Perioperative Pembrolizumab (MK-3475) Plus Neoadjuvant Chemotherapy Versus Perioperative Placebo Plus Neoadjuvant Chemotherapy for Cisplatin-eligible Muscle-invasive Bladder Cancer (MIBC) (MK-3475-866/KEYNOTE-866)

  • End date
    Jun 15, 2025
  • participants needed
  • sponsor
    Merck Sharp & Dohme Corp.
Updated on 25 November 2020
Toll Free Number
Primary Contact
Universitaetsklinikum Erlangen ( Site 0505) (8.7 mi away) Contact
+179 other location


A global study to evaluate peri-operative pembrolizumab with chemotherapy versus placebo to pembrolizumab plus chemotherapy in cisplatin eligible patients.

Treatment cisplatin, Placebo, Gemcitabine, Pembrolizumab, Surgery (radical cystectomy (RC) plus Pelvic Lymph Node Dissection [PLND])
Clinical Study IdentifierNCT03924856
SponsorMerck Sharp & Dohme Corp.
Last Modified on25 November 2020

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Inclusion Criteria

Is your age greater than or equal to 18 yrs?
Gender: Male or Female
Do you have Urinary Bladder Cancer, Muscle-invasive?
Do you have any of these conditions: Do you have Urinary Bladder Cancer, Muscle-invasive??
Do you have any of these conditions: Do you have Urinary Bladder Cancer, Muscle-invasive??
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): Participants with mixed histology are eligible provided the urothelial component is 50%
Participants whose tumors contain any neuroendocrine component are not
Urothelial carcinomas not originating from the bladder (e.g., upper tract
[ureters, renal pelvis], urethra) are not eligible
Have clinically non-metastatic bladder cancer (N0M0) determined by imaging (computed tomography (CT) chest or magnetic resonance imaging (MRI) of the abdomen/pelvis
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)
Have a transurethral resection (TUR) of a bladder tumor that is submitted and adequate to determine histology, muscle invasion, and PD-L1 status by central pathology vendor
Have Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
Have demonstrated adequate organ function

Exclusion Criteria

Has a known additional malignancy that is progressing or has required active anti-cancer treatment 3 years of study randomization with certain exceptions
Has received any prior systemic anti-neoplastic treatment for MIBC
Is cisplatin-ineligible, as defined by meeting any one of the study criteria
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 (e.g., CTLA-4, OX-40, CD137)
Has received therapy with hematopoietic growth factor such as granulocyte-colony stimulating factor (G-CSF) or granulocyte-monocyte-colony stimulating factor(GM-CSF) in 14 days prior to randomization
Has received prior systemic anti-cancer therapy including investigational agents within 3 years of randomization
Has received any prior radiotherapy to the bladder
Has received a live vaccine within 30 days prior to the first dose of study drug
Is currently participating in or has participated in a study of an investigational agent or has used an investigational device within 4 weeks prior to the first dose of study intervention
Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior the first dose of study drug
Has hypersensitivity to monoclonal antibodies (mAbs, including pembrolizumab) and/or any of their excipients
Has severe hypersensitivity (Grade 3) to cisplatin and/or gemcitabine and any of their excipients
Has an active autoimmune disease that has required systemic treatment in past 2 years
Has a history of (non-infectious) pneumonitis that required steroids or has current pneumonitis
Has an active infection requiring systemic therapy
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