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

NCT02832167 | Completed Phase 2 Results FDA Drug

• 2 other identifiers: CA209-6272016-000461-23
• Study Type: interventional
• Target: 239
• Locations: 2 countries
• Sites: 45

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.

Conditions

Cancer

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (13)

• Duration of Response (DOR)

  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)

  From the first dosing date to the date of the first confirmed response (up to approximately 10 months)

• Clinical Benefit Rate (CBR)

  From the first dosing date to the date of the last dose (approximately 24 months)

• Overall Survival Rate at 1 Year

  From the first dosing date to 1 year later

• Number of Participants Who Died

  From first dose to 100 days following last dose (up approximately 27 months)

Study Arms (1)

Nivolumab

EXPERIMENTAL

Biological: Nivolumab

Interventions

Nivolumab BIOLOGICAL

Specified dose on specified days

Also known as: BMS-936558, Opdivo

Nivolumab

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Bristol-Myers Squibb: lead

Study Sites (45)

Arizona Oncology Associates, PC

Tucson, Arizona, 85711, United States

Location

CBCC Global Research, Inc. at Comprehensive Blood and Cancer Center

Bakersfield, California, 93309, United States

Location

St. Jude Hospital Yorba Linda

Fullerton, California, 92835, United States

Location

LACN

Los Angeles, California, 90017, United States

Location

UCLA Main Campus - University California Los Angeles

Los Angeles, California, 90095, United States

Location

Torrence Health Association, DBA Torrance Memorial;Physician Network/Cancer Care Associates

Redondo Beach, California, 90277, United States

Location

Coastal Integrative Cancer Care

San Luis Obispo, California, 93401, United States

Location

Cancer Center of Santa Barbara with Sansum Clinic

Santa Barbara, California, 93105, United States

Location

Central Coast Medical Oncology Corporation

Santa Maria, California, 93454, United States

Location

Rocky Mountain Cancer Centers - Denver Midtwon

Denver, Colorado, 80218, United States

Location

St. Mary's Hospital And Regional Medical Center

Grand Junction, Colorado, 81501, United States

Location

Memorial Healthcare System

Hollywood, Florida, 33021, United States

Location

Florida Cancer Affiliates

Ocala, Florida, 34471, United States

Location

Orlando Health, Inc

Orlando, Florida, 32806, United States

Location

Florida Cancer Specialists & Research Institute

St. Petersburg, Florida, 33705, United States

Location

Florida Cancer Specialists

West Palm Beach, Florida, 33401, United States

Location

Illinois Cancer Specialists

Niles, Illinois, 60714, United States

Location

Fort Wayne Medical Oncology and Hematology, Inc.

Fort Wayne, Indiana, 46845, United States

Location

Maryland Oncology Hematology P.A.

Columbia, Maryland, 21044, United States

Location

Minnesota Oncology Hematology, P.A.

Minneapolis, Minnesota, 55404, United States

Location

HCA Midwest Healthcare

Kansas City, Missouri, 64132, United States

Location

Oncology Hematology West P.C. dba Nebraska Cancer Specialists

Omaha, Nebraska, 68130, United States

Location

Texas Oncology-Austin Central

Las Vegas, Nevada, 89148, United States

Location

Saint Barnabas Medical Cancer Center

Livingston, New Jersey, 07039, United States

Location

USOR - New York Oncology Hematology, P.C.

Albany, New York, 12206, United States

Location

Hematology Oncology Associates, PC

Medford, Oregon, 97504, United States

Location

Willamette Valley Cancer Institute and Research Center

Springfield, Oregon, 97477, United States

Location

Northwest Cancer Specialists, P.C.

Tualatin, Oregon, 97062, United States

Location

Greenville Health System

Greenville, South Carolina, 29615, United States

Location

West Cancer Center

Germantown, Tennessee, 38138, United States

Location

Tennessee Oncology

Lebanon, Tennessee, 37090, United States

Location

Texas Oncology - Baylor Charles A. Simmons Cancer Center

Dallas, Texas, 75246, United States

Location

Texas Oncology, P.A.

Fort Worth, Texas, 76104, United States

Location

The University of Texas MD Anderson Cancer Center-merge

Houston, Texas, 77030, United States

Location

Texas Oncology, P.A.

San Antonio, Texas, 78240, United States

Location

Texas Oncology The Woodlands

The Woodlands, Texas, 77380, United States

Location

Texas Oncology - Waco

Waco, Texas, 76712, United States

Location

Virginia Cancer Care Specialist, PC

Fairfax, Virginia, 22031, United States

Location

Oncology and Hematology Associates of Southwest Virginia, Inc., DBA Blue Ridge Cancer Care

Wytheville, Virginia, 24382, United States

Location

Local Institution

Berlin, 12200, Germany

Location

Local Institution

Bonn, 53127, Germany

Location

Local Institution

Dresden, 01307, Germany

Location

Local Institution

Essen, 45147, Germany

Location

Local Institution

Freiburg im Breisgau, 79106, Germany

Location

Klinikum Rechts der Isar der Technischen Universitaet Muenchen

München, 81675, Germany

Location

Related Links

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

MeSH Terms

Conditions

Neoplasms

Interventions

Nivolumab

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Results Point of Contact

• Title: Bristol-Myers Squibb Study Director
• Organization: Bristol-Myers Squibb

Clinical.Trials@bms.com

Please email

Study Officials

• Bristol-Myers Squibb

  Bristol-Myers Squibb

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR
• Expanded Access: Yes

Study Record Dates

• First Submitted: July 8, 2016
• First Posted: July 14, 2016
• Study Start: February 22, 2016
• Primary Completion: October 20, 2019
• Study Completion: June 24, 2021
• Last Updated: May 9, 2022
• Results First Posted: December 17, 2020

Record last verified: 2022-04

Locations

US (39); DE (6)