Clinical trial NCT02060188: A Study of Nivolumab Alone or Nivolumab Combination Therapy in Colon Cancer That Has Come Back or Has Spread
Official title: A Phase 2 Clinical Trial of Nivolumab, or Nivolumab Combinations in Recurrent and Metastatic Microsatellite Instability High (MSI-H) and Non-MSI-H Colon Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Microsatellite Unstable Colorectal Cancer
Microsatellite Stable Colorectal Cancer
Mismatch Repair Proficient Colorectal Cancer
Mismatch Repair Deficient Colorectal Cancer
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2014-02-11
Enrollment: 385
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to examine if Nivolumab by itself, or Nivolumab in combination with other anti-cancer drugs, will result in meaningful tumor size reduction, in participants with colon cancer that has come back or has spread, and who have a specific biomarker in their tumors.


Eligibility criteria: Inclusion Criteria:

* Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1
* Histologically confirmed recurrent or metastatic colorectal cancer
* Measurable disease per RECIST v1.1
* Microsatellite instability expression detected by an accredited laboratory
* Participants enrolled into the C3 Cohort must have not had treatment for their metastatic disease

Exclusion Criteria:

* Active brain metastases or leptomeningeal metastases are not allowed
* Prior treatment with an anti-Programmed Death Receptor (PD)-1, anti-PD-L1, anti-PD-L2, anti-Cytotoxic T-Cell Lymphoma-4 Antigen (CTLA-4) antibody, or any other antibody or drug specifically targeting T-cell co-stimulation or immune checkpoint pathways
* Prior malignancy active within the previous 3 years except for locally curable cancers
* Participants with active, known or suspected autoimmune disease
* Participants with a condition requiring systemic treatment with either corticosteroids or other immunosuppressive medications within 14 days of study drug administration

Other protocol-defined inclusion/exclusion criteria apply

Primary outcomes:
measure: Overall Response Rate (ORR) by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 by Investigator
timeFrame: The final analysis of the primary endpoint will occur at least 6 months after the last enrolled subject's first dose of study therapy (Approximately up to 34 months)
Secondary outcomes:
measure: ORR by RECIST v1.1 by Independent Radiology Review Committee (IRRC)
timeFrame: The final analysis of the secondary endpoint will occur the time of the primary endpoint analysis (Approximately up to 34 months)
Other outcomes:
Locations:
city: Gilbert
country: United States
facility: Local Institution - 0028
state: Arizona
city: Los Angeles
country: United States
facility: Local Institution - 0004
state: California
city: San Francisco
country: United States
facility: Local Institution - 0001
state: California
city: Atlanta
country: United States
facility: Local Institution - 0008
state: Georgia
city: Boston
country: United States
facility: Local Institution - 0002
state: Massachusetts
city: Boston
country: United States
facility: Local Institution - 0036
state: Massachusetts
city: Minneapolis
country: United States
facility: Local Institution - 0034
state: Minnesota
city: Durham
country: United States
facility: Local Institution - 0024
state: North Carolina
city: Winston-Salem
country: United States
facility: Local Institution - 0029
state: North Carolina
city: Portland
country: United States
facility: Local Institution - 0005
state: Oregon
city: Allentown
country: United States
facility: Local Institution - 0041
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Local Institution - 0013
state: Pennsylvania
city: Nashville
country: United States
facility: Local Institution - 0006
state: Tennessee
city: Houston
country: United States
facility: Local Institution - 0003
state: Texas
city: Westmead
country: Australia
facility: Local Institution - 0040
state: New South Wales
city: Southport
country: Australia
facility: Local Institution - 0039
state: Queensland
city: Melbourne
country: Australia
facility: Local Institution - 0037
state: Victoria
city: Brussels
country: Belgium
facility: Local Institution - 0019
city: Brussels
country: Belgium
facility: Local Institution - 0018
city: Leuven
country: Belgium
facility: Local Institution - 0020
city: Edmonton
country: Canada
facility: Local Institution - 0027
state: Alberta
city: Toronto
country: Canada
facility: Local Institution - 0016
state: Ontario
city: Paris
country: France
facility: Local Institution - 0025
city: Dublin 4
country: Ireland
facility: Local Institution - 0022
city: Dublin 9
country: Ireland
facility: Local Institution - 0023
city: Galway
country: Ireland
facility: Local Institution - 0033
city: Candiolo, Torino
country: Italy
facility: Local Institution - 0030
city: Modena
country: Italy
facility: Local Institution - 0035
city: Padova
country: Italy
facility: Local Institution - 0032
city: Madrid
country: Spain
facility: Local Institution - 0012
city: Madrid
country: Spain
facility: Local Institution - 0010
city: Sevilla
country: Spain
facility: Local Institution - 0011
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References:
citation: Lenz HJ, Van Cutsem E, Luisa Limon M, Wong KYM, Hendlisz A, Aglietta M, Garcia-Alfonso P, Neyns B, Luppi G, Cardin DB, Dragovich T, Shah U, Abdullaev S, Gricar J, Ledeine JM, Overman MJ, Lonardi S. First-Line Nivolumab Plus Low-Dose Ipilimumab for Microsatellite Instability-High/Mismatch Repair-Deficient Metastatic Colorectal Cancer: The Phase II CheckMate 142 Study. J Clin Oncol. 2022 Jan 10;40(2):161-170. doi: 10.1200/JCO.21.01015. Epub 2021 Oct 12.
citation: Overman MJ, Lonardi S, Wong KYM, Lenz HJ, Gelsomino F, Aglietta M, Morse MA, Van Cutsem E, McDermott R, Hill A, Sawyer MB, Hendlisz A, Neyns B, Svrcek M, Moss RA, Ledeine JM, Cao ZA, Kamble S, Kopetz S, Andre T. Durable Clinical Benefit With Nivolumab Plus Ipilimumab in DNA Mismatch Repair-Deficient/Microsatellite Instability-High Metastatic Colorectal Cancer. J Clin Oncol. 2018 Mar 10;36(8):773-779. doi: 10.1200/JCO.2017.76.9901. Epub 2018 Jan 20.
citation: Overman MJ, McDermott R, Leach JL, Lonardi S, Lenz HJ, Morse MA, Desai J, Hill A, Axelson M, Moss RA, Goldberg MV, Cao ZA, Ledeine JM, Maglinte GA, Kopetz S, Andre T. Nivolumab in patients with metastatic DNA mismatch repair-deficient or microsatellite instability-high colorectal cancer (CheckMate 142): an open-label, multicentre, phase 2 study. Lancet Oncol. 2017 Sep;18(9):1182-1191. doi: 10.1016/S1470-2045(17)30422-9. Epub 2017 Jul 19.