted: September 10, 2019
Last Verified: August 2019
Additional relevant MeSH terms:
Layout table for MeSH terms
Carcinoma, Transitional Cell
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Antineoplastic Agents, Immunological
Antineoplastic Agents