NCT04008030 · OUTCOME

Objective Response Rate (ORR) by Blinded Independent Review Center (BICR) - 1L Participants

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: NUMBER
Unit: Percentage of participants
Interval / dispersion: 95% Confidence Interval
Time frame: From date of randomization to the date of the initial objectively documented tumor progression, or the date of initiation of subsequent therapy, whichever occurs first (Up to approximately 60 months)

What was measured

Objective Response Rate (ORR) is defined as the percentage of all randomized participants whose best overall response is either confirmed complete response (CR) or confirmed partial response (PR). CR= Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \< 10 mm. PR= At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Progressive disease (PD)=At least a 20% increase in the sum of diameters of target lesions. the sum must also demonstrate an absolute increase of at least 5 mm.

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)

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.

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

Group	Source count
Arm A - Nivolumab Monotherapy	170
Arm B - Nivolumab + Ipilimumab	171
Arm C - Investigator's Choice Chemotherapy	84

Reported measurements

Source class 1

Values in Percentage of participants · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Arm A - Nivolumab Monotherapy	61.2	Not reported	53.4	68.5	Not reported
Arm B - Nivolumab + Ipilimumab	72.5	Not reported	65.2	79.1	Not reported
Arm C - Investigator's Choice Chemotherapy	27.4	Not reported	18.2	38.2	Not reported

Source statistical analyses

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

ci Lower Limit
3.91
ci Pct Value
95
ci Upper Limit
12.62
estimate Comment
Stratified by tumor sidedness (left vs. right)
group Ids
OG001
OG002
non Inferiority Comment
Arm B over Arm C
non Inferiority Type
SUPERIORITY
param Type
Odds Ratio (OR)
param Value
7.02
ci Lower Limit
1.06
ci Pct Value
95
ci Upper Limit
2.63
estimate Comment
Stratified by tumor sidedness (left vs. right)
group Ids
OG000
OG001
non Inferiority Comment
Arm B over Arm A
non Inferiority Type
SUPERIORITY
param Type
Odds Ratio (OR)
param Value
1.67

Complete source fields

analyses

ci Lower Limit
3.91
ci Pct Value
95
ci Upper Limit
12.62
estimate Comment
Stratified by tumor sidedness (left vs. right)
group Ids
OG001
OG002
non Inferiority Comment
Arm B over Arm C
non Inferiority Type
SUPERIORITY
param Type
Odds Ratio (OR)
param Value
7.02
ci Lower Limit
1.06
ci Pct Value
95
ci Upper Limit
2.63
estimate Comment
Stratified by tumor sidedness (left vs. right)
group Ids
OG000
OG001
non Inferiority Comment
Arm B over Arm A
non Inferiority Type
SUPERIORITY
param Type
Odds Ratio (OR)
param Value
1.67

classes

categories
measurements
group Id
OG000
lower Limit
53.4
upper Limit
68.5
value
61.2
group Id
OG001
lower Limit
65.2
upper Limit
79.1
value
72.5
group Id
OG002
lower Limit
18.2
upper Limit
38.2
value
27.4

denoms

counts
group Id
OG000
value
170
group Id
OG001
value
171
group Id
OG002
value
84
units
Participants

description

dispersion Type

95% Confidence Interval

groups

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
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
description
Participants received standard of care chemotherapy
id
OG002
title
Arm C - Investigator's Choice Chemotherapy

param Type

NUMBER

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)

reporting Status

POSTED

time Frame

From date of randomization to the date of the initial objectively documented tumor progression, or the date of initiation of subsequent therapy, whichever occurs first (Up to approximately 60 months)

title

Objective Response Rate (ORR) by Blinded Independent Review Center (BICR) - 1L Participants

type

SECONDARY

unit Of Measure

Percentage of participants

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