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

Metastatic Urothelial Carcinoma Clinical Trial

— KEYNOTE143  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02351739
• Other study ID #: ACE-ST-005
• Status: Completed
• Phase: Phase 2
• Start date: April 2015
• Est. completion date: April 2018

Study information

• Verified date: August 2019
• Source: Acerta Pharma BV
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 78
• Est. completion date: April 2018
• Est. primary completion date: February 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Transitional Cell
• Metastatic Urothelial Carcinoma

Intervention

Drug:
• pembrolizumab

• ACP-196 in combination with pembrolizumab

Locations

Country	Name	City	State
United States	University of Michigan	Ann Arbor	Michigan
United States	University of Chicago	Chicago	Illinois
United States	James Cancer Hospital	Columbus	Ohio
United States	Carolina Urologic Research Center	Myrtle Beach	South Carolina
United States	University of Pittsburgh	Pittsburgh	Pennsylvania
United States	Oregon Health and Science University	Portland	Oregon

Sponsors (2)

Lead Sponsor	Collaborator
Acerta Pharma BV	Merck Sharp & Dohme Corp.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.