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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

78 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-04-30

Study Completion Date

2018-04-30

Brief Summary

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

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Detailed Description

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Conditions

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Metastatic Urothelial Carcinoma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Pembrolizumab

Arm 1: pembrolizumab monotherapy

Group Type OTHER

pembrolizumab

Intervention Type DRUG

ACP-196 in combination with pembrolizumab

Arm 2: ACP-196 in combination with pembrolizumab

Group Type OTHER

ACP-196 in combination with pembrolizumab

Intervention Type DRUG

Interventions

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pembrolizumab

Intervention Type DRUG

ACP-196 in combination with pembrolizumab

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No