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Pembrolizumab for Bladder Cancer (AMBASSADOR Trial)

Phase 3

Waitlist Available

Led By Andrea B Apolo

Research Sponsored by National Cancer Institute (NCI)

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Calc. creatinine clearance >= 30 mL/min (using either Chronic Kidney Disease Epidemiology Collaboration [CKD-EPI] equation or Cockcroft-Gault formula)

Paraffin tissue samples obtained by transurethral resection of muscle-invasive bladder tumor, upper tract resection, or radical cystectomy/nephrectomy/ureterectomy/nephroureterectomy/cystoprostatectomy or urethrectomy must be available; this specimen submission is mandatory prior to registration as results will be used for stratification; specimens from radical/definitive surgery (radical cystectomy/nephrectomy/ureterectomy /nephroureterectomy/cystoprostatectomy and LN dissection) are preferred over transurethral resection, if available

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from randomization to the date of death from any cause, assessed up to 5 years

Awards & highlights

No Placebo-Only Group

Pivotal Trial

Summary

This trial looks at how well pembrolizumab works in treating patients with muscle-invasive bladder cancer or locally advanced urothelial cancer. Monoclonal antibodies that block the PD-1 axis can interfere with the ability of tumor cells to grow.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Pembrolizumab may cause immune-related side effects such as inflammation in organs (like pneumonitis), infusion reactions, fatigue, skin rash, hormone gland problems (like thyroid disorders), digestive issues (colitis), liver problems (hepatitis), and could worsen existing autoimmune diseases.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My kidneys work well enough, with a clearance rate of at least 30 mL/min.

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I have tissue samples from my bladder cancer surgery available for testing.

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I had surgery for bladder or upper tract cancer between 4 and 16 weeks ago.

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I had surgery for bladder or upper tract cancer between 4 and 16 weeks ago.

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I do not have an active or history of severe autoimmune disease.

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I do not have active hepatitis B or C.

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I haven't received any live vaccines in the last 30 days.

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I have not received any treatment after surgery to prevent cancer return.

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I am 18 years old or older.

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I have never been treated with PD-1/PD-L1 inhibitors.

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I am not pregnant or breastfeeding.

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I can take care of myself and perform daily activities.

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My cancer has not spread to other parts of my body according to scans.

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My cancer is mainly urothelial and has invaded muscle or lymph nodes, with no neuroendocrine parts.

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My scans show no signs of cancer spread.

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I do not need hemodialysis.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from randomization to the date of death from any cause, assessed up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from randomization to the date of death from any cause, assessed up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and from randomization to the date of death from any cause, assessed up to 5 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Disease

Overall survival

Secondary study objectives

Disease-free survival in PD-L1 positive and negative patients

Overall survival in PD-L1 positive and negative patients

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Cystoscopy

2016

Completed Phase 4

~810

Biospecimen Collection

2004

Completed Phase 3

~2030