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Trial record 1 of 1 for:    NCT02659059
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Nivolumab in Combination With Ipilimumab (Part 1); Nivolumab Plus Ipilimumab in Combination With Chemotherapy vs. Chemotherapy Alone (Part 2) as First Line Therapy in Stage IV Non-Small Cell Lung Cancer (CheckMate 568)

This study is currently recruiting participants.
Verified July 2017 by Bristol-Myers Squibb
Sponsor:
ClinicalTrials.gov Identifier:
NCT02659059
First Posted: January 20, 2016
Last Update Posted: July 25, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Bristol-Myers Squibb
  Purpose

The purpose of part 1 of this study is to determine the objective response rate (ORR) in stage IV NSCLC subjects treated with nivolumab in combination with ipilimumab as first line therapy.

The purpose of part 2 of this study is to compare overall survival of Nivolumab and ipilimumab combined with a short course of chemotherapy to standard of care chemotherapy in first line stage IV NSCLC.


Condition Intervention Phase
Non-Small-Cell Lung Cancer Biological: Nivolumab Biological: Ipilimumab Drug: Platinum Doublet Chemotherapy Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Study of Nivolumab in Combination With Ipilimumab (Part 1); and Nivolumab Plus Ipilimumab in Combination With Chemotherapy vs. Chemotherapy Alone (Part 2) as First Line Therapy in Stage IV Non-Small Cell Lung Cancer (NSCLC)

Resource links provided by NLM:


Further study details as provided by Bristol-Myers Squibb:

Primary Outcome Measures:
  • Objective response rate (ORR) [ Time Frame: 6 months after the last subject first treatment ]
    Part 1 -Nivolumab and ipilimumab

  • Comparison of Overall Survival (OS) [ Time Frame: 14 months after the last subject first treatment ]
    Part 2 - Nivolumab and ipilimumab plus chemotherapy vs. chemotherapy alone


Secondary Outcome Measures:
  • Progression free survival (PFS) [ Time Frame: 14 months after the last subject first treatment ]
  • Overall Survival (OS) [ Time Frame: 14 months after the last subject first treatment] ]
  • Overall Response Rate(ORR) [ Time Frame: 14 months after the last subject first treatment ]
  • Lung Cancer Symptom Score (LCSS) [ Time Frame: Up To 24 Weeks ]
  • Average Symptom Burden Index (ASBI) [ Time Frame: Up To 24 Weeks ]

Estimated Enrollment: 450
Actual Study Start Date: February 10, 2016
Estimated Study Completion Date: January 24, 2022
Estimated Primary Completion Date: June 9, 2019 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Nivolumab+Ipilimumab

Part 1

Specified Dose on Specified Days

Biological: Nivolumab
Specified Dose on Specified Days
Other Names:
  • BMS-936558
  • Opdivo
Biological: Ipilimumab
Specified Dose on Specified Days
Other Names:
  • BMS-734016
  • Yervoy
Experimental: Nivolumab+Ipilimumab + 2 cycles Platinum Doublet Chemotherapy

Part 2

Specified Dose on Specified Days

Biological: Nivolumab
Specified Dose on Specified Days
Other Names:
  • BMS-936558
  • Opdivo
Biological: Ipilimumab
Specified Dose on Specified Days
Other Names:
  • BMS-734016
  • Yervoy
Drug: Platinum Doublet Chemotherapy
Specified Dose on Specified Days
Active Comparator: Platinum Doublet Chemotherapy
Specified Dose on Specified Days
Drug: Platinum Doublet Chemotherapy
Specified Dose on Specified Days

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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

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

Inclusion Criteria:

  • Men and Women ≥ 18 years of age
  • Diagnosed with stage IV Non-Small Cell Lung Cancer
  • Diagnosed with recurrent stage IIIB non-small cell lung cancer and failed previous concurrent chemoradiation with no further curative options.

Exclusion Criteria:

  • Subjects with untreated CNS metastases are excluded.
  • Subjects with carcinomatous meningitis
  • Subjects with an active, known or suspected autoimmune disease.
  • Subjects with a condition requiring systemic treatment with either corticosteroids ( > 10 mg daily prednisone

equivalent) or other immunosuppressive medications within 14 days of first treatment.

  • Women who are pregnant, plan to become pregnant, and/or breastfeed during the study.

Other protocol defined inclusion/exclusion criteria could apply

  Contacts and Locations
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): NCT02659059


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 66 Study Locations
Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
  More Information

Additional Information:
Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT02659059     History of Changes
Other Study ID Numbers: CA209-568
First Submitted: January 15, 2016
First Posted: January 20, 2016
Last Update Posted: July 25, 2017
Last Verified: July 2017

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