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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT02996110




Registration number
NCT02996110
Ethics application status
Date submitted
15/12/2016
Date registered
19/12/2016
Date last updated
17/06/2020

Titles & IDs
Public title
A Study to Test Combination Treatments in People With Advanced Renal Cell Carcinoma
Scientific title
A Phase 2, Real-time Assessment of Combination Therapies in Immuno-Oncology Study in Participants With Advanced Renal Cell Carcinoma (FRACTION-RCC)
Secondary ID [1] 0 0
2016-003082-26
Secondary ID [2] 0 0
CA018-005
Universal Trial Number (UTN)
Trial acronym
FRACTION-RCC
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Advanced Cancer 0 0
Condition category
Condition code
Cancer 0 0 0 0
Kidney

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Other interventions - Nivolumab
Other interventions - Ipilimumab
Other interventions - Relatlimab
Treatment: Drugs - BMS-986205
Treatment: Drugs - BMS-813160

Active Comparator: Nivolumab + Ipilimumab - Nivolumab + Ipilimumab

Experimental: Nivolumab + Relatlimab - Nivolumab + Relatlimab

Experimental: Nivolumab + BMS-986205 - Nivolumab + BMS-986205

Experimental: Nivolumab + BMS-813160 - Nivolumab + BMS-813160 (CCR2/5 dual antagonist)


Other interventions: Nivolumab


Other interventions: Ipilimumab


Other interventions: Relatlimab


Treatment: Drugs: BMS-986205


Treatment: Drugs: BMS-813160


Intervention code [1] 0 0
Other interventions
Intervention code [2] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Objective Response Rate (ORR)
Timepoint [1] 0 0
Up to 24 weeks
Primary outcome [2] 0 0
Duration of Response (DOR)
Timepoint [2] 0 0
Up to 24 weeks
Primary outcome [3] 0 0
Progression-free Survival Rate (PFSR)
Timepoint [3] 0 0
Up to 24 weeks
Secondary outcome [1] 0 0
Safety as measured by incidence of AEs (Adverse Events)
Timepoint [1] 0 0
Up to 2 years
Secondary outcome [2] 0 0
Safety as measured by incidence of SAEs (Serious Adverse Events)
Timepoint [2] 0 0
Up to 2 years
Secondary outcome [3] 0 0
Tolerability as measured by incidence of AEs
Timepoint [3] 0 0
Up to 2 years
Secondary outcome [4] 0 0
Tolerability as measured by SAEs
Timepoint [4] 0 0
Up to 2 years

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 at least 1 lesion with measurable disease

- Life expectancy of at least 3 months

- Karnofsky Performance Status (KPS) must be =>70%
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Patients/subjects with suspected or known central nervous system metastases unless
adequately treated

- Patients/subjects with autoimmune disease

- Patients/subjects who need daily oxygen therapy

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
Recruiting
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,VIC
Recruitment hospital [1] 0 0
Westmead Hospital - Westmead
Recruitment hospital [2] 0 0
Monash Medical Centre Clayton - Bentleigh
Recruitment postcode(s) [1] 0 0
2145 - Westmead
Recruitment postcode(s) [2] 0 0
3165 - Bentleigh
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Connecticut
Country [3] 0 0
United States of America
State/province [3] 0 0
Florida
Country [4] 0 0
United States of America
State/province [4] 0 0
Georgia
Country [5] 0 0
United States of America
State/province [5] 0 0
Illinois
Country [6] 0 0
United States of America
State/province [6] 0 0
Maryland
Country [7] 0 0
United States of America
State/province [7] 0 0
Massachusetts
Country [8] 0 0
United States of America
State/province [8] 0 0
Michigan
Country [9] 0 0
United States of America
State/province [9] 0 0
Missouri
Country [10] 0 0
United States of America
State/province [10] 0 0
New York
Country [11] 0 0
United States of America
State/province [11] 0 0
North Carolina
Country [12] 0 0
United States of America
State/province [12] 0 0
Ohio
Country [13] 0 0
United States of America
State/province [13] 0 0
Oregon
Country [14] 0 0
United States of America
State/province [14] 0 0
Pennsylvania
Country [15] 0 0
United States of America
State/province [15] 0 0
South Carolina
Country [16] 0 0
United States of America
State/province [16] 0 0
Tennessee
Country [17] 0 0
United States of America
State/province [17] 0 0
Texas
Country [18] 0 0
United States of America
State/province [18] 0 0
Virginia
Country [19] 0 0
United States of America
State/province [19] 0 0
Washington
Country [20] 0 0
Austria
State/province [20] 0 0
Linz
Country [21] 0 0
Canada
State/province [21] 0 0
Nova Scotia
Country [22] 0 0
Canada
State/province [22] 0 0
Ontario
Country [23] 0 0
Canada
State/province [23] 0 0
Quebec
Country [24] 0 0
Israel
State/province [24] 0 0
Haifa
Country [25] 0 0
Israel
State/province [25] 0 0
Ramat Gan
Country [26] 0 0
Italy
State/province [26] 0 0
Milano
Country [27] 0 0
Italy
State/province [27] 0 0
Napoli

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 test the effectiveness and safety of various nivolumab
combinations compared to nivolumab and ipilimumab in participants with advanced kidney cancer
Trial website
https://clinicaltrials.gov/show/NCT02996110
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
Recruiting sites have contact information. Please contact the sites directly. If there is no contact information, please email:
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Clinical.Trials@bms.com
Contact person for scientific queries

Summary results
For IPD and results data, please see https://clinicaltrials.gov/show/NCT02996110