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OpenTrials
Completed

NCT Number: NCT02832167

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

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.

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Key information

Conditions

Cancer Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Local Institution, Berlin, Germany

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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 apply

Treatment and study plan

Nivolumab

Biological

Specified dose on specified days

Other names: BMS-936558, Opdivo

Primary outcomes

  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 (up to 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 outcomes

  1. Duration of Response (DOR)

    Time frame: From the time of first confirmed response to the date of the first documented progression (up to approximately 22 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.

    Median DOR computed using Kaplan-Meier method

  2. Time to Objective Response (TTR)

    Time frame: From the first dosing date to the date of the first confirmed response (up to 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 percent 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 (up 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 (up to 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 100 days following the last dose (up to approximately 27 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 (up to 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 100 days following the last dose (up to approximately 27 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 (up to approximately 25 months)

    Number of participants who experienced Select Adverse Events. Select Adverse Events categories include: gastrointestinal, hepatic, pulmonary, renal, skin, hypersensitivity/infusion reaction.

  11. Number of Participants Experiencing Adverse Events (AEs) Leading to Dose Delay or Dose Reduction

    Time frame: From first dose to 30 days following the last dose (up to approximately 25 months)

    Number of participants who experienced AEs leading to dose delay or dose reduction. 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 Laboratory Abnormalities in Specific Liver Tests

    Time frame: From first dose to 30 days following the last dose (up to approximately 25 months)

    Number of participants who experienced the laboratory abnormalities in specific liver tests described in the individual categories.

    ALT = Alanine Aminotransferase AST = Aspartate Aminotransferase ULN = Upper Limit of Normal

  13. Number of Participants Experiencing Laboratory Abnormalities in Specific Thyroid Tests

    Time frame: From first dose to 100 days following the last dose (up to approximately 27 months)

    Number of participants who experienced the laboratory abnormalities in specific thyroid tests described in the individual categories.

    TSH = Thyroid Stimulating Hormone LLN = Lower Limit of Normal ULN = Upper Limit of Normal

Sponsors and collaborators

Lead sponsor

Bristol-Myers Squibb

Industry

Registry information

Official study title

An Open Label Phase 2 Multi-cohort Trial of Nivolumab in Advanced or Metastatic Malignancies

Acronym: CheckMate 627

Important dates

Study start
2016
Primary completion
2019
Study completion
2021
First posted
Jul 14, 2016
Registry last updated
May 9, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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