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)

  • STATUS
    Recruiting
  • End date
    Jun 15, 2025
  • participants needed
    870
  • sponsor
    Merck Sharp & Dohme Corp.
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Updated on 9 January 2021
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Investigator
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Universitaetsklinikum Erlangen ( Site 0505) (8.7 mi away) Contact
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Summary

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

Details
Treatment cisplatin, Placebo, Gemcitabine, Pembrolizumab, Surgery (radical cystectomy (RC) plus Pelvic Lymph Node Dissection [PLND])
Clinical Study IdentifierNCT03924856
SponsorMerck Sharp & Dohme Corp.
Last Modified on9 January 2021

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Eligibility

 Yes No Not Sure

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??
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??
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??
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??
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??
Do you have any of these conditions: Do you have Urinary Bladder Cancer, Muscle-invasive??
Have a histologically confirmed diagnosis of urothelial carcinoma (UC) / muscle invasive bladder cancer (MIBC) (T2-T4aN0M0 or T1-T4aN1M0) with predominant (50%) urothelial histology
Have clinically non-metastatic bladder cancer (N1 M0) determined by imaging (computed tomography (CT) or magnetic resonance imaging (MRI) of the chest/abdomen/pelvis
Be deemed eligible for Radical Cystectomy (RC) + Pelvic Lymph Node Dissection (PLND)
Have adequate organ function
Male and female participants are eligible to participate if they agree to the contraception use as per study protocol
Have Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1

Exclusion Criteria

Has received any prior systemic treatment for MIBC or non-invasive muscle bladder cancer (NMIBC - prior treatment for NMIBC with intravesical BCG/chemotherapy is permitted) or prior therapy with an anti- programmed cell death 1 (PD-1), anti-programmed cell death ligand 1/ ligand 2 (PD-L1/L2), or anti-cytotoxic T-lymphocyte-associated protein 4 (CTLA-4)
Has N2 disease or metastatic disease (M1) as identified by imaging
Is cisplatin-ineligible, as defined by meeting any one of the cisplatin ineligibility criteria as per protocol
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 prior systemic anticancer therapy including investigational agents within 3 years of randomization or any radiotherapy to the bladder
Has undergone partial cystectomy of the bladder to remove any NMIBC or MIBC
Has received a live or live attenuated vaccine within 30 days before the first dose of study intervention
Has a diagnosis of immunodeficiency or has a known history of human immunodeficiency virus (HIV) infection, Hepatitis B infection or known active Hepatitis C infection
Has a known psychiatric or substance abuse disorder
Has had an allogenic tissue/solid organ transplant
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