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An Open Label Investigational Immuno-therapy Trial of Nivolumab in Cancers That Are Advanced or Have Spread (CheckMate 627)

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ClinicalTrials.gov Identifier: NCT02832167
Recruitment Status : Active, not recruiting
First Posted : July 14, 2016
Results First Posted : December 17, 2020
Last Update Posted : December 17, 2020
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb

Tracking Information
First Submitted Date  ICMJE July 8, 2016
First Posted Date  ICMJE July 14, 2016
Results First Submitted Date  ICMJE October 20, 2020
Results First Posted Date  ICMJE December 17, 2020
Last Update Posted Date December 17, 2020
Actual Study Start Date  ICMJE September 13, 2016
Actual Primary Completion Date October 20, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 19, 2020)
Objective Response Rate (ORR) [ Time Frame: From first dose to the date of objectively documented progression (per tumor-specific response criteria) or the date of subsequent therapy, whichever occurs first (approximately 24 months) ]
ORR is defined as the percentage of participants with a best overall response (BOR) of confirmed Complete Response (CR) or Partial Response (PR). Best overall response is defined as the best response designation, as determined by investigator, recorded in the specified timeframe, according to the RECIST 1.1 criteria.
Original Primary Outcome Measures  ICMJE
 (submitted: July 11, 2016)
Clinical Benefit Rate measured by radiologic tumor assessments [ Time Frame: Change from baseline to week 16 ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 19, 2020)
  • Duration of Response (DOR) [ Time Frame: From the time of first confirmed response to the date of the first documented progression (approximately 20 months) ]
    DOR is defined as the time from first confirmed response (Complete Response, CR or Partial Response, PR) to the date of the first documented tumor progression (as determined by investigator) or death due to any cause, whichever occurs first.
  • Time to Objective Response (TTR) [ Time Frame: From the first dosing date to the date of the first confirmed response (approximately 10 months) ]
    TTR is defined as the time from first dosing date to the date of the first confirmed response (Complete Response, CR or Partial Response, PR), as assessed by investigator.
  • Clinical Benefit Rate (CBR) [ Time Frame: From the first dosing date to the date of the last dose (approximately 24 months) ]
    CBR is defined as the percentage of participants with a best overall response of confirmed Complete Response (CR) or Partial Response (PR) or Stable Disease (SD).
  • Overall Survival Rate at 1 Year [ Time Frame: From the first dosing date to 1 year later ]
    Overall Survival (OS) is defined as the time from the first dosing date to the date of death. A participant who has not died will be censored at last known date alive. OS rate at 1 year is measured as the proportion of participants still alive at 1 year after first dosing, measured from Kaplan-Meier curve of OS.
  • Number of Participants Who Died [ Time Frame: From first dose to 100 days following last dose (approximately 27 months) ]
    Number of participants who died for any cause
  • Number of Participants Experiencing Adverse Events (AEs) [ Time Frame: From first dose to 30 days following the last dose (approximately 25 months) ]
    Number of participants who experienced any grade, any cause AEs
  • Number of Participants Experiencing Serious Adverse Events (SAEs) [ Time Frame: From first dose to 30 days following the last dose (approximately 25 months) ]
    Number of participants who experienced any grade, any cause SAEs
  • Number of Participants Experiencing Adverse Events (AEs) Leading to Discontinuation [ Time Frame: From first dose to 30 days following the last dose (approximately 25 months) ]
    Number of participants who experienced AEs leading to discontinuation of study therapy
  • Number of Participants Experiencing Immune-mediated Adverse Events (IMAEs) [ Time Frame: From first dose to 30 days following the last dose (approximately 25 months) ]
    Number of participants who experienced IMAEs. IMAEs are AEs consistent with an immune-mediated mechanism or immune-mediated component for which non-inflammatory etiologies (eg, infection or tumor progression) have been ruled out. IMAEs can include events with an alternate etiology which were exacerbated by the induction of autoimmunity.
  • Number of Participants Experiencing Select Adverse Events [ Time Frame: From first dose to 30 days following the last dose (approximately 25 months) ]
    Number of participants who experienced Select Adverse Events. Select Adverse Events categories include: any select AEs, drug-related select AEs, serious select AEs, drug related serious select AEs, any select AEs leading to discontinuation, drug-related select AEs leading to discontinuation
  • Number of Participants Experiencing Adverse Events (AEs) Leading to Dose Delay [ Time Frame: From first dose to 30 days following the last dose (approximately 25 months) ]
    Number of participants who experienced AEs leading to dose delay. A dose will be considered as delayed if the delay is exceeding 3 days after the intended dose date (i.e., greater than or equal to 4 days from scheduled dosing date)
  • Number of Participants Experiencing Specific Laboratory Abnormalities [ Time Frame: From first dose to 30 days following the last dose (approximately 25 months) ]
    Number of participants who experienced specific laboratory abnormalities (measured as change from baseline) in the following disciplines: Hematology, Serum Chemistry, Electrolytes, Abnormal Thyroid Function Test, Abnormal Hepatic Function Test
Original Secondary Outcome Measures  ICMJE
 (submitted: July 11, 2016)
  • Overall Survival rate (OS) [ Time Frame: 1 Year ]
  • Duration of clinical response [ Time Frame: Up to one year ]
  • Incidence of adverse events (AEs) [ Time Frame: Up to one year ]
    Safety and Tolerability
  • Grade of AEs [ Time Frame: Up to one year ]
    Safety and Tolerability
  • Radiologic Tumor Assessments to characterize Pseudoprogression [ Time Frame: Up to one year ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE An Open Label Investigational Immuno-therapy Trial of Nivolumab in Cancers That Are Advanced or Have Spread
Official Title  ICMJE An Open Label Phase 2 Multi-cohort Trial of Nivolumab in Advanced or Metastatic Malignancies
Brief Summary The purpose of this study is to determine whether nivolumab is an effective treatment for cancer that has advanced or has spread. Various tumor types may be eligible for enrollment.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Cancer
Intervention  ICMJE Biological: Nivolumab
Specified dose on specified days
Other Names:
  • BMS-936558
  • Opdivo
Study Arms  ICMJE Experimental: Nivolumab
Intervention: Biological: Nivolumab
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 Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: November 19, 2020)
239
Original Estimated Enrollment  ICMJE
 (submitted: July 11, 2016)
150
Estimated Study Completion Date  ICMJE July 20, 2021
Actual Primary Completion Date October 20, 2019   (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:

  • Diagnosed with advanced or metastatic malignancy
  • Received standard of care treatment for primary malignancy and standard of care treatment for relapsed cancer
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1

Exclusion Criteria:

  • Prior treatment with an antiPD1, antiPDL1, antiPDL2, antiCD137, or antiCTLA4 antibody, or any other antibody or drug specifically targeting Tcell co-stimulation or checkpoint pathways.
  • Subjects previously treated with investigational anticancer therapies less than 6 weeks prior to the first dose of Nivolumab
  • Subjects with an active, known, or suspected autoimmune disease

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 information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Germany,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02832167
Other Study ID Numbers  ICMJE CA209-627
2016-000461-23 ( 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 Not Provided
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 November 2020

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