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

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ClinicalTrials.gov Identifier: NCT03770299
Recruitment Status : Not yet recruiting
First Posted : December 10, 2018
Last Update Posted : September 25, 2019
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb

Tracking Information
First Submitted Date  ICMJE December 7, 2018
First Posted Date  ICMJE December 10, 2018
Last Update Posted Date September 25, 2019
Estimated Study Start Date  ICMJE June 15, 2020
Estimated Primary Completion Date March 14, 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 7, 2018)
Disease-free survival (DFS) [ Time Frame: Approximately 24 months ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03770299 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: December 7, 2018)
  • Circulating tumor DNA (ctDNA) response rate [ Time Frame: Approximately 36 months ]
  • ctDNA duration of response (DOR) [ Time Frame: Approximately 36 months ]
  • ctDNA time to response (TTR) [ Time Frame: Approximately 36 months ]
  • Incidence of adverse events (AEs) [ Time Frame: Approximately 36 months ]
  • Incidence of serious adverse events (SAEs) [ Time Frame: Approximately 36 months ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE An Investigational Immuno-therapy Study of Nivolumab Given After Surgery in Non-Small Cell Lung Cancer (NSCLC) Participants With Minimal Residual Disease
Official Title  ICMJE 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
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Non-Small Cell Lung Cancer
  • Non-Small-Cell Lung Carcinoma
  • Circulating Tumor DNA
Intervention  ICMJE
  • Biological: Nivolumab
    Specified dose on specified days
  • Drug: Vinorelbine
    Specified dose on specified days
  • Drug: Gemcitabine
    Specified dose on specified days
  • Drug: Docetaxel
    Specified dose on specified days
  • Drug: Pemetrexed
    Specified dose on specified days
  • Drug: Cisplatin
    Specified dose on specified days
  • Drug: Carboplatin
    Specified dose on specified days
  • Drug: Paclitaxel
    Specified dose on specified days
  • Other: Observation
    Observation by the investigator
Study Arms  ICMJE
  • Experimental: Arm A
    Nivolumab + SOC (chemotherapy in eligible participants or observation)
    Interventions:
    • Biological: Nivolumab
    • Drug: Vinorelbine
    • Drug: Gemcitabine
    • Drug: Docetaxel
    • Drug: Pemetrexed
    • Drug: Cisplatin
    • Drug: Carboplatin
    • Drug: Paclitaxel
    • Other: Observation
  • Active Comparator: Arm B
    SOC (chemotherapy in eligible participants or observation)
    Interventions:
    • Drug: Vinorelbine
    • Drug: Gemcitabine
    • Drug: Docetaxel
    • Drug: Pemetrexed
    • Drug: Cisplatin
    • Drug: Carboplatin
    • Drug: Paclitaxel
    • Other: Observation
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: December 7, 2018)
60
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE March 14, 2024
Estimated Primary Completion Date March 14, 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com

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 could apply

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Recruiting sites have contact information. Please contact the sites directly. If there is no contact information, please email: ClinicalTrials@bms.com
Contact: First line of the email MUST contain NCT # and Site #.
Listed Location Countries  ICMJE Germany,   Switzerland,   United Kingdom,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03770299
Other Study ID Numbers  ICMJE CA209-9TN
2018-003719-23 ( EudraCT Number )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
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
Responsible Party Bristol-Myers Squibb
Study Sponsor  ICMJE Bristol-Myers Squibb
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
PRS Account Bristol-Myers Squibb
Verification Date September 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP