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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05005273




Registration number
NCT05005273
Ethics application status
Date submitted
9/08/2021
Date registered
13/08/2021
Date last updated
28/02/2024

Titles & IDs
Public title
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
Scientific 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
Secondary ID [1] 0 0
2021-000039-29
Secondary ID [2] 0 0
CA020-016
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Non-Small Cell Lung Cancer 0 0
Condition category
Condition code
Cancer 0 0 0 0
Lung - Mesothelioma
Cancer 0 0 0 0
Lung - Non small cell
Cancer 0 0 0 0
Lung - Small cell

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Nivolumab
Treatment: Drugs - Ipilimumab
Treatment: Drugs - BMS-986207
Other interventions - Placebo

Experimental: Arm A -

Experimental: Arm B -


Treatment: Drugs: Nivolumab
Specified dose on specified days

Treatment: Drugs: Ipilimumab
Specified dose on specified days

Treatment: Drugs: BMS-986207
Specified dose on specified days

Other interventions: Placebo
Specified dose on specified days
Intervention code [1] 0 0
Treatment: Drugs
Intervention code [2] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Progression Free Survival by BICR
Timepoint [1] 0 0
From first dose to progression or death, 2.3 months
Secondary outcome [1] 0 0
Progression Free Survival by Investigator
Timepoint [1] 0 0
From first dose to progression or death, 2.3 months
Secondary outcome [2] 0 0
Overall Response Rate (ORR) by BICR
Timepoint [2] 0 0
From first dose to progression or death, 2.3 months
Secondary outcome [3] 0 0
Overall Response Rate (ORR) by Investigator
Timepoint [3] 0 0
From first dose to progression or death, 2.3 months
Secondary outcome [4] 0 0
Duration of Response (DOR) by Investigator
Timepoint [4] 0 0
From first dose to progression or death, 2.3 months
Secondary outcome [5] 0 0
Overall Survival (OS)
Timepoint [5] 0 0
From randomization to time of death, 2.3 months
Secondary outcome [6] 0 0
Number of Participants Who Had AEs, SAEs, AEs Leading to Discontinuation and Deaths.
Timepoint [6] 0 0
From first dose to progression or death, 2.3 months

Eligibility
Key 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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s

The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
3/10/2022
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
27/12/2022
Sample size
Target
Accrual to date
Final
1
Recruitment in Australia
Recruitment state(s)
NSW,VIC
Recruitment hospital [1] 0 0
Local Institution - 0063 - Orange
Recruitment hospital [2] 0 0
Local Institution - 0056 - Wahroonga
Recruitment hospital [3] 0 0
Local Institution - 0052 - Warrnambool
Recruitment postcode(s) [1] 0 0
2800 - Orange
Recruitment postcode(s) [2] 0 0
0 - Wahroonga
Recruitment postcode(s) [3] 0 0
3280 - Warrnambool
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arizona
Country [2] 0 0
United States of America
State/province [2] 0 0
California
Country [3] 0 0
United States of America
State/province [3] 0 0
Florida
Country [4] 0 0
United States of America
State/province [4] 0 0
Idaho
Country [5] 0 0
United States of America
State/province [5] 0 0
Kentucky
Country [6] 0 0
United States of America
State/province [6] 0 0
Michigan
Country [7] 0 0
United States of America
State/province [7] 0 0
New York
Country [8] 0 0
United States of America
State/province [8] 0 0
South Carolina
Country [9] 0 0
United States of America
State/province [9] 0 0
Wisconsin
Country [10] 0 0
Argentina
State/province [10] 0 0
Buenos Aires
Country [11] 0 0
Argentina
State/province [11] 0 0
Santa FE
Country [12] 0 0
Argentina
State/province [12] 0 0
San Juan
Country [13] 0 0
Belgium
State/province [13] 0 0
Antwerpen
Country [14] 0 0
Belgium
State/province [14] 0 0
Charleroi
Country [15] 0 0
Belgium
State/province [15] 0 0
Mons
Country [16] 0 0
Belgium
State/province [16] 0 0
Sint-Niklaas
Country [17] 0 0
Chile
State/province [17] 0 0
Metropolitana
Country [18] 0 0
Chile
State/province [18] 0 0
Valparaiso
Country [19] 0 0
France
State/province [19] 0 0
Limoges
Country [20] 0 0
France
State/province [20] 0 0
Nantes
Country [21] 0 0
France
State/province [21] 0 0
Pessac
Country [22] 0 0
France
State/province [22] 0 0
Rouen
Country [23] 0 0
France
State/province [23] 0 0
Saint Priest en Jarez
Country [24] 0 0
France
State/province [24] 0 0
Suresnes
Country [25] 0 0
France
State/province [25] 0 0
Toulon
Country [26] 0 0
Germany
State/province [26] 0 0
Bayern
Country [27] 0 0
Germany
State/province [27] 0 0
Hessen
Country [28] 0 0
Germany
State/province [28] 0 0
Gera
Country [29] 0 0
Germany
State/province [29] 0 0
Muenchen
Country [30] 0 0
Germany
State/province [30] 0 0
Wiesbaden
Country [31] 0 0
Israel
State/province [31] 0 0
Haifa
Country [32] 0 0
Israel
State/province [32] 0 0
Jerusalem
Country [33] 0 0
Italy
State/province [33] 0 0
MB
Country [34] 0 0
Italy
State/province [34] 0 0
MI
Country [35] 0 0
Italy
State/province [35] 0 0
Milano
Country [36] 0 0
Italy
State/province [36] 0 0
Naples
Country [37] 0 0
Italy
State/province [37] 0 0
Padova
Country [38] 0 0
Poland
State/province [38] 0 0
Bydgoszcz
Country [39] 0 0
Poland
State/province [39] 0 0
Lodz
Country [40] 0 0
Poland
State/province [40] 0 0
Otwock
Country [41] 0 0
Poland
State/province [41] 0 0
Szczecin
Country [42] 0 0
Spain
State/province [42] 0 0
Madrid
Country [43] 0 0
Spain
State/province [43] 0 0
Alicante
Country [44] 0 0
Spain
State/province [44] 0 0
Barcelona
Country [45] 0 0
Spain
State/province [45] 0 0
Jaen
Country [46] 0 0
Turkey
State/province [46] 0 0
Istanbul
Country [47] 0 0
Turkey
State/province [47] 0 0
Izmir
Country [48] 0 0
Turkey
State/province [48] 0 0
Samsun
Country [49] 0 0
Turkey
State/province [49] 0 0
Yuregir

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Bristol-Myers Squibb
Address
Country

Ethics approval
Ethics application status

Summary
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).
Trial website
https://clinicaltrials.gov/study/NCT05005273
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Bristol-Myers Squibb
Address 0 0
Bristol-Myers Squibb
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT05005273