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

Cancer Clinical Trial

— CheckMate 627  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02832167
• Other study ID #: CA209-627
• Secondary ID: 2016-000461-23
• Status: Completed
• Phase: Phase 2
• Start date: February 22, 2016
• Est. completion date: June 24, 2021

Study information

• Verified date: April 2022
• Source: Bristol-Myers Squibb
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 239
• Est. completion date: June 24, 2021
• Est. primary completion date: October 20, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cancer

Intervention

Biological:
• Nivolumab
Specified dose on specified days

Locations

Country	Name	City	State
Germany	Local Institution	Berlin
Germany	Local Institution	Bonn
Germany	Local Institution	Dresden
Germany	Local Institution	Essen
Germany	Local Institution	Freiburg
Germany	Klinikum Rechts der Isar der Technischen Universitaet Muenchen	Muenchen
United States	USOR - New York Oncology Hematology, P.C.	Albany	New York
United States	CBCC Global Research, Inc. at Comprehensive Blood and Cancer Center	Bakersfield	California
United States	Maryland Oncology Hematology P.A.	Columbia	Maryland
United States	Texas Oncology - Baylor Charles A. Simmons Cancer Center	Dallas	Texas
United States	Rocky Mountain Cancer Centers - Denver Midtwon	Denver	Colorado
United States	Virginia Cancer Care Specialist, PC	Fairfax	Virginia
United States	Fort Wayne Medical Oncology and Hematology, Inc.	Fort Wayne	Indiana
United States	Texas Oncology, P.A.	Fort Worth	Texas
United States	St. Jude Hospital Yorba Linda	Fullerton	California
United States	West Cancer Center	Germantown	Tennessee
United States	St. Mary's Hospital And Regional Medical Center	Grand Junction	Colorado
United States	Greenville Health System	Greenville	South Carolina
United States	Memorial Healthcare System	Hollywood	Florida
United States	The University of Texas MD Anderson Cancer Center-merge	Houston	Texas
United States	HCA Midwest Healthcare	Kansas City	Missouri
United States	Texas Oncology-Austin Central	Las Vegas	Nevada
United States	Tennessee Oncology	Lebanon	Tennessee
United States	Saint Barnabas Medical Cancer Center	Livingston	New Jersey
United States	LACN	Los Angeles	California
United States	UCLA Main Campus - University California Los Angeles	Los Angeles	California
United States	Hematology Oncology Associates, PC	Medford	Oregon
United States	Minnesota Oncology Hematology, P.A.	Minneapolis	Minnesota
United States	Illinois Cancer Specialists	Niles	Illinois
United States	Florida Cancer Affiliates	Ocala	Florida
United States	Oncology Hematology West P.C. dba Nebraska Cancer Specialists	Omaha	Nebraska
United States	Orlando Health, Inc	Orlando	Florida
United States	Torrence Health Association, DBA Torrance Memorial;Physician Network/Cancer Care Associates	Redondo Beach	California
United States	Florida Cancer Specialists & Research Institute	Saint Petersburg	Florida
United States	Texas Oncology, P.A.	San Antonio	Texas
United States	Coastal Integrative Cancer Care	San Luis Obispo	California
United States	Cancer Center of Santa Barbara with Sansum Clinic	Santa Barbara	California
United States	Central Coast Medical Oncology Corporation	Santa Maria	California
United States	Willamette Valley Cancer Institute and Research Center	Springfield	Oregon
United States	Texas Oncology The Woodlands	The Woodlands	Texas
United States	Northwest Cancer Specialists, P.C.	Tualatin	Oregon
United States	Arizona Oncology Associates, PC	Tucson	Arizona
United States	Texas Oncology - Waco	Waco	Texas
United States	Florida Cancer Specialists	West Palm Beach	Florida
United States	Oncology and Hematology Associates of Southwest Virginia, Inc., DBA Blue Ridge Cancer Care	Wytheville	Virginia

Sponsors (1)

Lead Sponsor	Collaborator
Bristol-Myers Squibb

Countries where clinical trial is conducted

United States,  Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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)
Secondary	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)
Secondary	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)
Secondary	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
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)

External Links

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