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An Exploratory Study of the Effects of Nivolumab Combined With Ipilimumab in Patients With Treatment-Naive Stage IV or Recurrent Non-Small Cell Lung Cancer (NSCLC) (CheckMate 592)

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ClinicalTrials.gov Identifier: NCT03001882
Recruitment Status : Recruiting
First Posted : December 23, 2016
Last Update Posted : August 14, 2018
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb

Brief Summary:
The purpose of this study is to explore the possible links between participant characteristics and their cancer, with how effective the combination of nivolumab with ipilimumab is, in participants with Stage IV or recurrent Non-Small Cell Lung Cancer (NSCLC).

Condition or disease Intervention/treatment Phase
Non-Small Cell Lung Cancer Biological: Nivolumab Biological: Ipilimumab Phase 2

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 250 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Exploratory Study of the Biologic Effects and Biomarkers of Nivolumab in Combination With Ipilimumab in Subjects With Treatment-Naive Stage IV or Recurrent Non-Small Cell Lung Cancer (NSCLC)
Actual Study Start Date : March 14, 2017
Estimated Primary Completion Date : September 28, 2021
Estimated Study Completion Date : December 14, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer

Arm Intervention/treatment
Experimental: Combination therapy
Nivolumab + Ipilimumab
Biological: Nivolumab
Specified dose on specified days
Other Names:
  • Opdivo
  • BMS-936558

Biological: Ipilimumab
Specified dose on specified days
Other Names:
  • Yervoy
  • BMS-734016




Primary Outcome Measures :
  1. Objective Response Rate (ORR) [ Time Frame: Approximately 48 months ]
    measured by time


Secondary Outcome Measures :
  1. Objective Response Rate (ORR) of patient subgroups defined by baseline biomarkers [ Time Frame: Approximately 48 months ]
    measured by time

  2. Disease Control Rate (DCR) of patient subgroups defined by baseline biomarkers [ Time Frame: Approximately 48 months ]
    measured by time

  3. Duration of Response (DOR) of patient subgroups defined by baseline biomarkers [ Time Frame: Approximately 48 months ]
    measured by time

  4. Time to Response (TTR) of patient subgroups defined by baseline biomarkers [ Time Frame: Approximately 48 months ]
    measured by time

  5. Progression Free Survival (PFS) of patient subgroups defined by baseline biomarkers [ Time Frame: Approximately 48 months ]
    measured by time

  6. Overall Survival (OS) of patient subgroups defined by baseline biomarkers [ Time Frame: Approximately 48 months ]
    measured by time

  7. Incidence of Adverse Events (AEs) [ Time Frame: Approximately 48 months ]
  8. Incidence of Serious Adverse Events (SAEs) [ Time Frame: Approximately 48 months ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Inclusion Criteria:

  • Histologically confirmed, stage IV or recurrent non-small cell lung cancer with no prior systemic anticancer therapy given as primary therapy for advanced or metastatic disease
  • Measurable disease by CT or MRI
  • Must have full activity or, if limited, must be able to walk and carry out light activities such as light house work or office work

Exclusion Criteria:

  • Patients with untreated central nervous system metastases
  • Participants with active, known or suspected autoimmune disease
  • Prior treatment with any drug that targets T cell co-stimulations pathways (such as checkpoint inhibitors)

Other protocol defined inclusion/exclusion criteria could apply


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03001882


Contacts
Contact: Recruiting sites have contact information. Please contact the sites directly. If there is no contact information, please email: Clinical.Trials@bms.com
Contact: First line of the email MUST contain NCT# and Site #.

  Show 27 Study Locations
Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb

Additional Information:
Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT03001882     History of Changes
Other Study ID Numbers: CA209-592
2018-000462-11 ( EudraCT Number )
First Posted: December 23, 2016    Key Record Dates
Last Update Posted: August 14, 2018
Last Verified: August 2018

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Nivolumab
Antibodies, Monoclonal
Antineoplastic Agents
Immunologic Factors
Physiological Effects of Drugs