search
Back to results

An Investigational Immuno-therapy Study of Nivolumab Given After Surgery in Non-Small Cell Lung Cancer (NSCLC) Participants With Minimal Residual Disease (CheckMate 9TN)

Primary Purpose

Non-Small Cell Lung Cancer, Non-Small-Cell Lung Carcinoma, Circulating Tumor DNA

Status
Withdrawn
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Nivolumab
Vinorelbine
Gemcitabine
Docetaxel
Pemetrexed
Cisplatin
Carboplatin
Paclitaxel
Observation
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

Eligibility Criteria

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

Inclusion Criteria prior to Surgery:

  • Suspected or histologically confirmed Stage IIA to IIIB NSCLC with disease that is considered resectable
  • Must be deemed eligible for complete resection and must agree to undergo standard of care surgery for complete resection of NSCLC
  • Treatment naive (no previous systemic treatment)

Inclusion Criteria prior to Treatment Randomization:

  • Must have undergone complete surgical resection of their Stage IIA to IIIB NSCLC
  • Must have adequately recovered from surgery at the time of randomization
  • Minimal residual disease (MRD) positive results as detected by ctDNA

Exclusion Criteria prior to Surgery:

  • Participants with known EGFR mutations which are sensitive to available targeted inhibitor therapy (Prior to treatment randomization in select sites)
  • Active, known or suspected autoimmune disease
  • Participants with a condition requiring systemic treatment with either corticosteroids (> 10 mg daily prednisone equivalent) or other immunosuppressive medications within 14 days of randomization

Exclusion Criteria prior to Treatment Randomization:

  • Must continue to meet Exclusion Criteria prior to Surgery
  • Must have no evidence of metastatic disease after surgery
  • Received a live/attenuated vaccine within 30 days of first treatment

Other protocol defined inclusion/exclusion criteria apply

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Arm A

    Arm B

    Arm Description

    Nivolumab + SOC (chemotherapy in eligible participants or observation)

    SOC (chemotherapy in eligible participants or observation)

    Outcomes

    Primary Outcome Measures

    Disease-free survival (DFS)

    Secondary Outcome Measures

    Circulating tumor DNA (ctDNA) response rate
    ctDNA duration of response (DOR)
    ctDNA time to response (TTR)
    Incidence of adverse events (AEs)
    Incidence of serious adverse events (SAEs)

    Full Information

    First Posted
    December 7, 2018
    Last Updated
    March 9, 2022
    Sponsor
    Bristol-Myers Squibb
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT03770299
    Brief Title
    An Investigational Immuno-therapy Study of Nivolumab Given After Surgery in Non-Small Cell Lung Cancer (NSCLC) Participants With Minimal Residual Disease
    Acronym
    CheckMate 9TN
    Official Title
    A Phase 2 Multi-Center Randomized Trial to Assess Early Intervention With Adjuvant Nivolumab in Non-Small Cell Lung Cancer Participants With ctDNA-detected Minimal Residual Disease After Surgical Resection
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2022
    Overall Recruitment Status
    Withdrawn
    Why Stopped
    Business objectives have changed
    Study Start Date
    January 15, 2021 (Anticipated)
    Primary Completion Date
    March 14, 2023 (Anticipated)
    Study Completion Date
    March 14, 2024 (Anticipated)

    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
    No

    5. Study Description

    Brief Summary
    The purpose of this study is to determine if nivolumab added to the standard of care therapy (SOC) given after surgery is more effective than SOC alone in prolonging disease free survival in NSCLC participants with minimal residual disease detected after surgery.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Non-Small Cell Lung Cancer, Non-Small-Cell Lung Carcinoma, Circulating Tumor DNA

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    0 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Arm A
    Arm Type
    Experimental
    Arm Description
    Nivolumab + SOC (chemotherapy in eligible participants or observation)
    Arm Title
    Arm B
    Arm Type
    Active Comparator
    Arm Description
    SOC (chemotherapy in eligible participants or observation)
    Intervention Type
    Biological
    Intervention Name(s)
    Nivolumab
    Intervention Description
    Specified dose on specified days
    Intervention Type
    Drug
    Intervention Name(s)
    Vinorelbine
    Intervention Description
    Specified dose on specified days
    Intervention Type
    Drug
    Intervention Name(s)
    Gemcitabine
    Intervention Description
    Specified dose on specified days
    Intervention Type
    Drug
    Intervention Name(s)
    Docetaxel
    Intervention Description
    Specified dose on specified days
    Intervention Type
    Drug
    Intervention Name(s)
    Pemetrexed
    Intervention Description
    Specified dose on specified days
    Intervention Type
    Drug
    Intervention Name(s)
    Cisplatin
    Intervention Description
    Specified dose on specified days
    Intervention Type
    Drug
    Intervention Name(s)
    Carboplatin
    Intervention Description
    Specified dose on specified days
    Intervention Type
    Drug
    Intervention Name(s)
    Paclitaxel
    Intervention Description
    Specified dose on specified days
    Intervention Type
    Other
    Intervention Name(s)
    Observation
    Intervention Description
    Observation by the investigator
    Primary Outcome Measure Information:
    Title
    Disease-free survival (DFS)
    Time Frame
    Approximately 24 months
    Secondary Outcome Measure Information:
    Title
    Circulating tumor DNA (ctDNA) response rate
    Time Frame
    Approximately 36 months
    Title
    ctDNA duration of response (DOR)
    Time Frame
    Approximately 36 months
    Title
    ctDNA time to response (TTR)
    Time Frame
    Approximately 36 months
    Title
    Incidence of adverse events (AEs)
    Time Frame
    Approximately 36 months
    Title
    Incidence of serious adverse events (SAEs)
    Time Frame
    Approximately 36 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria prior to Surgery: Suspected or histologically confirmed Stage IIA to IIIB NSCLC with disease that is considered resectable Must be deemed eligible for complete resection and must agree to undergo standard of care surgery for complete resection of NSCLC Treatment naive (no previous systemic treatment) Inclusion Criteria prior to Treatment Randomization: Must have undergone complete surgical resection of their Stage IIA to IIIB NSCLC Must have adequately recovered from surgery at the time of randomization Minimal residual disease (MRD) positive results as detected by ctDNA Exclusion Criteria prior to Surgery: Participants with known EGFR mutations which are sensitive to available targeted inhibitor therapy (Prior to treatment randomization in select sites) Active, known or suspected autoimmune disease Participants with a condition requiring systemic treatment with either corticosteroids (> 10 mg daily prednisone equivalent) or other immunosuppressive medications within 14 days of randomization Exclusion Criteria prior to Treatment Randomization: Must continue to meet Exclusion Criteria prior to Surgery Must have no evidence of metastatic disease after surgery Received a live/attenuated vaccine within 30 days of first treatment 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

    12. IPD Sharing Statement

    Plan to Share IPD
    Yes
    IPD Sharing Plan Description
    Individual patient level data from this study may be shared with qualified researchers, upon request, following the timelines and process detailed on https://www.bms.com/researchers-and-partners/independent-research/data-sharing-request-process.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/s/US/English/USenHome
    Description
    BMS Clinical Trial Patient Recruiting
    URL
    https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html
    Description
    Investigator Inquiry Form
    URL
    https://www.fda.gov/Safety/MedWatch/SafetyInformation/default.htm
    Description
    FDA Safety Alerts and Recalls

    Learn more about this trial

    An Investigational Immuno-therapy Study of Nivolumab Given After Surgery in Non-Small Cell Lung Cancer (NSCLC) Participants With Minimal Residual Disease

    We'll reach out to this number within 24 hrs