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

Phase 2

Completed

• Conditions: Cancer
• Interventions: Biological: Nivolumab

• 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

Study Timeline

• Study Start: 2016-02-22
• Study First Submitted: 2016-07-08
• Study First Submitted QC: 2016-07-11
• Study First Posted: 2016-07-14
• Primary Completion: 2019-10-20
• Results First Submitted: 2020-10-20
• Results First Submitted QC: 2020-11-19
• Results First Posted: 2020-12-17
• Study Completion: 2021-06-24
• Status Verified: 2022-04
• Last Update Submitted: 2022-04-06
• Last Update Posted: 2022-05-09

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Nivolumab	Nivolumab	-

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)

Cancer Center of Santa Barbara with Sansum Clinic; 🇺🇸 Santa Barbara, California, United States

Memorial Healthcare System; 🇺🇸 Hollywood, Florida, United States

Florida Cancer Specialists; 🇺🇸 West Palm Beach, Florida, United States

Maryland Oncology Hematology P.A.; 🇺🇸 Columbia, Maryland, United States

Texas Oncology - Baylor Charles A. Simmons Cancer Center; 🇺🇸 Dallas, Texas, United States

Saint Barnabas Medical Cancer Center; 🇺🇸 Livingston, New Jersey, United States

The University of Texas MD Anderson Cancer Center-merge; 🇺🇸 Houston, Texas, United States

Texas Oncology-Austin Central; 🇺🇸 Las Vegas, Nevada, United States

Arizona Oncology Associates, PC; 🇺🇸 Tucson, Arizona, United States

Torrence Health Association, DBA Torrance Memorial;Physician Network/Cancer Care Associates; 🇺🇸 Redondo Beach, California, United States

Coastal Integrative Cancer Care; 🇺🇸 San Luis Obispo, California, United States

LACN; 🇺🇸 Los Angeles, California, United States

St. Mary's Hospital And Regional Medical Center; 🇺🇸 Grand Junction, Colorado, United States

Illinois Cancer Specialists; 🇺🇸 Niles, Illinois, United States

Willamette Valley Cancer Institute and Research Center; 🇺🇸 Springfield, Oregon, United States

Tennessee Oncology; 🇺🇸 Lebanon, Tennessee, United States

CBCC Global Research, Inc. at Comprehensive Blood and Cancer Center; 🇺🇸 Bakersfield, California, United States

St. Jude Hospital Yorba Linda; 🇺🇸 Fullerton, California, United States

Central Coast Medical Oncology Corporation; 🇺🇸 Santa Maria, California, United States

Texas Oncology, P.A.; 🇺🇸 San Antonio, Texas, United States

Fort Wayne Medical Oncology and Hematology, Inc.; 🇺🇸 Fort Wayne, Indiana, United States

USOR - New York Oncology Hematology, P.C.; 🇺🇸 Albany, New York, United States

Hematology Oncology Associates, PC; 🇺🇸 Medford, Oregon, United States

Local Institution; 🇩🇪 Freiburg, Germany

Northwest Cancer Specialists, P.C.; 🇺🇸 Tualatin, Oregon, United States

Greenville Health System; 🇺🇸 Greenville, South Carolina, United States

Texas Oncology - Waco; 🇺🇸 Waco, Texas, United States

Texas Oncology The Woodlands; 🇺🇸 The Woodlands, Texas, United States

Klinikum Rechts der Isar der Technischen Universitaet Muenchen; 🇩🇪 Muenchen, Germany

UCLA Main Campus - University California Los Angeles; 🇺🇸 Los Angeles, California, United States

Florida Cancer Affiliates; 🇺🇸 Ocala, Florida, United States

West Cancer Center; 🇺🇸 Germantown, Tennessee, United States

Florida Cancer Specialists & Research Institute; 🇺🇸 Saint Petersburg, Florida, United States

Minnesota Oncology Hematology, P.A.; 🇺🇸 Minneapolis, Minnesota, United States

Virginia Cancer Care Specialist, PC; 🇺🇸 Fairfax, Virginia, United States

Rocky Mountain Cancer Centers - Denver Midtwon; 🇺🇸 Denver, Colorado, United States

Orlando Health, Inc; 🇺🇸 Orlando, Florida, United States

HCA Midwest Healthcare; 🇺🇸 Kansas City, Missouri, United States

Oncology Hematology West P.C. dba Nebraska Cancer Specialists; 🇺🇸 Omaha, Nebraska, United States

Oncology and Hematology Associates of Southwest Virginia, Inc., DBA Blue Ridge Cancer Care; 🇺🇸 Wytheville, Virginia, United States