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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/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
Scientific title
Phase II, Randomized, Study of Multiple Administration Regimens for Nivolumab Plus Ipilimumab in Subjects With Renal Cell Carcinoma
Secondary ID [1] 0 0
CA209-800
Universal Trial Number (UTN)
Trial acronym
CheckMate 800
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Renal Cell Carcinoma 0 0
Condition category
Condition code
Cancer 0 0 0 0
Non melanoma skin cancer
Cancer 0 0 0 0
Kidney

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Other - Opdivo
Treatment: Other - Yervoy

Experimental: Co-Administration - Nivolumab and Ipilimumab Co-Administration

Experimental: Sequential Administration - Nivolumab and Ipilimumab Sequential Administration


Treatment: Other: Opdivo
Specified dose on specified days

Treatment: Other: Yervoy
Specified dose on specified days
Intervention code [1] 0 0
Treatment: Other
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
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
Timepoint [1] 0 0
From randomization to 2 days following any dose in the combination period (assessed up to November 24th, 2017, approximately 9 months)
Secondary outcome [1] 0 0
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
Timepoint [1] 0 0
From randomization to 2 days following any dose in the combination period (assessed up to November 24th, 2017, approximately 9 months)
Secondary outcome [2] 0 0
The Percentage of Participants With Drug Related Grade 3-5 Adverse Events
Timepoint [2] 0 0
From first dose to 30 days after last dose of study therapy (up to approximately 48 months)
Secondary outcome [3] 0 0
The Percentage of Participants With All Causality Grade 3-5 Adverse Events
Timepoint [3] 0 0
From first dose to 30 days after last dose of study therapy (up to approximately 48 months)
Secondary outcome [4] 0 0
Objective Response Rate (ORR)
Timepoint [4] 0 0
From randomization to the date of objectively documented progression or the date of first subsequent anti-cancer (up to approximately 52 months)
Secondary outcome [5] 0 0
Progression Free Survival (PFS)
Timepoint [5] 0 0
From randomization to the first date of documented progression or death due to any cause (up to approximately 52 months)
Secondary outcome [6] 0 0
Geometric Mean Trough Concentrations of Nivolumab and Ipilimumab
Timepoint [6] 0 0
pre-dose on day 1 of cycle 2 and 4
Secondary outcome [7] 0 0
Geometric Mean End of Infusion (EOI) Concentrations of Nivolumab and Ipilimumab
Timepoint [7] 0 0
EOI on day 1 of cycle 1, 2, and 4

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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
16/02/2017
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
15/06/2021
Sample size
Target
Accrual to date
Final
104
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC
Recruitment hospital [1] 0 0
Local Institution - Waratah
Recruitment hospital [2] 0 0
Local Institution - Westmead
Recruitment hospital [3] 0 0
Local Institution - Herston
Recruitment hospital [4] 0 0
Local Institution - Elizabeth Vale
Recruitment hospital [5] 0 0
Local Institution - Malvern
Recruitment postcode(s) [1] 0 0
2298 - Waratah
Recruitment postcode(s) [2] 0 0
2145 - Westmead
Recruitment postcode(s) [3] 0 0
4029 - Herston
Recruitment postcode(s) [4] 0 0
5112 - Elizabeth Vale
Recruitment postcode(s) [5] 0 0
3144 - Malvern
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Florida
Country [2] 0 0
United States of America
State/province [2] 0 0
Iowa
Country [3] 0 0
United States of America
State/province [3] 0 0
North Carolina
Country [4] 0 0
United States of America
State/province [4] 0 0
Pennsylvania
Country [5] 0 0
Chile
State/province [5] 0 0
Metropolitana
Country [6] 0 0
Chile
State/province [6] 0 0
Santiago De Chile

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Bristol-Myers Squibb
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Bristol-Myers Squibb
Address 0 0
Bristol-Myers Squibb
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

No information has been provided regarding IPD availability


What supporting documents are/will be available?




Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results are available at https://clinicaltrials.gov/study/NCT03029780