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NCT04003636 · OUTCOME

Overall Survival (OS)

Pembrolizumab (MK-3475) Plus Gemcitabine/Cisplatin Versus Placebo Plus Gemcitabine/Cisplatin for First-Line Advanced and/or Unresectable Biliary Tract Carcinoma (BTC) (MK-3475-966/KEYNOTE-966) · Source last updated 2026-03-24

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 38 months

What was measured

Overall survival was defined as the time from randomization to death due to any cause.

Analysis population: All randomized participants

Groups in this outcome

Arm A: Pembrolizumab + Chemotherapy

Participants received pembrolizumab, 200 mg intravenous (IV) infusion, every 3 weeks (Q3W), Day 1 of each 3-week cycle for up to 35 cycles PLUS Gemcitabine, 1000 mg/m\^2, IV infusion Q3W, Day 1 and Day 8 of each 3-week cycle until progressive disease or unacceptable toxicity PLUS Cisplatin, 25 mg/m\^2 IV infusion, Q3W, Day 1 and Day 8 of each 3-week cycle for up to 8 cycles. Eligible participants who stopped the initial course of pembrolizumab with Stable Disease (SD) or better but progressed after discontinuation initiated a second course of pembrolizumab 200mg IV Q3W, Day 1 of each 3-week cycle for up to 17 cycles. Treatment with Gemcitabine could have been stopped at any time in first or second course due to toxicity or disease progression.

Arm B: Placebo + Chemotherapy

Participants received Placebo to Pembrolizumab, 200 mg IV infusion, every 3 weeks (Q3W), Day 1 of each 3-week cycle for up to 35 cycles PLUS Gemcitabine, 1000 mg/m\^2 IV infusion, Q3W, Day 1 and Day 8 of each 3-week cycle until progressive disease or unacceptable toxicity PLUS Cisplatin, 25 mg/m\^2 IV infusion, Q3W, Day 1 and Day 8 of each 3-week cycle for up to 8 cycles.

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

Analysis denominator · Participants

GroupSource count
Arm A: Pembrolizumab + Chemotherapy533
Arm B: Placebo + Chemotherapy536

Reported measurements

Source class 1
Values in Months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Arm A: Pembrolizumab + Chemotherapy12.7Not reported11.513.6Not reported
Arm B: Placebo + Chemotherapy10.9Not reported9.911.6Not reported

Source statistical analyses

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

  1. ci Lower Limit
    0.72
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    0.95
    estimate Comment
    Hazard Ratio (HR) and associated 95% confidence interval (CI) was calculated using Cox regression model with Efron's method of tie handling with treatment as a covariate.
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    0.0034
    p Value Comment
    One-sided p-value was calculated based on log rank test.
    param Type
    Hazard Ratio (HR)
    param Value
    0.83
    statistical Method
    Log Rank
Complete source fields
analyses
  1. ci Lower Limit
    0.72
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    0.95
    estimate Comment
    Hazard Ratio (HR) and associated 95% confidence interval (CI) was calculated using Cox regression model with Efron's method of tie handling with treatment as a covariate.
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    0.0034
    p Value Comment
    One-sided p-value was calculated based on log rank test.
    param Type
    Hazard Ratio (HR)
    param Value
    0.83
    statistical Method
    Log Rank
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        11.5
        upper Limit
        13.6
        value
        12.7
      2. group Id
        OG001
        lower Limit
        9.9
        upper Limit
        11.6
        value
        10.9
denoms
  1. counts
    1. group Id
      OG000
      value
      533
    2. group Id
      OG001
      value
      536
    units
    Participants
description
Overall survival was defined as the time from randomization to death due to any cause.
dispersion Type
95% Confidence Interval
groups
  1. description
    Participants received pembrolizumab, 200 mg intravenous (IV) infusion, every 3 weeks (Q3W), Day 1 of each 3-week cycle for up to 35 cycles PLUS Gemcitabine, 1000 mg/m\^2, IV infusion Q3W, Day 1 and Day 8 of each 3-week cycle until progressive disease or unacceptable toxicity PLUS Cisplatin, 25 mg/m\^2 IV infusion, Q3W, Day 1 and Day 8 of each 3-week cycle for up to 8 cycles. Eligible participants who stopped the initial course of pembrolizumab with Stable Disease (SD) or better but progressed after discontinuation initiated a second course of pembrolizumab 200mg IV Q3W, Day 1 of each 3-week cycle for up to 17 cycles. Treatment with Gemcitabine could have been stopped at any time in first or second course due to toxicity or disease progression.
    id
    OG000
    title
    Arm A: Pembrolizumab + Chemotherapy
  2. description
    Participants received Placebo to Pembrolizumab, 200 mg IV infusion, every 3 weeks (Q3W), Day 1 of each 3-week cycle for up to 35 cycles PLUS Gemcitabine, 1000 mg/m\^2 IV infusion, Q3W, Day 1 and Day 8 of each 3-week cycle until progressive disease or unacceptable toxicity PLUS Cisplatin, 25 mg/m\^2 IV infusion, Q3W, Day 1 and Day 8 of each 3-week cycle for up to 8 cycles.
    id
    OG001
    title
    Arm B: Placebo + Chemotherapy
param Type
MEDIAN
population Description
All randomized participants
reporting Status
POSTED
time Frame
Up to approximately 38 months
title
Overall Survival (OS)
type
PRIMARY
unit Of Measure
Months

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Preserved source evidence · Not medical advice