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Safety Study of Nivolumab to Treat Advanced or Metastatic Non-small Cell Lung Cancer

NCT ID: NCT03090737

Last Updated: 2022-12-05

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

129 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-06-02

Study Completion Date

2022-03-14

Brief Summary

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A study to evaluate the safety of Nivolumab in participants with advanced or metastatic non-small cell lung cancer

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Detailed Description

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Conditions

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Non-Small Cell Lung Cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Nivolumab

Specified Dose on Specified Days

Group Type EXPERIMENTAL

Nivolumab

Intervention Type BIOLOGICAL

Specified Dose on Specified Days

Interventions

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Nivolumab

Specified Dose on Specified Days

Intervention Type BIOLOGICAL

Other Intervention Names

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BMS-936558 Opdivo

Eligibility Criteria

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Inclusion Criteria

* Non small cell lung cancer (Squamous or non-squamous)
* At least one prior anti-cancer therapy that did not work
* ECOG Performance Scale 0-1

Exclusion Criteria

* Cancer that has spread to the brain or leptomeninges unless there is no evidence of progression by MRI for 8 weeks after treatment is complete and within 28 days before first dose of study drug
* Active, known or suspected autoimmune disease or infection
* Prior immuno-oncology therapy
* Corticosteroids within 2 weeks of study drug administration
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ono Pharmaceutical Co. Ltd

INDUSTRY

Sponsor Role collaborator

Bristol-Myers Squibb

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Bristol-Myers Squibb

Role: STUDY_DIRECTOR

Bristol-Myers Squibb

Locations

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Alabama Oncology

Birmingham, Alabama, United States

Site Status

Los Angeles Hematology Oncology Medical Group

Los Angeles, California, United States

Site Status

St Vincent Frontier Cancer Center

Billings, Montana, United States

Site Status

Broome Oncology

Johnson City, New York, United States

Site Status

Guthrie Medical Group Sayre

Sayre, Pennsylvania, United States

Site Status

Local Institution - 0015

Kingston, Ontario, Canada

Site Status

Local Institution - 0014

Oshawa, Ontario, Canada

Site Status

Local Institution - 0001

Toronto, Ontario, Canada

Site Status

Local Institution - 0017

Nagoya, Aichi-ken, Japan

Site Status

Local Institution - 0023

Osaka, Osaka, Japan

Site Status

Local Institution - 0018

Koto-ku, Tokyo, Japan

Site Status

Local Institution - 0016

Tokyo, , Japan

Site Status

Local Institution - 0003

Craiova, , Romania

Site Status

Local Institution - 0006

Sector 2, , Romania

Site Status

Local Institution - 0011

Port Elizabeth, Eastern Cape, South Africa

Site Status

Local Institution - 0013

Parktown, Johannesburg, Gauteng, South Africa

Site Status

Local Institution - 0012

George, Western Cape, South Africa

Site Status

Countries

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United States Canada Japan Romania South Africa

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Related Links

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https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html

BMS Clinical Trial Information

http://www.BMSStudyConnect.com

BMS Clinical Trial Patient Recruiting

http://www.fda.gov/safety/medwatch/safetyinformation/default.htm

FDA Safety Alerts and Recalls

Other Identifiers

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2016-003731-37

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

CA209-907

Identifier Type: -

Identifier Source: org_study_id

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