Efficacy and Safety Study of First-line Treatment With Pembrolizumab (MK-3475) Plus Chemotherapy Versus Placebo Plus Chemotherapy in Women With Persistent, Recurrent, or Metastatic Cervical Cancer (MK-3475-826/KEYNOTE-826)
Last updated:
Last updated
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2026-07-11
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A PHASE 3 RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED TRIAL OF PEMBROLIZUMAB (MK-3475) PLUS CHEMOTHERAPY VERSUS CHEMOTHERAPY PLUS PLACEBO FOR THE FIRST-LINE TREATMENT OF PERSISTENT, RECURRENT, OR METASTATIC CERVICAL CANCER (KEYNOTE-826)
Intervention/treatment:
Intervention/treatment
Name given to the drug used in the clinical trial. This may be a code name, a chemical name of the active ingredient, a non-proprietary name or brand name.
The disease or condition that's being studied in the clinical trial.
CERVICAL CANCER
Protocol code:
Protocol Code
An alpha-numeric sequence generated by the sponsor that can vary in length. Used as a reference to help identify a specific clinical trial protocol. Formerly referred to as 'protocol number'.
826-00
Control number:
Control number
A unique 6-digit identification number Health Canada assigns to each clinical trial application.
219149
Status:
Trial Status
The status for the clinical trial as a whole. Note that the status for each site may be different and should always be confirmed with the clinical trial sponsor. Health Canada uses information provided by the sponsor to an international clinical trial registry to determine status values for each clinical trial. Status values on the portal can include:
• Not yet recruiting - Participants are not yet being recruited or enrolled at any site. • Recruiting - Participants are currently being recruited. • Active, not recruiting - The clinical trial is ongoing but new participants are not currently being recruited or enrolled. • On hold - The clinical trial has been temporarily stopped, but it may start again. • Closed - The clinical trial has either ended normally and participants are no longer being examined or treated, or it has stopped early and will not start again. • Unknown - The status of the clinical trial has not been verified in the registry in the last 2 years. Please contact the sponsor. • No match, ongoing - Please contact sponsor for status information. • Other - Please contact sponsor for status information.
Closed
Approved:
Approved
The date that the clinical trial has been determined to meet Health Canada’s regulatory requirements. For drug clinical trials, this means that a no objection letter or an authorization was issued.
August 31, 2018
Date Completed:
Date completed
The date of the last participant’s last visit in the global study. The completion date may be actual or estimated, depending what was provided to the registry. Estimated completion dates may be in the past or future.
Trial phase:
Trial phase
The stage of a clinical trial, based on factors such as the objectives of the trial and number of participants. Phase data displayed in the portal is taken from international registry data.
For more information see "Phases of drug trials" on the Definitions webpage
This is an external link. The information is not authorized by the Government of Canada.
Eligibility
Eligibility
The characteristics people must have or the requirements they must meet to participate in the clinical trial. Eligibility criteria include both inclusion criteria (must have for a person to participate) and exclusion criteria (prevent a person from participating).
Review the exact criteria from the registry or the sponsor before making a decision to participate. The following values may be available on the portal:
Sex: an eligibility criteria based on biological characteristics. Information in the portal is based on available data and will default to 'all' when no other data is available.
Age: The age a person must be to participate in the clinical trial.
Accepts Healthy Volunteers: People who do not have the disease or condition can participate in the clinical trial.
Sex:
FEMALE
Age
18 Years and older
Accepts healthy volunteers:
No
Contacts and locations
Contact
Contact
Information for an individual or organisation that can respond to questions about this clinical trial. This information comes from the international registry.
Name
Senior Vice President, Global Clinical Development
The sponsor conducts the clinical trial and is responsible for every aspect. For example this could be a company, a university or an individual researcher.
MERCK CANADA INC
Locations
Alberta
Tom Baker Cancer Centre ( Site 1728)
Calgary, Alberta, T2N 4N2
British Columbia
BC Cancer-Kelowna - Sindi Ahluwalia Hawkins Centre ( Site 1734)
Kelowna, British Columbia, V1Y 5L3
BC Cancer - Vancouver Center ( Site 1722)
Vancouver, British Columbia, V5Z 4E6
Manitoba
CancerCare Manitoba ( Site 1725)
Winnipeg, Manitoba, R3E 0V9
Nova Scotia
Queen Elizabeth II Health Sciences Centre ( Site 1731)
Halifax, Nova Scotia, B3H 2Y9
Ontario
Juravinski Cancer Centre ( Site 1735)
Hamilton, Ontario, L8V 5C2
London Regional Cancer Program - London HSC ( Site 1723)
London, Ontario, N6A 5W9
Princess Margaret Cancer Centre ( Site 1732)
Toronto, Ontario, M5G 2M9
Sunnybrook Research Institute ( Site 1733)
Toronto, Ontario, M4N 3M5
The Ottawa Hospital Cancer Centre ( Site 1736)
Ottawa, Ontario, K1H 8L6
Quebec
Centre Hospitalier de l Universite de Montreal - CHUM ( Site 1721)
Montreal, Quebec, H2X 3E4
CHU de Quebec-Universite Laval-Hotel Dieu de Quebec ( Site 1724)
Québec, Quebec, G1R 2J6
CIUSSS de l Est de L Ile de Montreal - Hopital Maisonneuve-Rosemont ( Site 1726)
Montreal, Quebec, H1T 2M4
CIUSSS de l Estrie - CHUS - Centre Hosp. Univ. Sherbrooke ( Site 1730)
