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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)

Primary Purpose

Colorectal Cancer

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Nivolumab
Oxaliplatin
Leucovorin
Fluorouracil
Bevacizumab
Sponsored by
Bristol-Myers Squibb
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Colorectal Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Histologically confirmed metastatic colorectal cancer, not amenable to curative resection
  • No prior chemotherapy for metastatic colorectal cancer
  • ECOG Performance Status of 0-1
  • Ability to provide adequate tissue sample

Exclusion Criteria:

  • Patients with clinically relevant medical history, including autoimmune disease, cardiovascular disease, hepatic disease or bleeding disorders
  • Prior treatment with an anti-PD-1, anti-PD-L1, anti-PD-L2, or anti-CTLA-4 antibody, or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways
  • Any positive test result for hepatitis B virus or hepatitis C virus indicating presence of virus

Other protocol-defined inclusion/exclusion criteria apply

Sites / Locations

  • Uab Comprehensive Cancer Center
  • Local Institution - 0004
  • Local Institution - 0010
  • Local Institution - 0027
  • Local Institution - 0020
  • Local Institution - 0039
  • Local Institution - 0047
  • Local Institution - 0033
  • Local Institution - 0044
  • Local Institution - 0021
  • Local Institution - 0003
  • Local Institution - 0049
  • Local Institution - 0052
  • Local Institution - 0053
  • Local Institution - 0035
  • Local Institution - 0002
  • Local Institution - 0032
  • Local Institution - 0029
  • Local Institution - 0031
  • Local Institution - 0046
  • Levine Cancer Institute
  • Local Institution - 0038
  • Local Institution - 0005
  • Local Institution - 0024
  • Local Institution - 0023
  • Erlanger Oncology & Hematology - Univ. of TN
  • Local Institution - 0019
  • Local Institution - 0026
  • Local Institution - 0034
  • Local Institution - 0037
  • Local Institution - 0040
  • Local Institution - 0036
  • Local Institution - 0025
  • Local Institution - 0028
  • Local Institution - 0006
  • Local Institution - 0017
  • Local Institution - 0015
  • Local Institution - 0014
  • Local Institution - 0048
  • Local Institution - 0012
  • Local Institution - 0013
  • Local Institution - 0016
  • Local Institution - 0055
  • Local Institution - 0051
  • Local Institution - 0050
  • Local Institution - 0009
  • Local Institution - 0043
  • Local Institution - 0042
  • Local Institution - 0041

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Arm A

Arm B

Arm Description

Nivo + SOC

SOC

Outcomes

Primary Outcome Measures

Progression Free Survival (PFS) Per Blinded Independent Central Review (BICR)
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.

Secondary Outcome Measures

Objective Response Rate (ORR) Per Blinded Independent Central Review (BICR)
ORR is defined as the percentage of participants with a best overall response (BOR) of complete response (CR) or partial response (PR). BOR is defined as the best response designation as determined by BICR per RECIST 1.1, recorded between the date of randomization and the date of objectively documented progression per RECIST 1.1 or the date of subsequent anticancer therapy (including tumor-directed radiotherapy and tumor-directed surgery), whichever occurs first. PR is defined as at least a 30% decrease in the sum of diameters of target lesions. CR is defined as the disappearance of all target lesions and the reduction of any pathological lymph nodes to <10 mm.
Objective Response Rate (ORR) Per Investigator Assessment
ORR is defined as the percentage of participants with a best overall response (BOR) of complete response (CR) or partial response (PR). BOR is defined as the best response designation as determined by tumor assessments by the Investigator per RECIST 1.1, recorded between the date of randomization and the date of objectively documented progression per RECIST 1.1 or the date of subsequent anticancer therapy (including tumor-directed radiotherapy and tumor-directed surgery), whichever occurs first. PR is defined as at least a 30% decrease in the sum of diameters of target lesions. CR is defined as the disappearance of all target lesions and the reduction of any pathological lymph nodes to <10 mm.
Progression Free Survival (PFS) Per Investigator Assessment
PFS is defined as the time from randomization to the date of the first documented progression, as determined by tumor assessments by the Investigator, or death due to any cause, whichever occurs first.
Time to Objective Response Per Blinded Independent Central Review (BICR)
Time to objective response (TTR) is defined as the time from the randomization date to the date of the first confirmed CR or PR (as assessed by BICR and as assessed by investigator). TTR is derived for responders only.
Time to Objective Response Per Investigator Assessment
TTR is defined as the time from the randomization date to the date of the first confirmed CR or PR (as assessed by BICR and as assessed by investigator). TTR is derived for responders only.
Duration of Response (DoR) Per Blinded Independent Central Review (BICR)
Duration of objective response (DoR) is defined as the time between the date of first confirmed response to the date of the first documented tumor progression as assessed by the BICR based on RECIST 1.1 criteria or death due to any cause, whichever occurs first.
Duration of Response (DoR) Per Investigator Assessment
Duration of objective response (DoR) is defined as the time between the date of first confirmed response to the date of the first documented tumor progression as assessed by the investigator based on RECIST 1.1 criteria or death due to any cause, whichever occurs first.
Overall Survival (OS) Summary
OS is defined as the time from the date of randomization to the date of death. A participant who has not died will be censored at last known date alive.
Number of Participants With Adverse Events (AEs)
Number of participants with any grade of adverse events (AEs) graded by Common Terminology Criteria for Adverse Events (CTCAE v4.0) to determine safety and tolerability
Number of Participants With Serious Adverse Events (SAEs)
Number of participants with any grade of serious adverse events (AEs) graded by Common Terminology Criteria for Adverse Events (CTCAE v4.0) to determine safety and tolerability
Deaths
The number of participants who died during the treatment period
Abnormalities in Specific Liver Tests
Laboratory test results of laboratory abnormalities in hepatic parameters during the treatment period per CTCAE (Version 4) in SI units.
Abnormalities in Specific Thyroid Tests
Laboratory test results of laboratory abnormalities in specific thyroid tests during the treatment period per CTCAE (Version 4) in SI units.

