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

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

Official Title
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Randomized Phase 2 Trial of ACP-196 and Pembrolizumab Immunotherapy Dual CHECKpoint Inhibition In Platinum Resistant Metastatic Urothelial Carcinoma (RAPID CHECK Study)

Conditions
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Metastatic Urothelial Carcinoma

Intervention / Treatment
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* Drug: pembrolizumab
* Drug: ACP-196 in combination with pembrolizumab


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Pembrolizumab<br>Arm 1: pembrolizumab monotherapy | Drug: pembrolizumab<br> <br> |
| Other: ACP-196 in combination with pembrolizumab<br>Arm 2: ACP-196 in combination with pembrolizumab | Drug: ACP-196 in combination with pembrolizumab<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Overall Response | 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 | Every 12 weeks for up to 2 years. |