NCT04008030|Active Not RecruitingPhase 3ResultsDMCFDA Drug

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)

CheckMate 8HW

A Phase 3 Randomized Clinical Trial of Nivolumab Alone, Nivolumab in Combination With Ipilimumab, or Investigator's Choice Chemotherapy in Participants With Microsatellite Instability High (MSI-H) or Mismatch Repair Deficient (dMMR) Metastatic Colorectal Cancer

Bristol-Myers Squibb ClinicalTrials.gov

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2 other identifiers

CA209-8HW2018-000040-26

Study Type

interventional

Target

839

Locations

23 countries

Sites

152

Timeline

RegisteredJul 2019

StartedAug 2019

CompletionJun 2026

Brief Summary

The main purpose of this study is to compare the clinical benefit, as measured by Progression-Free Survival (PFS), Objective Response Rate (ORR), and Overall Survival (OS), achieved by nivolumab in combination with ipilimumab or by nivolumab monotherapy in participants with Microsatellite Instability High (MSI-H) or Mismatch Repair Deficient (dMMR) metastatic colorectal cancer (mCRC). This study will also compare nivolumab plus ipilimumab combination vs chemotherapy for treatment of MSI-H/dMMR mCRC participants.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Strong global presence with extensive site network

Enrollment

839

participants targeted

Target at P75+ for phase_3

Timeline

0mo left

Started Aug 2019

Longer than P75 for phase_3

Geographic Reach

23 countries

152 active sites

Status

active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

6.9 years study duration

Study Progress99%

Aug 2019Jun 2026

First Submitted

Initial submission to the registry

July 2, 2019

Completed

3 days until next milestone

First Posted

Study publicly available on registry

July 5, 2019

Completed

1 month until next milestone

Study Start

First participant enrolled

August 5, 2019

Completed

5.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 28, 2024

Completed

1.1 years until next milestone

Results Posted

Study results publicly available

September 22, 2025

Completed

9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 10, 2026

Expected

Last Updated

October 3, 2025

Status Verified

September 1, 2025

Enrollment Period

5.1 years

First QC Date

July 2, 2019

Results QC Date

August 29, 2025

Last Update Submit

September 22, 2025

Conditions

Metastatic Colorectal Cancer

Outcome Measures

Primary Outcomes (2)

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

Secondary Outcomes (15)

Progression-free Survival (PFS) by Blinded Independent Review Center (BICR) - 1L Participants
From date of randomization to the date of first objectively documented disease progression or death due to any cause, whichever occurs first
Progression-free Survival (PFS) by Blinded Independent Review Center (BICR) - Arm B vs. Arm A All Randomized Participants
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)
Progression-free Survival (PFS) by Blinded Independent Review Center (BICR) - 1L Randomized Participants
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)
Progression-free Survival (PFS) by Blinded Independent Review Center (BICR) - Crossover and First Line Arm
From date of randomization to the date of first objectively documented disease progression or death due to any cause, whichever occurs first
Progression-free Survival (PFS) by Blinded Independent Review Center (BICR) by Polymerase Chain Reaction (PCR) - Arm B vs. Arm A
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)
+10 more secondary outcomes

Study Arms (3)

Arm A: Nivolumab Monotherapy

EXPERIMENTAL

Biological: Nivolumab

Arm B: Nivolumab + Ipilimumab Combination

EXPERIMENTAL

Biological: IpilimumabBiological: Nivolumab

Arm C: Investigator's Choice Chemotherapy

ACTIVE COMPARATOR

Participants in Arm C would be allowed to receive Nivolumab + Ipilimumab if they progress

Drug: OxaliplatinDrug: LeucovorinDrug: FluorouracilDrug: IrinotecanDrug: BevacizumabDrug: Cetuximab