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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

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.

Condition or disease Intervention/treatment Phase
Cancer Biological: Nivolumab Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 239 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open Label Phase 2 Multi-cohort Trial of Nivolumab in Advanced or Metastatic Malignancies
Actual Study Start Date : September 13, 2016
Actual Primary Completion Date : October 20, 2019
Estimated Study Completion Date : July 20, 2021

Resource links provided by the National Library of Medicine

Drug Information available for: Nivolumab

Arm Intervention/treatment
Experimental: Nivolumab Biological: Nivolumab
Specified dose on specified days
Other Names:
  • BMS-936558
  • Opdivo




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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).

  4. 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.

  5. 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

  6. 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

  7. 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

  8. 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

  9. 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.

  10. 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

  11. 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)

  12. 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



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

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


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): NCT02832167


Locations
Show Show 45 study locations
Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
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Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
  Study Documents (Full-Text)

Documents provided by Bristol-Myers Squibb:
Study Protocol  [PDF] May 31, 2018
Statistical Analysis Plan  [PDF] June 24, 2018

Additional Information:
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Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT02832167    
Other Study ID Numbers: CA209-627
2016-000461-23 ( EudraCT Number )
First Posted: July 14, 2016    Key Record Dates
Results First Posted: December 17, 2020
Last Update Posted: December 17, 2020
Last Verified: November 2020

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Nivolumab
Antineoplastic Agents, Immunological
Antineoplastic Agents