search
Back to results

A Study to Test Combination Treatments in People With Advanced Renal Cell Carcinoma (FRACTION-RCC)

Primary Purpose

Advanced Cancer

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Nivolumab
Ipilimumab
Relatlimab
BMS-986205
BMS-813160
Sponsored by
Bristol-Myers Squibb
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Advanced Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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%

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 apply

Sites / Locations

  • Local Institution - 0037
  • Local Institution
  • Local Institution - 0031
  • Local Institution - 0006
  • Local Institution - 0007
  • Dana Farber Cancer Institute
  • Massachusetts General Hospital
  • Local Institution - 0011
  • Local Institution - 0008
  • Roswell Park Cancer Institute
  • Local Institution - 0005
  • Local Institution - 0043
  • Local Institution - 0014
  • Oregon Health & Science University
  • Local Institution - 0002
  • Hollings Cancer Center
  • Local Institution - 0025
  • Ut Southwestern Medical Center
  • Local Institution - 0024
  • University of Washington - Seattle Cancer Care Alliance
  • Local Institution - 0032
  • Monash Medical Centre Clayton
  • Local Institution - 0044
  • Local Institution - 0038
  • Local Institution - 0029
  • Local Institution - 0035
  • Local Institution - 0034
  • Local Institution - 0030
  • Local Institution
  • Local Institution
  • Local Institution - 0010
  • Local Institution - 0012

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Experimental

Experimental

Experimental

Arm Label

Nivolumab + Ipilimumab

Nivolumab + Relatlimab

Nivolumab + BMS-986205

Nivolumab + BMS-813160

Arm Description

Nivolumab + Ipilimumab

Nivolumab + Relatlimab

Nivolumab + BMS-986205

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

Outcomes

Primary Outcome Measures

Objective Response Rate (ORR) Per Investigator
ORR is percent of participants whose best overall response (BOR) is complete response (CR) or partial response (PR). BOR is the best response from the start of the study treatment until objectively documented progression per RECIST v1.1 or subsequent anticancer therapy, whichever occurs first. For participants who received re-treatment or were re-randomized, the re-treatment and re-randomized therapies were considered subsequent anticancer therapy. CR is the disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) have reduction in short axis to <10 mm. PR is at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. The Response Evaluation Criteria in Solid Tumors (RECIST) is a standard way to measure the response of a tumor to treatment. CR+PR, confidence interval based on Clopper and Pearson method.
Median Duration of Response (DOR) Per Investigator
Duration of Response is defined as the time between the date of first response and the date of first documented disease progression as determined by RECIST 1.1 or death due to any cause (death occurring after re-treatment or randomization to new combination treatment was not considered), whichever occurred first. Complete Response (CR) is the disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. Partial Response (PR) is at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Median computed using Kaplan -Meier method
Progression Free Survival Rate (PFSR) at 24 Weeks.
The PFSR at 24 weeks is defined as the proportion of treated participants remaining progression free and surviving at 24 weeks since the first dosing date. Progressive Disease (PD) is at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, 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). Point estimates are derived from Kaplan-Meier analyses, the 95% CIs are derived from Greenwood formula

Secondary Outcome Measures

Number of Participants With Adverse Events (AEs)
An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation participant administered study treatment and that does not necessarily have a causal relationship with this treatment.
Number of Participants With Serious Adverse Events (SAEs)
Serious Adverse Event (SAE) is defined as any untoward medical occurrence that, at any dose results in death, is life-threatening (defined as an event in which the participant was at risk of death at the time of the event; it does not refer to an event which hypothetically might have caused death if it were more severe), requires inpatient hospitalization or causes prolongation of existing hospitalization
Number of Participants With Adverse Events (AEs) Leading to Discontinuation
An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation participant administered study treatment and that does not necessarily have a causal relationship with this treatment.
Number of Participants Who Died
Death is defined as the cessation of all vital functions of the body including the heartbeat, brain activity (including the brain stem), and breathing.
Number of Participants With Abnormal Thyroid Test Results - Track 1
The number of participants with laboratory abnormalities in specific thyroid tests based on SI conventional units. TSH = Thyroid Stimulating Hormone LLN = Lower Limit of Normal ULN = Upper Limit of Normal.
Number of Participants With Abnormal Thyroid Test Results - Track 2
The number of participants with laboratory abnormalities in specific thyroid tests based on SI conventional units. TSH = Thyroid Stimulating Hormone LLN = Lower Limit of Normal ULN = Upper Limit of Normal
Number of Participants With Abnormal Hepatic Test Results - Track 1
The number of participants with laboratory abnormalities in specific liver tests based on SI conventional units. ALT = Alanine Aminotransferase AST = Aspartate Aminotransferase ULN = Upper Limit of Normal
Number of Participants With Abnormal Hepatic Test Results - Track 2
The number of participants with laboratory abnormalities in specific liver tests based on SI conventional units. ALT = Alanine Aminotransferase AST = Aspartate Aminotransferase ULN = Upper Limit of Normal

Full Information

First Posted
December 15, 2016
Last Updated
November 18, 2022
Sponsor
Bristol-Myers Squibb
search

