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An Investigational Immuno-therapy Study for Safety of Nivolumab in Combination With Ipilimumab to Treat Advanced Cancers | Clinical Trials | Clareo Health

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An Investigational Immuno-therapy Study for Safety of Nivolumab in Combination With Ipilimumab to Treat Advanced Cancers

A Phase 3b/4 Safety Trial of Flat Dose Nivolumab In Combination With Ipilimumab in Participants With Non-Small Cell Lung Cancer

NCT02869789•Bristol-Myers Squibb

View on ClinicalTrials.gov

Summary

A study to evaluate the safety of Nivolumab given in combination with Ipilimumab in patients with advanced cancers. The initial group will enroll patients with newly diagnosed Stage 4 or non-small cell lung cancer that has come back.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Histologically confirmed Stage 4 or recurrent non-small cell lung cancer
•Eastern Cooperative Oncology Group (ECOG) score 0-1 (Physically able to carry out light housework or office work through to being fully active as you were before cancer)
•No prior systemic anticancer therapy (including EGFR and ALK inhibitors)
•Tissue or Programmed death-ligand 1 (PD-L1) results available
•Eastern Cooperative Oncology Group (ECOG) score 2 or
•Eastern Cooperative Oncology Group (ECOG) score 0-1 and one disease specific criteria as listed in the protocol
•High Tumor Mutation Burden

Exclusion Criteria

•Untreated brain metastases
•An active malignancy that requires concurrent intervention
•Active, known or suspected autoimmune disease
•Carcinomatous meningitis, which means there is inflammation of the covering of the brain, caused by cancer

Locations (136)

Local Institution - 0121

Birmingham, Alabama, United States

Local Institution - 0148

Phoenix, Arizona, United States

Local Institution - 0085

Tucson, Arizona, United States

Local Institution - 0164

Little Rock, Arkansas, United States

Local Institution - 0146

Bakersfield, California, United States

Marin Cancer Care, Inc

Greenbrae, California, United States

Los Angeles Hematology/Oncology Medical Group

Los Angeles, California, United States

Local Institution - 0115

Los Angeles, California, United States

Torrance Health Association

Redondo Beach, California, United States

Va San Diego Healthcare System

San Diego, California, United States

Key Dates

Start Date

October 5, 2016

Primary Completion Date

May 13, 2022

Completion Date

May 13, 2022

Last Updated

June 15, 2023

Enrollment

1,041

ACTUAL participants

Conditions

Lung Cancer

Interventions

Nivolumab in combination with Ipilimumab

DRUG

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RECRUITING

Association Between Galectin-3 Levels and Outcomes in Patients With Renal Cell Carcinoma, Transitional Cell Carcinoma , Non Small Cell Lung Cancer, and Hepatocellular Carcinoma, Treated With PD-1/PDL-1 Inhibitors

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: June 15, 2023Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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An Investigational Immuno-therapy Study for Safety of Nivolumab in Combination With Ipilimumab to Treat Advanced Cancers

Inclusion Criteria

Exclusion Criteria

A Study of Therapeutic Drug Monitoring-Based Atezolizumab Dosing

Association Between Galectin-3 Levels and Outcomes in Patients With Renal Cell Carcinoma, Transitional Cell Carcinoma , Non Small Cell Lung Cancer, and Hepatocellular Carcinoma, Treated With PD-1/PDL-1 Inhibitors

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Andamertinib With or Without Platinum-doublet Chemotherapy Versus Platinum-doublet Chemotherapy in Patients With NSCLC Harboring Atypical EGFR Mutations