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

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: Non-Small Cell Lung Cancer
• Intervention / Treatment: Other: Placebo; Drug: Ipilimumab; Drug: Nivolumab; Drug: BMS-986207

• Study Type: Interventional
• Enrollment (Actual): 1
• Phase: Phase 2

Contacts and Locations

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

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

How is the study designed?

Design Details

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

Number of Arms

2

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	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	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	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	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	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)	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.		From first dose to progression or death, 2.3 months

Collaborators and Investigators

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

Publications and helpful links

Helpful Links

• BMS Clinical Trial Information
• BMS Clinical Trial Patient Recruiting
• FDA Safety Alerts and Recalls

Study record dates

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: NSCLC; Non-Small Cell Lung Cancer; Nivolumab; Ipilimumab; Opdivo; Yervoy; BMS-986207
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Carcinoma, Non-Small-Cell Lung; Molecular Mechanisms of Pharmacological Action; Antineoplastic Agents; Antineoplastic Agents, Immunological; Immune Checkpoint Inhibitors; Nivolumab; Ipilimumab
• 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