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

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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02869789
Recruitment Status : Active, not recruiting
First Posted : August 17, 2016
Last Update Posted : August 11, 2020
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb

Tracking Information
First Submitted Date  ICMJE August 12, 2016
First Posted Date  ICMJE August 17, 2016
Last Update Posted Date August 11, 2020
Actual Study Start Date  ICMJE October 5, 2016
Estimated Primary Completion Date October 14, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 7, 2018)
  • Number of participants who experience high grade AEs (Adverse Events) [ Time Frame: Up to 40 months ]
    Cohorts A, B, and C
  • Percentage of participants who experience high grade AEs [ Time Frame: Up to 40 months ]
    Cohorts A, B, and C
Original Primary Outcome Measures  ICMJE
 (submitted: August 12, 2016)
  • Number of participants who experience high grade AEs (Adverse Events) [ Time Frame: Up to 40 months ]
  • Percentage of participants who experience high grade AEs [ Time Frame: Up to 40 months ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 7, 2018)
  • Progression-free survival (PFS) [ Time Frame: Up to 40 months ]
    Cohorts A, B, and C
  • ORR [ Time Frame: Up to 40 months ]
    Cohorts A, B, and C
  • Duration of Response (DOR) [ Time Frame: Up to 40 months ]
    Cohorts A, B, and C
  • Functional Assessment of Cancer Therapy-Lung (FACT-L) [ Time Frame: Up to 40 months ]
    Cohorts A, A1, B, and C
  • Overall Survival (OS) [ Time Frame: Up to 40 months ]
    Cohorts A, B, and C
Original Secondary Outcome Measures  ICMJE
 (submitted: August 12, 2016)
  • Progression-free survival (PFS) [ Time Frame: Up to 40 months ]
  • Objective Response Rate (ORR) [ Time Frame: Up to 40 months ]
  • Duration of Response (DOR) [ Time Frame: Up to 40 months ]
  • Functional Assessment of Cancer Therapy-Lung (FACT-L) [ Time Frame: Up to 40 months ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE An Investigational Immuno-therapy Study for Safety of Nivolumab in Combination With Ipilimumab to Treat Advanced Cancers
Official Title  ICMJE A Phase 3b/4 Safety Trial of Flat Dose Nivolumab In Combination With Ipilimumab in Participants With Non-Small Cell Lung Cancer
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Lung Cancer
Intervention  ICMJE Drug: Nivolumab in combination with Ipilimumab
Specified dose on specified days
Other Names:
  • BMS-936558 (Nivolumab)
  • Opdivo (Nivolumab)
  • BMS-734016 (Ipilimumab)
  • Yervoy (Ipilimumab)
Study Arms  ICMJE Experimental: Nivolumab in combination with Ipilimumab
Specified dose on specified days
Intervention: Drug: Nivolumab in combination with Ipilimumab
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: April 28, 2020)
1036
Original Estimated Enrollment  ICMJE
 (submitted: August 12, 2016)
700
Estimated Study Completion Date  ICMJE October 4, 2022
Estimated Primary Completion Date October 14, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Argentina,   Belgium,   Brazil,   Canada,   Chile,   Czechia,   France,   Germany,   Greece,   Hungary,   Italy,   Mexico,   Netherlands,   Poland,   Romania,   Russian Federation,   Spain,   Switzerland,   Turkey,   United Kingdom,   United States
Removed Location Countries Czech Republic
 
Administrative Information
NCT Number  ICMJE NCT02869789
Other Study ID Numbers  ICMJE CA209-817
2016-002621-10 ( EudraCT Number )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Bristol-Myers Squibb
Study Sponsor  ICMJE Bristol-Myers Squibb
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
PRS Account Bristol-Myers Squibb
Verification Date August 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP