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

January 29, 2024 updated by: Bristol-Myers Squibb

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

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

1

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Argentina
      • Buenos Aires, Argentina, 1061
        • Local Institution - 0062
      • Buenos Aires, Argentina, 1125
        • Local Institution - 0021
      • Buenos Aires, Argentina, 1280
        • Local Institution - 0011
      • Buenos Aires, Argentina, C1122
        • Local Institution - 0048
      • San Juan, Argentina, 5400
        • Local Institution - 0057
    • Buenos Aires
      • Pergamino, Buenos Aires, Argentina, 2700
        • Local Institution - 0009
    • Santa FE
      • Rosario, Santa FE, Argentina, S2000DEJ
        • Local Institution - 0054
  • Australia
    • New South Wales
      • Orange, New South Wales, Australia, 2800
        • Local Institution - 0063
      • Wahroonga, New South Wales, Australia
        • Local Institution - 0056
    • Victoria
      • Warrnambool, Victoria, Australia, 3280
        • Local Institution - 0052
  • Belgium
      • Charleroi, Belgium, 6000
        • Local Institution - 0040
      • Mons, Belgium, 7000
        • Local Institution - 0043
      • Sint-Niklaas, Belgium, 9100
        • Local Institution - 0019
    • Antwerpen
      • Mechelen, Antwerpen, Belgium, 2800
        • Local Institution - 0034
  • Chile
    • Metropolitana
      • Santiago, Metropolitana, Chile, 8320000
        • Local Institution - 0050
    • Valparaiso
      • Vina del Mar, Valparaiso, Chile, 2520000
        • Local Institution - 0035
      • Vina del Mar, Valparaiso, Chile, 2520598
        • Local Institution - 0015
  • France
      • Limoges, France, 87042
        • Local Institution - 0037
      • Nantes, France, 44093
        • Local Institution - 0030
      • Pessac, France, 33604
        • Local Institution - 0044
      • Rouen, France, 76000
        • Local Institution - 0016
      • Saint Priest en Jarez, France, 42271
        • Local Institution - 0031
      • Suresnes, France, 92150
        • Local Institution - 0013
      • Toulon, France, 83056
        • Local Institution - 0042
  • Germany
      • Gera, Germany, 7548
        • Local Institution - 0017
      • Muenchen, Germany, 81925
        • Local Institution - 0023
      • Wiesbaden, Germany, 65199
        • Local Institution - 0059
    • Bayern
      • Gauting, Bayern, Germany, 82131
        • Local Institution - 0005
    • Hessen
      • Frankfurt, Hessen, Germany, 60590
        • Local Institution - 0022
  • Israel
      • Haifa, Israel, 3339419
        • Local Institution - 0064
      • Jerusalem, Israel, 91200
        • Local Institution - 0079
      • Jerusalem, Israel, 9103102
        • Local Institution - 0061
      • Jerusalem, Israel, 91200
        • Local Institution - 0078
  • Italy
      • Milano, Italy, 20133
        • Local Institution
      • Naples, Italy, 80131
        • Local Institution - 0028
      • Padova, Italy, 35128
        • Local Institution - 0001
    • MB
      • Monza, MB, Italy, 20900
        • Local Institution - 0039
    • MI
      • Rozzano, MI, Italy, 20089
        • Local Institution - 0020
  • Poland
      • Bydgoszcz, Poland, 85-796
        • Local Institution - 0024
      • Lodz, Poland, 93-338
        • Local Institution - 0003
      • Otwock, Poland, 05-400
        • Local Institution - 0038
      • Szczecin, Poland, 70-452
        • Local Institution - 0058
  • Spain
      • Alicante, Spain, 3010
        • Local Institution - 0041
      • Barcelona, Spain, 08017
        • Local Institution - 0026
      • Barcelona, Spain, 08028
        • Local Institution - 0075
      • Barcelona, Spain, 08908
        • Local Institution - 0006
      • Jaen, Spain, 23007
        • Local Institution - 0046
      • Madrid, Spain, 28040
        • Local Institution - 0032
    • Madrid
      • Majadahonda, Madrid, Spain, 28220
        • Local Institution - 0033
  • Turkey
      • Istanbul, Turkey, 34010
        • Local Institution - 0076
      • Istanbul, Turkey, 34098
        • Local Institution - 0066
      • Izmir, Turkey, 35575
        • Local Institution - 0065
      • Samsun, Turkey, 55200
        • Local Institution - 0067
      • Yuregir, Turkey, 01250
        • Local Institution - 0072
  • United States
    • Arizona
      • Tucson, Arizona, United States, 85719
        • Local Institution - 0080
    • California
      • Fountain Valley, California, United States, 92708
        • Local Institution - 0051
    • Florida
      • Fort Myers, Florida, United States, 33901
        • Local Institution - 0070
      • Gainesville, Florida, United States, 32610
        • Local Institution - 0073
      • Orange City, Florida, United States, 32763
        • Local Institution - 0036
      • Pensacola, Florida, United States, 32504
        • Local Institution - 0045
      • Port Saint Lucie, Florida, United States, 34952
        • Local Institution
      • Saint Petersburg, Florida, United States, 33705
        • Local Institution - 0068
      • Tallahassee, Florida, United States, 32308
        • Local Institution
      • West Palm Beach, Florida, United States, 33401
        • Local Institution
    • Idaho
      • Boise, Idaho, United States, 83706
        • Local Institution - 0081
      • Coeur d'Alene, Idaho, United States, 83214
        • Local Institution - 0077
    • Kentucky
      • Edgewood, Kentucky, United States, 41017
        • Local Institution - 0074
    • Michigan
      • Ann Arbor, Michigan, United States, 48109
        • Local Institution - 0002
    • New York
      • Brooklyn, New York, United States, 11220
        • Local Institution - 0049
    • South Carolina
      • Charleston, South Carolina, United States, 29414
        • Local Institution - 0012
    • Wisconsin
      • Milwaukee, Wisconsin, United States, 53226
        • Local Institution - 0053

