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Be Part of Research - Trial Details - Efficacy and Safety of Pembrolizumab (MK-3475) in Combination With Bacillus Calmette-Guerin (BCG) in High-Risk Non-Muscle Invasive Bladder Cancer (HR NMIBC) (MK-3475-676/KEYNOTE-676)
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Efficacy and Safety of Pembrolizumab (MK-3475) in Combination With Bacillus Calmette-Guerin (BCG) in High-Risk Non-Muscle Invasive Bladder Cancer (HR NMIBC) (MK-3475-676/KEYNOTE-676)

Not Recruiting

Open to: ALL

Age: 18.0 - N/A

Inverness London London

Medical Conditions

Urinary Bladder Neoplasms
Non-Muscle Invasive Bladder Neoplasms

This information is provided directly by researchers, and we recognise that it isn't always easy to understand. We are working with researchers to improve the accessibility of this information. In some summaries, you may come across links to external websites. These websites will have more information to help you better understand the study.


Researchers are looking for new ways to treat high-risk non muscle invasive bladder cancer (HR NMIBC). NMIBC is cancer in the tissue that lines the inside of the bladder but has not spread to the bladder muscle or outside of the bladder. High-risk means NMIBC may have a high chance of getting worse or coming back after treatment.

The goals of this study are to learn: 1. If more people who receive pembrolizumab with Bacillus Calmette-Guerin (BCG) have no signs of cancer in their body and live longer without the cancer growing, spreading, or coming back compared to people who receive BCG alone. 2. About the safety and how well people tolerate BCG alone or in combination with pembrolizumab.

Start dates may differ between countries and research sites. The research team are responsible for keeping the information up-to-date.  

The recruitment start and end dates are as follows:

Dec 2018 Dec 2025

Publications

"Kamat AM, Shore N, Hahn N, Alanee S, Nishiyama H, Shariat S, Nam K, Kapadia E, Frenkl T, Steinberg G. KEYNOTE-676: Phase III study of BCG and pembrolizumab for persistent/recurrent high-risk NMIBC. Future Oncol. 2020 Apr;16(10):507-516. doi: 10.2217/fon-2019-0817. Epub 2020 Mar 12."; "32162533"

INTERVENTIONAL

Intervention Type : BIOLOGICAL
Intervention Description : Pembrolizumab IV infusion of 200 mg Q3W for BCG Post-Induction Cohort (Cohort A), or IV infusion of 400 mg Q6W for BCG NaĂŻve Cohort (Cohort B), according to randomization

Intervention Arm Group : BCG plus Pembrolizumab: BCG NaĂŻve Cohort B-Full Maintenance (Arm B-2);BCG plus Pembrolizumab: BCG NaĂŻve Cohort B-Reduced Maintenance (Arm B-1);BCG plus Pembrolizumab: Post-induction Cohort A (Arm A-1);

Intervention Type : BIOLOGICAL
Intervention Description : BCG (intravesical instillation): powder for instillation fluid for intravesical use, administered during Induction and Maintenance therapy

Intervention Arm Group : BCG Monotherapy: BCG NaĂŻve Cohort B (Arm B-3);BCG Monotherapy: Post-induction Cohort A (Arm A-2);BCG plus Pembrolizumab: BCG NaĂŻve Cohort B-Full Maintenance (Arm B-2);BCG plus Pembrolizumab: BCG NaĂŻve Cohort B-Reduced Maintenance (Arm B-1);BCG plus Pembrolizumab: Post-induction Cohort A (Arm A-1);



You can take part if:



You may not be able to take part if:


This is in the inclusion criteria above


Below are the locations for where you can take part in the trial. Please note that not all sites may be open.

  • Raigmore Hospital ( Site 1006)
    Inverness
    Highland
    IV2 3UJ
  • St Bartholomew s Hospital ( Site 1008)
    London
    London, City Of
    EC1A 7BE
  • St Georges University Hospitals NHS Foundation Trust. ( Site 1005)
    London
    London, City Of
    SW17 0QT


The study is sponsored by Merck Sharp & Dohme LLC



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Read full details for Trial ID: NCT03711032
Last updated 10 December 2024

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