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NCT05116189 · OUTCOME

PFS Per RECIST 1.1 by Blinded Independent Central Review (BICR) in Participants With PD-L1 CPS ≥1

Pembrolizumab/Placebo Plus Paclitaxel With or Without Bevacizumab for Platinum-resistant Recurrent Ovarian Cancer (MK-3475-B96/KEYNOTE-B96/ENGOT-ov65). · Source last updated 2026-03-09

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 ~38 months

What was measured

PFS is defined as the time from randomization to the first documented disease progression per RECIST 1.1 based on blinded independent central review assessment or death due to any cause, whichever occurs first. Per RECIST 1.1, PD is defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of ≥5 mm. The appearance of one or more lesions and the unequivocal progression of non-target lesions is also considered PD. The PFS per RECIST 1.1 as assessed by blinded independent central review (BICR) in participants with PD-L1 CPS ≥1 is reported here. PFS was calculated using the product-limit (Kaplan-Meier) method for censored data.

Analysis population: The analysis population includes all randomized participants with PD-L1 positive tumors (CPS≥1). Participants were analyzed in the treatment group to which they are randomized.

Groups in this outcome

Pembrolizumab + Paclitaxel ± Bevacizumab

Participants receive pembrolizumab 400 mg via intravenous (IV) infusion on Day 1 of each 6-week cycle for up to 18 cycles (approximately 2 years) PLUS paclitaxel 80 mg/m\^2 via IV infusion on Days 1, 8, and 15 of each 3-week cycle until intolerance or disease progression. Participants who experience severe hypersensitivity reaction to paclitaxel or an adverse event requiring discontinuation of paclitaxel may receive docetaxel (75 mg/m\^2 every 3 weeks \[Q3W\]) after Sponsor consultation. Participants may also receive bevacizumab 10 mg/kg via IV infusion of each 2-week cycle until intolerance, disease progression, or at the Investigator's discretion.

Placebo + Paclitaxel ± Bevacizumab

Participants receive placebo via IV infusion on Day 1 of each 6-week cycle for up to 18 cycles (approximately 2 years) PLUS paclitaxel 80 mg/m\^2 via IV infusion on Days 1, 8, and 15 of each 3-week cycle until intolerance or disease progression. Participants who experience severe hypersensitivity reaction to paclitaxel or an adverse event requiring discontinuation of paclitaxel may receive docetaxel (75 mg/m\^2 every 3 weeks \[Q3W\]) after Sponsor consultation. Participants may also receive bevacizumab 10 mg/kg via IV infusion of each 2-week cycle until intolerance, disease progression, or at the Investigator's discretion.

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

Analysis denominator · Participants

GroupSource count
Pembrolizumab + Paclitaxel ± Bevacizumab234
Placebo + Paclitaxel ± Bevacizumab232

Reported measurements

Source class 1
Values in Months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Pembrolizumab + Paclitaxel ± Bevacizumab8.5Not reported8.110.4Not reported
Placebo + Paclitaxel ± Bevacizumab7.6Not reported6.28.3Not reported