1. Study Identification

Unique Protocol Identification Number
NCT02996110
Brief Title
A Study to Test Combination Treatments in People With Advanced Renal Cell Carcinoma
Acronym
FRACTION-RCC
Official Title
A Phase 2, Real-time Assessment of Combination Therapies in Immuno-Oncology Study in Participants With Advanced Renal Cell Carcinoma (FRACTION-RCC)
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Completed
Study Start Date
February 2, 2017 (Actual)
Primary Completion Date
November 23, 2021 (Actual)
Study Completion Date
November 23, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bristol-Myers Squibb

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Advanced Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
182 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Nivolumab + Ipilimumab
Arm Type
Active Comparator
Arm Description
Nivolumab + Ipilimumab
Arm Title
Nivolumab + Relatlimab
Arm Type
Experimental
Arm Description
Nivolumab + Relatlimab
Arm Title
Nivolumab + BMS-986205
Arm Type
Experimental
Arm Description
Nivolumab + BMS-986205
Arm Title
Nivolumab + BMS-813160
Arm Type
Experimental
Arm Description
Nivolumab + BMS-813160 (CCR2/5 dual antagonist)
Intervention Type
Biological
Intervention Name(s)
Nivolumab
Other Intervention Name(s)
Opdivo, BMS-936558
Intervention Description
Specified Dose on Specified Days
Intervention Type
Biological
Intervention Name(s)
Ipilimumab
Other Intervention Name(s)
BMS-734016, Yervoy
Intervention Description
Specified Dose on Specified Days
Intervention Type
Biological
Intervention Name(s)
Relatlimab
Other Intervention Name(s)
BMS-986016
Intervention Description
Specified Dose on Specified Days
Intervention Type
Drug
Intervention Name(s)
BMS-986205
Intervention Description
Specified Dose on Specified Days
Intervention Type
Drug
Intervention Name(s)
BMS-813160
Intervention Description
Specified Dose on Specified Days
Primary Outcome Measure Information:
Title
Objective Response Rate (ORR) Per Investigator
Description
ORR is percent of participants whose best overall response (BOR) is complete response (CR) or partial response (PR). BOR is the best response from the start of the study treatment until objectively documented progression per RECIST v1.1 or subsequent anticancer therapy, whichever occurs first. For participants who received re-treatment or were re-randomized, the re-treatment and re-randomized therapies were considered subsequent anticancer therapy. CR is the disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) have reduction in short axis to <10 mm. PR is at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. The Response Evaluation Criteria in Solid Tumors (RECIST) is a standard way to measure the response of a tumor to treatment. CR+PR, confidence interval based on Clopper and Pearson method.
Time Frame
From first dose of study treatment until progression or subsequent anticancer therapy, whichever occurs first (assessed up to approximately 247 weeks)
Title
Median Duration of Response (DOR) Per Investigator
Description
Duration of Response is defined as the time between the date of first response and the date of first documented disease progression as determined by RECIST 1.1 or death due to any cause (death occurring after re-treatment or randomization to new combination treatment was not considered), whichever occurred first. Complete Response (CR) is the disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. Partial Response (PR) is at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Median computed using Kaplan -Meier method
Time Frame
From first dose to the date of first documented disease progression or death due to any cause (assessed from an average of 22 weeks up to approximately 247 weeks)
Title
Progression Free Survival Rate (PFSR) at 24 Weeks.
Description
The PFSR at 24 weeks is defined as the proportion of treated participants remaining progression free and surviving at 24 weeks since the first dosing date. Progressive Disease (PD) is at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, 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). Point estimates are derived from Kaplan-Meier analyses, the 95% CIs are derived from Greenwood formula
Time Frame
24 weeks after first treatment dose.
Secondary Outcome Measure Information:
Title
Number of Participants With Adverse Events (AEs)
Description
An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation participant administered study treatment and that does not necessarily have a causal relationship with this treatment.
Time Frame
From first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks)
Title
Number of Participants With Serious Adverse Events (SAEs)
Description
Serious Adverse Event (SAE) is defined as any untoward medical occurrence that, at any dose results in death, is life-threatening (defined as an event in which the participant was at risk of death at the time of the event; it does not refer to an event which hypothetically might have caused death if it were more severe), requires inpatient hospitalization or causes prolongation of existing hospitalization
Time Frame
From first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks)
Title
Number of Participants With Adverse Events (AEs) Leading to Discontinuation
Description
An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation participant administered study treatment and that does not necessarily have a causal relationship with this treatment.
Time Frame
From first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks)
Title
Number of Participants Who Died
Description
Death is defined as the cessation of all vital functions of the body including the heartbeat, brain activity (including the brain stem), and breathing.
Time Frame
From first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks)
Title
Number of Participants With Abnormal Thyroid Test Results - Track 1
Description
