A Study of the Combination of ACP-196 and Pembrolizumab in Subjects with Platinum-Refractory Metastatic Bladder Cancer

Overview

About this study

The purpose of this study is to evaluate the effect of combining ACP-196 and Pembrolizumab in subjects with platinum resistant metastatic bladder cancer.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

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 regimen 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
    • Other cancer from which the subject has been disease free for ≥ 2 years which will not limit survival to < 2 years
  • Known central nervous system metastases and/or carcinomatous meningitis 
  • A life-threatening illness, medical condition or organ system dysfunction which could compromise the subject's safety 
  • Significant cardiovascular disease such as uncontrolled or symptomatic arrhythmias, congestive heart failure, or myocardial infarction within 6 months of screening

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Estrella Carballido, M.D.

Closed for enrollment

Contact information:

Cancer Center Clinical Trials Referral Office

855-776-0015

Scottsdale/Phoenix, Ariz.

Mayo Clinic principal investigator

Estrella Carballido, M.D.

Closed for enrollment

Contact information:

Cancer Center Clinical Trials Referral Office

855-776-0015

More information

Publications

Publications are currently not available

Additional contact information

Cancer-related trials contact form

Phone: 855-776-0015 (toll-free)

International patient clinical studies questions