Protocol Details
Phase III Randomized Adjuvant study of Pembrolizumab in muScle invaSive and locAlly aDvanced urOthelial caRcinoma (AMBASSADOR) versus Observation
This study is NOT currently recruiting participants.
Summary
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) | None |
Intervention(s) | Drug: Pembrolizumab
|
Supporting Site | National Cancer Institute |
Background:
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.
Eligibility
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
Citations:
Not Provided
Contacts:
Clinical Trials Number:
NCT03244384