Clinical trial NCT05005273: A Study to Assess BMS-986207 in Combination With Nivolumab and Ipilimumab as First-line Treatment for Participants With Stage IV Non-Small Cell Lung Cancer
Official title: A Phase 2 Randomized Study of BMS-986207 in Combination With Nivolumab and Ipilimumab as First-line Treatment for Participants With Stage IV Non-Small Cell Lung Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Non-Small Cell Lung Cancer
Keywords: Non-Small Cell Lung Cancer
NSCLC
BMS-986207
Nivolumab
Opdivo
Ipilimumab
Yervoy
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2021-08-13
Enrollment: 1
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: The purpose of this study is to determine the safety and efficacy of BMS-986207 in combination with nivolumab and ipilimumab as first-line treatment for participants with stage IV non-small cell lung cancer (NSCLC).


Eligibility criteria: Inclusion Criteria:

* Histologically confirmed metastatic 1L Stage IV non-small cell lung cancer (NSCLC) of squamous or nonsquamous histology
* No prior systemic anti-cancer treatment given as primary therapy for advanced or metastatic NSCLC
* Measurable disease as per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
* Eastern Cooperative Oncology Group (ECOG) performance status 0-1
* A formalin-fixed, paraffin-embedded (FFPE) tumor tissue block or a minimum of 20 unstained slides of tumor tissue obtained during screening or prior to enrollment
* Life expectancy of at least 3 months at the time of first dose

Exclusion Criteria:

* Participants with epidermal growth factor receptor (EGFR), anaplastic lymphoma kinase (ALK), or c-ros oncogene 1 (ROS-1) mutations which are sensitive to available targeted inhibitor therapy. Participants with nonsquamous histology and unknown EGFR, ALK, or ROS-1 status are also excluded
* Participants with known B-rapidly accelerated fibrosarcoma proto-oncogene (BRAF) V600E mutations that are sensitive to available targeted inhibitor therapy. Participants with unknown or indeterminate BRAF mutation status are eligible.
* Untreated central nervous system metastases
* Leptomeningeal metastases (carcinomatous meningitis)
* Concurrent malignancy requiring treatment
* Active, known, or suspected autoimmune disease
* Interstitial lung disease
* Uncontrolled or significant cardiovascular disease

Other protocol-defined inclusion/exclusion criteria apply

Primary outcomes:
measure: Progression Free Survival by BICR
timeFrame: From first dose to progression or death, 2.3 months
Secondary outcomes:
measure: Progression Free Survival by Investigator
timeFrame: From first dose to progression or death, 2.3 months
measure: Overall Response Rate (ORR) by BICR
timeFrame: From first dose to progression or death, 2.3 months
measure: Overall Response Rate (ORR) by Investigator
timeFrame: From first dose to progression or death, 2.3 months
measure: Duration of Response (DOR) by Investigator
timeFrame: From first dose to progression or death, 2.3 months
measure: Overall Survival (OS)
timeFrame: From randomization to time of death, 2.3 months
measure: Number of Participants Who Had AEs, SAEs, AEs Leading to Discontinuation and Deaths.
timeFrame: From first dose to progression or death, 2.3 months
Other outcomes:
Locations:
city: Tucson
country: United States
facility: Local Institution - 0080
state: Arizona
city: Fountain Valley
country: United States
facility: Local Institution - 0051
state: California
city: Fort Myers
country: United States
facility: Local Institution - 0070
state: Florida
city: Gainesville
country: United States
facility: Local Institution - 0073
state: Florida
city: Orange City
country: United States
facility: Local Institution - 0036
state: Florida
city: Pensacola
country: United States
facility: Local Institution - 0045
state: Florida
city: Port Saint Lucie
country: United States
facility: Local Institution
state: Florida
city: Saint Petersburg
country: United States
facility: Local Institution - 0068
state: Florida
city: Tallahassee
country: United States
facility: Local Institution
state: Florida
city: West Palm Beach
country: United States
facility: Local Institution
state: Florida
city: Boise
country: United States
facility: Local Institution - 0081
state: Idaho
city: Coeur d'Alene
country: United States
facility: Local Institution - 0077
state: Idaho
city: Edgewood
country: United States
facility: Local Institution - 0074
state: Kentucky
city: Ann Arbor
country: United States
facility: Local Institution - 0002
state: Michigan
city: Brooklyn
country: United States
facility: Local Institution - 0049
state: New York
city: Charleston
country: United States
facility: Local Institution - 0012
state: South Carolina
city: Milwaukee
country: United States
facility: Local Institution - 0053
state: Wisconsin
city: Pergamino
country: Argentina
facility: Local Institution - 0009
state: Buenos Aires
city: Rosario
country: Argentina
facility: Local Institution - 0054
state: Santa FE
city: Buenos Aires
country: Argentina
facility: Local Institution - 0062
city: Buenos Aires
country: Argentina
facility: Local Institution - 0021
city: Buenos Aires
country: Argentina
facility: Local Institution - 0011
city: Buenos Aires
country: Argentina
facility: Local Institution - 0048
city: San Juan
country: Argentina
facility: Local Institution - 0057
city: Orange
country: Australia
facility: Local Institution - 0063
state: New South Wales
city: Wahroonga
country: Australia
facility: Local Institution - 0056
state: New South Wales
city: Warrnambool
country: Australia
facility: Local Institution - 0052
state: Victoria
city: Mechelen
country: Belgium
facility: Local Institution - 0034
state: Antwerpen
city: Charleroi
country: Belgium
facility: Local Institution - 0040
city: Mons
country: Belgium
facility: Local Institution - 0043
city: Sint-Niklaas
country: Belgium
facility: Local Institution - 0019
city: Santiago
country: Chile
facility: Local Institution - 0050
state: Metropolitana
city: Vina del Mar
country: Chile
facility: Local Institution - 0035
state: Valparaiso
city: Vina del Mar
country: Chile
facility: Local Institution - 0015
state: Valparaiso
city: Limoges
country: France
facility: Local Institution - 0037
city: Nantes
country: France
facility: Local Institution - 0030
city: Pessac
country: France
facility: Local Institution - 0044
city: Rouen
country: France
facility: Local Institution - 0016
city: Saint Priest en Jarez
country: France
facility: Local Institution - 0031
city: Suresnes
country: France
facility: Local Institution - 0013
city: Toulon
country: France
facility: Local Institution - 0042
city: Gauting
country: Germany
facility: Local Institution - 0005
state: Bayern
city: Frankfurt
country: Germany
facility: Local Institution - 0022
state: Hessen
city: Gera
country: Germany
facility: Local Institution - 0017
city: Muenchen
country: Germany
facility: Local Institution - 0023
city: Wiesbaden
country: Germany
facility: Local Institution - 0059
city: Haifa
country: Israel
facility: Local Institution - 0064
city: Jerusalem
country: Israel
facility: Local Institution - 0061
city: Jerusalem
country: Israel
facility: Local Institution - 0078
city: Jerusalem
country: Israel
facility: Local Institution - 0079
city: Monza
country: Italy
facility: Local Institution - 0039
state: MB
city: Rozzano
country: Italy
facility: Local Institution - 0020
state: MI
city: Milano
country: Italy
facility: Local Institution
city: Naples
country: Italy
facility: Local Institution - 0028
city: Padova
country: Italy
facility: Local Institution - 0001
city: Bydgoszcz
country: Poland
facility: Local Institution - 0024
city: Lodz
country: Poland
facility: Local Institution - 0003
city: Otwock
country: Poland
facility: Local Institution - 0038
city: Szczecin
country: Poland
facility: Local Institution - 0058
city: Majadahonda
country: Spain
facility: Local Institution - 0033
state: Madrid
city: Alicante
country: Spain
facility: Local Institution - 0041
city: Barcelona
country: Spain
facility: Local Institution - 0026
city: Barcelona
country: Spain
facility: Local Institution - 0075
city: Barcelona
country: Spain
facility: Local Institution - 0006
city: Jaen
country: Spain
facility: Local Institution - 0046
city: Madrid
country: Spain
facility: Local Institution - 0032
city: Istanbul
country: Turkey
facility: Local Institution - 0076
city: Istanbul
country: Turkey
facility: Local Institution - 0066
city: Izmir
country: Turkey
facility: Local Institution - 0065
city: Samsun
country: Turkey
facility: Local Institution - 0067
city: Yuregir
country: Turkey
facility: Local Institution - 0072
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References: