Pembrolizumab for Bladder Cancer
(AMBASSADOR Trial)

Recruiting in Palo Alto (17 mi)

+1038 other locations

Overseen byAndrea B Apolo

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: National Cancer Institute (NCI)

No Placebo Group

Pivotal Trial (Near Approval)

Prior Safety Data

Breakthrough Therapy

Approved in 3 Jurisdictions

Trial Summary

What is the purpose of this trial?This phase III trial studies how well pembrolizumab works in treating patients with bladder cancer that has spread into the deep muscle of the bladder wall (muscle-invasive) or urothelial cancer that has spread from where it started to nearby tissue or lymph nodes (locally advanced). Monoclonal antibodies recognizing and blocking checkpoint molecules can enhance the patient's immune response and therefore help fight cancer. Pembrolizumab is one of the monoclonal antibodies that block the PD-1 axis and can interfere with the ability of tumor cells to grow.

Eligibility Criteria

Adults with muscle-invasive bladder cancer or locally advanced urothelial cancer who've had surgery but no metastasis, no recent radiation, chemo, or major surgery. Must not be pregnant/nursing and have proper organ function. Excludes those with active hepatitis B/C, autoimmune diseases requiring steroids, prior PD-1/PD-L1 therapy, live vaccines recently taken.

Inclusion Criteria

Your hemoglobin level is 9 grams per deciliter or higher.

You have received a specific type of chemotherapy before surgery, or you have certain health issues that make you ineligible for a particular type of chemotherapy, or you have chosen not to receive a specific type of chemotherapy after surgery.

Your bilirubin levels are within a certain range, unless you have a condition called Gilbert's, in which case they can be a bit higher.

+35 more

Participant Groups

The trial is testing Pembrolizumab's effectiveness post-surgery in patients with certain types of bladder and urothelial cancers. It involves monitoring through scans and tests like CT Urography and MRI to see if this drug can prevent cancer from returning by boosting the immune system.

2Treatment groups

Experimental Treatment

Active Control

Group I: Arm A (pembrolizumab)Experimental Treatment9 Interventions

Patients receive pembrolizumab IV over 30 minutes on day 1. Treatment repeats every 21 days for up to 18 cycles in the absence of disease progression or unacceptable toxicity. Patients undergo a CT scan, CT urography, and/or MRI throughout the trial. Patients may also undergo a cystoscopy and blood sample collection during screening and on study.

Group II: Arm B (observation)Active Control9 Interventions

Patients undergo observation. Patients undergo a CT scan, CT urography, and/or MRI throughout the trial. Patients may also undergo a cystoscopy and blood sample collection during screening and on study.