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NCT04008030 · OUTCOME

Progression-free Survival (PFS) by Investigator - Arm A and Arm B All Lines With dMMR/MSI-H mCRC

A Study of Nivolumab, Nivolumab Plus Ipilimumab, or Investigator's Choice Chemotherapy for the Treatment of Participants With Deficient Mismatch Repair (dMMR)/Microsatellite Instability High (MSI-H) Metastatic Colorectal Cancer (mCRC) · Source last updated 2026-08-20

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
From date of randomization to the date of first objectively documented disease progression or death due to any cause, whichever occurs first (Up to approximately 60 months)

What was measured

Investigator-assessed Progression-free survival (PFS) is defined as the time from the randomization date to the date of first objectively documented disease progression per RECIST 1.1 (i.e, radiologic) or death due to any cause, whichever occurs first.

Analysis population: All randomized participants with centrally confirmed DNA mismatch repairdeficient/microsatellite instability-high metastatic colorectal cancer (dMMR/MSI-H mCRC) in Arm A and Arm B only.

Groups in this outcome

Arm A - Nivolumab Monotherapy

Nivolumab 240 mg infusion on Day 1 and every two weeks during cycles 1 and 2 for a total of 6 doses. Starting from Cycle 3 Day 1 participants received Nivolumab 480 mg infusion every 4 weeks.

Arm B - Nivolumab + Ipilimumab

Nivolumab 240 mg infusion followed by Ipilimumab 1 mg/kg IV on Day 1 and every three weeks during cycles 1 and 2 for a total of 4 doses. Starting from Cycle 3 Day 1, participants received Nivolumab 480 mg infusion every 4 weeks.

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 - Nivolumab Monotherapy286
Arm B - Nivolumab + Ipilimumab296

Reported measurements

Source class 1
Values in Months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Arm A - Nivolumab Monotherapy38.14Not reported27.20NAInsufficient number of participants with events based on Kaplan-Meier Estimates
Arm B - Nivolumab + IpilimumabNANot reported54.08NAInsufficient number of participants with events based on Kaplan-Meier Estimates

Source statistical analyses

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

  1. ci Lower Limit
    0.48
    ci Pct Value
    95
    ci Upper Limit
    0.80
    estimate Comment
    Cox Model stratified by tumor sidedness (left vs. right) and prior lines of therapy (0, 1, \>= 2) as entered into the IRT.
    group Ids
    1. OG000
    2. OG001
    non Inferiority Comment
    Arm B over Arm A
    non Inferiority Type
    SUPERIORITY
    param Type
    Hazard Ratio (HR)
    param Value
    0.62
Complete source fields
analyses
  1. ci Lower Limit
    0.48
    ci Pct Value
    95
    ci Upper Limit
    0.80
    estimate Comment
    Cox Model stratified by tumor sidedness (left vs. right) and prior lines of therapy (0, 1, \>= 2) as entered into the IRT.
    group Ids
    1. OG000
    2. OG001
    non Inferiority Comment
    Arm B over Arm A
    non Inferiority Type
    SUPERIORITY
    param Type
    Hazard Ratio (HR)
    param Value
    0.62
classes
  1. categories
    1. measurements
      1. comment
        Insufficient number of participants with events based on Kaplan-Meier Estimates
        group Id
        OG000
        lower Limit
        27.20
        upper Limit
        NA
        value
        38.14
      2. comment
        Insufficient number of participants with events based on Kaplan-Meier Estimates
        group Id
        OG001
        lower Limit
        54.08
        upper Limit
        NA
        value
        NA
denoms
  1. counts
    1. group Id
      OG000
      value
      286
    2. group Id
      OG001
      value
      296
    units
    Participants
description
Investigator-assessed Progression-free survival (PFS) is defined as the time from the randomization date to the date of first objectively documented disease progression per RECIST 1.1 (i.e, radiologic) or death due to any cause, whichever occurs first.
dispersion Type
95% Confidence Interval
groups
  1. description
    Nivolumab 240 mg infusion on Day 1 and every two weeks during cycles 1 and 2 for a total of 6 doses. Starting from Cycle 3 Day 1 participants received Nivolumab 480 mg infusion every 4 weeks.
    id
    OG000
    title
    Arm A - Nivolumab Monotherapy
  2. description
    Nivolumab 240 mg infusion followed by Ipilimumab 1 mg/kg IV on Day 1 and every three weeks during cycles 1 and 2 for a total of 4 doses. Starting from Cycle 3 Day 1, participants received Nivolumab 480 mg infusion every 4 weeks.
    id
    OG001
    title
    Arm B - Nivolumab + Ipilimumab
param Type
MEDIAN
population Description
All randomized participants with centrally confirmed DNA mismatch repairdeficient/microsatellite instability-high metastatic colorectal cancer (dMMR/MSI-H mCRC) in Arm A and Arm B only.
reporting Status
POSTED
time Frame
From date of randomization to the date of first objectively documented disease progression or death due to any cause, whichever occurs first (Up to approximately 60 months)
title
Progression-free Survival (PFS) by Investigator - Arm A and Arm B All Lines With dMMR/MSI-H mCRC
type
SECONDARY
unit Of Measure
Months

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

Preserved source evidence · Independent clinical review pending · Not medical advice