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Nivolumab in Combination With Ipilimumab (Part 1); Nivolumab Plus Ipilimumab in Combination With Chemotherapy (Part 2) as First Line Therapy in Stage IV Non-Small Cell Lung Cancer (CheckMate 568)

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ClinicalTrials.gov Identifier: NCT02659059
Recruitment Status : Active, not recruiting
First Posted : January 20, 2016
Last Update Posted : September 19, 2018
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb

Brief Summary:

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 determine the safety and tolerability of nivolumab and ipilimumab combined with a short course of chemotherapy in first line stage IV NSCLC.


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

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 507 participants
Allocation: Non-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 (Part 2) as First Line Therapy in Stage IV Non-Small Cell Lung Cancer (NSCLC)
Actual Study Start Date : February 10, 2016
Estimated Primary Completion Date : November 6, 2018
Estimated Study Completion Date : April 20, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer

Arm Intervention/treatment
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



Primary Outcome Measures :
  1. Objective response rate (ORR) [ Time Frame: Up to 6 months after the last subject first treatment ]

    Part 1 - nivolumab + ipilimumab

    In all treated PD-L1 positive (≥ 1%)


  2. ORR [ Time Frame: Up to 6 months after the last subject first treatment ]

    Part 1 - nivolumab + ipilimumab

    In all treated PD-L1 negative (< 1%)


  3. Number of Patients with dose Limiting Toxicities (DLTs) [ Time Frame: 9 weeks after last subject first treatment ]

    Part 2 - nivolumab + ipilimumab + 2 cycles platinum doublet chemotherapy

    To determine DLT


  4. Number of Adverse Events (AEs) [ Time Frame: Up to 6 months after the last subject first treatment ]

    Part 2 - nivolumab + ipilimumab + 2 cycles platinum doublet chemotherapy

    Safety and Tolerability


  5. Number of Serious Adverse Events (SAEs) [ Time Frame: Up to 6 months after the last subject first treatment ]

    Part 2 - nivolumab + ipilimumab + 2 cycles platinum doublet chemotherapy

    Safety and Tolerability


  6. Number of Deaths [ Time Frame: Up to 6 months after the last subject first treatment ]

    Part 2 - nivolumab + ipilimumab + 2 cycles platinum doublet chemotherapy

    Safety and Tolerability


  7. Number of Laboratory Abnormalities Graded by Common Terminology Criteria for Adverse Events (CTCAE) [ Time Frame: Up to 6 months after the last subject first treatment ]

    Part 2 - nivolumab + ipilimumab + 2 cycles platinum doublet chemotherapy

    Safety and Tolerability



Secondary Outcome Measures :
  1. Progression free survival (PFS) [ Time Frame: 6 months after the last subject first treatment ]
    Part 1 - nivolumab + ipilimumab

  2. Overall Response Rate (ORR) [ Time Frame: 6 months after the last subject first treatment ]
    Part 1 - nivolumab + ipilimumab

  3. Overall Survival (OS) [ Time Frame: 14 months after the last subject first treatment ]
    Part 1 - nivolumab + ipilimumab

  4. PFS [ Time Frame: 6 months after the last subject first treatment ]
    Part 2 - nivolumab + ipilimumab + 2 cycles platinum doublet chemotherapy

  5. ORR [ Time Frame: 6 months after the last subject first treatment ]
    Part 2 - nivolumab + ipilimumab + 2 cycles platinum doublet chemotherapy

  6. OS [ Time Frame: 6 months after the last subject first treatment ]
    Part 2 - nivolumab + ipilimumab + 2 cycles platinum doublet chemotherapy



Information from the National Library of Medicine

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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 (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


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


  Show 32 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: NCT02659059     History of Changes
Other Study ID Numbers: CA209-568
First Posted: January 20, 2016    Key Record Dates
Last Update Posted: September 19, 2018
Last Verified: September 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