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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

Primary Purpose

Non-Small Cell Lung Cancer

Status
Terminated
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Nivolumab
Ipilimumab
BMS-986207
Placebo
Sponsored by
Bristol-Myers Squibb
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Non-Small Cell Lung Cancer focused on measuring Non-Small Cell Lung Cancer, NSCLC, BMS-986207, Nivolumab, Opdivo, Ipilimumab, Yervoy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Local Institution - 0080
  • Local Institution - 0051
  • Local Institution - 0070
  • Local Institution - 0073
  • Local Institution - 0036
  • Local Institution - 0045
  • Local Institution
  • Local Institution - 0068
  • Local Institution
  • Local Institution
  • Local Institution - 0081
  • Local Institution - 0077
  • Local Institution - 0074
  • Local Institution - 0002
  • Local Institution - 0049
  • Local Institution - 0012
  • Local Institution - 0053
  • Local Institution - 0009
  • Local Institution - 0054
  • Local Institution - 0062
  • Local Institution - 0021
  • Local Institution - 0011
  • Local Institution - 0048
  • Local Institution - 0057
  • Local Institution - 0063
  • Local Institution - 0056
  • Local Institution - 0052
  • Local Institution - 0040
  • Local Institution - 0034
  • Local Institution - 0043
  • Local Institution - 0019
  • Local Institution - 0050
  • Local Institution - 0035
  • Local Institution - 0015
  • Local Institution - 0037
  • Local Institution - 0030
  • Local Institution - 0044
  • Local Institution - 0016
  • Local Institution - 0031
  • Local Institution - 0013
  • Local Institution - 0042
  • Local Institution - 0005
  • Local Institution - 0022
  • Local Institution - 0017
  • Local Institution - 0023
  • Local Institution - 0059
  • Local Institution - 0064
  • Local Institution - 0061
  • Local Institution - 0078
  • Local Institution - 0079
  • Local Institution - 0039
  • Local Institution - 0020
  • Local Institution
  • Local Institution - 0028
  • Local Institution - 0001
  • Local Institution - 0024
  • Local Institution - 0003
  • Local Institution - 0038
  • Local Institution - 0058
  • Local Institution - 0033
  • Local Institution - 0041
  • Local Institution - 0026
  • Local Institution - 0075
  • Local Institution - 0006
  • Local Institution - 0046
  • Local Institution - 0032
  • Local Institution - 0076
  • Local Institution - 0066
  • Local Institution - 0065
  • Local Institution - 0067
  • Local Institution - 0072

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Arm A

Arm B

Arm Description

Outcomes

Primary Outcome Measures

Progression-free survival (PFS) based on Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 by Blinded Independent Central Review (BICR)

Secondary Outcome Measures

PFS based on RECIST v1.1 by BICR
Incidence of adverse events (AEs)
Incidence of serious adverse events (SAEs)
Incidence of AEs leading to discontinuation
Incidence of deaths
Objective response rate (ORR) based on RECIST v1.1 by BICR
Overall Survival (OS)
PFS based on RECIST v1.1 by Investigator's assessment
PFS in subgroups based on RECIST v1.1 by BICR
PFS in subgroups based on RECIST v1.1 by investigator's assessment
ORR based on RECIST v1.1 by Investigator's assessment
Duration of Response (DOR) based on RECIST v1.1 by BICR
DOR based on RECIST v1.1 by Investigator's assessment
OS in subgroups

Full Information

First Posted
August 9, 2021
Last Updated
January 31, 2023
Sponsor
Bristol-Myers Squibb
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1. Study Identification

Unique Protocol Identification Number
NCT05005273
Brief 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
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

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Terminated
Why Stopped
The Study has been terminated due to safety reasons, adverse change in the risk/benefit.
Study Start Date
October 3, 2022 (Actual)
Primary Completion Date
December 27, 2022 (Actual)
Study Completion Date
December 27, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bristol-Myers Squibb