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Arm A
Drug: Ipilimumab
Specified dose on specified days
Other Names:
  • BMS-734016
  • Yervoy
Drug: Nivolumab
Specified dose on specified days
Other Names:
  • Opdivo
  • BMS-963558
Drug: BMS-986207
Specified dose on specified days
Experimental: Arm B
Other: Placebo
Specified dose on specified days
Drug: Ipilimumab
Specified dose on specified days
Other Names:
  • BMS-734016
  • Yervoy
Drug: Nivolumab
Specified dose on specified days
Other Names:
  • Opdivo
  • BMS-963558

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progression Free Survival by BICR
Time Frame: From first dose to progression or death, 2.3 months

PFS is defined for all randomized participants as the date from randomization to the date of the documentation of disease progression by BICR or death due to any cause, whichever is earlier.

Progressive Disease (PD): At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions is also considered progression.
From first dose to progression or death, 2.3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progression Free Survival by Investigator
Time Frame: From first dose to progression or death, 2.3 months

PFS is defined for all randomized participants as the date from randomization to the date of the documentation of disease progression or death due to any cause, whichever is earlier.

Progressive Disease (PD): At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions is also considered progression.
From first dose to progression or death, 2.3 months
Overall Response Rate (ORR) by BICR
Time Frame: From first dose to progression or death, 2.3 months

ORR is defined as the percentage of participants with a confirmed Best overall response of Complete Response (CR) or Partial Response (PR) by RECIST v1.1.

Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to < 10 mm.

Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.
From first dose to progression or death, 2.3 months
Overall Response Rate (ORR) by Investigator
Time Frame: From first dose to progression or death, 2.3 months

ORR is defined as the percentage of participants with a confirmed Best overall response of Complete Response (CR) or Partial Response (PR) by RECIST v1.1.

Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to < 10 mm.

Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.
From first dose to progression or death, 2.3 months
Duration of Response (DOR) by Investigator
Time Frame: From first dose to progression or death, 2.3 months

DOR is defined for participants who have a confirmed CR or PR as the date from first documented CR or PR per RECIST v1.1 to the date of the documentation of disease progression or death due to any cause, whichever is earlier.

Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to < 10 mm.

Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.
From first dose to progression or death, 2.3 months
Overall Survival (OS)
Time Frame: From randomization to time of death, 2.3 months
OS is defined as the time from randomization to the time of death due to any cause.
From randomization to time of death, 2.3 months
Number of Participants Who Had AEs, SAEs, AEs Leading to Discontinuation and Deaths.
Time Frame: From first dose to progression or death, 2.3 months
From first dose to progression or death, 2.3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bristol-Myers Squibb

Investigators

  • Study Director: Bristol-Myers Squibb, Bristol-Myers Squibb

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 3, 2022

Primary Completion (Actual)

December 27, 2022

Study Completion (Actual)

December 27, 2022

Study Registration Dates

First Submitted

August 9, 2021

First Submitted That Met QC Criteria

August 9, 2021

First Posted (Actual)

August 13, 2021

Study Record Updates

Last Update Posted (Estimated)

February 28, 2024

Last Update Submitted That Met QC Criteria

January 29, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CA020-016
  • 2021-000039-29 (EudraCT Number)
  • U1111-1263-4850 (Other Identifier: WHO)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD 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 Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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