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

June 1, 2022 updated by: Bristol-Myers Squibb

Phase II, Randomized, Study of Multiple Administration Regimens for Nivolumab Plus Ipilimumab in Subjects With Renal Cell Carcinoma

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

104

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • New South Wales
      • Waratah, New South Wales, Australia, 2298
        • Local Institution
      • Westmead, New South Wales, Australia, 2145
        • Local Institution
    • Queensland
      • Herston, Queensland, Australia, 4029
        • Local Institution
    • South Australia
      • Elizabeth Vale, South Australia, Australia, 5112
        • Local Institution
    • Victoria
      • Malvern, Victoria, Australia, 3144
        • Local Institution
  • Chile
    • Metropolitana
      • Santiago, Metropolitana, Chile, 7500921
        • Fundación Arturo López Pérez
    • Santiago De Chile
      • Recoleta, Santiago De Chile, Chile
        • Centro Internacional de Estudios Clínicos
  • United States
    • Florida
      • Jacksonville, Florida, United States, 32256
        • Cancer Specialists of North FL
    • Iowa
      • Iowa City, Iowa, United States, 52242
        • University of Iowa Hospitals and Clinics
    • North Carolina
      • Charlotte, North Carolina, United States, 28204
        • Levine Cancer Institute
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15212-0000
        • Local Institution

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Co-Administration
Nivolumab and Ipilimumab Co-Administration
Biological: Opdivo
Specified dose on specified days
Other Names:
  • Nivolumab
Biological: Yervoy
Specified dose on specified days
Other Names:
  • Ipilimumab
Experimental: Sequential Administration
Nivolumab and Ipilimumab Sequential Administration
Biological: Opdivo
Specified dose on specified days
Other Names:
  • Nivolumab
Biological: Yervoy
Specified dose on specified days
Other Names:
  • Ipilimumab

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
From randomization to 2 days following any dose in the combination period (assessed up to November 24th, 2017, approximately 9 months)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
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 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.
From first dose to 30 days after last dose of study therapy (up to approximately 48 months)
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
From first dose to 30 days after last dose of study therapy (up to approximately 48 months)
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.
From randomization to the date of objectively documented progression or the date of first subsequent anti-cancer (up to approximately 52 months)
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)
From randomization to the first date of documented progression or death due to any cause (up to approximately 52 months)
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
pre-dose on day 1 of cycle 2 and 4
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
EOI on day 1 of cycle 1, 2, and 4

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bristol-Myers Squibb

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 16, 2017

Primary Completion (Actual)

November 27, 2017

Study Completion (Actual)

June 15, 2021

Study Registration Dates

First Submitted

January 20, 2017

First Submitted That Met QC Criteria

January 20, 2017

First Posted (Estimate)

January 24, 2017

Study Record Updates

Last Update Posted (Actual)

June 29, 2022

Last Update Submitted That Met QC Criteria

June 1, 2022

Last Verified

June 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CA209-800

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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