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

Completed · Phase 2

Conditions studied: Metastatic Urothelial Carcinoma

In brief

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

Key facts

Study ID

NCT02351739

Run by

Acerta Pharma BV

People needed

78

Starts

2015-04-01

Expected to finish

2018-04-01

Last updated by the study team

2019-09-10

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• University of Chicago — Chicago, Illinois, United States
• University of Michigan — Ann Arbor, Michigan, United States
• Study site — Durham, North Carolina, United States
• James Cancer Hospital — Columbus, Ohio, United States
• Oregon Health and Science University — Portland, Oregon, United States
• University of Pittsburgh — Pittsburgh, Pennsylvania, United States
• Carolina Urologic Research Center — Myrtle Beach, South Carolina, United States

Full record on ClinicalTrials.gov

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