A Study of Nivolumab Combined With Ipilimumab Versus Nivolumab Alone in Participants With Advanced Kidney Cancer
Primary Purpose
Renal Cell Carcinoma
Status
Active
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Nivolumab
Ipilimumab
Ipilimumab placebo
Sponsored by
About this trial
This is an interventional treatment trial for Renal Cell Carcinoma
Eligibility Criteria
For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com
Inclusion Criteria:
- Histological confirmation of renal carcinoma with clear cell component including participants who may have sarcomatoid features.
- Advanced (not amenable to curative surgery or radiation therapy) renal cell carcinoma (RCC) or metastatic RCC (mRCC).
- Measurable disease by computed tomography (CT) or magnetic resonance imaging (MRI) per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) criteria.
- No prior systemic therapy for RCC
- Must be intermediate or poor risk as per International Metastatic RCC Database Consortium (IMDC).
Exclusion Criteria:
- Any active central nervous system (CNS) metastases.
- Active, known, or suspected autoimmune disease.
- Prior treatment with an anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, anti-CTLA-4 antibody, or any other agents specifically targeting T-cell co-stimulation or checkpoint pathways
Other protocol-defined inclusion/exclusion criteria apply
Sites / Locations
- Local Institution - 0013
- Local Institution - 0053
- Local Institution - 0066
- Local Institution - 0088
- Local Institution - 0086
- The Reading Hosp Med Ctr Reg Cancer Ctr
- Local Institution - 0084
- Local Institution - 0100
- Local Institution - 0011
- Local Institution - 0060
- Local Institution - 0025
- Local Institution - 0001
- Local Institution - 0005
- Local Institution - 0002
- Local Institution - 0033
- Local Institution - 0031
- Local Institution - 0032
- Local Institution - 0003
- Local Institution - 0034
- Local Institution - 0017
- Local Institution - 0004
- Local Institution - 0012
- Local Institution - 0020
- Local Institution - 0097
- Local Institution - 0019
- Local Institution - 0018
- Local Institution - 0096
- Local Institution - 0078
- Local Institution - 0091
- Local Institution - 0073
- Local Institution - 0069
- Local Institution - 0075
- Local Institution - 0074
- Local Institution - 0094
- Local Institution - 0081
- Local Institution - 0080
- Local Institution - 0071
- Local Institution - 0092
- Local Institution - 0093
- Local Institution - 0072
- Local Institution - 0068
- Local Institution - 0023
- Local Institution - 0024
- Local Institution - 0082
- Local Institution - 0014
- Local Institution - 0016
- Local Institution - 0021
- Local Institution - 0015
- Local Institution - 0077
- Local Institution - 0006
- Local Institution - 0009
- Local Institution - 0010
- Local Institution - 0067
- Local Institution - 0008
- Local Institution - 0046
- Local Institution - 0030
- Local Institution - 0095
- Local Institution - 0062
- Local Institution - 0026
- Local Institution - 0029
- Local Institution - 0027
- Local Institution - 0050
- Local Institution - 0061
- Local Institution - 0056
- Local Institution - 0065
- Local Institution - 0054
- Local Institution - 0058
- Local Institution - 0038
- Local Institution - 0037
- Local Institution - 0042
- Local Institution - 0036
- Local Institution - 0035
- Local Institution - 0045
- Local Institution - 0039
- Local Institution - 0043
- Local Institution - 0044
- Local Institution - 0041
- Local Institution - 0040
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Nivolumab + ipilimumab
Nivolumab + ipilimumab placebo
Arm Description
Outcomes
Primary Outcome Measures
Progression free survival (PFS) by blinded independent central review (BICR)
Objective response rate (ORR) by BICR
Secondary Outcome Measures
Overall survival (OS)
Overall response rate (ORR) by investigator
Disease control rate (DCR) by investigator
Duration of response (DoR) by investigator
Time to objective response (TTR) by investigator
Progression Free Survival (PFS) by investigator
Progression free survival secondary objective (PFS2) by investigator
Disease control rate (DCR) by BICR
Duration of response (DoR) by BICR
Time to objective response (TTR) by BICR
Incidence of Adverse Events (AEs)
Incidence of drug-related AEs
Incidence of Severe Adverse Events (SAEs)
Incidence of drug-related SAEs
Incidence of clinically significant changes in clinical laboratory results: Hematology tests
Incidence of clinically significant changes in clinical laboratory results: Coagulation tests
Incidence of clinically significant changes in clinical laboratory results: Clinical Chemistry tests
Incidence of clinically significant changes in clinical laboratory results: Serology tests
PFS based on gene expression (GEP) signatures
Objective response rate (ORR) based on GEP signatures
OS based on GEP signatures
OS based on programmed cell death protein ligand-1 (PD-L1) expression
ORR by BICR based on PD-L1 expression
PFS by BICR based on PD-L1 expression
Full Information
NCT ID
NCT03873402
First Posted
March 11, 2019
Last Updated
September 26, 2023
Sponsor
Bristol-Myers Squibb
1. Study Identification
Unique Protocol Identification Number
NCT03873402
Brief Title
A Study of Nivolumab Combined With Ipilimumab Versus Nivolumab Alone in Participants With Advanced Kidney Cancer
Official Title
A Phase 3b, Randomized, Double-blind Study of Nivolumab Combined With Ipilimumab Versus Nivolumab Monotherapy for Patients With Previously Untreated Advanced Renal Cell Carcinoma and Intermediate- or Poor-Risk Factors
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
June 21, 2019 (Actual)
Primary Completion Date
April 30, 2024 (Anticipated)
Study Completion Date
March 11, 2025 (Anticipated)
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 nivolumab combined with ipilimumab compared to nivolumab monotherapy in participants with previously untreated kidney cancer that has spread.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Renal Cell Carcinoma
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
437 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Nivolumab + ipilimumab
Arm Type
Experimental
Arm Title
Nivolumab + ipilimumab placebo
Arm Type
Experimental
Intervention Type
Biological
Intervention Name(s)
Nivolumab
Other Intervention Name(s)
Opdivo
Intervention Description
Specified dose on specified days
Intervention Type
Biological
Intervention Name(s)
Ipilimumab
Other Intervention Name(s)
Yervoy
Intervention Description
Specified dose on specified days
Intervention Type
Other
Intervention Name(s)
Ipilimumab placebo
Intervention Description
Specified dose on specified days
Primary Outcome Measure Information:
Title
Progression free survival (PFS) by blinded independent central review (BICR)
Time Frame
Up to 34 months
Title
Objective response rate (ORR) by BICR
Time Frame
Up to 23 months
Secondary Outcome Measure Information:
Title
Overall survival (OS)
Time Frame
Up to 4 years
Title
Overall response rate (ORR) by investigator
Time Frame
Up to 4 years
Title
Disease control rate (DCR) by investigator
Time Frame
Up to 4 years
Title
Duration of response (DoR) by investigator
Time Frame
Up to 4 years
Title
Time to objective response (TTR) by investigator
Time Frame
Up to 4 years
Title
Progression Free Survival (PFS) by investigator
Time Frame
Up to 4 years
Title
Progression free survival secondary objective (PFS2) by investigator
Time Frame
Up to 4 years
Title
Disease control rate (DCR) by BICR
Time Frame
Up to 4 years
Title
Duration of response (DoR) by BICR
Time Frame
Up to 4 years
Title
Time to objective response (TTR) by BICR
Time Frame
Up to 4 years
Title
Incidence of Adverse Events (AEs)
Time Frame
Up to 4 years
Title
Incidence of drug-related AEs
Time Frame
Up to 4 years
Title
Incidence of Severe Adverse Events (SAEs)
Time Frame
Up to 4 years
Title
Incidence of drug-related SAEs
Time Frame
Up to 4 years
Title
Incidence of clinically significant changes in clinical laboratory results: Hematology tests
Time Frame
Up to 4 years
Title
Incidence of clinically significant changes in clinical laboratory results: Coagulation tests
Time Frame
Up to 4 years
Title
Incidence of clinically significant changes in clinical laboratory results: Clinical Chemistry tests
Time Frame
Up to 4 years
Title
Incidence of clinically significant changes in clinical laboratory results: Serology tests
Time Frame
Up to 4 years
Title
PFS based on gene expression (GEP) signatures
Time Frame
Up to 4 years
Title
Objective response rate (ORR) based on GEP signatures
Time Frame
Up to 4 years
Title
OS based on GEP signatures
Time Frame
Up to 4 years
Title
OS based on programmed cell death protein ligand-1 (PD-L1) expression
Time Frame
Up to 4 years
Title
ORR by BICR based on PD-L1 expression
Time Frame
Up to 4 years
Title
PFS by BICR based on PD-L1 expression
Time Frame
Up to 4 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com
Inclusion Criteria:
Histological confirmation of renal carcinoma with clear cell component including participants who may have sarcomatoid features.
Advanced (not amenable to curative surgery or radiation therapy) renal cell carcinoma (RCC) or metastatic RCC (mRCC).
Measurable disease by computed tomography (CT) or magnetic resonance imaging (MRI) per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) criteria.
No prior systemic therapy for RCC
Must be intermediate or poor risk as per International Metastatic RCC Database Consortium (IMDC).
Exclusion Criteria:
Any active central nervous system (CNS) metastases.
Active, known, or suspected autoimmune disease.
Prior treatment with an anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, anti-CTLA-4 antibody, or any other agents specifically targeting T-cell co-stimulation or checkpoint pathways
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 - 0013
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20007
Country
United States
Facility Name
Local Institution - 0053
City
Athens
State/Province
Georgia
ZIP/Postal Code
30607
Country
United States
Facility Name
Local Institution - 0066
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Facility Name
Local Institution - 0088
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Facility Name
Local Institution - 0086
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Facility Name
The Reading Hosp Med Ctr Reg Cancer Ctr
City
West Reading
State/Province
Pennsylvania
ZIP/Postal Code
19611
Country
United States
Facility Name
Local Institution - 0084
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29414
Country
United States
Facility Name
Local Institution - 0100
City
Capital Federal
State/Province
Buenos Aires
ZIP/Postal Code
1419
Country
Argentina
Facility Name
Local Institution - 0011
City
Ciudad Autónoma de Buenos Aires
State/Province
Buenos Aires
ZIP/Postal Code
1280
Country
Argentina
Facility Name
Local Institution - 0060
City
Mar del Plata
State/Province
Buenos Aires
ZIP/Postal Code
7600
Country
Argentina
Facility Name
Local Institution - 0025
City
Rio Cuarto
State/Province
Cordoba
ZIP/Postal Code
