This study is NOT currently recruiting participants.
Number
18-C-0008
Sponsoring Institute
National Cancer Institute (NCI)
Recruitment Detail
Type: No longer recruiting/follow-up only Gender: Male & Female Min Age: 18 Years Max Age: N/A
Referral Letter Required
No
Population Exclusion(s)
Pregnant Women;Fetuses;Children
Keywords
PD-1; Checkpoint Inhibitor; Adjuvant Chemotherapy; Survival; Muscle-Invasive Bladder Cancer
Recruitment Keyword(s)
None
Condition(s)
Urinary Bladder Neoplasms; Neoplasms, Bladder; Bladder Cancer
Investigational Drug(s)
Pembrolizumab
Investigational Device(s)
Intervention(s)
Drug: Pembrolizumab
Supporting Site
National Cancer Institute
Muscle-invasive bladder cancer occurs in the deep muscle of the bladder wall. The drug pembrolizumab uses a person s immune system to treat cancer. Researchers want to study treatment with this drug after muscle-invasive bladder cancer is removed. They want to see how it compares with standard treatment.
Objective:
To study the effects of using pembrolizumab after the removal of muscle-invasive bladder cancer.
Eligibility:
People ages 18 and older who have had surgery to remove muscle-invasive bladder cancer
Design:
Participants will be screened with:
Medical history
Physical exam
Blood tests
Scans
Participants will have a tumor sample tested for a certain protein.
Participants will be randomly assigned to a group:
Group 1 will have treatment with pembrolizumab. They will get it by vein over 30 minutes once every 3 weeks for 1 year. Then they will be monitored for another 4 years. They will have visits every few months for those 5 years.
Group 2 will have scans without treatment. They will be contacted every 3 weeks by phone to see how they are feeling. They will have a visit every 6 weeks for 1 year. Then they will have visits every few months for 5 years.
Participants can choose to join another study:
Quality of Life Study: Participants will answer questions about their physical and emotional well-being 4 times.
Sample Collections for Lab Studies or Future Studies: Participants will give blood samples 3 times. A tumor sample taken during their surgery will be stored for future studies.
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Inclusion Criteria: -Age: 18 years or greater -Histologically confirmed muscle-invasive urothelial carcinoma of the bladder or upper tract -Patient must have had radical cystectomy, nephrectomy, nephroureterectomy, ureterectomy, cystoprostatectomy, or urethrectomy >=4 weeks but <=16 weeks prior to pre-registration. -No gross cancer at the surgical margins. Microscopic invasive positive margins are allowed. CIS at margins is considered negative margins. -No evidence of residual cancer or metastasis after surgery. -No active autoimmune disease or history of autoimmune disease -No major surgery, radiation therapy or neoadjuvant chemotherapy <= 4 weeks before enrollment -ECOG performance status 0-2 -Normal organ and marrow function
-Age: 18 years or greater
-Histologically confirmed muscle-invasive urothelial carcinoma of the bladder or upper tract
-Patient must have had radical cystectomy, nephrectomy, nephroureterectomy, ureterectomy, cystoprostatectomy, or urethrectomy >=4 weeks but <=16 weeks prior to pre-registration.
-No gross cancer at the surgical margins. Microscopic invasive positive margins are allowed. CIS at margins is considered negative margins.
-No evidence of residual cancer or metastasis after surgery.
-No active autoimmune disease or history of autoimmune disease
-No major surgery, radiation therapy or neoadjuvant chemotherapy <= 4 weeks before enrollment
-ECOG performance status 0-2
-Normal organ and marrow function
Principal Investigator
Referral Contact
For more information: