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-866)

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
  • 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. 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 (including prostatectomy if applicable) as per AUA/ASTRO/ASCO/SUO guidelines. 4) Have a transurethral resection (TUR) of a bladder tumor (obtained within 60 days prior to enrollment [ICF signed]) that is submitted and adequate to determine histology, muscle invasion, and PD-L1 status by central pathology vendor.

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

  • 1) Has a known additional malignancy that is progressing or has required active anti-cancer treatment =3years of study randomization Note: Participants with basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or carcinoma in situ (eg, breast carcinoma, cervical cancer in situ) that have undergone potentially curative therapy are not excluded. Participants with prior non-muscle invasive bladder cancer (NMIBC) receiving therapy prior to randomization are not excluded. Participants with low-risk prostate cancer (T1-T2a, Gleason score =6, and prostate-specific antigen [PSA] <10 ng/mL) either treated with definitive intent any time prior to screening or untreated in active surveillance are not excluded. 2) Has received any prior systemic anti-neoplastic treatment for MIBC. Note: Prior treatment for NMIBC with intra-vesical instillation therapy such as BCG or intra-vesical chemotherapy is permitted. 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 therapy with hematopoietic growth factor such as granulocyte-colony stimulating factor (G-CSF) or GM-CSF in 14 days prior to randomization. 5) Has received prior systemic anti-cancer therapy including investigational agents within 3 years of randomization.


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