5800
Country
Argentina
Facility Name
Local Institution - 0001
City
Viedma
State/Province
Río Negro
ZIP/Postal Code
R8500ACE
Country
Argentina
Facility Name
Local Institution - 0005
City
Cordoba
ZIP/Postal Code
X5004FHP
Country
Argentina
Facility Name
Local Institution - 0002
City
San Juan
ZIP/Postal Code
5400
Country
Argentina
Facility Name
Local Institution - 0033
City
Graz
ZIP/Postal Code
8036
Country
Austria
Facility Name
Local Institution - 0031
City
Vienna
ZIP/Postal Code
1090
Country
Austria
Facility Name
Local Institution - 0032
City
Wels
ZIP/Postal Code
4600
Country
Austria
Facility Name
Local Institution - 0003
City
Santiago
State/Province
Metropolitana
ZIP/Postal Code
8330024
Country
Chile
Facility Name
Local Institution - 0034
City
Santiago
State/Province
Metropolitana
ZIP/Postal Code
8420383
Country
Chile
Facility Name
Local Institution - 0017
City
Independencia
State/Province
Santiago
Country
Chile
Facility Name
Local Institution - 0004
City
Vina del Mar
State/Province
Valparaiso
ZIP/Postal Code
2520598
Country
Chile
Facility Name
Local Institution - 0012
City
Vina del Mar
State/Province
Valparaiso
ZIP/Postal Code
2540364
Country
Chile
Facility Name
Local Institution - 0020
City
Brno
State/Province
Jihomoravský Kraj
ZIP/Postal Code
602 00
Country
Czechia
Facility Name
Local Institution - 0097
City
Brno
ZIP/Postal Code
656 53
Country
Czechia
Facility Name
Local Institution - 0019
City
Praha 10
ZIP/Postal Code
100 34
Country
Czechia
Facility Name
Local Institution - 0018
City
Praha 4
ZIP/Postal Code
140 59
Country
Czechia
Facility Name
Local Institution - 0096
City
Nice
State/Province
Alpes-Maritimes
ZIP/Postal Code
06189
Country
France
Facility Name
Local Institution - 0078
City
Nancy
State/Province
Meurthe-et-Moselle
ZIP/Postal Code
54100
Country
France
Facility Name
Local Institution - 0091
City
Valenciennes
State/Province
Nord
ZIP/Postal Code
59300
Country
France
Facility Name
Local Institution - 0073
City
ANGERS Cedex 2
ZIP/Postal Code
49055
Country
France
Facility Name
Local Institution - 0069
City
Angers
ZIP/Postal Code
49100
Country
France
Facility Name
Local Institution - 0075
City
Besançon Cedex
ZIP/Postal Code
25030
Country
France
Facility Name
Local Institution - 0074
City
Brest
ZIP/Postal Code
29200
Country
France
Facility Name
Local Institution - 0094
City
Caen
ZIP/Postal Code
14076
Country
France
Facility Name
Local Institution - 0081
City
Hyeres
ZIP/Postal Code
83400
Country
France
Facility Name
Local Institution - 0080
City
La Tronche
ZIP/Postal Code
38043
Country
France
Facility Name
Local Institution - 0071
City
Marseille Cedex 9
ZIP/Postal Code
13273
Country
France
Facility Name
Local Institution - 0092
City
Paris
ZIP/Postal Code
75014
Country
France
Facility Name
Local Institution - 0093
City
Strasbourg Cedex
ZIP/Postal Code
67091
Country
France
Facility Name
Local Institution - 0072
City
Suresnes
ZIP/Postal Code
92151
Country
France
Facility Name
Local Institution - 0068
City
Villejuif
ZIP/Postal Code
94800
Country
France
Facility Name
Local Institution - 0023
City
Athens
ZIP/Postal Code
15125
Country
Greece
Facility Name
Local Institution - 0024
City
Larissa
ZIP/Postal Code
41110
Country
Greece
Facility Name
Local Institution - 0082
City
Brescia
State/Province
Lombardia
ZIP/Postal Code
25123
Country
Italy
Facility Name
Local Institution - 0014
City
Arezzo
ZIP/Postal Code
52100
Country
Italy
Facility Name
Local Institution - 0016
City
Aviano (PN)
ZIP/Postal Code
33081
Country
Italy
Facility Name
Local Institution - 0021
City
Milan
ZIP/Postal Code
20141
Country
Italy
Facility Name
Local Institution - 0015
City
Parma
ZIP/Postal Code
43100
Country
Italy
Facility Name
Local Institution - 0077
City
