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
    790
  • sponsor
    Merck Sharp & Dohme Corp.
Updated on 25 November 2020
Investigator
Toll Free Number
Primary Contact
Universitaetsklinikum Erlangen ( Site 0505) (8.7 mi away) Contact
+179 other location

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 on25 November 2020

Adding a note
adding personal notes guide

Select a piece of text and start making personal notes.

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??
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
eligible
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
Clear my responses

How to participate?

Step 1 Connect with a site
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar
Name

Primary Contact

site
Name

Phone Email

0/250
Please verify that you are not a bot.
Step 2 Get screened

Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more
Step 3 Enroll in the clinical study

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

Learn more
Step 4 Get your study results

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

Learn more

Similar trials to consider

Loading...

Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer

Study

user name

Annotated by • 

 • 

Private

Reply by • Private
Loading...

Lorem ipsum dolor sit amet consectetur, adipisicing elit. Ipsa vel nobis alias. Quae eveniet velit voluptate quo doloribus maxime et dicta in sequi, corporis quod. Ea, dolor eius? Dolore, vel!

  The passcode will expire in None.
Loading...

No made yet