NCT03635567 · OUTCOME

OS in Participants With PD-L1 CPS ≥10

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) · Source last updated 2026-02-04

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Measure: MEDIAN
Unit: Months
Interval / dispersion: 95% Confidence Interval
Time frame: Up to approximately 46 months

What was measured

OS was defined as the time from randomization to death due to any cause. The OS for all randomized participants with PD-L1 CPS ≥10 is presented.

Analysis population: All randomized participants with PD-L1 CPS ≥10 based on the treatment group to which they were randomized.

Groups in this outcome

Pembrolizumab+Chemotherapy

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. Eligible participants who stopped the initial course of pembrolizumab with Stable Disease (SD) or better but progressed after discontinuation may have been able to initiate a second course of pembrolizumab for up to 17 cycles (up to approximately 1 additional year) at the investigator's discretion.

Placebo+Chemotherapy

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.

Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.

Analysis denominator · Participants

Group	Source count
Pembrolizumab+Chemotherapy	158
Placebo+Chemotherapy	159

Reported measurements

Source class 1

Values in Months · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Pembrolizumab+Chemotherapy	29.6	Not reported	20.6	NA	NA = Upper limit not reached at time of data cut-off due to insufficient number of participants with an event.
Placebo+Chemotherapy	17.4	Not reported	14.0	24.7	Not reported

Source statistical analyses

Group order, estimate direction, methods and comments are retained. No treatment ranking is inferred.

ci Lower Limit
0.44
ci Num Sides
TWO_SIDED
ci Pct Value
95
ci Upper Limit
0.78
group Description
Treatment comparison (HR) was based on Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by metastatic at initial diagnosis (FIGO \[2009\] stage IVB) (yes or no), bevacizumab use (yes or no), and PD-L1 status (CPS\<1, CPS 1 to \<10, or CPS ≥10).
group Ids
OG000
OG001
non Inferiority Type
OTHER
p Value
<0.0001
p Value Comment
No formal hypothesis testing performed; nominal p-value provided for treatment comparison.
param Type
Hazard Ratio (HR)
param Value
0.58
statistical Comment
Nominal p-value based on log-rank test stratified by metastatic at initial diagnosis (FIGO \[2009\] stage IVB), bevacizumab use, and PD-L1 status.
statistical Method
Stratified Log-Rank

Complete source fields

analyses

ci Lower Limit
0.44
ci Num Sides
TWO_SIDED
ci Pct Value
95
ci Upper Limit
0.78
group Description
Treatment comparison (HR) was based on Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by metastatic at initial diagnosis (FIGO \[2009\] stage IVB) (yes or no), bevacizumab use (yes or no), and PD-L1 status (CPS\<1, CPS 1 to \<10, or CPS ≥10).
group Ids
OG000
OG001
non Inferiority Type
OTHER
p Value
<0.0001
p Value Comment
No formal hypothesis testing performed; nominal p-value provided for treatment comparison.
param Type
Hazard Ratio (HR)
param Value
0.58
statistical Comment
Nominal p-value based on log-rank test stratified by metastatic at initial diagnosis (FIGO \[2009\] stage IVB), bevacizumab use, and PD-L1 status.
statistical Method
Stratified Log-Rank

classes

categories
measurements
comment
NA = Upper limit not reached at time of data cut-off due to insufficient number of participants with an event.
group Id
OG000
lower Limit
20.6
upper Limit
NA
value
29.6
group Id
OG001
lower Limit
14.0
upper Limit
24.7
value
17.4

denoms

counts
group Id
OG000
value
158
group Id
OG001
value
159
units
Participants

description

OS was defined as the time from randomization to death due to any cause. The OS for all randomized participants with PD-L1 CPS ≥10 is presented.

dispersion Type

95% Confidence Interval

groups

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. Eligible participants who stopped the initial course of pembrolizumab with Stable Disease (SD) or better but progressed after discontinuation may have been able to initiate a second course of pembrolizumab for up to 17 cycles (up to approximately 1 additional year) at the investigator's discretion.
id
OG000
title
Pembrolizumab+Chemotherapy
description
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.
id
OG001
title
Placebo+Chemotherapy

param Type

MEDIAN

population Description

All randomized participants with PD-L1 CPS ≥10 based on the treatment group to which they were randomized.

reporting Status

POSTED

time Frame

Up to approximately 46 months

title

OS in Participants With PD-L1 CPS ≥10

type

PRIMARY

unit Of Measure

Months

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Preserved source evidence · Not medical advice