Clinical trial NCT03414983: 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
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
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Colorectal Cancer
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
Collaborators: name: Ono Pharmaceutical Co. Ltd
First posted: 2018-01-30
Enrollment: 196
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).


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

Primary outcomes:
measure: Progression Free Survival (PFS) Per Blinded Independent Central Review (BICR)
timeFrame: From randomization to up to the date of the first documented progression (up to 16 months)
Secondary outcomes:
measure: Progression Free Survival (PFS) Per Investigator Assessment
timeFrame: From randomization up to the date of the first documented progression (up to approximately 44 months)
measure: Objective Response Rate (ORR) Per Blinded Independent Central Review (BICR)
timeFrame: 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)
measure: Objective Response Rate (ORR) Per Investigator Assessment
timeFrame: 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)
measure: Duration of Response (DoR) Per Blinded Independent Central Review (BICR)
timeFrame: 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)
measure: Duration of Response (DoR) Per Investigator Assessment
timeFrame: 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)
measure: Time to Objective Response Per Blinded Independent Central Review (BICR)
timeFrame: From the randomization date up to the date of the first confirmed CR or PR (up to approximately 44 months)
measure: Time to Objective Response Per Investigator Assessment
timeFrame: From the randomization date up to the date of the first confirmed CR or PR (up to 44 months)
measure: Overall Survival (OS)
timeFrame: From the date of randomization up to the date of death (up to 44 months)
measure: Number of Participants With Adverse Events (AEs)
timeFrame: From first dose to 30 days post last dose (up to 45 months)
measure: Number of Participants With Serious Adverse Events (SAEs)
timeFrame: From first dose to 30 days post last dose (up to 45 months)
measure: Number of Participants Experiencing Death
timeFrame: From first dose up to 6 weeks post last dose (up to 46 months)
measure: Number of Participants With Laboratory Abnormalities in Specific Liver Tests
timeFrame: From first dose up to 30 days post last dose (up to 45 months)
measure: Number of Participants With Laboratory Abnormalities in Specific Thyroid Tests
timeFrame: From first dose up to 30 days post last dose (up to 45 months)
measure: Disease Control Rate (DCR) Per Blinded Independent Central Review (BICR)
timeFrame: 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)
measure: Disease Control Rate (DCR) Per Investigator
timeFrame: 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)
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Uab Comprehensive Cancer Center
state: Alabama
city: Los Angeles
country: United States
facility: Local Institution - 0004
state: California
city: Aurora
country: United States
facility: Local Institution - 0010
state: Colorado
city: Denver
country: United States
facility: Local Institution - 0027
state: Colorado
city: New Haven
country: United States
facility: Local Institution - 0020
state: Connecticut
city: Miami
country: United States
facility: Local Institution - 0039
state: Florida
city: Saint Petersburg
country: United States
facility: Local Institution - 0047
state: Florida
city: Arlington Heights
country: United States
facility: Local Institution - 0033
state: Illinois
city: Indianapolis
country: United States
facility: Local Institution - 0044
state: Indiana
city: Bethesda
country: United States
facility: Local Institution - 0021
state: Maryland
city: Boston
country: United States
facility: Local Institution - 0003
state: Massachusetts
city: Boston
country: United States
facility: Local Institution - 0049
state: Massachusetts
city: Boston
country: United States
facility: Local Institution - 0052
state: Massachusetts
city: Boston
country: United States
facility: Local Institution - 0053
state: Massachusetts
city: Minneapolis
country: United States
facility: Local Institution - 0035
state: Minnesota
city: Rochester
country: United States
facility: Local Institution - 0002
state: Minnesota
city: Papillion
country: United States
facility: Local Institution - 0032
state: Nebraska
city: Henderson
country: United States
facility: Local Institution - 0029
state: Nevada
city: Johnson City
country: United States
facility: Local Institution - 0031
state: New York
city: New York
country: United States
facility: Local Institution - 0046
state: New York
city: Charlotte
country: United States
facility: Levine Cancer Institute
state: North Carolina
city: Portland
country: United States
facility: Local Institution - 0038
state: Oregon
city: Philadelphia
country: United States
facility: Local Institution - 0005
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Local Institution - 0024
state: Pennsylvania
city: Sioux Falls
country: United States
facility: Local Institution - 0023
state: South Dakota
city: Chattanooga
country: United States
facility: Erlanger Oncology & Hematology - Univ. of TN
state: Tennessee
city: Nashville
country: United States
facility: Local Institution - 0019
state: Tennessee
city: Bedford
country: United States
facility: Local Institution - 0026
state: Texas
city: Dallas
country: United States
facility: Local Institution - 0034
state: Texas
city: Fort Worth
country: United States
facility: Local Institution - 0037
state: Texas
city: San Antonio
country: United States
facility: Local Institution - 0040
state: Texas
city: Tyler
country: United States
facility: Local Institution - 0036
state: Texas
city: Richmond
country: United States
facility: Local Institution - 0025
state: Virginia
city: Roanoke
country: United States
facility: Local Institution - 0028
state: Virginia
city: Madison
country: United States
facility: Local Institution - 0006
state: Wisconsin
city: Edmonton
country: Canada
facility: Local Institution - 0017
state: Alberta
city: Ottawa
country: Canada
facility: Local Institution - 0015
state: Ontario
city: Toronto
country: Canada
facility: Local Institution - 0014
state: Ontario
city: Montreal
country: Canada
facility: Local Institution - 0048
state: Quebec
city: Quebec City
country: Canada
facility: Local Institution - 0012
state: Quebec
city: Sherbrooke
country: Canada
facility: Local Institution - 0013
state: Quebec
city: Trois-Rivieres
country: Canada
facility: Local Institution - 0016
state: Quebec
city: Nagoya
country: Japan
facility: Local Institution - 0055
state: Aichi
city: Kashiwa-shi
country: Japan
facility: Local Institution - 0051
state: Chiba
city: Sunto-gun
country: Japan
facility: Local Institution - 0050
state: Shizuoka
city: San Juan
country: Puerto Rico
facility: Local Institution - 0009
city: Barcelona
country: Spain
facility: Local Institution - 0043
city: Madrid
country: Spain
facility: Local Institution - 0042
city: Majadahonda - Madrid
country: Spain
facility: Local Institution - 0041
Study officials:
affiliation: Bristol-Myers Suibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References: