NCT03048136

Brief Summary

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

Trial Health

37
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Mar 2018

Shorter than P25 for phase_3 nonsmall-cell-lung-cancer

Geographic Reach
5 countries

17 active sites

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 8, 2017

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 9, 2017

Completed
1.1 years until next milestone

Study Start

First participant enrolled

March 9, 2018

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 29, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 29, 2019

Completed
Last Updated

April 17, 2018

Status Verified

April 1, 2018

Enrollment Period

1.6 years

First QC Date

February 8, 2017

Last Update Submit

April 13, 2018

Conditions

Non-Small Cell Lung Cancer

Outcome Measures

Primary Outcomes (2)

  • Incidence of high grade (Grade 3-4 and Grade 5) treatment-related select adverse events

    Approximately 3 months

  • Incidence of high grade (Grade 3-4 and Grade 5) immune-mediated adverse events

    Approximately 3 months

Secondary Outcomes (4)

  • Progression-free survival (PFS) as determined by the investigator using Response Evaluation Criteria in Solid Tumors (RECIST v1.1)

    Up to 24 months

  • Objective Response Rate (ORR) as assessed by the Investigator using tumor progression per Response Evaluation Criteria in Solid Tumors (RECIST v1.1)

    Up to 24 months

  • Overall survival (OS) as defined as the time from first dosing to the date of death

    Up to 5 years

  • Duration of Response (DOR) as assessed by the investigator using Response Evaluation Criteria in Solid Tumors (RECIST v1.1)

    Up to 24 months

Study Arms (2)

Flat-Dose

EXPERIMENTAL

Nivolumab flat dose + Ipilimumab

Drug: NivolumabDrug: Ipilimumab

Weight-Based Dose

EXPERIMENTAL

Nivolumab weight-based dose + Ipilimumab

Drug: NivolumabDrug: Ipilimumab

Interventions

NivolumabDRUG

Specified dose on specified days

Also known as: BMS-936558, Opdivo
Flat-DoseWeight-Based Dose
IpilimumabDRUG

Specified dose on specified days

Also known as: BMS-734016, Yervoy
Flat-DoseWeight-Based Dose

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (17)

Local Institution

San Francisco, California, 94115, United States

Location

Local Institution

Lincoln, Nebraska, 68506, United States

Location

Local Institution

Hackensack, New Jersey, 07601, United States

Location

Local Institution

Columbus, Ohio, 43210, United States

Location

Local Institution

Lancaster, Pennsylvania, 17604, United States

Location

Local Institution

Langhorne, Pennsylvania, 19047, United States

Location

Local Institution

Sayre, Pennsylvania, 18840, United States

Location

Local Institution

Charleston, South Carolina, 29414, United States

Location

Local Institution

St. George, Utah, 84770, United States

Location

Local Institution

Viedma, Río Negro Province, 8500, Argentina

Location

Local Institution

Montreal, Quebec, H1M 1B1, Canada

Location

Local Institution

Dresden, 01307, Germany

Location

Local Institution

Gauting, 82131, Germany

Location

Local Institution

Gerlingen, 70839, Germany

Location

Local Institution

Großhansdorf, 22927, Germany

Location

Local Institution

Lima, 27, Peru

Location

Local Institution

Lima, Peru

Location

Related Links

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

NivolumabIpilimumab

Condition Hierarchy (Ancestors)

Carcinoma, BronchogenicBronchial NeoplasmsLung NeoplasmsRespiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, HumanizedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulins

Study Officials

  • Bristol-Myers Squibb

    Bristol-Myers Squibb

    STUDY DIRECTOR
0

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 8, 2017

First Posted

February 9, 2017

Study Start

March 9, 2018

Primary Completion

September 29, 2019

Study Completion

September 29, 2019

Last Updated

April 17, 2018

Record last verified: 2018-04

Locations

US(9)DE(4)CA(1)PE(2)AR(1)