Roma
ZIP/Postal Code
00128
Country
Italy
Facility Name
Local Institution - 0006
City
Ciudad de Mexico
State/Province
Distrito Federal
ZIP/Postal Code
06100
Country
Mexico
Facility Name
Local Institution - 0009
City
Mexico
State/Province
Distrito Federal
ZIP/Postal Code
14080
Country
Mexico
Facility Name
Local Institution - 0010
City
Mexico
State/Province
Distrito Federal
ZIP/Postal Code
14080
Country
Mexico
Facility Name
Local Institution - 0067
City
Monterrey
State/Province
Nuevo LEON
ZIP/Postal Code
64040
Country
Mexico
Facility Name
Local Institution - 0008
City
Chihuahua
ZIP/Postal Code
31000
Country
Mexico
Facility Name
Local Institution - 0046
City
Querétaro
ZIP/Postal Code
76000
Country
Mexico
Facility Name
Local Institution - 0030
City
Biala Podlaska
ZIP/Postal Code
21-500
Country
Poland
Facility Name
Local Institution - 0095
City
Bydgoszcz
ZIP/Postal Code
85-796
Country
Poland
Facility Name
Local Institution - 0062
City
Bytom
ZIP/Postal Code
41-902
Country
Poland
Facility Name
Local Institution - 0026
City
Gdansk
ZIP/Postal Code
80-219
Country
Poland
Facility Name
Local Institution - 0029
City
Poznan
ZIP/Postal Code
61-848
Country
Poland
Facility Name
Local Institution - 0027
City
Warszawa
ZIP/Postal Code
02-781
Country
Poland
Facility Name
Local Institution - 0050
City
Lisboa
ZIP/Postal Code
1649-035
Country
Portugal
Facility Name
Local Institution - 0061
City
Bucharest
ZIP/Postal Code
020122
Country
Romania
Facility Name
Local Institution - 0056
City
Cluj-Napoca
ZIP/Postal Code
400015
Country
Romania
Facility Name
Local Institution - 0065
City
Craiova
ZIP/Postal Code
200542
Country
Romania
Facility Name
Local Institution - 0054
City
Saint Petersburg
State/Province
Sankt-Peterburg
ZIP/Postal Code
195009
Country
Russian Federation
Facility Name
Local Institution - 0058
City
Novosibirsk
ZIP/Postal Code
630099
Country
Russian Federation
Facility Name
Local Institution - 0038
City
Barcelona
ZIP/Postal Code
08003
Country
Spain
Facility Name
Local Institution - 0037
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
Facility Name
Local Institution - 0042
City
Cordoba
ZIP/Postal Code
14004
Country
Spain
Facility Name
Local Institution - 0036
City
Madrid
ZIP/Postal Code
28034
Country
Spain
Facility Name
Local Institution - 0035
City
Madrid
ZIP/Postal Code
28046
Country
Spain
Facility Name
Local Institution - 0045
City
Pamplona
ZIP/Postal Code
31008
Country
Spain
Facility Name
Local Institution - 0039
City
Sabadell
ZIP/Postal Code
08208
Country
Spain
Facility Name
Local Institution - 0043
City
Santander
ZIP/Postal Code
39008
Country
Spain
Facility Name
Local Institution - 0044
City
Santiago Compostela
ZIP/Postal Code
15706
Country
Spain
Facility Name
Local Institution - 0041
City
Sevilla
ZIP/Postal Code
41013
Country
Spain
Facility Name
Local Institution - 0040
City
Valencia
ZIP/Postal Code
46009
Country
Spain
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
Individual patient level data from this study may be shared with qualified researchers, upon request, following the timelines and process detailed on https://www.bms.com/researchers-and-partners/independent-research/data-sharing-request-process.html
Links:
URL
https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html
Description
BMS Clinical Trial Information
URL
https://www.bmsstudyconnect.com/s/US/English/USenHome
Description
BMS Clinical Trial Patient Recruiting
URL
https://www.fda.gov/Safety/MedWatch/SafetyInformation/default.htm
Description
FDA Safety Alerts and Recalls
Learn more about this trial
A Study of Nivolumab Combined With Ipilimumab Versus Nivolumab Alone in Participants With Advanced Kidney Cancer
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