Full Information

First Posted
January 24, 2018
Last Updated
March 22, 2023
Sponsor
Bristol-Myers Squibb
Collaborators
Ono Pharmaceutical Co. Ltd
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1. Study Identification

Unique Protocol Identification Number
NCT03414983
Brief Title
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
Acronym
CheckMate 9X8
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Completed
Study Start Date
February 20, 2018 (Actual)
Primary Completion Date
February 1, 2021 (Actual)
Study Completion Date
December 28, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bristol-Myers Squibb
Collaborators
Ono Pharmaceutical Co. Ltd

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
196 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Arm A
Arm Type
Experimental
Arm Description
Nivo + SOC
Arm Title
Arm B
Arm Type
Active Comparator
Arm Description
SOC
Intervention Type
Biological
Intervention Name(s)
Nivolumab
Other Intervention Name(s)
BMS-936558, Opdivo
Intervention Description
Specified dose on specified days
Intervention Type
Drug
Intervention Name(s)
Oxaliplatin
Intervention Description
Specified dose on specified days
Intervention Type
Drug
Intervention Name(s)
Leucovorin
Other Intervention Name(s)
Calcium Folinate
Intervention Description
Specified dose on specified days
Intervention Type
Drug
Intervention Name(s)
Fluorouracil
Intervention Description
Specified dose on specified days
Intervention Type
Drug
Intervention Name(s)
Bevacizumab
Other Intervention Name(s)
Avastin
Intervention Description
Specified dose on specified days
Primary Outcome Measure Information:
Title
Progression Free Survival (PFS) Per Blinded Independent Central Review (BICR)
Description
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.
Time Frame
From randomization to up to the date of the first documented progression (up to 16 months)
Secondary Outcome Measure Information:
Title
Objective Response Rate (ORR) Per Blinded Independent Central Review (BICR)
Description
ORR is defined as the percentage of participants with a best overall response (BOR) of complete response (CR) or partial response (PR). BOR is defined as the best response designation as determined by BICR per RECIST 1.1, recorded between the date of randomization and the date of objectively documented progression per RECIST 1.1 or the date of subsequent anticancer therapy (including tumor-directed radiotherapy and tumor-directed surgery), whichever occurs first. PR is defined as at least a 30% decrease in the sum of diameters of target lesions. CR is defined as the disappearance of all target lesions and the reduction of any pathological lymph nodes to <10 mm.
Time Frame
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 36 months)
Title
Objective Response Rate (ORR) Per Investigator Assessment
Description
ORR is defined as the percentage of participants with a best overall response (BOR) of complete response (CR) or partial response (PR). BOR is defined as the best response designation as determined by tumor assessments by the Investigator per RECIST 1.1, recorded between the date of randomization and the date of objectively documented progression per RECIST 1.1 or the date of subsequent anticancer therapy (including tumor-directed radiotherapy and tumor-directed surgery), whichever occurs first. PR is defined as at least a 30% decrease in the sum of diameters of target lesions. CR is defined as the disappearance of all target lesions and the reduction of any pathological lymph nodes to <10 mm.
Time Frame
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 36 months)
Title
Progression Free Survival (PFS) Per Investigator Assessment
Description
PFS is defined as the time from randomization to the date of the first documented progression, as determined by tumor assessments by the Investigator, or death due to any cause, whichever occurs first.
Time Frame
From randomization up to the date of the first documented progression (up to 16 months)
Title
Time to Objective Response Per Blinded Independent Central Review (BICR)
Description
Time to objective response (TTR) is defined as the time from the randomization date to the date of the first confirmed CR or PR (as assessed by BICR and as assessed by investigator). TTR is derived for responders only.
Time Frame
From the randomization date up to the date of the first confirmed CR or PR (up to 36 months)
Title
Time to Objective Response Per Investigator Assessment
Description
TTR is defined as the time from the randomization date to the date of the first confirmed CR or PR (as assessed by BICR and as assessed by investigator). TTR is derived for responders only.
Time Frame
From the randomization date up to the date of the first confirmed CR or PR (up to 36 months)
