A Safety Study of Nivolumab in Combination With Ipilimumab in Participants With Advanced Non-small Cell Lung Cancer (CheckMate 955)

April 13, 2018 updated by: Bristol-Myers Squibb

A Phase Ib/II Safety Trial of Nivolumab in Combination With Ipilimumab Administered in Participants With Chemotherapy-naive Stage IV or Recurrent Non-small Cell Lung Cancer (NSCLC) (CheckMate 955: CHECKpoint Pathway and nivoluMAb Clinical Trial Evaluation 955)

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

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Interventional

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Argentina
    • RIO Negro
      • Viedma, RIO Negro, Argentina, 8500
        • Local Institution
  • Canada
    • Quebec
      • Montreal, Quebec, Canada, H1M 1B1
        • Local Institution
  • Germany
      • Dresden, Germany, 01307
        • Local Institution
      • Gauting, Germany, 82131
        • Local Institution
      • Gerlingen, Germany, 70839
        • Local Institution
      • Grosshansdorf, Germany, 22927
        • Local Institution
  • Peru
      • Lima, Peru
        • Local Institution
      • Lima, Peru, 27
        • Local Institution
  • United States
    • California
      • San Francisco, California, United States, 94115
        • Local Institution
    • Nebraska
      • Lincoln, Nebraska, United States, 68506
        • Local Institution
    • New Jersey
      • Hackensack, New Jersey, United States, 07601
        • Local Institution
    • Ohio
      • Columbus, Ohio, United States, 43210
        • Local Institution
    • Pennsylvania
      • Lancaster, Pennsylvania, United States, 17604
        • Local Institution
      • Langhorne, Pennsylvania, United States, 19047
        • Local Institution
      • Sayre, Pennsylvania, United States, 18840
        • Local Institution
    • South Carolina
      • Charleston, South Carolina, United States, 29414
        • Local Institution
    • Utah
      • Saint George, Utah, United States, 84770
        • Local Institution

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com

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

Other protocol defined inclusion/exclusion criteria could apply

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Flat-Dose
Nivolumab flat dose + Ipilimumab
Drug: Ipilimumab
Specified dose on specified days
Other Names:
  • BMS-734016
  • Yervoy
Drug: Nivolumab
Specified dose on specified days
Other Names:
  • BMS-936558
  • Opdivo
EXPERIMENTAL: Weight-Based Dose
Nivolumab weight-based dose + Ipilimumab
Drug: Ipilimumab
Specified dose on specified days
Other Names:
  • BMS-734016
  • Yervoy
Drug: Nivolumab
Specified dose on specified days
Other Names:
  • BMS-936558
  • Opdivo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Incidence of high grade (Grade 3-4 and Grade 5) treatment-related select adverse events
Time Frame: Approximately 3 months
Approximately 3 months
Incidence of high grade (Grade 3-4 and Grade 5) immune-mediated adverse events
Time Frame: Approximately 3 months
Approximately 3 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Progression-free survival (PFS) as determined by the investigator using Response Evaluation Criteria in Solid Tumors (RECIST v1.1)
Time Frame: Up to 24 months
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)
Time Frame: Up to 24 months
Up to 24 months
Overall survival (OS) as defined as the time from first dosing to the date of death
Time Frame: Up to 5 years
Up to 5 years
Duration of Response (DOR) as assessed by the investigator using Response Evaluation Criteria in Solid Tumors (RECIST v1.1)
Time Frame: Up to 24 months
Up to 24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bristol-Myers Squibb

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ANTICIPATED)

March 9, 2018

Primary Completion (ANTICIPATED)

September 29, 2019

Study Completion (ANTICIPATED)

September 29, 2019

Study Registration Dates

First Submitted

February 8, 2017

First Submitted That Met QC Criteria

February 8, 2017

First Posted (ESTIMATE)

February 9, 2017

Study Record Updates

Last Update Posted (ACTUAL)

April 17, 2018

Last Update Submitted That Met QC Criteria

April 13, 2018

Last Verified

April 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CA209-955

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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