The number of participants with laboratory abnormalities in specific thyroid tests based on SI conventional units. TSH = Thyroid Stimulating Hormone LLN = Lower Limit of Normal ULN = Upper Limit of Normal.
Time Frame
From first dose to 30 days after last dose of study therapy (approximately 108 weeks)
Title
Number of Participants With Abnormal Thyroid Test Results - Track 2
Description
The number of participants with laboratory abnormalities in specific thyroid tests based on SI conventional units. TSH = Thyroid Stimulating Hormone LLN = Lower Limit of Normal ULN = Upper Limit of Normal
Time Frame
From first dose to 30 days after last dose of study therapy (approximately 108 weeks)
Title
Number of Participants With Abnormal Hepatic Test Results - Track 1
Description
The number of participants with laboratory abnormalities in specific liver tests based on SI conventional units. ALT = Alanine Aminotransferase AST = Aspartate Aminotransferase ULN = Upper Limit of Normal
Time Frame
From first dose to 30 days after last dose of study therapy (approximately 108 weeks)
Title
Number of Participants With Abnormal Hepatic Test Results - Track 2
Description
The number of participants with laboratory abnormalities in specific liver tests based on SI conventional units. ALT = Alanine Aminotransferase AST = Aspartate Aminotransferase ULN = Upper Limit of Normal
Time Frame
From first dose to 30 days after last dose of study therapy (approximately 108 weeks)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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% 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 apply
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bristol-Myers Squibb
Organizational Affiliation
Bristol-Myers Squibb
Official's Role
Study Director
Facility Information:
Facility Name
Local Institution - 0037
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06520
Country
United States
Facility Name
Local Institution
City
Tampa
State/Province
Florida
ZIP/Postal Code
33612-9497
Country
United States
Facility Name
Local Institution - 0031
City
Augusta
State/Province
Georgia
ZIP/Postal Code
30912
Country
United States
Facility Name
Local Institution - 0006
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Facility Name
Local Institution - 0007
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21287
Country
United States
Facility Name
Dana Farber Cancer Institute
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Facility Name
Local Institution - 0011
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48201
Country
United States
Facility Name
Local Institution - 0008
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
Roswell Park Cancer Institute
City
Buffalo
State/Province
New York
ZIP/Postal Code
14263
Country
United States
Facility Name
Local Institution - 0005
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
Facility Name
Local Institution - 0043
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28204
Country
United States
Facility Name
Local Institution - 0014
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
Facility Name
Oregon Health & Science University
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States
Facility Name
Local Institution - 0002
City
Allentown
State/Province
Pennsylvania
ZIP/Postal Code
18103
Country
United States
Facility Name
Hollings Cancer Center
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States
Facility Name
Local Institution - 0025
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37203
Country
United States
Facility Name
Ut Southwestern Medical Center
City
Dallas
State/Province
Texas
ZIP/Postal Code
75390-8570
Country
United States
Facility Name
Local Institution - 0024
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22908
Country
United States
Facility Name
University of Washington - Seattle Cancer Care Alliance
City
Seattle
State/Province
Washington
ZIP/Postal Code
98109
Country
United States
Facility Name
Local Institution - 0032
City
Westmead
State/Province
New South Wales
ZIP/Postal Code
2145
Country
Australia
Facility Name
Monash Medical Centre Clayton
City
Bentleigh
State/Province
Victoria
ZIP/Postal Code
3165
Country
Australia
Facility Name
Local Institution - 0044
City
Linz
State/Province
Oberösterreich
ZIP/Postal Code
4010
Country
Austria
Facility Name
Local Institution - 0038
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8V 5C2
Country
Canada
Facility Name
Local Institution - 0029
City
Oshawa
State/Province
Ontario
ZIP/Postal Code
L1G 2B9
Country
Canada
Facility Name
Local Institution - 0035
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 1Z6
Country
Canada
Facility Name
Local Institution - 0034
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H3T 1E2
Country
Canada
Facility Name
Local Institution - 0030
City
Québec
State/Province
Quebec
ZIP/Postal Code
G1R 2J6
Country
Canada
Facility Name
Local Institution
City
Haifa
ZIP/Postal Code
3109601
Country
Israel
Facility Name
Local Institution
City
Ramat Gan
ZIP/Postal Code
52621
Country
Israel
Facility Name
Local Institution - 0010
City
Milano
ZIP/Postal Code
20133
Country
Italy
Facility Name
Local Institution - 0012
City
Napoli
ZIP/Postal Code
80131
Country
Italy

12. IPD Sharing Statement

Citations:
PubMed Identifier
36328377
Citation
Choueiri TK, Kluger H, George S, Tykodi SS, Kuzel TM, Perets R, Nair S, Procopio G, Carducci MA, Castonguay V, Folefac E, Lee CH, Hotte SJ, Miller WH Jr, Saggi SS, Lee CW, Desilva H, Bhagavatheeswaran P, Motzer RJ, Escudier B. FRACTION-RCC: nivolumab plus ipilimumab for advanced renal cell carcinoma after progression on immuno-oncology therapy. J Immunother Cancer. 2022 Nov;10(11):e005780. doi: 10.1136/jitc-2022-005780.
Results Reference
derived
Links:
URL
https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html
Description
BMS Clinical Trial Information
URL
https://www.BMSStudyConnect.com
Description
BMS Clinical Trial Patient Recruiting

Learn more about this trial

A Study to Test Combination Treatments in People With Advanced Renal Cell Carcinoma

We'll reach out to this number within 24 hrs