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-Small Cell Lung Cancer
Keywords
Non-Small Cell Lung Cancer, NSCLC, BMS-986207, Nivolumab, Opdivo, Ipilimumab, Yervoy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
1 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Arm A
Arm Type
Experimental
Arm Title
Arm B
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Nivolumab
Other Intervention Name(s)
Opdivo, BMS-963558
Intervention Description
Specified dose on specified days
Intervention Type
Drug
Intervention Name(s)
Ipilimumab
Other Intervention Name(s)
Yervoy, BMS-734016
Intervention Description
Specified dose on specified days
Intervention Type
Drug
Intervention Name(s)
BMS-986207
Intervention Description
Specified dose on specified days
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
Specified dose on specified days
Primary Outcome Measure Information:
Title
Progression-free survival (PFS) based on Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 by Blinded Independent Central Review (BICR)
Time Frame
Up to 25 months
Secondary Outcome Measure Information:
Title
PFS based on RECIST v1.1 by BICR
Time Frame
Up to 25 months
Title
Incidence of adverse events (AEs)
Time Frame
Up to 4 years
Title
Incidence of serious adverse events (SAEs)
Time Frame
Up to 4 years
Title
Incidence of AEs leading to discontinuation
Time Frame
Up to 4 years
Title
Incidence of deaths
Time Frame
Up to 4 years
Title
Objective response rate (ORR) based on RECIST v1.1 by BICR
Time Frame
Up to 25 months
Title
Overall Survival (OS)
Time Frame
Up to 30 months
Title
PFS based on RECIST v1.1 by Investigator's assessment
Time Frame
Up to 25 months
Title
PFS in subgroups based on RECIST v1.1 by BICR
Time Frame
Up to 25 months
Title
PFS in subgroups based on RECIST v1.1 by investigator's assessment
Time Frame
Up to 25 months
Title
ORR based on RECIST v1.1 by Investigator's assessment
Time Frame
Up to 25 months
Title
Duration of Response (DOR) based on RECIST v1.1 by BICR
Time Frame
Up to 25 months
Title
DOR based on RECIST v1.1 by Investigator's assessment
Time Frame
Up to 25 months
Title
OS in subgroups
Time Frame
Up to 30 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bristol-Myers Squibb
Organizational Affiliation
Bristol-Myers Squibb
Official's Role
Study Director
Facility Information:
Facility Name
Local Institution - 0080
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85719
Country
United States
Facility Name
Local Institution - 0051
City
Fountain Valley
State/Province
California
ZIP/Postal Code
92708
Country
United States
Facility Name
Local Institution - 0070
City
Fort Myers
State/Province
Florida
ZIP/Postal Code
33901
Country
United States
Facility Name
Local Institution - 0073
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32610
Country
United States
Facility Name
Local Institution - 0036
City
Orange City
State/Province
Florida
ZIP/Postal Code
32763
Country
United States
Facility Name
Local Institution - 0045
City
Pensacola
State/Province
Florida
ZIP/Postal Code
32504
Country
United States
Facility Name
Local Institution
City
Port Saint Lucie
State/Province
Florida
ZIP/Postal Code
34952
Country
United States
Facility Name
Local Institution - 0068
City
Saint Petersburg
State/Province
Florida
ZIP/Postal Code
33705
Country
United States
Facility Name
Local Institution
City
Tallahassee
State/Province
Florida
ZIP/Postal Code
32308
Country
United States
Facility Name
Local Institution
City
West Palm Beach
State/Province
Florida
ZIP/Postal Code
33401
Country
United States
Facility Name
Local Institution - 0081
City
Boise
State/Province
Idaho
ZIP/Postal Code
83706
Country
United States
Facility Name
Local Institution - 0077
City
Coeur d'Alene
State/Province
Idaho
ZIP/Postal Code
83214
Country
United States
Facility Name
Local Institution - 0074
City
Edgewood
State/Province
Kentucky
ZIP/Postal Code
41017
Country
United States
Facility Name
Local Institution - 0002
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
Facility Name
Local Institution - 0049
City
Brooklyn
State/Province
New York
ZIP/Postal Code
11220
Country
United States
Facility Name
Local Institution - 0012
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29414
Country
United States
Facility Name
Local Institution - 0053
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53226
Country
United States
Facility Name
Local Institution - 0009
City
Pergamino
State/Province
Buenos Aires
ZIP/Postal Code
2700
Country
Argentina
Facility Name
Local Institution - 0054
City
Rosario
State/Province
Santa FE
ZIP/Postal Code
S2000DEJ
Country
Argentina
Facility Name
Local Institution - 0062
City
Buenos Aires
ZIP/Postal Code
1061
Country
Argentina
Facility Name
Local Institution - 0021
City
Buenos Aires
ZIP/Postal Code
1125
Country
Argentina
Facility Name
Local Institution - 0011
City
Buenos Aires
ZIP/Postal Code
1280
Country
Argentina
Facility Name
Local Institution - 0048
City
Buenos Aires
ZIP/Postal Code
C1122
Country
Argentina
Facility Name
Local Institution - 0057
City
San Juan
ZIP/Postal Code
5400
Country
Argentina
Facility Name
Local Institution - 0063
City
Orange
State/Province
New South Wales
ZIP/Postal Code
2800
Country
Australia
Facility Name
Local Institution - 0056
City
Wahroonga
