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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)

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: NCT03029780
Recruitment Status : Completed
First Posted : January 24, 2017
Results First Posted : December 19, 2018
Last Update Posted : June 29, 2022
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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 104 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 16, 2017
Actual Primary Completion Date : November 27, 2017
Actual Study Completion Date : June 15, 2021


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. The Percentage of Participant With Adverse Events (AEs) in the Broad Scope MedDRA Anaphylactic Reaction Standardized MedDRA Queries (SMQ) Within 2 Days After Any Dose in the Combination Period [ Time Frame: From randomization to 2 days following any dose in the combination period (assessed up to November 24th, 2017, approximately 9 months) ]
    The percentage of participants who experienced at least 1 adverse event 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).


Secondary Outcome Measures :
  1. The Percentage of Participant With Adverse Events in the Narrow Scope MedDRA Anaphylactic Reaction Standardized MedDRA Queries (SMQ) Occurring Within 2 Days After Any Dose in the Combination Period [ Time Frame: From randomization to 2 days following any dose in the combination period (assessed up to November 24th, 2017, approximately 9 months) ]
    The percentage of participants who experienced at least 1 adverse event in the MedDRA Anaphylactic Reaction narrow scope SMQ with onset on the day of or within 2 days after any study therapy infusion during the combination period (Part 1).

  2. The Percentage of Participants With Drug Related Grade 3-5 Adverse Events [ Time Frame: From first dose to 30 days after last dose of study therapy (up to approximately 48 months) ]
    The percentage of participants who experienced at least 1 adverse event 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. Evaluated using Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.0 criteria.

  3. The Percentage of Participants With All Causality Grade 3-5 Adverse Events [ Time Frame: From first dose to 30 days after last dose of study therapy (up to approximately 48 months) ]
    The percentage of participants who experienced at least 1 adverse event 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. Evaluated using the NCI CTCAE version 4.0 criteria

  4. Objective Response Rate (ORR) [ Time Frame: From randomization to the date of objectively documented progression or the date of first subsequent anti-cancer (up to approximately 52 months) ]
    The percentage of participants with a best overall response (BOR) of complete response (CR) or partial response (PR). 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, whichever occurs first. For participants without documented progression or subsequent therapy, all available response designations will contribute to the BOR assessment. Complete Response is defined as the disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to < 10mm. Partial Response is defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.

  5. Progression Free Survival (PFS) [ Time Frame: From randomization to the first date of documented progression or death due to any cause (up to approximately 52 months) ]
    The time between the date of randomization and the first date of documented progression, or death due to any cause, whichever occurs first (per investigator). Participants who die without progression will be considered to have progressed on the date of their death. Participants who did not progress or die are censored on the date of their last evaluable tumor assessment. Participants with no on study tumor assessments and who did not die will be censored on their date of randomization. Participants who started anti-cancer therapy without a prior reported progression will be censored on the date of their last evaluable tumor assessment prior to the first subsequent anti-cancer therapy. Progression is defined as at least a 20% increase in the sum of diameters of target lesions. The sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progression)

  6. Geometric Mean Trough Concentrations of Nivolumab and Ipilimumab [ Time Frame: pre-dose on day 1 of cycle 2 and 4 ]
    Serum concentration-time data of nivolumab and ipilimumab administered as a fixed ratio combination to that of sequentially administered nivolumab and ipilimumab is summarized prior to the next dose (predose). 1 Cycle = 3 weeks

  7. Geometric Mean End of Infusion (EOI) Concentrations of Nivolumab and Ipilimumab [ Time Frame: EOI on day 1 of cycle 1, 2, and 4 ]
    Serum concentration-time data of nivolumab and ipilimumab administered as a fixed ratio combination to that of sequentially administered nivolumab and ipilimumab is summarized at the end of infusion (EOI). 1 Cycle = 3 weeks



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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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
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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, South Australia
Local Institution
Elizabeth Vale, South Australia, Australia, 5112
Australia, Victoria
Local Institution
Malvern, Victoria, Australia, 3144
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
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Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
  Study Documents (Full-Text)

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

Additional Information:
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Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT03029780    
Other Study ID Numbers: CA209-800
First Posted: January 24, 2017    Key Record Dates
Results First Posted: December 19, 2018
Last Update Posted: June 29, 2022
Last Verified: June 2022

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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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
Ipilimumab
Antineoplastic Agents, Immunological
Antineoplastic Agents
Immune Checkpoint Inhibitors
Molecular Mechanisms of Pharmacological Action