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

NCT03090737 | Completed Phase 2 Results FDA Drug

• 2 other identifiers: CA209-9072016-003731-37
• Study Type: interventional
• Target: 129
• Locations: 5 countries
• Sites: 17

Brief Summary

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

Conditions

Non-Small Cell Lung Cancer

Outcome Measures

Primary Outcomes (1)

• The Number of Participants Experiencing High Grade (Grades 3-4 and Grade 5) Drug-Related Select Adverse Events (AE)

  The number of participants who experienced at least 1 select AE of Grade 3-5, judged to be related to study drug per investigator with onset on or after first dose of study treatment and within 30 days of last dose of study treatment, divided by number of treated participants. AE grade is defined using National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.0 criteria. The select AEs consist of pulmonary events, gastrointestinal events, hepatic events, renal events, skin events, endocrine events categories, thyroid disorders, diabetes, pituitary, adrenal disorder subcategories. Grade 3 is defined as severe or medically significant but not immediately life-threatening. Grade 4 is defined as life-threatening consequences and urgent intervention indicated. Grade 5 is defined as death related to AE.

  From the first dose of study treatment to up to 30 days of the last dose of study treatment (up to 24 months)

Secondary Outcomes (4)

• Progression Free Survival (PFS)

  From first dose to the date of the first documented tumor progression (up to approximately 5 months)

• Objective Response Rate (ORR)

  From the date of first dose to the date of the initial objectively documented tumor progression or the date of subsequent therapy, whichever occurs first (up to approximately 25 months).

• Overall Survival (OS)

  From first dosing date and the date of death due to any cause (up to approximately 4 years and 9 months)

• Duration of Response (DOR)

  From the date of first confirmed response up to the date of the first documented tumor progression (per RECIST 1.1), or death due to any cause, whichever occurs first (up to approximately 48 months).

Study Arms (1)

Nivolumab

EXPERIMENTAL

Specified Dose on Specified Days

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:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Bristol-Myers Squibb: lead
• Ono Pharmaceutical Co. Ltd: collaborator

Study Sites (17)

Alabama Oncology

Birmingham, Alabama, 35205, United States

Location

Los Angeles Hematology Oncology Medical Group

Los Angeles, California, 90017, United States

Location

St Vincent Frontier Cancer Center

Billings, Montana, 59102, United States

Location

Broome Oncology

Johnson City, New York, 13790, United States

Location

Guthrie Medical Group Sayre

Sayre, Pennsylvania, 18840, United States

Location

Local Institution - 0015

Kingston, Ontario, K7L 2V7, Canada

Location

Local Institution - 0014

Oshawa, Ontario, L1G 2B9, Canada

Location

Local Institution - 0001

Toronto, Ontario, M5G 2M9, Canada

Location

Local Institution - 0017

Nagoya, Aichi-ken, 4648681, Japan

Location

Local Institution - 0023

Osaka, Osaka, 5418567, Japan

Location

Local Institution - 0018

Koto-ku, Tokyo, 1358550, Japan

Location

Local Institution - 0016

Tokyo, 1040045, Japan

Location

Local Institution - 0003

Craiova, 200347, Romania

Location

Local Institution - 0006

Sector 2, 022328, Romania

Location

Local Institution - 0011

Port Elizabeth, Eastern Cape, 6045, South Africa

Location

Local Institution - 0013

Parktown, Johannesburg, Gauteng, 2193, South Africa

Location

Local Institution - 0012

George, Western Cape, 6530, South Africa

Location

Related Links

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

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

Nivolumab

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

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.Trails@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

Study Record Dates

• First Submitted: March 20, 2017
• First Posted: March 27, 2017
• Study Start: June 2, 2017
• Primary Completion: February 16, 2021
• Study Completion: March 14, 2022
• Last Updated: December 5, 2022
• Results First Posted: March 14, 2022

Record last verified: 2022-12

Locations

US (5); JP (4); CA (3); RO (2); ZA (3)