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A Phase 3 Randomized Study of Cystectomy plus Perioperative Pembrolizumab versus Cystectomy Alone in Cisplatin-ineligible Participants with Muscle invasive Bladder Cancer (KEYNOTE-905)

General Information

Age Group

Adult

Status

Recruiting

Protocol Number

NCT03924895

Background Information

The purpose of this study is to see if pembrolizumab before and after surgery is more effective than surgery alone in patients with muscle-invasive bladder cancer (MIBC). 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 drug, pembrolizumab given before and after surgery, and see how well the body handles pembrolizumab before and after surgery. The study will help determine if pembrolizumab and surgery, compared to surgery alone, 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 department of Inova Fairfax Hospital

Eligibility Information

  • A histologically confirmed diagnosis of muscle invasive bladder cancer (T2-T4aN0M0) with predominant (≥50%) urothelial histology
  • Have clinically non-metastatic bladder cancer (N0M0) determined by imaging (CT chest and CT or MRI of the abdomen/pelvis), confirmed by BICR
  • Ineligible for treatment with cisplatin
  • Additional eligibility in protocol

Ineligibility Information

  • A known additional non-urothelial malignancy that is progressing or has required active treatment in the last 3 years
  • Prior systemic anti-neoplastic treatment for MIBC
  • Prior radiotherapy to the bladder
  • Additional ineligibility in protocol

For more information, go to: https://clinicaltrials.gov/ct2/show/NCT03924895