Title
Duration of Response (DoR) Per Blinded Independent Central Review (BICR)
Description
Duration of objective response (DoR) is defined as the time between the date of first confirmed response to the date of the first documented tumor progression as assessed by the BICR based on RECIST 1.1 criteria or death due to any cause, whichever occurs first.
Time Frame
From the date of first confirmed response (CR or PR) up to the date of the first documented progression (per RECIST 1.1) or death due to any cause, whichever occurs first (up to 14 months)
Title
Duration of Response (DoR) Per Investigator Assessment
Description
Duration of objective response (DoR) is defined as the time between the date of first confirmed response to the date of the first documented tumor progression as assessed by the investigator based on RECIST 1.1 criteria or death due to any cause, whichever occurs first.
Time Frame
From the date of first confirmed response (CR or PR) up to the date of the first documented progression (per RECIST 1.1) or death due to any cause, whichever occurs first (up to 15 months)
Title
Overall Survival (OS) Summary
Description
OS is defined as the time from the date of randomization to the date of death. A participant who has not died will be censored at last known date alive.
Time Frame
From the date of randomization up to the date of death (up to 36 months)
Title
Number of Participants With Adverse Events (AEs)
Description
Number of participants with any grade of adverse events (AEs) graded by Common Terminology Criteria for Adverse Events (CTCAE v4.0) to determine safety and tolerability
Time Frame
From first dose to 30 days post last dose (up to 35 months)
Title
Number of Participants With Serious Adverse Events (SAEs)
Description
Number of participants with any grade of serious adverse events (AEs) graded by Common Terminology Criteria for Adverse Events (CTCAE v4.0) to determine safety and tolerability
Time Frame
From first dose to 30 days post last dose (up to 35 months)
Title
Deaths
Description
The number of participants who died during the treatment period
Time Frame
From first dose up to 6 weeks post last dose (up to 36 months)
Title
Abnormalities in Specific Liver Tests
Description
Laboratory test results of laboratory abnormalities in hepatic parameters during the treatment period per CTCAE (Version 4) in SI units.
Time Frame
From first dose up to 30 days post last dose (up to 35 months)
Title
Abnormalities in Specific Thyroid Tests
Description
Laboratory test results of laboratory abnormalities in specific thyroid tests during the treatment period per CTCAE (Version 4) in SI units.
Time Frame
From first dose up to 30 days post last dose (up to 35 months)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Histologically confirmed metastatic colorectal cancer, not amenable to curative resection No prior chemotherapy for metastatic colorectal cancer ECOG Performance Status of 0-1 Ability to provide adequate tissue sample Exclusion Criteria: Patients with clinically relevant medical history, including autoimmune disease, cardiovascular disease, hepatic disease or bleeding disorders Prior treatment with an anti-PD-1, anti-PD-L1, anti-PD-L2, or anti-CTLA-4 antibody, or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways Any positive test result for hepatitis B virus or hepatitis C virus indicating presence of virus Other protocol-defined inclusion/exclusion criteria apply
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bristol-Myers Squibb
Organizational Affiliation
Bristol-Myers Suibb
Official's Role
Study Director
Facility Information:
Facility Name
Uab Comprehensive Cancer Center
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294-3300
Country
United States
Facility Name
Local Institution - 0004
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033
Country
United States
Facility Name
Local Institution - 0010
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Facility Name
Local Institution - 0027
City
Denver
State/Province
Colorado
ZIP/Postal Code
80218
Country
United States
Facility Name
Local Institution - 0020
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06520
Country
United States
Facility Name
Local Institution - 0039
City
Miami
State/Province
Florida
ZIP/Postal Code
33176
Country
United States
Facility Name
Local Institution - 0047
City
Saint Petersburg
State/Province
Florida
ZIP/Postal Code
33705
Country
United States
Facility Name
Local Institution - 0033
City
Arlington Heights
State/Province
Illinois
ZIP/Postal Code
60005
Country
United States
Facility Name
Local Institution - 0044
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46260
Country
United States
Facility Name
Local Institution - 0021
City
Bethesda
State/Province
Maryland
