Clinical trial NCT03001882: An Exploratory Study of the Effects of Nivolumab Combined With Ipilimumab in Patients With Treatment-Naive Stage IV or Recurrent Non-Small Cell Lung Cancer (NSCLC)
Official title: An Exploratory Study of the Biologic Effects and Biomarkers of Nivolumab in Combination With Ipilimumab in Subjects With Treatment-Naive Stage IV or Recurrent Non-Small Cell Lung Cancer (NSCLC)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Non-Small Cell Lung Cancer
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
Collaborators: name: Yale University
First posted: 2016-12-23
Enrollment: 230
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to explore the possible links between participant characteristics and their cancer, with how effective the combination of nivolumab with ipilimumab is, in participants with Stage IV or recurrent Non-Small Cell Lung Cancer (NSCLC).


Eligibility criteria: Inclusion Criteria:

* Histologically confirmed, stage IV or recurrent non-small cell lung cancer with no prior systemic anticancer therapy given as primary therapy for advanced or metastatic disease
* Measurable disease by CT or MRI
* Must have full activity or, if limited, must be able to walk and carry out light activities such as light house work or office work

Exclusion Criteria:

* Participants with untreated central nervous system metastases
* Participants with active, known or suspected autoimmune disease
* Prior treatment with any drug that targets T cell co-stimulations pathways (such as checkpoint inhibitors)

Other protocol defined inclusion/exclusion criteria apply

Primary outcomes:
measure: Objective Response Rate (ORR) Per Investigator by Blood TMB (bTMB) Within PD-L1 Subgroup (TMB Cut-point = 16 Mutations/MB)
timeFrame: From first dose up to the date of objectively documented progression, or the date of initiation of palliative local therapy or the date of initiation of subsequent anticancer therapy (up to approximately 58 months)
measure: Objective Response Rate (ORR) Per Investigator by Blood TMB (bTMB) Within PD-L1 Subgroup (Blood TMB Cut-point = 21-mutations/MB)
timeFrame: From first dose up to the date of objectively documented progression, or the date of initiation of palliative local therapy or the date of initiation of subsequent anticancer therapy (up to approximately 58 months)
measure: Objective Response Rate (ORR) Per Investigator by Tissue TMB Within PD-L1 Subgroup (Tissue TMB Cut-point = 10-mutations/MB)
timeFrame: From first dose up to the date of objectively documented progression, or the date of initiation of palliative local therapy or the date of initiation of subsequent anticancer therapy (up to approximately 58 months)
Secondary outcomes:
measure: Objective Response Rate (ORR) for All Treated Participants by Investigator Per RECIST 1.1
timeFrame: From first dose until the date of objectively documented progression, or the date of initiation of palliative local therapy or the date of initiation of subsequent anticancer therapy, whichever occurs first (Up to approximately 67 months)
measure: Disease Control Rate (DCR) for Part 1
timeFrame: From first dose until the date of objectively documented progression, or the date of initiation of palliative local therapy or the date of initiation of subsequent anticancer therapy, whichever occurs first (Up to approximately 67 months)
measure: Duration of Response (DOR) for Part 1
timeFrame: From first dose to the date of the first documented tumor progression or death due to any cause (Up to approximately 67 months)
measure: Time to Response (TTR) for Part 1
timeFrame: From first dose to the time the criteria for Complete Response/Partial Response are first met (Up to approximately 67 months)
measure: Progression Free Survival (PFS)
timeFrame: From first dose to the date of the first documented tumor progression or death due to any causes (Assessed up to approximately 67 months)
measure: Overall Survival (OS)
timeFrame: From first dose to the date of death (Assessed up to approximately 67 months)
measure: Number of Participants With Adverse Events (AEs) for Study Part 2
timeFrame: From first dose to 30 days after last dosing date (assessed up to approximately 27 months)
measure: Number of Participants With Serious Adverse Events (SAEs) for Study Part 2
timeFrame: From first dose to 30 days after last dosing date (assessed up to approximately 27 months)
measure: Number of Participants With Select Adverse Events (AEs) for Study Part 2
timeFrame: From first dose to 30 days after last dosing date (up to approximately 27 months)
Other outcomes:
Locations:
city: Springdale
country: United States
facility: Local Institution - 0006
state: Arkansas
city: New Haven
country: United States
facility: Local Institution - 0001
state: Connecticut
city: Jacksonville
country: United States
facility: Local Institution - 0005
state: Florida
city: Atlanta
country: United States
facility: Local Institution - 0009
state: Georgia
city: Saint Louis
country: United States
facility: Local Institution - 0003
state: Missouri
city: Bronx
country: United States
facility: Local Institution - 0038
state: New York
city: Cleveland
country: United States
facility: Local Institution - 0002
state: Ohio
city: Cleveland
country: United States
facility: Local Institution - 0008
state: Ohio
city: Greenville
country: United States
facility: Local Institution - 0007
state: South Carolina
city: Nashville
country: United States
facility: Local Institution - 0004
state: Tennessee
city: La Louvière
country: Belgium
facility: Local Institution - 0017
state: Hainaut
city: Gent
country: Belgium
facility: Local Institution - 0018
city: Gent
country: Belgium
facility: Local Institution - 0028
city: Liege
country: Belgium
facility: Local Institution - 0027
city: Sint-Niklaas
country: Belgium
facility: Local Institution - 0016
city: Paris Cedex 5
country: France
facility: Local Institution - 0036
city: Pierre Benite
country: France
facility: Local Institution - 0033
city: Strasbourg Cedex
country: France
facility: Local Institution - 0034
city: Toulon
country: France
facility: Local Institution - 0039
city: Essen
country: Germany
facility: Local Institution - 0015
city: Immenstadt
country: Germany
facility: Local Institution - 0014
city: Loewenstein
country: Germany
facility: Local Institution - 0013
city: Stuttgart
country: Germany
facility: Local Institution - 0012
city: Bergamo
country: Italy
facility: Local Institution - 0023
city: Catania
country: Italy
facility: Local Institution - 0025
city: Parma
country: Italy
facility: Local Institution - 0026
city: Perugia
country: Italy
facility: Local Institution - 0024
city: Amsterdam
country: Netherlands
facility: Local Institution - 0021
city: Nijmegen
country: Netherlands
facility: Local Institution - 0022
city: Cluj-Napoca
country: Romania
facility: Local Institution - 0011
state: Cluj
city: Craiova
country: Romania
facility: Local Institution - 0010
city: Barcelona
country: Spain
facility: Local Institution - 0031
city: Madrid
country: Spain
facility: Local Institution - 0029
city: Madrid
country: Spain
facility: Local Institution - 0030
city: Sevilla
country: Spain
facility: Local Institution - 0032
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References: