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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/NCT03141177
Registration number
NCT03141177
Ethics application status
Date submitted
3/05/2017
Date registered
4/05/2017
Date last updated
17/01/2024
Titles & IDs
Public title
A Study of Nivolumab Combined With Cabozantinib Compared to Sunitinib in Previously Untreated Advanced or Metastatic Renal Cell Carcinoma
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Scientific title
A Phase 3, Randomized, Open-Label Study of Nivolumab Combined With Cabozantinib Versus Sunitinib in Participants With Previously Untreated Advanced or Metastatic Renal Cell Carcinoma
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Secondary ID [1]
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2017-000759-20
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Secondary ID [2]
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CA209-9ER
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Universal Trial Number (UTN)
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Trial acronym
CheckMate 9ER
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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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0
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0
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Non melanoma skin cancer
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Cancer
0
0
0
0
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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 - Nivolumab
Treatment: Drugs - Cabozantinib
Treatment: Drugs - Sunitinib
Other interventions - Ipilimumab
Experimental: Doublet - Nivolumab and Cabozantinib
Active Comparator: Monotherapy - Sunitinib
Experimental: Triplet - Nivolumab, Ipilimumab, Cabozantinib
*Enrollment to the triplet arm was discontinued by protocol amendment
Other interventions: Nivolumab
Specified dose on specified day
Treatment: Drugs: Cabozantinib
Specified dose on specified days
Treatment: Drugs: Sunitinib
Specified dose on specified days.
Other interventions: Ipilimumab
Specified dose on specified days
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Intervention code [1]
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Other interventions
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Intervention code [2]
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Treatment: Drugs
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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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Progression Free Survival (PFS)
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Assessment method [1]
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PFS is defined as the time from date of randomization to the first documented tumor progression date or death due to any cause, whichever occurs first based on BICR assessment using RECIST v1.1. Participants who die without a reported progression will be considered to have progressed on the date of their death. Participants who did not progress or die will be censored on the date of their last evaluable tumor assessment on or prior to initiation of subsequent anti-cancer therapy. Progressive disease (PD); 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study
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Timepoint [1]
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From randomization date to date of first documented tumor progression or death, whichever occurs first (Up to 31 months)
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Secondary outcome [1]
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Overall Survival (OS)
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Assessment method [1]
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Overall Survival is defined as the time between the date of randomization and the date of death due to any cause. For participants that are alive, their survival time will be censored at the date of last contact date (or "last known alive date").
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Timepoint [1]
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From randomization date to death date (Up to 31 months)
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Secondary outcome [2]
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Objective Response Rate (ORR)
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Assessment method [2]
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Objective Response Rate (ORR) is defined as the percentage of randomized participants who achieve a best response of confirmed complete response (CR) or confirmed partial response (PR) based on BICR assessments (using RECIST v1.1 criteria) divided by the number of all randomized participants.
Complete response (CR): Disappearance of all target lesions. Partial response (PR): 30% decrease in the sum of diameters of target lesions.
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Timepoint [2]
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Up to 31 Months
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Secondary outcome [3]
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Number of Participants Experiencing Adverse Events (AEs)
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Assessment method [3]
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Number of participants experiencing various types of any grade adverse events (AEs) during the specified time frame.
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Timepoint [3]
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From first dose to 100 days following last dose (Up to 32 Months)
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Secondary outcome [4]
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Number of Participants Experiencing Serious Adverse Events (SAEs)
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Assessment method [4]
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Number of participants experiencing various types of any grade serious adverse events (SAEs) during the specified time frame.
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Timepoint [4]
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From first to dose to 100 days following last dose (Up to 32 months)
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Secondary outcome [5]
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Number of Participants Experiencing Adverse Events (AEs) Leading to Discontinuation
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Assessment method [5]
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Number of participants experiencing various types of any grade adverse events (AEs) leading to discontinuation during the specified time frame.
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Timepoint [5]
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From first dose to 30 days following last dose (Up to 30 months)
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Secondary outcome [6]
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Number of Deaths
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Assessment method [6]
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Number of deaths due to any cause during the specified time frame.
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Timepoint [6]
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From first dose to (up to 31 months) following first dose
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Secondary outcome [7]
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Number of Participants With Laboratory Abnormalities
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Assessment method [7]
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Number of participants experiencing laboratory abnormalities in hematology, serum chemistry and electrolytes with grade 3 or higher during the specified time frame.
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Timepoint [7]
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From first dose to 30 days following last dose (Up to 30 Months)
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Secondary outcome [8]
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Number of Participants With Laboratory Values Grade Shifting From Baseline
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Assessment method [8]
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Number of participants experiencing worsening shift from baseline in any grade and grade 3-4 of laboratory values during the specified time frame.
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Timepoint [8]
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From first dose to 30 days following last dose (Up to 30 Months)
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Eligibility
Key inclusion criteria
For more information regarding Bristol-Myers Squibb Clinical Trial participation, please
visit www.BMSStudyConnect.com
- Histological confirmation of RCC with a clear-cell component, including participants
who may also have sarcomatoid features
- Advanced (not amenable to curative surgery or radiation therapy) or metastatic (AJCC
Stage IV) RCC
- No prior systemic therapy for RCC with the following exception:
i) One prior adjuvant or neoadjuvant therapy for completely resectable RCC if such
therapy did not include an agent that targets VEGF or VEGF receptors and if recurrence
occurred at least 6 months after the last dose of adjuvant or neoadjuvant therapy
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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
- Any active CNS metastases
- Any active, known or suspected autoimmune disease
- Any condition requiring systemic treatment with either corticosteroids (> 10 mg daily
prednisone equivalent) or other immunosuppressive medications within 14 days of
randomization
- Participants who have received a live/attenuated vaccine within 30 days of first
treatment
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 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Active, not recruiting
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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
22/08/2017
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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
17/04/2024
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Actual
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Sample size
Target
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Accrual to date
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Final
701
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Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC,WA
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Recruitment hospital [1]
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Local Institution - 0002 - North Ryde
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Local Institution - 0008 - Sydney
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Local Institution - 0007 - Doubleview
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Local Institution - 0129 - South Brisbane
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0 - North Ryde
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2010 - Sydney
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2139 - Sydney
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2145 - Westmead
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4006 - Herston
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4215 - Southport
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Recruitment postcode(s) [7]
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5112 - Elizabeth Vale
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3144 - Malvern
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6018 - Doubleview
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4101 - South Brisbane
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Recruitment outside Australia
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Truro
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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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Other collaborator category [1]
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Exelixis
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Ono Pharmaceutical Co. Ltd
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Ethics approval
Ethics application status
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Summary
Brief summary
The purpose of this study is to determine whether Nivolumab Combined with Cabozantinib is
safe and effective compared to Sunitinib in previously untreated advanced or metastatic renal
cell carcinoma
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Trial website
https://clinicaltrials.gov/ct2/show/NCT03141177
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
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Bristol-Myers Squibb
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Bristol-Myers Squibb
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT03141177
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