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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 | Eligibility | Citations | Contacts

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.

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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


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Citations:

Not Provided

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Contacts:

Principal Investigator

Referral Contact

For more information:

Andrea B. Apolo, M.D.
National Cancer Institute (NCI)
NIHBC 10 - CLINICAL CENTER BG RM 13N240
10 CENTER DR
BETHESDA MD 20892
(301) 480-0536
apoloab@mail.nih.gov

Lisa Ley, R.N.
National Cancer Institute (NCI)
BG 10 RM 13N254
10 CENTER DR
BETHESDA MD 20814
(240) 858-3524
lisa.ley@nih.gov

NCI Referral Office
National Institute of Health Clinical Center (CC), 9000 Rockville Pike, Bethesda, Maryland 20892, United States: NCI Clinical Trials Referral Office
1-888-NCI-1937

Clinical Trials Number:

NCT03244384

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