Overview

This trial is active, not recruiting.

Condition metastatic urothelial carcinoma
Treatments pembrolizumab, acp-196 in combination with pembrolizumab
Phase phase 2
Targets PD-1, BTK
Sponsor Acerta Pharma BV
Collaborator Merck Sharp & Dohme Corp.
Start date April 2015
End date May 2017
Trial size 75 participants
Trial identifier NCT02351739, ACE-ST-005

Summary

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

United States Maryland
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Other)
Arm 1: pembrolizumab monotherapy
pembrolizumab
(Other)
Arm 2: ACP-196 in combination with pembrolizumab
acp-196 in combination with pembrolizumab

Primary Outcomes

Measure
To determine the overall response rate (ORR) of pembrolizumab monotherapy and the combination of ACP-196 and pembrolizumab in subjects
time frame: 52 weeks

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title Randomized Phase 2 Trial of ACP-196 and Pembrolizumab Immunotherapy Dual CHECKpoint Inhibition In Platinum Resistant Metastatic Urothelial Carcinoma (RAPID CHECK Study)
Trial information was received from ClinicalTrials.gov and was last updated in November 2016.
Information provided to ClinicalTrials.gov by Acerta Pharma BV.