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

Acerta Pharma

Status and phase: Completed; Phase 2

Conditions: Metastatic Urothelial Carcinoma

Treatments: Drug: ACP-196 in combination with pembrolizumab; Drug: pembrolizumab

Study type: Interventional

Funder types: Industry

Identifiers

NCT02351739

ACE-ST-005

Details and patient eligibility

About

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

Enrollment: 78 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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78 participants in 2 patient groups

Pembrolizumab

Other group

Description:

Arm 1: pembrolizumab monotherapy

Treatment:

Drug: pembrolizumab

ACP-196 in combination with pembrolizumab

Other group

Description:

Arm 2: ACP-196 in combination with pembrolizumab

Treatment:

Drug: ACP-196 in combination with pembrolizumab