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

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.

Study Overview

• Status: Completed
• Conditions: Cancer
• Intervention / Treatment: Biological: Nivolumab

• Study Type: Interventional
• Enrollment (Actual): 239
• Phase: Phase 2

Expanded Access

Approved for sale to the public. See expanded access record.

Contacts and Locations

Study Locations

• Germany
  • Berlin, Germany, 12200
    • Local Institution
  • Bonn, Germany, 53127
    • Local Institution
  • Dresden, Germany, 01307
    • Local Institution
  • Essen, Germany, 45147
    • Local Institution
  • Freiburg, Germany, 79106
    • Local Institution
  • Muenchen, Germany, 81675
    • Klinikum Rechts der Isar der Technischen Universitaet Muenchen
• United States
  • Arizona
    • Tucson, Arizona, United States, 85711
      • Arizona Oncology Associates, PC
  • California
    • Bakersfield, California, United States, 93309
      • CBCC Global Research, Inc. at Comprehensive Blood and Cancer Center
    • Fullerton, California, United States, 92835
      • St. Jude Hospital Yorba Linda
    • Los Angeles, California, United States, 90017
      • LACN
    • Los Angeles, California, United States, 90095
      • UCLA Main Campus - University California Los Angeles
    • Redondo Beach, California, United States, 90277
      • Torrence Health Association, DBA Torrance Memorial;Physician Network/Cancer Care Associates
    • San Luis Obispo, California, United States, 93401
      • Coastal Integrative Cancer Care
    • Santa Barbara, California, United States, 93105
      • Cancer Center of Santa Barbara with Sansum Clinic
    • Santa Maria, California, United States, 93454
      • Central Coast Medical Oncology Corporation
  • Colorado
    • Denver, Colorado, United States, 80218
      • Rocky Mountain Cancer Centers - Denver Midtwon
    • Grand Junction, Colorado, United States, 81501
      • St. Mary's Hospital And Regional Medical Center
  • Florida
    • Hollywood, Florida, United States, 33021
      • Memorial Healthcare System
    • Ocala, Florida, United States, 34471
      • Florida Cancer Affiliates
    • Orlando, Florida, United States, 32806
      • Orlando Health, Inc
    • Saint Petersburg, Florida, United States, 33705
      • Florida Cancer Specialists & Research Institute
    • West Palm Beach, Florida, United States, 33401
      • Florida Cancer Specialists
  • Illinois
    • Niles, Illinois, United States, 60714
      • Illinois Cancer Specialists
  • Indiana
    • Fort Wayne, Indiana, United States, 46845
      • Fort Wayne Medical Oncology and Hematology, Inc.
  • Maryland
    • Columbia, Maryland, United States, 21044
      • Maryland Oncology Hematology P.A.
  • Minnesota
    • Minneapolis, Minnesota, United States, 55404
      • Minnesota Oncology Hematology, P.A.
  • Missouri
    • Kansas City, Missouri, United States, 64132
      • HCA Midwest Healthcare
  • Nebraska
    • Omaha, Nebraska, United States, 68130
      • Oncology Hematology West p.c. dba Nebraska Cancer Specialists
  • Nevada
    • Las Vegas, Nevada, United States, 89148
      • Texas Oncology-Austin Central
  • New Jersey
    • Livingston, New Jersey, United States, 07039
      • Saint Barnabas Medical Cancer Center
  • New York
    • Albany, New York, United States, 12206
      • USOR - New York Oncology Hematology, P.C.
  • Oregon
    • Medford, Oregon, United States, 97504
      • Hematology Oncology Associates, PC
    • Springfield, Oregon, United States, 97477
      • Willamette Valley Cancer Institute and Research Center
    • Tualatin, Oregon, United States, 97062
      • Northwest Cancer Specialists, P.C.
  • South Carolina
    • Greenville, South Carolina, United States, 29615
      • Greenville Health System
  • Tennessee
    • Germantown, Tennessee, United States, 38138
      • West Cancer Center
    • Lebanon, Tennessee, United States, 37090
      • Tennessee Oncology
  • Texas
    • Dallas, Texas, United States, 75246
      • Texas Oncology - Baylor Charles A. Simmons Cancer Center
    • Fort Worth, Texas, United States, 76104
      • Texas Oncology, P.A.
    • Houston, Texas, United States, 77030
      • The University of Texas MD Anderson Cancer Center-merge
    • San Antonio, Texas, United States, 78240
      • Texas Oncology, P.A.
    • The Woodlands, Texas, United States, 77380
      • Texas Oncology the Woodlands
    • Waco, Texas, United States, 76712
      • Texas Oncology - Waco
  • Virginia
    • Fairfax, Virginia, United States, 22031
      • Virginia Cancer Care Specialist, PC
    • Wytheville, Virginia, United States, 24382
      • Oncology and Hematology Associates of Southwest Virginia, Inc., DBA Blue Ridge Cancer Care

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Nivolumab	Biological: Nivolumab; Specified dose on specified days; Other Names: BMS-936558; Opdivo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	From the time of first confirmed response to the date of the first documented progression (up to approximately 22 months)
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.	From the first dosing date to the date of the first confirmed response (up to approximately 10 months)
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).	From the first dosing date to the date of the last dose (approximately 24 months)
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.	From the first dosing date to 1 year later
Number of Participants Who Died	Number of participants who died for any cause	From first dose to 100 days following last dose (up approximately 27 months)
Number of Participants Experiencing Adverse Events (AEs)	Number of participants who experienced any grade, any cause AEs	From first dose to 30 days following the last dose (up to approximately 25 months)
Number of Participants Experiencing Serious Adverse Events (SAEs)	Number of participants who experienced any grade, any cause SAEs	From first dose to 100 days following the last dose (up to approximately 27 months)
Number of Participants Experiencing Adverse Events (AEs) Leading to Discontinuation	Number of participants who experienced AEs leading to discontinuation of study therapy	From first dose to 30 days following the last dose (up to approximately 25 months)
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.	From first dose to 100 days following the last dose (up to approximately 27 months)
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.	From first dose to 30 days following the last dose (up to approximately 25 months)
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)	From first dose to 30 days following the last dose (up to approximately 25 months)
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	From first dose to 30 days following the last dose (up to approximately 25 months)
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	From first dose to 100 days following the last dose (up to approximately 27 months)

Collaborators and Investigators

• Sponsor: Bristol-Myers Squibb

Publications and helpful links

Helpful Links

• BMS Clinical Trial Information
• BMS Clinical Trial Patient Recruiting
• Investigator Inquiry Form
• FDA Safety Alerts and Recalls

Study record dates

Study Major Dates

• Study Start (Actual): February 22, 2016
• Primary Completion (Actual): October 20, 2019
• Study Completion (Actual): June 24, 2021

Study Registration Dates

• First Submitted: July 8, 2016
• First Submitted That Met QC Criteria: July 11, 2016
• First Posted (Estimate): July 14, 2016

Study Record Updates

• Last Update Posted (Actual): May 9, 2022
• Last Update Submitted That Met QC Criteria: April 6, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Molecular Mechanisms of Pharmacological Action; Antineoplastic Agents; Antineoplastic Agents, Immunological; Immune Checkpoint Inhibitors; Nivolumab
• Other Study ID Numbers: CA209-627; 2016-000461-23 (EudraCT Number)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No