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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 : Active, not recruiting
First Posted : January 24, 2017
Results First Posted : December 18, 2018
Last Update Posted : December 18, 2018
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb

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.

Condition or disease Intervention/treatment Phase
Renal Cell Carcinoma Biological: Opdivo Biological: Yervoy Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 118 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase II, Randomized, Study of Multiple Administration Regimens for Nivolumab Plus Ipilimumab in Subjects With Renal Cell Carcinoma
Actual Study Start Date : February 9, 2017
Actual Primary Completion Date : November 27, 2017
Estimated Study Completion Date : February 21, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Co-Administration
Nivolumab and Ipilimumab Co-Administration
Biological: Opdivo
Specified dose on specified days
Other Name: Nivolumab

Biological: Yervoy
Specified dose on specified days
Other Name: Ipilimumab

Experimental: Sequential Administration
Nivolumab and Ipilimumab Sequential Administration
Biological: Opdivo
Specified dose on specified days
Other Name: Nivolumab

Biological: Yervoy
Specified dose on specified days
Other Name: Ipilimumab




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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

  4. 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.

  5. 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

  6. 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



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:

  • 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


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): NCT03029780


Locations
United States, Florida
Cancer Specialists of North FL
Jacksonville, Florida, United States, 32256
United States, Iowa
University Of Iowa Hospitals And Clinics
Iowa City, Iowa, United States, 52242
United States, North Carolina
Levine Cancer Institute
Charlotte, North Carolina, United States, 28204
United States, Pennsylvania
Local Institution
Pittsburgh, Pennsylvania, United States, 15212-0000
Australia, New South Wales
Local Institution
Waratah, New South Wales, Australia, 2298
Local Institution
Westmead, New South Wales, Australia, 2145
Australia, Queensland
Local Institution
Herston, Queensland, Australia, 4029
Australia, Victoria
Local Institution
Malvern, Victoria, Australia, 3144
Australia
Local Institution
Elizabeth Vale, Australia, 5112
Chile
Fundacion Arturo Lopez Perez
Santiago, Metropolitana, Chile, 7500921
Centro Internacional de Estudios Clinicos
Recoleta, Santiago DE Chile, Chile
Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
  Study Documents (Full-Text)

Documents provided by Bristol-Myers Squibb:
Statistical Analysis Plan  [PDF] September 11, 2017
Study Protocol  [PDF] August 2, 2017


Additional Information:
Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT03029780     History of Changes
Other Study ID Numbers: CA209-800
First Posted: January 24, 2017    Key Record Dates
Results First Posted: December 18, 2018
Last Update Posted: December 18, 2018
Last Verified: November 2018

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Carcinoma
Carcinoma, Renal Cell
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Adenocarcinoma
Kidney Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Kidney Diseases
Urologic Diseases
Nivolumab
Antibodies, Monoclonal
Antineoplastic Agents
Immunologic Factors
Physiological Effects of Drugs