A Safety Study of Nivolumab in Combination With Ipilimumab in Participants With Advanced Non-small Cell Lung Cancer

NCT ID: NCT03048136

Last Updated: 2018-04-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE3

Study Classification

INTERVENTIONAL

Study Start Date

2018-03-09

Study Completion Date

2019-09-29

Brief Summary

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A Study to Evaluate Safety in Participants with Chemotherapy-naïve Stage IV or Recurrent Non-small Cell Lung Cancer Treated With Nivolumab in Combination with Ipilimumab

Detailed Description

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A Study to Evaluate Safety in Participants with Chemotherapy-naïve Stage IV or Recurrent Non-small Cell Lung Cancer Treated With Nivolumab in Combination with Ipilimumab

Conditions

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Non-Small Cell Lung Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Flat-Dose

Nivolumab flat dose + Ipilimumab

Group Type EXPERIMENTAL

Nivolumab

Intervention Type DRUG

Specified dose on specified days

Ipilimumab

Intervention Type DRUG

Specified dose on specified days

Weight-Based Dose

Nivolumab weight-based dose + Ipilimumab

Group Type EXPERIMENTAL

Nivolumab

Intervention Type DRUG

Specified dose on specified days

Ipilimumab

Intervention Type DRUG

Specified dose on specified days

Interventions

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Nivolumab

Specified dose on specified days

Intervention Type DRUG

Ipilimumab

Specified dose on specified days

Intervention Type DRUG

Other Intervention Names

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BMS-936558 Opdivo BMS-734016 Yervoy

Eligibility Criteria

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Inclusion Criteria

* 1\) Stage IV or recurrent non-Small cell lung cancer
* 2\) Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-1
* 3\) Prior adjuvant or neoadjuvant chemotherapy for local, advanced disease allowed if completed at least 6 months prior to randomization

Exclusion Criteria

* 1\) Known epidermal growth factor receptor (EGFR) mutations or anaplastic lymphoma syndrome(ALK) translocations that are sensitive to targeted inhibitor therapy
* 2\) Active, known or suspected autoimmune disease or HIV infection
* 3\) Prior treatment with any drug that targets T cell co-stimulation pathways (such as checkpoint inhibitors)
* 4\) Untreated Central Nervous System metastases
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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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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Local Institution

San Francisco, California, United States

Site Status

Local Institution

Lincoln, Nebraska, United States

Site Status

Local Institution

Hackensack, New Jersey, United States

Site Status

Local Institution

Columbus, Ohio, United States

Site Status

Local Institution

Lancaster, Pennsylvania, United States

Site Status

Local Institution

Langhorne, Pennsylvania, United States

Site Status

Local Institution

Sayre, Pennsylvania, United States

Site Status

Local Institution

Charleston, South Carolina, United States

Site Status

Local Institution

St. George, Utah, United States

Site Status

Local Institution

Viedma, Río Negro Province, Argentina

Site Status

Local Institution

Montreal, Quebec, Canada

Site Status

Local Institution

Dresden, , Germany

Site Status

Local Institution

Gauting, , Germany

Site Status

Local Institution

Gerlingen, , Germany

Site Status

Local Institution

Großhansdorf, , Germany

Site Status

Local Institution

Lima, , Peru

Site Status

Local Institution

Lima, , Peru

Site Status

Countries

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United States Argentina Canada Germany Peru

Related Links

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Other Identifiers

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CA209-955

Identifier Type: -

Identifier Source: org_study_id

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