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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
AMBASSADOR 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.Check my eligibility
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.See study design
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.
AMBASSADOR Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
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.
AMBASSADOR Trial 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
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Disease
Overall survival
Secondary outcome measures
Disease-free survival in PD-L1 positive and negative patients
Overall survival in PD-L1 positive and negative patients
AMBASSADOR 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
Biospecimen Collection
2004
Completed Phase 2
~1720
Magnetic Resonance Imaging
2017
Completed Phase 3
~1160
Computed Tomography
2017
Completed Phase 2
~2720
Pembrolizumab
2017
Completed Phase 2
~2010
Cystoscopy
2016
Completed Phase 4
~810
Find a Location
Who is running the clinical trial?
National Cancer Institute (NCI)Lead Sponsor
13,717 Previous Clinical Trials
40,952,625 Total Patients Enrolled
Andrea B ApoloPrincipal InvestigatorAlliance for Clinical Trials in Oncology
3 Previous Clinical Trials
526 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility 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.My kidneys work well enough, with a clearance rate of at least 30 mL/min.You had chemotherapy before surgery and the cancer is at a certain stage, or you are not able to use cisplatin for treatment and the cancer is at a certain stage, or you choose not to have additional chemotherapy after surgery and the cancer is at a certain stage.I had surgery for bladder or upper tract cancer between 4 and 16 weeks ago.I do not have an active or history of severe autoimmune disease.I have certain conditions managed with creams or ointments, and my blood tests show immune system activity but no organ damage.I haven't received any live vaccines in the last 30 days.I have not received any treatment after surgery to prevent cancer return.I am 18 years old or older.I have tissue samples from my bladder cancer surgery available for testing.I had surgery for bladder or upper tract cancer between 4 and 16 weeks ago.I have no remaining cancer after surgery and had a clear bladder check if applicable.I do not have an active autoimmune disease or a history that may require steroids.I do not have active hepatitis B or C.Your blood albumin level is at least 2.8 grams per deciliter.My surgery did not leave behind visible cancer, but tiny cancer cells may remain.I have never been treated with PD-1/PD-L1 inhibitors.You have a low count of white blood cells.I am not pregnant or breastfeeding.I have not had radiation therapy in the last 4 weeks.Your AST and ALT levels are not more than 3 times the upper limit of normal.Your platelet count is at least 75,000 per cubic millimeter.I can take care of myself and perform daily activities.I have not had major surgery in the last 4 weeks.I am on hormone replacement therapy for a specific condition.I meet the initial requirements to sign up for the trial.I haven't had lung inflammation needing steroids in the last 5 years.I haven't had chemotherapy in the last 4 weeks.I am a woman who can have children and have a recent negative pregnancy test.My cancer has not spread to other parts of my body according to scans.Your absolute neutrophil count is at least 1,200 per cubic millimeter.My cancer is mainly urothelial and has invaded muscle or lymph nodes, with no neuroendocrine parts.My scans show no signs of cancer spread.I do not need hemodialysis.
Research Study Groups:
This trial has the following groups:- Group 1: Arm A (pembrolizumab)
- Group 2: Arm B (observation)
Awards:
This trial has 2 awards, including:- 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.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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