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A Phase 3, Randomized, Double-blind Study to Evaluate Perioperative Pembrolizumab (MK-3475) + Neoadjuvant Chemotherapy versus Perioperative Placebo + Neoadjuvant Chemotherapy in Cisplatin-eligible Participants with Muscle-invasive Bladder Cancer (KEYNOTE-

General Information

Age Group

Adult

Status

Recruiting

Protocol Number

NCT03924856

Background Information

The purpose of this study is to see if pembrolizumab in combination with chemotherapy and surgery is more effective than placebo (a look-alike product with no active ingredients) with chemotherapy and surgery. This will be measured by tissue samples that are taken during surgery as well as imaging performed at different time points. The study will test the safety of the study drugs, pembrolizumab in combination with chemotherapy and surgery, and see how well the body handles pembrolizumab compared to placebo in combination with chemotherapy and surgery. The study will help determine if pembrolizumab helps patients have a better quality of life and helps patients live longer.

Offered At

Inova Schar Cancer Institute
8081 Innovation Park Drive
Fairfax, VA 22031

A program of Inova Fairfax Hospital

Eligibility Information

  • A histologically confirmed diagnosis of muscle invasive bladder cancer (T2-T4aN0M0) with predominant (≥50%) urothelial histology
  • Adequate organ function
  • Additional eligibility in protocol

Ineligibility Information

  • Prior systemic anti-neoplastic treatment for MIBC. (Prior treatment for NMIBC with intra-vesical instillation therapy such as BCG or intra-vesical chemotherapy is permitted)
  • Impaired renal function with measured or calculated creatinine clearance
  • Prior therapy with an anti-PD-1, anti-PD-L1, or anti PD-L2 agent or withan agent directed to another stimulatory or co-inhibitory T-cell receptor (eg, CTLA-4, OX-40, CD137)
  • Received therapy with hematopoietic growth factor such as granulocyte-colony stimulating factor (G-CSF) or GM-CSF in 14 days prior to randomization
  • Prior systemic anti-cancer therapy including investigational agents within 3 years of randomization
  • Prior radiotherapy to the bladder
  • Additional ineligibility in protocol

For more information, go to: https://clinicaltrials.gov/ct2/show/NCT03924856