Source statistical analyses

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

  1. ci Lower Limit
    0.60
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    0.95
    ci Upper Limit
    0.93
    estimate Comment
    HR \& 95% CI is based on Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by planned bevacizumab use (yes vs no), region (US vs EU vs ROW) and PD-L1 status (CPS \<1 vs CPS 1 to \<10 vs CPS \>=10).
    group Description
    The hazard ratio (HR) and 95% confidence interval (CI) is based on Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by planned bevacizumab use in the study (yes vs no), region (US vs EU vs ROW) and PD-L1 status (CPS \<1 vs CPS 1 to \<10 vs CPS \>=10). One-sided p-value based on log-rank test stratified by planned bevacizumab use in the study (yes vs no), region (US vs EU vs ROW) and PD-L1 status (CPS \<1 vs CPS 1 to \<10 vs CPS \>=10).
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    0.0051
    p Value Comment
    One-sided p-value based on log-rank test stratified by planned bevacizumab use in the study (yes vs no), region (US vs EU vs ROW) and PD-L1 status (CPS \<1 vs CPS 1 to \<10 vs CPS \>=10).
    param Type
    Hazard Ratio (HR)
    param Value
    0.75
    statistical Method
    Log Rank
Complete source fields
analyses
  1. ci Lower Limit
    0.60
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    0.95
    ci Upper Limit
    0.93
    estimate Comment
    HR \& 95% CI is based on Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by planned bevacizumab use (yes vs no), region (US vs EU vs ROW) and PD-L1 status (CPS \<1 vs CPS 1 to \<10 vs CPS \>=10).
    group Description
    The hazard ratio (HR) and 95% confidence interval (CI) is based on Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by planned bevacizumab use in the study (yes vs no), region (US vs EU vs ROW) and PD-L1 status (CPS \<1 vs CPS 1 to \<10 vs CPS \>=10). One-sided p-value based on log-rank test stratified by planned bevacizumab use in the study (yes vs no), region (US vs EU vs ROW) and PD-L1 status (CPS \<1 vs CPS 1 to \<10 vs CPS \>=10).
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    0.0051
    p Value Comment
    One-sided p-value based on log-rank test stratified by planned bevacizumab use in the study (yes vs no), region (US vs EU vs ROW) and PD-L1 status (CPS \<1 vs CPS 1 to \<10 vs CPS \>=10).
    param Type
    Hazard Ratio (HR)
    param Value
    0.75
    statistical Method
    Log Rank
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        8.1
        upper Limit
        10.4
        value
        8.5
      2. group Id
        OG001
        lower Limit
        6.2
        upper Limit
        8.3
        value
        7.6
denoms
  1. counts
    1. group Id
      OG000
      value
      234
    2. group Id
      OG001
      value
      232
    units
    Participants
description
PFS is defined as the time from randomization to the first documented disease progression per RECIST 1.1 based on blinded independent central review assessment or death due to any cause, whichever occurs first. Per RECIST 1.1, PD is defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of ≥5 mm. The appearance of one or more lesions and the unequivocal progression of non-target lesions is also considered PD. The PFS per RECIST 1.1 as assessed by blinded independent central review (BICR) in participants with PD-L1 CPS ≥1 is reported here. PFS was calculated using the product-limit (Kaplan-Meier) method for censored data.
dispersion Type
95% Confidence Interval
groups
  1. description
    Participants receive pembrolizumab 400 mg via intravenous (IV) infusion on Day 1 of each 6-week cycle for up to 18 cycles (approximately 2 years) PLUS paclitaxel 80 mg/m\^2 via IV infusion on Days 1, 8, and 15 of each 3-week cycle until intolerance or disease progression. Participants who experience severe hypersensitivity reaction to paclitaxel or an adverse event requiring discontinuation of paclitaxel may receive docetaxel (75 mg/m\^2 every 3 weeks \[Q3W\]) after Sponsor consultation. Participants may also receive bevacizumab 10 mg/kg via IV infusion of each 2-week cycle until intolerance, disease progression, or at the Investigator's discretion.
    id
    OG000
    title
    Pembrolizumab + Paclitaxel ± Bevacizumab
  2. description
    Participants receive placebo via IV infusion on Day 1 of each 6-week cycle for up to 18 cycles (approximately 2 years) PLUS paclitaxel 80 mg/m\^2 via IV infusion on Days 1, 8, and 15 of each 3-week cycle until intolerance or disease progression. Participants who experience severe hypersensitivity reaction to paclitaxel or an adverse event requiring discontinuation of paclitaxel may receive docetaxel (75 mg/m\^2 every 3 weeks \[Q3W\]) after Sponsor consultation. Participants may also receive bevacizumab 10 mg/kg via IV infusion of each 2-week cycle until intolerance, disease progression, or at the Investigator's discretion.
    id
    OG001
    title
    Placebo + Paclitaxel ± Bevacizumab
param Type
MEDIAN
population Description
The analysis population includes all randomized participants with PD-L1 positive tumors (CPS≥1). Participants were analyzed in the treatment group to which they are randomized.
reporting Status
POSTED
time Frame
Up to ~38 months
title
PFS Per RECIST 1.1 by Blinded Independent Central Review (BICR) in Participants With PD-L1 CPS ≥1
type
SECONDARY
unit Of Measure
Months

Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0

Preserved source evidence · Not medical advice