The safety and efficacy of this agent(s), or use in this setting, has not been established or is subject to confirmation. For an agent(s) whose safety and efficacy has not been established or confirmed, future regulatory approval or commercial availability is not guaranteed.
Active Not-enrolling
United States, Argentina, Australia, Belgium, Canada, Colombia, Denmark, France, Germany, Hungary, Ireland, Israel, Italy, Japan, Korea, Republic of, Malaysia, Mexico, Philippines, Poland, Russian Federation, Singapore, South Africa, Spain, Sweden, Thailand, Turkey, Ukraine, United Kingdom
for more information at clinicaltrials.gov
EXPERIMENTAL: Arm A: Pembrolizumab + Surgery
Participants receive 3 preoperative cycles of pembrolizumab, followed by standard of care surgery, followed by 14 cycles of postoperative pembrolizumab. Each cycle is 21 days.
DRUG: Pembrolizumab
Pembrolizumab 200 mg by intravenous (IV) infusion, given on Day 1 of each 21-day cycle.
PROCEDURE: Surgery (radical cystectomy (RC) plus Pelvic Lymph Node Dissection [PLND])
Surgical RC+PLND will be done in accordance with the American Urological Association (AUA)/American Society of Clinical Oncology (ASCO)/American Society for Radiation Oncology (ASTRO)/Society of Urologic Oncology (SUO) guidelines.
ACTIVE_COMPARATOR: Arm B: Surgery alone
Participants receive standard of care surgery alone.
PROCEDURE: Surgery (radical cystectomy (RC) plus Pelvic Lymph Node Dissection [PLND])
Surgical RC+PLND will be done in accordance with the American Urological Association (AUA)/American Society of Clinical Oncology (ASCO)/American Society for Radiation Oncology (ASTRO)/Society of Urologic Oncology (SUO) guidelines.
EXPERIMENTAL: Arm C: Enfortumab Vedotin + Pembrolizumab + Surgery
Participants receive 3 preoperative cycles of enfortumab vedotin + pembrolizumab, followed by standard of care surgery, followed by 6 cycles of postoperative enfortumab vedotin + pembrolizumab, followed by 8 cycles of pembrolizumab alone. Each cycle is 21 days.
DRUG: Enfortumab Vedotin
Enfortumab vedotin 1.25 mg/kg by intravenous (IV) infusion, given on Days 1 and 8 of each 21-day cycle.
Event-Free Survival (EFS) between Arm C and Arm B
EFS is defined as the time from randomization to the first occurrence of any of the following events: progression of disease that precludes RC surgery or failure to undergo RC surgery in participants with residual disease, gross residual disease left behind at the time of surgery, local or distant recurrence as assessed by imaging and/or biopsy, or death due to any cause.
Up to approximately 7.7 years
EFS between Arm A and Arm B
EFS is defined as the time from randomization to the first occurrence of any of the following events: progression of disease that precludes RC surgery or failure to undergo RC surgery in participants with residual disease, gross residual disease left behind at the time of surgery, local or distant recurrence as assessed by imaging and/or biopsy, or death due to any cause.
Up to approximately 7.7 years
Overall Survival (OS) between Arm C and Arm B
OS is defined as the time from randomization to death due to any cause.
Up to approximately 8.4 years
OS between Arm A and Arm B
OS is defined as the time from randomization to death due to any cause.
Up to approximately 8.4 years
Pathologic Complete Response (pCR) Rate between Arm C and Arm B
Pathologic complete response rate is defined as the percentage of participants having pCR. pCR is defined as absence of viable tumor (pT0N0) in examined tissue from RC and PLND, as determined centrally.
Up to approximately 5.7 years
pCR Rate between Arm A and Arm B
Pathologic complete response rate is defined as the percentage of participants having pCR. pCR is defined as absence of viable tumor (pT0N0) in examined tissue from RC and PLND, as determined centrally.
Up to approximately 5.7 years
Disease-Free Survival (DFS)
DFS is defined as the time from first post-surgery baseline scan until: * local or distant recurrence as assessed by imaging and/or biopsy * Death due to any cause
Up to approximately 7.7 years
Pathologic Downstaging (pDS) Rate between Arm A and Arm B
Pathologic downstaging rate is defined as the percentage of participants having pDS. pDS is defined as participants with a tumor classification of \
Up to approximately 5.7 years
pDS Rate between Arm C and Arm B
Pathologic downstaging rate is defined as the percentage of participants having pDS. pDS is defined as participants with a tumor classification of \
Up to approximately 5.7 years
Number of Participants Experiencing Adverse Events (AEs)
An AE is defined as any unfavorable and unintended sign, symptom, or disease (new or worsening) temporally associated with the use of study therapy, regardless of whether or not a causal relationship with the study therapy can be determined.
Up to approximately 8.4 years
Number of Participants Discontinuing Study Drug Due to Adverse Events (AEs)
An AE is defined as any unfavorable and unintended sign, symptom, or disease (new or worsening) temporally associated with the use of study therapy, regardless of whether or not a causal relationship with the study therapy can be determined.
Up to approximately 1 year
Number of Participants Experiencing Perioperative Complications
The number of participants who experience perioperative complications will be presented.
Up to approximately 1 year
857
Sponsor: Merck Sharp & Dohme LLC
Collaborator: Seagen Inc., Astellas Pharma Global Development, Inc.
For more information, call or email the Pfizer Clinical Trial Contact Center:
When calling, please reference this study number:
NCT# stands for National Clinical Trial number. This is a unique identification code given to each clinical trial registered on ClinicalTrials.gov. The format is "NCT" followed by an 8-digit number (for example, NCT00000419). Also called the ClinicalTrials.gov identifier.
NCT03924895
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