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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT03029780




Registration number
NCT03029780
Ethics application status
Date submitted
20/01/2017
Date registered
24/01/2017
Date last updated
19/12/2018

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
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

Intervention code [1] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Incidence Rate of Adverse Events (AEs) in the Broad Scope MedDRA Anaphylactic Reaction SMQ Within 2 Days After Any Dose in Combination Period. - 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.
Timepoint [1] 0 0
From the time of randomization to end of combination period (assessed up to November 24th, 2017, approximately 9 months)
Secondary outcome [1] 0 0
Incidence Rate of AEs in the Narrow Scope MedDRA Anaphylactic Reaction SMQ Occurring Within 2 Days After Any Dose in the Part 1 Period - 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.
Timepoint [1] 0 0
From the time of randomization to end of combination period (assessed up to November 24th, 2017, approximately 9 months)
Secondary outcome [2] 0 0
Incidence Rate of Drug Related Grade 3-5 AEs. - 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.
Timepoint [2] 0 0
From the time of randomization to end of combination period (assessed up to November 24th, 2017, approximately 9 months)
Secondary outcome [3] 0 0
Incidence Rate of All Causality Grade 3-5 AE - 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
Timepoint [3] 0 0
From the time of randomization to end of combination period (assessed up to November 24th, 2017, approximately 9 months)
Secondary outcome [4] 0 0
Nivolumab and Ipilimumab Geometric Mean Concentrations at End of Infusion (EOI) and Predose at Cycle 1, 2 and 4 - 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.
Timepoint [4] 0 0
From the date of first dose to end of combination stage approximately 9 months
Secondary outcome [5] 0 0
Objective Response Rate (ORR) - 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
Timepoint [5] 0 0
From the date of first dose to end of combination stage approximately 9 months
Secondary outcome [6] 0 0
Progression Free Survival (PFS) - 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
Timepoint [6] 0 0
From the date of first dose to end of combination stage approximately 9 months

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
Gender
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
Unknown status
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,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 - Malvern
Recruitment hospital [5] 0 0
Local Institution - Elizabeth Vale
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
3144 - Malvern
Recruitment postcode(s) [5] 0 0
5112 - Elizabeth Vale
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
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.
Trial website
https://clinicaltrials.gov/show/NCT03029780
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

Summary results
For IPD and results data, please see https://clinicaltrials.gov/show/NCT03029780