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An Investigational Immuno-Therapy Safety and Efficacy Study of Multiple Administration Regimens for Nivolumab Plus Ipilimumab in Subjects With Renal Cell Carcinoma (CheckMate 800)

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ClinicalTrials.gov Identifier: NCT03029780
Recruitment Status : Unknown
Verified November 2018 by Bristol-Myers Squibb.
Recruitment status was:  Active, not recruiting
First Posted : January 24, 2017
Results First Posted : December 19, 2018
Last Update Posted : December 19, 2018
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb

Tracking Information
First Submitted Date  ICMJE January 20, 2017
First Posted Date  ICMJE January 24, 2017
Results First Submitted Date  ICMJE November 27, 2018
Results First Posted Date  ICMJE December 19, 2018
Last Update Posted Date December 19, 2018
Actual Study Start Date  ICMJE February 9, 2017
Actual Primary Completion Date November 27, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 27, 2018)
Incidence Rate of Adverse Events (AEs) in the Broad Scope MedDRA Anaphylactic Reaction SMQ Within 2 Days After Any Dose in Combination Period. [ Time Frame: From the time of randomization to end of combination period (assessed up to November 24th, 2017, approximately 9 months) ]
This incidence rate is defined as the number of participants who experienced at least 1 AE in the MedDRA Anaphylactic Reaction broad scope SMQ with onset on the day of or within 2 days after any study therapy infusion during the combination period (Part 1) divided by number of treated participants.
Original Primary Outcome Measures  ICMJE
 (submitted: January 20, 2017)
Incidence of adverse events (AEs) in anaphylactic reaction SMQ (Standardized Medical Dictionary for Regulatory Activities Queries) [ Time Frame: Up to 20 weeks ]
Broad Scope
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 27, 2018)
  • Incidence Rate of AEs in the Narrow Scope MedDRA Anaphylactic Reaction SMQ Occurring Within 2 Days After Any Dose in the Part 1 Period [ Time Frame: From the time of randomization to end of combination period (assessed up to November 24th, 2017, approximately 9 months) ]
    This incidence rate is defined similarly to the primary endpoint except that the event rate will be based on terms within the narrow scope SMQ rather than the broad scope.
  • Incidence Rate of Drug Related Grade 3-5 AEs. [ Time Frame: From the time of randomization to end of combination period (assessed up to November 24th, 2017, approximately 9 months) ]
    The drug-related Grade 3 - 5 AE rate is defined as number of participants who experienced at least 1 AE of Grade 3 or higher, judged to be related to study treatment by the investigator, with onset on or after the first dose of study treatment and within 30 days of the last dose of study treatment, divided by number of treated participants. Evaluated using Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.0 criteria.
  • Incidence Rate of All Causality Grade 3-5 AE [ Time Frame: From the time of randomization to end of combination period (assessed up to November 24th, 2017, approximately 9 months) ]
    The all causality Grade 3 - 5 AE rate is defined as number of participants who experienced at least 1 AE of Grade 3 or higher with onset on or after the first dose of study treatment and within 30 days of the last dose of study treatment, divided by number of treated participants. Evaluated using the NCI CTCAE version 4.0 criteria
  • Nivolumab and Ipilimumab Geometric Mean Concentrations at End of Infusion (EOI) and Predose at Cycle 1, 2 and 4 [ Time Frame: From the date of first dose to end of combination stage approximately 9 months ]
    To determine pharmacokinetics (PK) comparisons of Nivolumab and Ipilimumab administered as FRC to that of sequentially administered Nivolumab and Ipilimumab. PK will be measured using serum concentration-time data.
  • Objective Response Rate (ORR) [ Time Frame: From the date of first dose to end of combination stage approximately 9 months ]
    The ORR is defined as the number of participants with a BOR of CR or PR divided by the number of treated participants. The BOR is defined as the best response designation, as determined by the investigator, recorded between the date of randomization and the date of objectively documented progression per RECIST 1.1 or the date of first subsequent anti-cancer therapy including radiotherapy, tumor-directed surgery, or systemic anticancer therapy, whichever occurs first. For participants without documented progression or subsequent therapy, all available response designations will contribute to the BOR assessment
  • Progression Free Survival (PFS) [ Time Frame: From the date of first dose to end of combination stage approximately 9 months ]
    PFS is defined as the time between the date of randomization and the first date of documented progression, as determined by the investigator, or death due to any cause, whichever occurs first
Original Secondary Outcome Measures  ICMJE
 (submitted: January 20, 2017)
  • Incidence of AEs in anaphylactic reaction SMQ (Standardized Medical Dictionary for Regulatory Activities Queries) [ Time Frame: Up to 20 weeks ]
    Narrow Scope
  • Incidence of grade 3-5 AEs [ Time Frame: Up to 20 weeks ]
  • Pharmacokinetics (PK) as measured using serum concentration-time data [ Time Frame: Up to 20 weeks ]
  • Objective Response Rate (ORR) [ Time Frame: Up to 20 weeks ]
  • Progression Free Survival (PFS) [ Time Frame: Up to 20 weeks ]
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 Safety and Efficacy Study of Multiple Administration Regimens for Nivolumab Plus Ipilimumab in Subjects With Renal Cell Carcinoma
Official Title  ICMJE Phase II, Randomized, Study of Multiple Administration Regimens for Nivolumab Plus Ipilimumab in Subjects With Renal Cell Carcinoma
Brief Summary The purpose of this study is to evaluate safety and efficacy of different administration regimens of nivolumab plus ipilimumab in subjects with renal cell carcinoma.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Renal Cell Carcinoma
Intervention  ICMJE
  • Biological: Opdivo
    Specified dose on specified days
    Other Name: Nivolumab
  • Biological: Yervoy
    Specified dose on specified days
    Other Name: Ipilimumab
Study Arms  ICMJE
  • Experimental: Co-Administration
    Nivolumab and Ipilimumab Co-Administration
    Interventions:
    • Biological: Opdivo
    • Biological: Yervoy
  • Experimental: Sequential Administration
    Nivolumab and Ipilimumab Sequential Administration
    Interventions:
    • Biological: Opdivo
    • Biological: Yervoy
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 Unknown status
Actual Enrollment  ICMJE
 (submitted: December 22, 2017)
118
Original Estimated Enrollment  ICMJE
 (submitted: January 20, 2017)
100
Estimated Study Completion Date  ICMJE February 21, 2021
Actual Primary Completion Date November 27, 2017   (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:

  • Advanced Renal Cell Carcinoma
  • 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
  • Must have at least 1 lesion with measurable disease

Exclusion Criteria:

  • Subjects with active central nervous system metastases
  • Subjects who received prior therapy with checkpoint inhibitor
  • Subjects with active, known or suspected autoimmune disease

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 Australia,   Chile,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03029780
Other Study ID Numbers  ICMJE CA209-800
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 November 2018

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