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Trial record 1 of 1 for:    CA020-016
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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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05005273
Recruitment Status : Recruiting
First Posted : August 13, 2021
Last Update Posted : November 16, 2022
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb

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).

Condition or disease Intervention/treatment Phase
Non-Small Cell Lung Cancer Drug: Nivolumab Drug: Ipilimumab Drug: BMS-986207 Other: Placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 180 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
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
Actual Study Start Date : October 3, 2022
Estimated Primary Completion Date : September 14, 2024
Estimated Study Completion Date : August 14, 2026

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer

Arm Intervention/treatment
Experimental: Arm A Drug: Nivolumab
Specified dose on specified days
Other Names:
  • Opdivo
  • BMS-963558

Drug: Ipilimumab
Specified dose on specified days
Other Names:
  • Yervoy
  • BMS-734016

Drug: BMS-986207
Specified dose on specified days

Experimental: Arm B Drug: Nivolumab
Specified dose on specified days
Other Names:
  • Opdivo
  • BMS-963558

Drug: Ipilimumab
Specified dose on specified days
Other Names:
  • Yervoy
  • BMS-734016

Other: Placebo
Specified dose on specified days




Primary Outcome Measures :
  1. 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 Measures :
  1. PFS based on RECIST v1.1 by BICR [ Time Frame: Up to 25 months ]
  2. Incidence of adverse events (AEs) [ Time Frame: Up to 4 years ]
  3. Incidence of serious adverse events (SAEs) [ Time Frame: Up to 4 years ]
  4. Incidence of AEs leading to discontinuation [ Time Frame: Up to 4 years ]
  5. Incidence of deaths [ Time Frame: Up to 4 years ]
  6. Objective response rate (ORR) based on RECIST v1.1 by BICR [ Time Frame: Up to 25 months ]
  7. Overall Survival (OS) [ Time Frame: Up to 30 months ]
  8. PFS based on RECIST v1.1 by Investigator's assessment [ Time Frame: Up to 25 months ]
  9. PFS in subgroups based on RECIST v1.1 by BICR [ Time Frame: Up to 25 months ]
  10. PFS in subgroups based on RECIST v1.1 by investigator's assessment [ Time Frame: Up to 25 months ]
  11. ORR based on RECIST v1.1 by Investigator's assessment [ Time Frame: Up to 25 months ]
  12. Duration of Response (DOR) based on RECIST v1.1 by BICR [ Time Frame: Up to 25 months ]
  13. DOR based on RECIST v1.1 by Investigator's assessment [ Time Frame: Up to 25 months ]
  14. OS in subgroups [ Time Frame: Up to 30 months ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05005273


Contacts
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Contact: BMS Study Connect Contact Center www.BMSStudyConnect.com 855-907-3286 Clinical.Trials@bms.com
Contact: First line of the email MUST contain NCT # and Site #.

Locations
Show Show 75 study locations
Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
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Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
Additional Information:
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Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT05005273    
Other Study ID Numbers: CA020-016
2021-000039-29 ( EudraCT Number )
U1111-1263-4850 ( Other Identifier: WHO )
First Posted: August 13, 2021    Key Record Dates
Last Update Posted: November 16, 2022
Last Verified: November 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
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

Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Clinical Study Report (CSR)
Time Frame: See Plan Description
Access Criteria: See Plan Description
URL: https://www.bms.com/researchers-and-partners/clinical-trials-and-research/disclosure-commitment.html

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Bristol-Myers Squibb:
Non-Small Cell Lung Cancer
NSCLC
BMS-986207
Nivolumab
Opdivo
Ipilimumab
Yervoy
Additional relevant MeSH terms:
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Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Nivolumab
Ipilimumab
Antineoplastic Agents, Immunological
Antineoplastic Agents
Immune Checkpoint Inhibitors
Molecular Mechanisms of Pharmacological Action