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NCT02314169 · OUTCOME

Progression-free Survival (PFS) (Part B)

Nivolumab With or Without Ipilimumab in Treating Patients With Refractory Metastatic Anal Canal Cancer · Source last updated 2026-07-31

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

Measure
MEDIAN
Unit
months
Interval / dispersion
90% Confidence Interval
Time frame
Time period from the date of randomization to the date of PD or death whichever occurred first, assessed up to 2 years

What was measured

From initiation of treatment with nivolumab until the time of disease progression, time measured in months. Kaplan-Meier analysis performed to estimate the median progression-free survival with a 90% confidence interval.

Groups in this outcome

Part B Arm I (Nivolumab)

Participants enrolled into Arm I received single agent Nivolumab.

Part B Arm II (Nivolumab, Ipilimumab

Participants enrolled into Arm II received combination Nivolumab plus Ipilimumab.

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

Analysis denominator · Participants

GroupSource count
Part B Arm I (Nivolumab)52
Part B Arm II (Nivolumab, Ipilimumab48

Reported measurements

Source class 1
Values in months · Interval/dispersion: 90% Confidence Interval
GroupValueSpreadLowerUpperComment
Part B Arm I (Nivolumab)2.9Not reported1.93.8Not reported
Part B Arm II (Nivolumab, Ipilimumab3.7Not reported2.05.6Not reported

Source statistical analyses

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

  1. group Description
    one-side log rank test comparing median PFS between treatment arms
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    0.25
    statistical Comment
    one-side log rank test
    statistical Method
    Log Rank
Complete source fields
analyses
  1. group Description
    one-side log rank test comparing median PFS between treatment arms
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    0.25
    statistical Comment
    one-side log rank test
    statistical Method
    Log Rank
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        1.9
        upper Limit
        3.8
        value
        2.9
      2. group Id
        OG001
        lower Limit
        2.0
        upper Limit
        5.6
        value
        3.7
denoms
  1. counts
    1. group Id
      OG000
      value
      52
    2. group Id
      OG001
      value
      48
    units
    Participants
description
From initiation of treatment with nivolumab until the time of disease progression, time measured in months. Kaplan-Meier analysis performed to estimate the median progression-free survival with a 90% confidence interval.
dispersion Type
90% Confidence Interval
groups
  1. description
    Participants enrolled into Arm I received single agent Nivolumab.
    id
    OG000
    title
    Part B Arm I (Nivolumab)
  2. description
    Participants enrolled into Arm II received combination Nivolumab plus Ipilimumab.
    id
    OG001
    title
    Part B Arm II (Nivolumab, Ipilimumab
param Type
MEDIAN
reporting Status
POSTED
time Frame
Time period from the date of randomization to the date of PD or death whichever occurred first, assessed up to 2 years
title
Progression-free Survival (PFS) (Part B)
type
PRIMARY
unit Of Measure
months

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

Preserved source evidence · Not medical advice