AzTrials
AzTrials

CancerPhase 2CheckMate 627NCT02832167

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

A Phase 2 study testing Nivolumab in people with Cancer, run by Bristol-Myers Squibb at 45 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Cancer
What is being tested?
Nivolumab
Could I receive a placebo?
No, everyone receives an active treatment
How many people
239 participants
Where
45 sitesin 2 countries
Study dates
22 Feb 2016to 24 Jun 2021
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

45 sites in 2 countries.

45 sites in 2 countries

United States39 sites

  • USOR - New York Oncology Hematology, P.C.

    Albany, New York, 12206

  • CBCC Global Research, Inc. at Comprehensive Blood and Cancer Center

    Bakersfield, California, 93309

  • Maryland Oncology Hematology P.A.

    Columbia, Maryland, 21044

  • Texas Oncology - Baylor Charles A. Simmons Cancer Center

    Dallas, Texas, 75246

  • Rocky Mountain Cancer Centers - Denver Midtwon

    Denver, Colorado, 80218

  • Virginia Cancer Care Specialist, PC

    Fairfax, Virginia, 22031

  • Fort Wayne Medical Oncology and Hematology, Inc.

    Fort Wayne, Indiana, 46845

  • Texas Oncology, P.A.

    Fort Worth, Texas, 76104

  • St. Jude Hospital Yorba Linda

    Fullerton, California, 92835

  • West Cancer Center

    Germantown, Tennessee, 38138

  • St. Mary's Hospital And Regional Medical Center

    Grand Junction, Colorado, 81501

  • Greenville Health System

    Greenville, South Carolina, 29615

  • Memorial Healthcare System

    Hollywood, Florida, 33021

  • The University of Texas MD Anderson Cancer Center-merge

    Houston, Texas, 77030

  • HCA Midwest Healthcare

    Kansas City, Missouri, 64132

  • Texas Oncology-Austin Central

    Las Vegas, Nevada, 89148

  • Tennessee Oncology

    Lebanon, Tennessee, 37090

  • Saint Barnabas Medical Cancer Center

    Livingston, New Jersey, 07039

  • LACN

    Los Angeles, California, 90017

  • UCLA Main Campus - University California Los Angeles

    Los Angeles, California, 90095

  • Hematology Oncology Associates, PC

    Medford, Oregon, 97504

  • Minnesota Oncology Hematology, P.A.

    Minneapolis, Minnesota, 55404

  • Illinois Cancer Specialists

    Niles, Illinois, 60714

  • Florida Cancer Affiliates

    Ocala, Florida, 34471

  • Oncology Hematology West P.C. dba Nebraska Cancer Specialists

    Omaha, Nebraska, 68130

  • Orlando Health, Inc

    Orlando, Florida, 32806

  • Torrence Health Association, DBA Torrance Memorial;Physician Network/Cancer Care Associates

    Redondo Beach, California, 90277

  • Texas Oncology, P.A.

    San Antonio, Texas, 78240

  • Coastal Integrative Cancer Care

    San Luis Obispo, California, 93401

  • Cancer Center of Santa Barbara with Sansum Clinic

    Santa Barbara, California, 93105

  • Central Coast Medical Oncology Corporation

    Santa Maria, California, 93454

  • Willamette Valley Cancer Institute and Research Center

    Springfield, Oregon, 97477

  • Florida Cancer Specialists & Research Institute

    St. Petersburg, Florida, 33705

  • Texas Oncology The Woodlands

    The Woodlands, Texas, 77380

  • Northwest Cancer Specialists, P.C.

    Tualatin, Oregon, 97062

  • Arizona Oncology Associates, PC

    Tucson, Arizona, 85711

  • Texas Oncology - Waco

    Waco, Texas, 76712

  • Florida Cancer Specialists

    West Palm Beach, Florida, 33401

  • Oncology and Hematology Associates of Southwest Virginia, Inc., DBA Blue Ridge Cancer Care

    Wytheville, Virginia, 24382

Other trials in United States

Germany6 sites

  • Local Institution

    Berlin, 12200

  • Local Institution

    Bonn, 53127

  • Local Institution

    Dresden, 01307

  • Local Institution

    Essen, 45147

  • Local Institution

    Freiburg im Breisgau, 79106

  • Klinikum Rechts der Isar der Technischen Universitaet Muenchen

    München, 81675

Other trials in Germany

About this study

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

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.

Conditions
Cancer
Being tested
Nivolumab
Medical subject headings
Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • NivolumabBiological

    Also called BMS-936558, Opdivo

    Specified dose on specified days

Study groups in NCT02832167
Study groupRoleWhat they receive
NivolumabExperimentalNot described
Receives: Biological: Nivolumab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Objective Response Rate (ORR)

    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.

    Measured: 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)

Secondary outcomes (13)

  1. Duration of Response (DOR)

    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

    Measured: From the time of first confirmed response to the date of the first documented progression (up to approximately 22 months)

  2. Time to Objective Response (TTR)

    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.

    Measured: From the first dosing date to the date of the first confirmed response (up to approximately 10 months)

  3. Clinical Benefit Rate (CBR)

    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).

    Measured: From the first dosing date to the date of the last dose (approximately 24 months)

  4. Overall Survival Rate at 1 Year

    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.

    Measured: From the first dosing date to 1 year later

  5. Number of Participants Who Died

    Number of participants who died for any cause

    Measured: From first dose to 100 days following last dose (up approximately 27 months)

  6. Number of Participants Experiencing Adverse Events (AEs)

    Number of participants who experienced any grade, any cause AEs

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

  7. Number of Participants Experiencing Serious Adverse Events (SAEs)

    Number of participants who experienced any grade, any cause SAEs

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

  8. Number of Participants Experiencing Adverse Events (AEs) Leading to Discontinuation

    Number of participants who experienced AEs leading to discontinuation of study therapy

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

  9. Number of Participants Experiencing Immune-mediated Adverse Events (IMAEs)

    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.

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

  10. Number of Participants Experiencing Select Adverse Events

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

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

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

    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)

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

  12. Number of Participants Experiencing Laboratory Abnormalities in Specific Liver Tests

    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

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

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

    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

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Jul 2016 (estimated)
  2. Study start22 Feb 2016
  3. Primary completion20 Oct 2019
  4. Study completion24 Jun 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
239 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02832167
Sponsor's protocol ID
CA209-627
Other IDs
2016-000461-23, 2016
Acronym
CheckMate 627
Status last verified
Apr 2022
First submitted
8 Jul 2016
Last updated
9 May 2022
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Expanded access
Available

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Nivolumab in people with Cancer, run by Bristol-Myers Squibb at 45 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 9 May 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 45 sites in United States, Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 17 Dec 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02832167.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 May 2022.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in