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NCT04008030 · OUTCOME

Progression-free Survival (PFS) by Blinded Independent Review Center (BICR) - Arm B vs. Arm C 1L Participants Centrally Confirmed MSI-H/dMMR

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 32 months)

What was measured

BICR-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) who have not received prior therapy for metastatic disease (1L) in Arm B and Arm C only

Groups in this outcome

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.

Arm C - Investigator's Choice Chemotherapy

Participants received standard of care chemotherapy

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 B - Nivolumab + Ipilimumab171
Arm C - Investigator's Choice Chemotherapy84

Reported measurements

Source class 1
Values in Months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Arm B - Nivolumab + IpilimumabNANot reported38.44NAInsufficient number of participants with events based on Kaplan-Meier Estimates
Arm C - Investigator's Choice Chemotherapy5.85Not reported4.377.79Not reported

Source statistical analyses

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

  1. ci Lower Limit
    0.14
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    0.32
    estimate Comment
    From a Cox Model stratified by tumor sidedness (left vs. right) as entered into the IRT.
    group Ids
    1. OG000
    2. OG001
    non Inferiority Comment
    Arm B over Arm C
    non Inferiority Type
    SUPERIORITY
    p Value
    <0.0001
    p Value Comment
    Boundary for statistical significance p-value \< 0.0209.
    param Type
    Hazard Ratio (HR)
    param Value
    0.21
    statistical Comment
    Log-rank test stratified by the same factors as used in the Cox proportional hazard model.
    statistical Method
    Log Rank
Complete source fields
analyses
  1. ci Lower Limit
    0.14
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    0.32
    estimate Comment
    From a Cox Model stratified by tumor sidedness (left vs. right) as entered into the IRT.
    group Ids
    1. OG000
    2. OG001
    non Inferiority Comment
    Arm B over Arm C
    non Inferiority Type
    SUPERIORITY
    p Value
    <0.0001
    p Value Comment
    Boundary for statistical significance p-value \< 0.0209.
    param Type
    Hazard Ratio (HR)
    param Value
    0.21
    statistical Comment
    Log-rank test stratified by the same factors as used in the Cox proportional hazard model.
    statistical Method
    Log Rank
classes
  1. categories
    1. measurements
      1. comment
        Insufficient number of participants with events based on Kaplan-Meier Estimates
        group Id
        OG000
        lower Limit
        38.44
        upper Limit
        NA
        value
        NA
      2. group Id
        OG001
        lower Limit
        4.37
        upper Limit
        7.79
        value
        5.85
denoms
  1. counts
    1. group Id
      OG000
      value
      171
    2. group Id
      OG001
      value
      84
    units
    Participants
description
BICR-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 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
    OG000
    title
    Arm B - Nivolumab + Ipilimumab
  2. description
    Participants received standard of care chemotherapy
    id
    OG001
    title
    Arm C - Investigator's Choice Chemotherapy
param Type
MEDIAN
population Description
All randomized participants with centrally confirmed DNA mismatch repairdeficient/microsatellite instability-high metastatic colorectal cancer (dMMR/MSI-H mCRC) who have not received prior therapy for metastatic disease (1L) in Arm B and Arm C 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 32 months)
title
Progression-free Survival (PFS) by Blinded Independent Review Center (BICR) - Arm B vs. Arm C 1L Participants Centrally Confirmed MSI-H/dMMR
type
PRIMARY
unit Of Measure
Months

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

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