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

• ClinicalTrials.gov Identifier: NCT03029780
• Recruitment Status: Unknown
• First Posted: January 24, 2017
• Results First Posted: December 19, 2018
• Last Update Posted: December 19, 2018
• Sponsor: Bristol-Myers Squibb
• Information provided by (Responsible Party): Bristol-Myers Squibb

Tracking Information

• First Submitted Date: January 20, 2017
• First Posted Date: January 24, 2017
• Results First Submitted Date: November 27, 2018
• Results First Posted Date: December 19, 2018
• Last Update Posted Date: December 19, 2018
• Actual Study Start Date: February 9, 2017
• Actual Primary Completion Date: November 27, 2017 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (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 (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

Current Secondary Outcome Measures (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 (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: An Investigational Immuno-Therapy Safety and Efficacy Study of Multiple Administration Regimens for Nivolumab Plus Ipilimumab in Subjects With Renal Cell Carcinoma
• Official Title: 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: Interventional
• Study Phase: Phase 2
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Renal Cell Carcinoma

Intervention

• Biological: Opdivo
  Specified dose on specified days
  Other Name: Nivolumab
• Biological: Yervoy
  Specified dose on specified days
  Other Name: Ipilimumab

Study Arms

• 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

Recruitment Information

• Recruitment Status: Unknown status
• Actual Enrollment (submitted: December 22, 2017): 118
• Original Estimated Enrollment (submitted: January 20, 2017): 100
• Estimated Study Completion Date: February 21, 2021
• Actual Primary Completion Date: November 27, 2017 (Final data collection date for primary outcome measure)

Eligibility Criteria

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

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Australia, Chile, United States

Administrative Information

• NCT Number: NCT03029780
• Other Study ID Numbers: 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: Not Provided
• Responsible Party: Bristol-Myers Squibb
• Study Sponsor: Bristol-Myers Squibb
• Collaborators: Not Provided

Investigators

• Study Director: Bristol-Myers Squibb; Bristol-Myers Squibb

• PRS Account: Bristol-Myers Squibb
• Verification Date: November 2018