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)
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ClinicalTrials.gov Identifier: NCT03635567 |
Recruitment Status :
Active, not recruiting
First Posted : August 17, 2018
Results First Posted : October 12, 2023
Last Update Posted : January 17, 2024
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Sponsor:
Merck Sharp & Dohme LLC
Information provided by (Responsible Party):
Merck Sharp & Dohme LLC
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Study Type | Interventional |
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Study Design | Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Triple (Participant, Investigator, Outcomes Assessor); Primary Purpose: Treatment |
Condition |
Cervical Cancer |
Interventions |
Biological: Pembrolizumab Drug: Paclitaxel Drug: Cisplatin Drug: Carboplatin Biological: Bevacizumab Drug: Placebo to pembrolizumab |
Enrollment | 617 |
Participant Flow
Recruitment Details | |
Pre-assignment Details |
Arm/Group Title | Pembrolizumab+Chemotherapy | Placebo+Chemotherapy |
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Arm/Group Description | On Day 1 of each 21-day cycle, participants received an intravenous (IV) infusion of pembrolizumab 200 mg for up to 35 cycles (up to approximately 2 years) PLUS Investigator choice of chemotherapy for up to 6 cycles (paclitaxel 175 mg/m^2 PLUS cisplatin 50 mg/m^2 WITH or WITHOUT bevacizumab 15 mg/kg per local label OR paclitaxel 175 mg/m^2 PLUS carboplatin Area Under the Curve (AUC) 5 for up to 6 cycles, WITH or WITHOUT bevacizumab 15 mg/kg per local label). All treatments were administered until disease progression or toxicity. | On Day 1 of each 21-day cycle, participants received an IV infusion of placebo (Normal Saline or Dextrose solution) for up to 35 cycles (up to approximately 2 years) PLUS Investigator choice of chemotherapy for up to 6 cycles (paclitaxel 175 mg/m^2 PLUS cisplatin 50 mg/m^2 WITH or WITHOUT bevacizumab 15 mg/kg per local label OR paclitaxel 175 mg/m^2 PLUS carboplatin AUC 5 for up to 6 cycles, WITH or WITHOUT bevacizumab 15 mg/kg per local label). All treatments were administered until disease progression or toxicity. |
Period Title: Overall Study | ||
Started | 308 | 309 |
Treated | 307 | 309 |
Received Second Course of Pembrolizumab | 8 | 0 |
Completed | 0 | 0 |
Not Completed | 308 | 309 |
Reason Not Completed | ||
Lost to Follow-up | 0 | 2 |
Withdrawal by Subject | 9 | 10 |
Ongoing in Study | 125 | 76 |
Death | 174 | 221 |
Baseline Characteristics
Arm/Group Title | Pembrolizumab+Chemotherapy | Placebo+Chemotherapy | Total | |
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Arm/Group Description | On Day 1 of each 21-day cycle, participants received an intravenous (IV) infusion of pembrolizumab 200 mg for up to 35 cycles (up to approximately 2 years) PLUS Investigator choice of chemotherapy for up to 6 cycles (paclitaxel 175 mg/m^2 PLUS cisplatin 50 mg/m^2 WITH or WITHOUT bevacizumab 15 mg/kg per local label OR paclitaxel 175 mg/m^2 PLUS carboplatin Area Under the Curve (AUC) 5 for up to 6 cycles, WITH or WITHOUT bevacizumab 15 mg/kg per local label). All treatments were administered until disease progression or toxicity. | On Day 1 of each 21-day cycle, participants received an IV infusion of placebo (Normal Saline or Dextrose solution) for up to 35 cycles (up to approximately 2 years) PLUS Investigator choice of chemotherapy for up to 6 cycles (paclitaxel 175 mg/m^2 PLUS cisplatin 50 mg/m^2 WITH or WITHOUT bevacizumab 15 mg/kg per local label OR paclitaxel 175 mg/m^2 PLUS carboplatin AUC 5 for up to 6 cycles, WITH or WITHOUT bevacizumab 15 mg/kg per local label). All treatments were administered until disease progression or toxicity. | Total of all reporting groups | |
Overall Number of Baseline Participants | 308 | 309 | 617 | |
Baseline Analysis Population Description |
[Not Specified]
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Age, Continuous
Mean (Standard Deviation) Unit of measure: Years |
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Number Analyzed | 308 participants | 309 participants | 617 participants | |
51.7 (11.9) | 50.7 (12.7) | 51.2 (12.3) | ||
Sex: Female, Male
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 308 participants | 309 participants | 617 participants | |
Female |
308 100.0%
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309 100.0%
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617 100.0%
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Male |
0 0.0%
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0 0.0%
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0 0.0%
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Ethnicity (NIH/OMB)
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 308 participants | 309 participants | 617 participants | |
Hispanic or Latino |
109 35.4%
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121 39.2%
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230 37.3%
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Not Hispanic or Latino |
193 62.7%
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184 59.5%
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377 61.1%
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Unknown or Not Reported |
6 1.9%
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4 1.3%
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10 1.6%
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Race (NIH/OMB)
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 308 participants | 309 participants | 617 participants | |
American Indian or Alaska Native |
18 5.8%
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21 6.8%
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39 6.3%
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Asian |
65 21.1%
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45 14.6%
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110 17.8%
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Native Hawaiian or Other Pacific Islander |
0 0.0%
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0 0.0%
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0 0.0%
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Black or African American |
4 1.3%
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2 0.6%
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6 1.0%
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White |
170 55.2%
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190 61.5%
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360 58.3%
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More than one race |
32 10.4%
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34 11.0%
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66 10.7%
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Unknown or Not Reported |
19 6.2%
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17 5.5%
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36 5.8%
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Programmed Cell Death-Ligand 1 (PD-L1) Combined Positive Score (CPS) Status
[1] Measure Type: Count of Participants Unit of measure: Participants |
Number Analyzed | 308 participants | 309 participants | 617 participants |
PD-L1 CPS<1 |
35 11.4%
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34 11.0%
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69 11.2%
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1≤ PD-L1 CPS<10 |
115 37.3%
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116 37.5%
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231 37.4%
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PD-L1 CPS≥10 |
158 51.3%
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159 51.5%
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317 51.4%
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[1]
Measure Description: Participants were assessed for their PD-L1 tumor expression level by immunohistochemistry assay using tumor tissue. Randomization of participants in the study were stratified by their PD-L1 CPS at baseline (PD-L1 CPS<1, 1≤ PD-L1 CPS<10, or PD-L1 CPS≥10).
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Metastatic at Initial Diagnosis
[1] Measure Type: Count of Participants Unit of measure: Participants |
Number Analyzed | 308 participants | 309 participants | 617 participants |
Yes |
94 30.5%
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96 31.1%
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190 30.8%
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No |
214 69.5%
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213 68.9%
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427 69.2%
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[1]
Measure Description: Randomization of participants was stratified by whether they were metastatic at initial diagnosis (Yes or No). Metastatic was defined as Stage IV based on the Fédération Internationale de Gynécologie et d'Obstétrique (FIGO) (2009).
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Investigator Choice to Use Bevacizumab
[1] Measure Type: Count of Participants Unit of measure: Participants |
Number Analyzed | 308 participants | 309 participants | 617 participants |
Yes |
196 63.6%
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193 62.5%
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389 63.0%
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No |
112 36.4%
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116 37.5%
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228 37.0%
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[1]
Measure Description: Randomization of participants was stratified by the Investigator's choice for the participant to receive bevacizumab (Yes or No).
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Outcome Measures
Adverse Events
Limitations and Caveats
[Not Specified]
More Information
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts
the PI's rights to discuss or publish trial results after the trial is completed.
The Sponsor will generally support publication of multicenter studies only in their entirety and not as individual site data. In this case, a coordinating investigator will be designated by mutual agreement. If publication activity is not directed by the Sponsor, the investigator agrees to submit all manuscripts or abstracts to the Sponsor before submission. This allows the Sponsor to protect proprietary information and to provide comments.
Results Point of Contact
Name/Title: | Senior Vice President, Global Clinical Development |
Organization: | Merck Sharp & Dohme LLC |
Phone: | 1-800-672-6372 |
EMail: | ClinicalTrialsDisclosure@merck.com |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Merck Sharp & Dohme LLC |
ClinicalTrials.gov Identifier: | NCT03635567 |
Other Study ID Numbers: |
3475-826 MK-3475-826 ( Other Identifier: Merck ) KEYNOTE-826 ( Other Identifier: Merck ) 184183 ( Registry Identifier: JAPAC-CTI ) 2018-001440-53 ( EudraCT Number ) |
First Submitted: | August 15, 2018 |
First Posted: | August 17, 2018 |
Results First Submitted: | September 20, 2023 |
Results First Posted: | October 12, 2023 |
Last Update Posted: | January 17, 2024 |