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Completed

NCT Number: NCT02351739

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

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

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Key information

Conditions

Metastatic Urothelial Carcinoma Carcinoma Carcinoma, Transitional Cell Neoplasms Neoplasms by Histologic Type Neoplasms, Glandular and Epithelial

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

University of Chicago, Chicago, Illinois, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Pembrolizumab

Drug

ACP-196 in combination with pembrolizumab

Drug

Primary outcomes

  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

Sponsors and collaborators

Lead sponsor

Acerta Pharma BV

Industry

Collaborators

  • Merck Sharp & Dohme LLC

Registry information

Official study title

Randomized Phase 2 Trial of ACP-196 and Pembrolizumab Immunotherapy Dual CHECKpoint Inhibition In Platinum Resistant Metastatic Urothelial Carcinoma (RAPID CHECK Study)

Acronym: KEYNOTE143

Important dates

Study start
2015
Primary completion
2018
Study completion
2018
First posted
Jan 30, 2015
Registry last updated
Sep 10, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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