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

Phase 2

Completed

• Conditions: Metastatic Urothelial Carcinoma
• Interventions: Drug: ACP-196 in combination with pembrolizumab; Drug: pembrolizumab

• Registration Number: NCT02351739
• Lead Sponsor: Acerta Pharma BV

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-01-28
• Study First Submitted QC: 2015-01-29
• Study First Posted: 2015-01-30
• Study Start: 2015-04
• Primary Completion: 2018-02
• Study Completion: 2018-04
• Results First Submitted: 2019-07-19
• Status Verified: 2019-08
• Results First Submitted QC: 2019-08-22
• Last Update Submitted: 2019-08-22
• Results First Posted: 2019-09-10
• Last Update Posted: 2019-09-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 78

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ACP-196 in combination with pembrolizumab	ACP-196 in combination with pembrolizumab	Arm 2: ACP-196 in combination with pembrolizumab
Pembrolizumab	pembrolizumab	Arm 1: pembrolizumab monotherapy

Primary Outcome Measures

Name	Time	Method
Number of Participants With Overall Response	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

Trial Locations

Locations (6)

University of Michigan; 🇺🇸 Ann Arbor, Michigan, United States

University of Chicago; 🇺🇸 Chicago, Illinois, United States

James Cancer Hospital; 🇺🇸 Columbus, Ohio, United States

Oregon Health and Science University; 🇺🇸 Portland, Oregon, United States

Carolina Urologic Research Center; 🇺🇸 Myrtle Beach, South Carolina, United States

University of Pittsburgh; 🇺🇸 Pittsburgh, Pennsylvania, United States