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An Investigational Immuno-therapy Study for Safety of Nivolumab in Combination With Ipilimumab to Treat Advanced Cancers

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ClinicalTrials.gov Identifier: NCT02869789
Recruitment Status : Recruiting
First Posted : August 17, 2016
Last Update Posted : December 14, 2018
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb

Brief Summary:
A study to evaluate the safety of Nivolumab given in combination with Ipilimumab in patients with advanced cancers. The initial group will enroll patients with newly diagnosed Stage 4 or non-small cell lung cancer that has come back.

Condition or disease Intervention/treatment Phase
Lung Cancer Drug: Nivolumab in combination with Ipilimumab Phase 4

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1100 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 3b/4 Safety Trial of Flat Dose Nivolumab In Combination With Ipilimumab in Participants With Non-Small Cell Lung Cancer
Actual Study Start Date : September 14, 2016
Estimated Primary Completion Date : June 16, 2020
Estimated Study Completion Date : November 17, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer

Arm Intervention/treatment
Experimental: Nivolumab in combination with Ipilimumab
Specified dose on specified days
Drug: Nivolumab in combination with Ipilimumab
Specified dose on specified days
Other Names:
  • BMS-936558 (Nivolumab)
  • Opdivo (Nivolumab)
  • BMS-734016 (Ipilimumab)
  • Yervoy (Ipilimumab)




Primary Outcome Measures :
  1. Number of participants who experience high grade AEs (Adverse Events) [ Time Frame: Up to 40 months ]
    Cohorts A, B, and C

  2. Percentage of participants who experience high grade AEs [ Time Frame: Up to 40 months ]
    Cohorts A, B, and C


Secondary Outcome Measures :
  1. Progression-free survival (PFS) [ Time Frame: Up to 40 months ]
    Cohorts A, B, and C

  2. ORR [ Time Frame: Up to 40 months ]
    Cohorts A, B, and C

  3. Duration of Response (DOR) [ Time Frame: Up to 40 months ]
    Cohorts A, B, and C

  4. Functional Assessment of Cancer Therapy-Lung (FACT-L) [ Time Frame: Up to 40 months ]
    Cohorts A, A1, B, and C

  5. Overall Survival (OS) [ Time Frame: Up to 40 months ]
    Cohorts A, B, and C



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 Clinical Trial participation, please visit www.BMSStudyConnect.com

Inclusion Criteria:

  • Histologically confirmed Stage 4 or recurrent non-small cell lung cancer
  • Eastern Cooperative Oncology Group (ECOG) score 0-1 (Physically able to carry out light housework or office work through to being fully active as you were before cancer)
  • No prior systemic anticancer therapy (including EGFR and ALK inhibitors)
  • Tissue or Programmed death-ligand 1 (PD-L1) results available

Cohort 1A Inclusion Criteria:

  • Eastern Cooperative Oncology Group (ECOG) score 2 or
  • Eastern Cooperative Oncology Group (ECOG) score 0-1 and one disease specific criteria as listed in the protocol

Cohort C Inclusion Criteria:

  • High Tumor Mutation Burden

Exclusion Criteria:

  • Untreated brain metastases
  • An active malignancy that requires concurrent intervention
  • Active, known or suspected autoimmune disease
  • Carcinomatous meningitis, which means there is inflammation of the covering of the brain, caused by cancer

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): NCT02869789


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 155 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: NCT02869789     History of Changes
Other Study ID Numbers: CA209-817
2016-002621-10 ( EudraCT Number )
First Posted: August 17, 2016    Key Record Dates
Last Update Posted: December 14, 2018
Last Verified: December 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
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Nivolumab
Antibodies, Monoclonal
Antineoplastic Agents
Immunologic Factors
Physiological Effects of Drugs