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

Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

  • Conditions:
    Muscle-invasive Bladder Cancer (mibc)
  • Age: Between 18 - 100 Years
  • Gender: Male or Female
  • Other Inclusion Criteria:
    1) Have a histologically confirmed diagnosis of muscle invasive bladder cancer (T2-T4aN0M0) with predominant (=50%) urothelial histology (histology and presence of muscle invasion to be confirmed by BICR). 2) Have clinically non-metastatic bladder cancer (N0M0) determined by imaging (CT chest and CT or MRI of the abdomen/pelvis), confirmed by BICR. 3) Be deemed eligible for RC + PLND by his/her urologist and/or oncologist and agree to undergo curative intent standard RC + PLND.

You may not be eligible for this study if the following are true:

  • 1) Has a known additional non-urothelial malignancy that is progressing or has required active treatment =3 years of study randomization. 2) Has received any prior systemic anti-neoplastic treatment for MIBC. 3) Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (eg, CTLA-4, OX-40, CD137). 4) Has received prior systemic anti-cancer therapy including investigational agents within 3 years prior to randomization.

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