NCT03414983|CompletedPhase 2ResultsFDA Drug

An Investigational Immunotherapy Study of Nivolumab With Standard of Care Therapy vs Standard of Care Therapy for First-Line Treatment of Colorectal Cancer That Has Spread

CheckMate 9X8

An Open-Label Exploratory Phase 2/3 Study of Nivolumab With Standard of Care Therapy vs Standard of Care Therapy for First-Line Treatment of Metastatic Colorectal Cancer

Bristol-Myers Squibb ClinicalTrials.gov

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2 other identifiers

CA209-9X82017-003662-27

Study Type

interventional

Target

196

Locations

5 countries

Sites

Timeline

RegisteredJan 2018

StartedFeb 2018

CompletionDec 2022

Brief Summary

This purpose of this study is to evaluate nivolumab (BMS-936558) in combination with standard of care (SOC) chemotherapy with bevacizumab for the treatment of first-line metastatic colorectal cancer (mCRC).

Trial Health

On Track

Trial Health Score

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

Enrollment

196

participants targeted

Target at P75+ for phase_2 colorectal-cancer

Timeline

Completed

Started Feb 2018

Typical duration for phase_2 colorectal-cancer

Geographic Reach

5 countries

49 active sites

Status

completed

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

4.9 years study duration

First Submitted

Initial submission to the registry

January 24, 2018

Completed

6 days until next milestone

First Posted

Study publicly available on registry

January 30, 2018

Completed

21 days until next milestone

Study Start

First participant enrolled

February 20, 2018

Completed

3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2021

Completed

1.1 years until next milestone

Results Posted

Study results publicly available

February 25, 2022

Completed

10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 28, 2022

Completed

Last Updated

November 18, 2023

Status Verified

October 1, 2023

Enrollment Period

3 years

First QC Date

January 24, 2018

Results QC Date

February 1, 2022

Last Update Submit

October 27, 2023

Conditions

Colorectal Cancer

Outcome Measures

Primary Outcomes (1)

Progression Free Survival (PFS) Per Blinded Independent Central Review (BICR)
Progression Free Survival (PFS) is defined as the time from randomization to the date of the first documented progression, as determined by BICR (per RECIST 1.1), or death due to any cause, whichever occurs first. Baseline tumor assessment is defined as tumor scans prior to or on randomization date. Participants who did not have documented progression per BICR and who did not die or participants who started any subsequent anti-cancer therapy without a prior reported progression per BICR will be censored at the date of the last tumor assessment on or prior to initiation of the subsequent anticancer therapy, if any. Participants who die without a reported prior progression per BICR will be considered to have progressed on the date of death. Participants who did not have any baseline or post baseline tumor assessments and did not die (or died after initiation of the subsequent anti-cancer therapy) will be censored at the randomization date.
From randomization to up to the date of the first documented progression (up to 16 months)

Secondary Outcomes (15)

Progression Free Survival (PFS) Per Investigator Assessment
From randomization up to the date of the first documented progression (up to approximately 44 months)
Objective Response Rate (ORR) Per Blinded Independent Central Review (BICR)
From the date of randomization up to the date of objectively documented progression or the date of subsequent anticancer therapy, whichever occurs first (up to approximately 44 months)
Objective Response Rate (ORR) Per Investigator Assessment
From the date of randomization up to the date of objectively documented progression or the date of subsequent anticancer therapy, whichever occurs first (up to approximately 44 months)
Duration of Response (DoR) Per Blinded Independent Central Review (BICR)
From randomization up to the date of the first documented progression (per RECIST 1.1) or death due to any cause, whichever occurs first (up to 44 months)
Duration of Response (DoR) Per Investigator Assessment
From randomization up to the date of the first documented progression (per RECIST 1.1) or death due to any cause, whichever occurs first (up to 44 months)
+10 more secondary outcomes

Study Arms (2)

Arm A

EXPERIMENTAL

Nivo + SOC

Biological: NivolumabDrug: OxaliplatinDrug: LeucovorinDrug: FluorouracilDrug: Bevacizumab

Arm B

ACTIVE COMPARATOR

SOC

Drug: OxaliplatinDrug: LeucovorinDrug: FluorouracilDrug: Bevacizumab