Clinical trial NCT03873402: 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
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE3
Conditions: Renal Cell Carcinoma
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2019-03-13
Enrollment: 437
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Progression free survival (PFS) by blinded independent central review (BICR)
timeFrame: Up to 34 months
measure: Objective response rate (ORR) by BICR
timeFrame: Up to 23 months
Secondary outcomes:
measure: Overall survival (OS)
timeFrame: Up to 4 years
measure: Overall response rate (ORR) by investigator
timeFrame: Up to 4 years
measure: Disease control rate (DCR) by investigator
timeFrame: Up to 4 years
measure: Duration of response (DoR) by investigator
timeFrame: Up to 4 years
measure: Time to objective response (TTR) by investigator
timeFrame: Up to 4 years
measure: Progression Free Survival (PFS) by investigator
timeFrame: Up to 4 years
measure: Progression free survival secondary objective (PFS2) by investigator
timeFrame: Up to 4 years
measure: Disease control rate (DCR) by BICR
timeFrame: Up to 4 years
measure: Duration of response (DoR) by BICR
timeFrame: Up to 4 years
measure: Time to objective response (TTR) by BICR
timeFrame: Up to 4 years
measure: Incidence of Adverse Events (AEs)
timeFrame: Up to 4 years
measure: Incidence of drug-related AEs
timeFrame: Up to 4 years
measure: Incidence of Severe Adverse Events (SAEs)
timeFrame: Up to 4 years
measure: Incidence of drug-related SAEs
timeFrame: Up to 4 years
measure: Incidence of clinically significant changes in clinical laboratory results: Hematology tests
timeFrame: Up to 4 years
measure: Incidence of clinically significant changes in clinical laboratory results: Coagulation tests
timeFrame: Up to 4 years
measure: Incidence of clinically significant changes in clinical laboratory results: Clinical Chemistry tests
timeFrame: Up to 4 years
measure: Incidence of clinically significant changes in clinical laboratory results: Serology tests
timeFrame: Up to 4 years
measure: PFS based on gene expression (GEP) signatures
timeFrame: Up to 4 years
measure: Objective response rate (ORR) based on GEP signatures
timeFrame: Up to 4 years
measure: OS based on GEP signatures
timeFrame: Up to 4 years
measure: OS based on programmed cell death protein ligand-1 (PD-L1) expression
timeFrame: Up to 4 years
measure: ORR by BICR based on PD-L1 expression
timeFrame: Up to 4 years
measure: PFS by BICR based on PD-L1 expression
timeFrame: Up to 4 years
Other outcomes:
Locations:
city: Washington
country: United States
facility: Local Institution - 0013
state: District of Columbia
city: Athens
country: United States
facility: Local Institution - 0053
state: Georgia
city: Boston
country: United States
facility: Local Institution - 0066
state: Massachusetts
city: Boston
country: United States
facility: Local Institution - 0088
state: Massachusetts
city: Boston
country: United States
facility: Local Institution - 0086
state: Massachusetts
city: West Reading
country: United States
facility: The Reading Hosp Med Ctr Reg Cancer Ctr
state: Pennsylvania
city: Charleston
country: United States
facility: Local Institution - 0084
state: South Carolina
city: Capital Federal
country: Argentina
facility: Local Institution - 0100
state: Buenos Aires
city: Ciudad Autónoma de Buenos Aires
country: Argentina
facility: Local Institution - 0011
state: Buenos Aires
city: Mar del Plata
country: Argentina
facility: Local Institution - 0060
state: Buenos Aires
city: Rio Cuarto
country: Argentina
facility: Local Institution - 0025
state: Cordoba
city: Viedma
country: Argentina
facility: Local Institution - 0001
state: Río Negro
city: Cordoba
country: Argentina
facility: Local Institution - 0005
city: San Juan
country: Argentina
facility: Local Institution - 0002
city: Graz
country: Austria
facility: Local Institution - 0033
city: Vienna
country: Austria
facility: Local Institution - 0031
city: Wels
country: Austria
facility: Local Institution - 0032