ZIP/Postal Code
20817
Country
United States
Facility Name
Local Institution - 0003
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Facility Name
Local Institution - 0049
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Facility Name
Local Institution - 0052
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Facility Name
Local Institution - 0053
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Facility Name
Local Institution - 0035
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55404
Country
United States
Facility Name
Local Institution - 0002
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Facility Name
Local Institution - 0032
City
Papillion
State/Province
Nebraska
ZIP/Postal Code
68046
Country
United States
Facility Name
Local Institution - 0029
City
Henderson
State/Province
Nevada
ZIP/Postal Code
89074
Country
United States
Facility Name
Local Institution - 0031
City
Johnson City
State/Province
New York
ZIP/Postal Code
13790
Country
United States
Facility Name
Local Institution - 0046
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Facility Name
Levine Cancer Institute
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28262
Country
United States
Facility Name
Local Institution - 0038
City
Portland
State/Province
Oregon
ZIP/Postal Code
97227
Country
United States
Facility Name
Local Institution - 0005
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
Local Institution - 0024
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15212
Country
United States
Facility Name
Local Institution - 0023
City
Sioux Falls
State/Province
South Dakota
ZIP/Postal Code
57104
Country
United States
Facility Name
Erlanger Oncology & Hematology - Univ. of TN
City
Chattanooga
State/Province
Tennessee
ZIP/Postal Code
37403
Country
United States
Facility Name
Local Institution - 0019
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37203
Country
United States
Facility Name
Local Institution - 0026
City
Bedford
State/Province
Texas
ZIP/Postal Code
76022
Country
United States
Facility Name
Local Institution - 0034
City
Dallas
State/Province
Texas
ZIP/Postal Code
75246
Country
United States
Facility Name
Local Institution - 0037
City
Fort Worth
State/Province
Texas
ZIP/Postal Code
76104
Country
United States
Facility Name
Local Institution - 0040
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78217
Country
United States
Facility Name
Local Institution - 0036
City
Tyler
State/Province
Texas
ZIP/Postal Code
75702
Country
United States
Facility Name
Local Institution - 0025
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23229
Country
United States
Facility Name
Local Institution - 0028
City
Roanoke
State/Province
Virginia
ZIP/Postal Code
24014
Country
United States
Facility Name
Local Institution - 0006
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53705
Country
United States
Facility Name
Local Institution - 0017
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T6G 1Z2
Country
Canada
Facility Name
Local Institution - 0015
City
Ottawa
State/Province
Ontario
ZIP/Postal Code
K1H 8L6
Country
Canada
Facility Name
Local Institution - 0014
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 2M9
Country
Canada
Facility Name
Local Institution - 0048
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H2X 1P1
Country
Canada
Facility Name
Local Institution - 0012
City
Quebec City
State/Province
Quebec
ZIP/Postal Code
G1J 1Z4
Country
Canada
Facility Name
Local Institution - 0013
City
Sherbrooke
State/Province
Quebec
ZIP/Postal Code
J1H 5N4
Country
Canada
Facility Name
Local Institution - 0016
City
Trois-Rivieres
State/Province
Quebec
ZIP/Postal Code
G8Z 3R9
Country
Canada
Facility Name
Local Institution - 0055
City
Nagoya
State/Province
Aichi
ZIP/Postal Code
4648681
Country
Japan
Facility Name
Local Institution - 0051
City
Kashiwa-shi
State/Province
Chiba
ZIP/Postal Code
2778577
Country
Japan
Facility Name
Local Institution - 0050
City
Sunto-gun
State/Province
Shizuoka
ZIP/Postal Code
4118777
Country
Japan
Facility Name
Local Institution - 0009
City
San Juan
ZIP/Postal Code
00927
Country
Puerto Rico
Facility Name
Local Institution - 0043
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
Facility Name
Local Institution - 0042
City
Madrid
ZIP/Postal Code
28034
Country
Spain
Facility Name
Local Institution - 0041
City
Majadahonda - Madrid
ZIP/Postal Code
28222
Country
Spain

12. IPD Sharing Statement

Links:
URL
https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html
Description
BMS Clinical Trial Information
URL
https://www.bmsstudyconnect.com/us/en/home.html
Description
BMS Clinical Trial Patient Recruiting

Learn more about this trial

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

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