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

Phase 2

Completed

Conditions: Cancer

Registration Number: NCT02832167

Lead Sponsor: 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.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 239

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 & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Objective Response Rate (ORR)	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 Outcome Measures

Name	Time	Method
Duration of Response (DOR)	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
Time to Objective Response (TTR)	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.
Clinical Benefit Rate (CBR)	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).
Overall Survival Rate at 1 Year	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.
Number of Participants Who Died	From first dose to 100 days following last dose (up approximately 27 months)	Number of participants who died for any cause
Number of Participants Experiencing Adverse Events (AEs)	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
Number of Participants Experiencing Serious Adverse Events (SAEs)	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
Number of Participants Experiencing Adverse Events (AEs) Leading to Discontinuation	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
Number of Participants Experiencing Immune-mediated Adverse Events (IMAEs)	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.
Number of Participants Experiencing Select Adverse Events	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.
Number of Participants Experiencing Adverse Events (AEs) Leading to Dose Delay or Dose Reduction	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)
Number of Participants Experiencing Laboratory Abnormalities in Specific Liver Tests	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
Number of Participants Experiencing Laboratory Abnormalities in Specific Thyroid Tests	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

Trial Locations

Locations (40): Arizona Oncology Associates, PC
🇺🇸
Tucson, Arizona, United States
CBCC Global Research, Inc. at Comprehensive Blood and Cancer Center
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Bakersfield, California, United States
St. Jude Hospital Yorba Linda
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Fullerton, California, United States
LACN
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Los Angeles, California, United States
UCLA Main Campus - University California Los Angeles
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Los Angeles, California, United States
Torrence Health Association, DBA Torrance Memorial;Physician Network/Cancer Care Associates
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Redondo Beach, California, United States
Coastal Integrative Cancer Care
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San Luis Obispo, California, United States
Cancer Center of Santa Barbara with Sansum Clinic
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Santa Barbara, California, United States
Central Coast Medical Oncology Corporation
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Santa Maria, California, United States
Rocky Mountain Cancer Centers - Denver Midtwon
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Denver, Colorado, United States
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Arizona Oncology Associates, PC
🇺🇸Tucson, Arizona, United States