Clinical trial NCT02832167: An Open Label Investigational Immuno-therapy Trial of Nivolumab in Cancers That Are Advanced or Have Spread
Official title: An Open Label Phase 2 Multi-cohort Trial of Nivolumab in Advanced or Metastatic Malignancies
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Cancer
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2016-07-14
Enrollment: 239
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Objective Response Rate (ORR)
timeFrame: 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:
measure: Duration of Response (DOR)
timeFrame: From the time of first confirmed response to the date of the first documented progression (up to approximately 22 months)
measure: Time to Objective Response (TTR)
timeFrame: From the first dosing date to the date of the first confirmed response (up to approximately 10 months)
measure: Clinical Benefit Rate (CBR)
timeFrame: From the first dosing date to the date of the last dose (approximately 24 months)
measure: Overall Survival Rate at 1 Year
timeFrame: From the first dosing date to 1 year later
measure: Number of Participants Who Died
timeFrame: From first dose to 100 days following last dose (up approximately 27 months)
measure: Number of Participants Experiencing Adverse Events (AEs)
timeFrame: From first dose to 30 days following the last dose (up to approximately 25 months)
measure: Number of Participants Experiencing Serious Adverse Events (SAEs)
timeFrame: From first dose to 100 days following the last dose (up to approximately 27 months)
measure: Number of Participants Experiencing Adverse Events (AEs) Leading to Discontinuation
timeFrame: From first dose to 30 days following the last dose (up to approximately 25 months)
measure: Number of Participants Experiencing Immune-mediated Adverse Events (IMAEs)
timeFrame: From first dose to 100 days following the last dose (up to approximately 27 months)
measure: Number of Participants Experiencing Select Adverse Events
timeFrame: From first dose to 30 days following the last dose (up to approximately 25 months)
measure: Number of Participants Experiencing Adverse Events (AEs) Leading to Dose Delay or Dose Reduction
timeFrame: From first dose to 30 days following the last dose (up to approximately 25 months)
measure: Number of Participants Experiencing Laboratory Abnormalities in Specific Liver Tests
timeFrame: From first dose to 30 days following the last dose (up to approximately 25 months)
measure: Number of Participants Experiencing Laboratory Abnormalities in Specific Thyroid Tests
timeFrame: From first dose to 100 days following the last dose (up to approximately 27 months)
Other outcomes:
Locations:
city: Tucson
country: United States
facility: Arizona Oncology Associates, PC
state: Arizona
city: Bakersfield
country: United States
facility: CBCC Global Research, Inc. at Comprehensive Blood and Cancer Center
state: California
city: Fullerton
country: United States
facility: St. Jude Hospital Yorba Linda
state: California
city: Los Angeles
country: United States
facility: LACN
state: California
city: Los Angeles
country: United States
facility: UCLA Main Campus - University California Los Angeles
state: California
city: Redondo Beach
country: United States
facility: Torrence Health Association, DBA Torrance Memorial;Physician Network/Cancer Care Associates
state: California
city: San Luis Obispo
country: United States
facility: Coastal Integrative Cancer Care
state: California
city: Santa Barbara
country: United States
facility: Cancer Center of Santa Barbara with Sansum Clinic
state: California
city: Santa Maria
country: United States
facility: Central Coast Medical Oncology Corporation
state: California
city: Denver
country: United States
facility: Rocky Mountain Cancer Centers - Denver Midtwon
state: Colorado
city: Grand Junction
country: United States
facility: St. Mary's Hospital And Regional Medical Center
state: Colorado
city: Hollywood
country: United States
facility: Memorial Healthcare System
state: Florida
city: Ocala
country: United States
facility: Florida Cancer Affiliates
state: Florida
city: Orlando
country: United States
facility: Orlando Health, Inc
state: Florida
city: Saint Petersburg
country: United States
facility: Florida Cancer Specialists & Research Institute
state: Florida
city: West Palm Beach
country: United States
facility: Florida Cancer Specialists
state: Florida
city: Niles
country: United States
facility: Illinois Cancer Specialists
state: Illinois
city: Fort Wayne
country: United States
facility: Fort Wayne Medical Oncology and Hematology, Inc.
state: Indiana
city: Columbia
country: United States
facility: Maryland Oncology Hematology P.A.
state: Maryland
city: Minneapolis
country: United States
facility: Minnesota Oncology Hematology, P.A.
state: Minnesota
city: Kansas City
country: United States
facility: HCA Midwest Healthcare
state: Missouri
city: Omaha
country: United States
facility: Oncology Hematology West P.C. dba Nebraska Cancer Specialists
state: Nebraska
city: Las Vegas
country: United States
facility: Texas Oncology-Austin Central
state: Nevada
city: Livingston
country: United States
facility: Saint Barnabas Medical Cancer Center
state: New Jersey
city: Albany
country: United States
facility: USOR - New York Oncology Hematology, P.C.
state: New York
city: Medford
country: United States
facility: Hematology Oncology Associates, PC
state: Oregon
city: Springfield
country: United States
facility: Willamette Valley Cancer Institute and Research Center
state: Oregon
city: Tualatin
country: United States
facility: Northwest Cancer Specialists, P.C.
state: Oregon
city: Greenville
country: United States
facility: Greenville Health System
state: South Carolina
city: Germantown
country: United States
facility: West Cancer Center
state: Tennessee
city: Lebanon
country: United States
facility: Tennessee Oncology
state: Tennessee
city: Dallas
country: United States
facility: Texas Oncology - Baylor Charles A. Simmons Cancer Center
state: Texas
city: Fort Worth
country: United States
facility: Texas Oncology, P.A.
state: Texas
city: Houston
country: United States
facility: The University of Texas MD Anderson Cancer Center-merge
state: Texas
city: San Antonio
country: United States
facility: Texas Oncology, P.A.
state: Texas
city: The Woodlands
country: United States
facility: Texas Oncology The Woodlands
state: Texas
city: Waco
country: United States
facility: Texas Oncology - Waco
state: Texas
city: Fairfax
country: United States
facility: Virginia Cancer Care Specialist, PC
state: Virginia
city: Wytheville
country: United States
facility: Oncology and Hematology Associates of Southwest Virginia, Inc., DBA Blue Ridge Cancer Care
state: Virginia
city: Berlin
country: Germany
facility: Local Institution
city: Bonn
country: Germany
facility: Local Institution
city: Dresden
country: Germany
facility: Local Institution
city: Essen
country: Germany
facility: Local Institution
city: Freiburg
country: Germany
facility: Local Institution
city: Muenchen
country: Germany
facility: Klinikum Rechts der Isar der Technischen Universitaet Muenchen
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References: