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

• Status: Completed
• Trial end date: 2018-04-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Acerta Pharma BV
• Collaborator: Merck Sharp & Dohme Corp.
• Treatments: Acalabrutinib; Pembrolizumab

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