State/Province
New South Wales
ZIP/Postal Code
0
Country
Australia
Facility Name
Local Institution - 0052
City
Warrnambool
State/Province
Victoria
ZIP/Postal Code
3280
Country
Australia
Facility Name
Local Institution - 0040
City
Charleroi
ZIP/Postal Code
6000
Country
Belgium
Facility Name
Local Institution - 0034
City
Mechelen
ZIP/Postal Code
2800
Country
Belgium
Facility Name
Local Institution - 0043
City
Mons
ZIP/Postal Code
7000
Country
Belgium
Facility Name
Local Institution - 0019
City
Sint-Niklaas
ZIP/Postal Code
9100
Country
Belgium
Facility Name
Local Institution - 0050
City
Santiago
State/Province
Metropolitana
ZIP/Postal Code
8320000
Country
Chile
Facility Name
Local Institution - 0035
City
Vina del Mar
State/Province
Valparaiso
ZIP/Postal Code
2520000
Country
Chile
Facility Name
Local Institution - 0015
City
Vina del Mar
State/Province
Valparaiso
ZIP/Postal Code
2520598
Country
Chile
Facility Name
Local Institution - 0037
City
Limoges
ZIP/Postal Code
87042
Country
France
Facility Name
Local Institution - 0030
City
Nantes
ZIP/Postal Code
44093
Country
France
Facility Name
Local Institution - 0044
City
Pessac
ZIP/Postal Code
33604
Country
France
Facility Name
Local Institution - 0016
City
Rouen
ZIP/Postal Code
76000
Country
France
Facility Name
Local Institution - 0031
City
Saint Priest en Jarez
ZIP/Postal Code
42271
Country
France
Facility Name
Local Institution - 0013
City
Suresnes
ZIP/Postal Code
92150
Country
France
Facility Name
Local Institution - 0042
City
Toulon
ZIP/Postal Code
83056
Country
France
Facility Name
Local Institution - 0005
City
Gauting
State/Province
Bayern
ZIP/Postal Code
82131
Country
Germany
Facility Name
Local Institution - 0022
City
Frankfurt
State/Province
Hessen
ZIP/Postal Code
60590
Country
Germany
Facility Name
Local Institution - 0017
City
Gera
ZIP/Postal Code
7548
Country
Germany
Facility Name
Local Institution - 0023
City
Muenchen
ZIP/Postal Code
81925
Country
Germany
Facility Name
Local Institution - 0059
City
Wiesbaden
ZIP/Postal Code
65199
Country
Germany
Facility Name
Local Institution - 0064
City
Haifa
ZIP/Postal Code
3339419
Country
Israel
Facility Name
Local Institution - 0061
City
Jerusalem
ZIP/Postal Code
9103102
Country
Israel
Facility Name
Local Institution - 0078
City
Jerusalem
ZIP/Postal Code
91200
Country
Israel
Facility Name
Local Institution - 0079
City
Jerusalem
ZIP/Postal Code
91200
Country
Israel
Facility Name
Local Institution - 0039
City
Monza
State/Province
MB
ZIP/Postal Code
20900
Country
Italy
Facility Name
Local Institution - 0020
City
Rozzano
State/Province
MI
ZIP/Postal Code
20089
Country
Italy
Facility Name
Local Institution
City
Milano
ZIP/Postal Code
20133
Country
Italy
Facility Name
Local Institution - 0028
City
Naples
ZIP/Postal Code
80131
Country
Italy
Facility Name
Local Institution - 0001
City
Padova
ZIP/Postal Code
35128
Country
Italy
Facility Name
Local Institution - 0024
City
Bydgoszcz
ZIP/Postal Code
85-796
Country
Poland
Facility Name
Local Institution - 0003
City
Lodz
ZIP/Postal Code
93-338
Country
Poland
Facility Name
Local Institution - 0038
City
Otwock
ZIP/Postal Code
05-400
Country
Poland
Facility Name
Local Institution - 0058
City
Szczecin
ZIP/Postal Code
70-452
Country
Poland
Facility Name
Local Institution - 0033
City
Majadahonda
State/Province
Madrid
ZIP/Postal Code
28220
Country
Spain
Facility Name
Local Institution - 0041
City
Alicante
ZIP/Postal Code
3010
Country
Spain
Facility Name
Local Institution - 0026
City
Barcelona
ZIP/Postal Code
08017
Country
Spain
Facility Name
Local Institution - 0075
City
Barcelona
ZIP/Postal Code
08028
Country
Spain
Facility Name
Local Institution - 0006
City
Barcelona
ZIP/Postal Code
08908
Country
Spain
Facility Name
Local Institution - 0046
City
Jaen
ZIP/Postal Code
23007
Country
Spain
Facility Name
Local Institution - 0032
City
Madrid
ZIP/Postal Code
28040
Country
Spain
Facility Name
Local Institution - 0076
City
Istanbul
ZIP/Postal Code
34010
Country
Turkey
Facility Name
Local Institution - 0066
City
Istanbul
ZIP/Postal Code
34098
Country
Turkey
Facility Name
Local Institution - 0065
City
Izmir
ZIP/Postal Code
35575
Country
Turkey
Facility Name
Local Institution - 0067
City
Samsun
ZIP/Postal Code
55200
Country
Turkey
Facility Name
Local Institution - 0072
City
Yuregir
ZIP/Postal Code
01250
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
BMS will provide access to individual anonymized participant data upon request from qualified researchers, and subject to certain criteria. Additional information regarding Bristol Myer Squibb's data sharing policy and process can be found at: https://www.bms.com/researchers-and-partners/clinical-trials-and-research/disclosurecommitment.html
IPD Sharing Time Frame
See Plan Description
IPD Sharing Access Criteria
See Plan Description
IPD Sharing URL
https://www.bms.com/researchers-and-partners/clinical-trials-and-research/disclosure-commitment.html
Links:
URL
https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html
Description
BMS Clinical Trial Information
URL
https://www.bmsstudyconnect.com/us/en/home.html
Description
BMS Clinical Trial Patient Recruiting

Learn more about this trial

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

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