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

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ClinicalTrials.gov Identifier: NCT02351739
Recruitment Status : Active, not recruiting
First Posted : January 30, 2015
Last Update Posted : September 13, 2017
Sponsor:
Collaborator:
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

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 75 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)
Study Start Date : April 2015
Estimated Primary Completion Date : December 2017
Estimated Study Completion Date : January 2018


Arm Intervention/treatment
Pembrolizumab
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. To determine the overall response rate (ORR) of pembrolizumab monotherapy and the combination of ACP-196 and pembrolizumab in subjects [ Time Frame: 52 weeks ]


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

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 ClinicalTrials.gov identifier (NCT number): NCT02351739


Locations
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.
Investigators
Study Director: David Wages, MD Acerta Pharma

Responsible Party: Acerta Pharma BV
ClinicalTrials.gov Identifier: NCT02351739     History of Changes
Other Study ID Numbers: ACE-ST-005
First Posted: January 30, 2015    Key Record Dates
Last Update Posted: September 13, 2017
Last Verified: September 2017

Additional relevant MeSH terms:
Carcinoma
Carcinoma, Transitional Cell
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Pembrolizumab
Antineoplastic Agents