Skip to content
Triangle logo TriangleGet started
← Full study record

NCT03062358 · OUTCOME

Objective Response Rate (ORR) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1)

Study of Pembrolizumab (MK-3475) or Placebo Given With Best Supportive Care in Asian Participants With Previously Treated Advanced Hepatocellular Carcinoma (MK-3475-394/KEYNOTE-394) · Source last updated 2025-09-30

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

Measure
NUMBER
Unit
Percentage of participants
Interval / dispersion
95% Confidence Interval
Time frame
Up to approximately 4 years

What was measured

ORR is the percentage of participants who achieve complete response (CR) or partial response (PR) with confirmation per RECIST 1.1 by BICR. CR is the disappearance of all target lesions; PR is at least a 30% decrease in the sum of diameters of target lesions.

Analysis population: All randomized participants based on the treatment group to which they were randomized.

Groups in this outcome

Pembrolizumab + BSC

Participants received 200 mg pembrolizumab by IV infusion on Day 1 of each 3-week cycle for up to 35 cycles of treatment plus BSC.

Placebo + BSC

Participants received placebo by IV infusion on Day 1 of each 3-week cycle for up to 35 cycles of treatment plus BSC.

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 + BSC300
Placebo + BSC153

Reported measurements

Source class 1
Values in Percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Pembrolizumab + BSC12.7Not reported9.117.0Not reported
Placebo + BSC1.3Not reported0.24.6Not reported

Source statistical analyses

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

  1. ci Lower Limit
    6.7
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    16.0
    estimate Comment
    Difference in % vs Placebo
    group Description
    Difference in % vs Placebo
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    OTHER
    other Analysis Description
    Based on Miettinen \& Nurminen method stratified by macrovascular invasion (Yes vs. No), α-Fetoprotein (ng/mL) (\< 200 vs. \>= 200) and region (China vs. ex-China) with all cells that correspond to macrovascular invasion=Yes combined.
    p Value
    0.00004
    param Type
    Percent Difference
    param Value
    11.4
    statistical Comment
    H0: difference in % =0 versus H1: difference in % \> 0.
    statistical Method
    One-sided p-value for testing
Complete source fields
analyses
  1. ci Lower Limit
    6.7
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    16.0
    estimate Comment
    Difference in % vs Placebo
    group Description
    Difference in % vs Placebo
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    OTHER
    other Analysis Description
    Based on Miettinen \& Nurminen method stratified by macrovascular invasion (Yes vs. No), α-Fetoprotein (ng/mL) (\< 200 vs. \>= 200) and region (China vs. ex-China) with all cells that correspond to macrovascular invasion=Yes combined.
    p Value
    0.00004
    param Type
    Percent Difference
    param Value
    11.4
    statistical Comment
    H0: difference in % =0 versus H1: difference in % \> 0.
    statistical Method
    One-sided p-value for testing
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        9.1
        upper Limit
        17.0
        value
        12.7
      2. group Id
        OG001
        lower Limit
        0.2
        upper Limit
        4.6
        value
        1.3
denoms
  1. counts
    1. group Id
      OG000
      value
      300
    2. group Id
      OG001
      value
      153
    units
    Participants
description
ORR is the percentage of participants who achieve complete response (CR) or partial response (PR) with confirmation per RECIST 1.1 by BICR. CR is the disappearance of all target lesions; PR is at least a 30% decrease in the sum of diameters of target lesions.
dispersion Type
95% Confidence Interval
groups
  1. description
    Participants received 200 mg pembrolizumab by IV infusion on Day 1 of each 3-week cycle for up to 35 cycles of treatment plus BSC.
    id
    OG000
    title
    Pembrolizumab + BSC
  2. description
    Participants received placebo by IV infusion on Day 1 of each 3-week cycle for up to 35 cycles of treatment plus BSC.
    id
    OG001
    title
    Placebo + BSC
param Type
NUMBER
population Description
All randomized participants based on the treatment group to which they were randomized.
reporting Status
POSTED
time Frame
Up to approximately 4 years
title
Objective Response Rate (ORR) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1)
type
SECONDARY
unit Of Measure
Percentage of participants

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

Preserved source evidence · Not medical advice