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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT03029780
Registration number
NCT03029780
Ethics application status
Date submitted
20/01/2017
Date registered
24/01/2017
Date last updated
29/06/2022
Titles & IDs
Public title
An Investigational Immuno-Therapy Safety and Efficacy Study of Multiple Administration Regimens for Nivolumab Plus Ipilimumab in Subjects With Renal Cell Carcinoma
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Scientific title
Phase II, Randomized, Study of Multiple Administration Regimens for Nivolumab Plus Ipilimumab in Subjects With Renal Cell Carcinoma
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Secondary ID [1]
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CA209-800
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Universal Trial Number (UTN)
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Trial acronym
CheckMate 800
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Renal Cell Carcinoma
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Condition category
Condition code
Cancer
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Non melanoma skin cancer
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Cancer
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Kidney
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Other interventions - Opdivo
Other interventions - Yervoy
Experimental: Co-Administration - Nivolumab and Ipilimumab Co-Administration
Experimental: Sequential Administration - Nivolumab and Ipilimumab Sequential Administration
Other interventions: Opdivo
Specified dose on specified days
Other interventions: Yervoy
Specified dose on specified days
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Intervention code [1]
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Other interventions
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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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
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Assessment method [1]
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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).
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Timepoint [1]
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From randomization to 2 days following any dose in the combination period (assessed up to November 24th, 2017, approximately 9 months)
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Secondary outcome [1]
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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
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Assessment method [1]
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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).
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Timepoint [1]
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From randomization to 2 days following any dose in the combination period (assessed up to November 24th, 2017, approximately 9 months)
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Secondary outcome [2]
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The Percentage of Participants With Drug Related Grade 3-5 Adverse Events
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Assessment method [2]
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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.
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Timepoint [2]
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From first dose to 30 days after last dose of study therapy (up to approximately 48 months)
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Secondary outcome [3]
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The Percentage of Participants With All Causality Grade 3-5 Adverse Events
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Assessment method [3]
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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
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Timepoint [3]
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From first dose to 30 days after last dose of study therapy (up to approximately 48 months)
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Secondary outcome [4]
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Objective Response Rate (ORR)
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Assessment method [4]
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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.
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Timepoint [4]
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From randomization to the date of objectively documented progression or the date of first subsequent anti-cancer (up to approximately 52 months)
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Secondary outcome [5]
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Progression Free Survival (PFS)
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Assessment method [5]
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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)
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Timepoint [5]
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From randomization to the first date of documented progression or death due to any cause (up to approximately 52 months)
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Secondary outcome [6]
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Geometric Mean Trough Concentrations of Nivolumab and Ipilimumab
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Assessment method [6]
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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
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Timepoint [6]
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pre-dose on day 1 of cycle 2 and 4
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Secondary outcome [7]
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Geometric Mean End of Infusion (EOI) Concentrations of Nivolumab and Ipilimumab
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Assessment method [7]
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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
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Timepoint [7]
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EOI on day 1 of cycle 1, 2, and 4
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Eligibility
Key inclusion criteria
For more information regarding Bristol-Myers Squibb Clinical Trial participation, please
visit www.BMSStudyConnect.com
- 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
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key 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
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 2
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
16/02/2017
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
15/06/2021
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Sample size
Target
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Accrual to date
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Final
104
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Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC
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Recruitment hospital [1]
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Local Institution - Waratah
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Recruitment hospital [2]
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Local Institution - Westmead
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Recruitment hospital [3]
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Local Institution - Herston
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Recruitment hospital [4]
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Local Institution - Elizabeth Vale
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Recruitment hospital [5]
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Local Institution - Malvern
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Recruitment postcode(s) [1]
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2298 - Waratah
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Recruitment postcode(s) [2]
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2145 - Westmead
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Recruitment postcode(s) [3]
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4029 - Herston
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Recruitment postcode(s) [4]
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5112 - Elizabeth Vale
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Recruitment postcode(s) [5]
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3144 - Malvern
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Recruitment outside Australia
Country [1]
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United States of America
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State/province [1]
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Florida
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Country [2]
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United States of America
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State/province [2]
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Iowa
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Country [3]
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United States of America
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State/province [3]
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North Carolina
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Country [4]
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United States of America
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State/province [4]
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Pennsylvania
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Country [5]
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Chile
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State/province [5]
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Metropolitana
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Country [6]
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Chile
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State/province [6]
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Santiago De Chile
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Bristol-Myers Squibb
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Address
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Country
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Ethics approval
Ethics application status
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Summary
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.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT03029780
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Bristol-Myers Squibb
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Address
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Bristol-Myers Squibb
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT03029780
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