city: Santiago
country: Chile
facility: Local Institution - 0003
state: Metropolitana
city: Santiago
country: Chile
facility: Local Institution - 0034
state: Metropolitana
city: Independencia
country: Chile
facility: Local Institution - 0017
state: Santiago
city: Vina del Mar
country: Chile
facility: Local Institution - 0004
state: Valparaiso
city: Viña El Mar
country: Chile
facility: Local Institution - 0012
state: Valparaíso
city: Brno
country: Czechia
facility: Local Institution - 0020
state: Jihomoravský Kraj
city: Brno
country: Czechia
facility: Local Institution - 0097
city: Praha 10
country: Czechia
facility: Local Institution - 0019
city: Praha 4
country: Czechia
facility: Local Institution - 0018
city: Nice
country: France
facility: Local Institution - 0096
state: Alpes-Maritimes
city: Brest
country: France
facility: Local Institution - 0074
state: Finistère
city: Nancy
country: France
facility: Local Institution - 0078
state: Meurthe-et-Moselle
city: Valenciennes
country: France
facility: Local Institution - 0091
state: Nord
city: ANGERS Cedex 2
country: France
facility: Local Institution - 0073
city: Angers
country: France
facility: Local Institution - 0069
city: Besançon Cedex
country: France
facility: Local Institution - 0075
city: Caen
country: France
facility: Local Institution - 0094
city: Hyeres
country: France
facility: Local Institution - 0081
city: La Tronche
country: France
facility: Local Institution - 0080
city: Marseille Cedex 9
country: France
facility: Local Institution - 0071
city: Paris
country: France
facility: Local Institution - 0092
city: Strasbourg Cedex
country: France
facility: Local Institution - 0093
city: Suresnes
country: France
facility: Local Institution - 0072
city: Villejuif
country: France
facility: Local Institution - 0068
city: Athens
country: Greece
facility: Local Institution - 0023
city: Larissa
country: Greece
facility: Local Institution - 0024
city: Brescia
country: Italy
facility: Local Institution - 0082
state: Lombardia
city: Arezzo
country: Italy
facility: Local Institution - 0014
city: Aviano (PN)
country: Italy
facility: Local Institution - 0016
city: Milan
country: Italy
facility: Local Institution - 0021
city: Parma
country: Italy
facility: Local Institution - 0015
city: Roma
country: Italy
facility: Local Institution - 0077
city: Ciudad de Mexico
country: Mexico
facility: Local Institution - 0006
state: Distrito Federal
city: Mexico
country: Mexico
facility: Local Institution - 0009
state: Distrito Federal
city: Mexico
country: Mexico
facility: Local Institution - 0010
state: Distrito Federal
city: Monterrey
country: Mexico
facility: Local Institution - 0067
state: Nuevo LEON
city: Chihuahua
country: Mexico
facility: Local Institution - 0008
city: Querétaro
country: Mexico
facility: Local Institution - 0046
city: Biala Podlaska
country: Poland
facility: Local Institution - 0030
city: Bydgoszcz
country: Poland
facility: Local Institution - 0095
city: Bytom
country: Poland
facility: Local Institution - 0062
city: Gdansk
country: Poland
facility: Local Institution - 0026
city: Poznan
country: Poland
facility: Local Institution - 0029
city: Warszawa
country: Poland
facility: Local Institution - 0027
city: Lisboa
country: Portugal
facility: Local Institution - 0050
city: Bucharest
country: Romania
facility: Local Institution - 0061
city: Cluj-Napoca
country: Romania
facility: Local Institution - 0056
city: Craiova
country: Romania
facility: Local Institution - 0065
city: Saint Petersburg
country: Russian Federation
facility: Local Institution - 0054
state: Sankt-Peterburg
city: Novosibirsk
country: Russian Federation
facility: Local Institution - 0058
city: Barcelona
country: Spain
facility: Local Institution - 0038
city: Barcelona
country: Spain
facility: Local Institution - 0037
city: Cordoba
country: Spain
facility: Local Institution - 0042
city: Madrid
country: Spain
facility: Local Institution - 0036
city: Madrid
country: Spain
facility: Local Institution - 0035
city: Pamplona
country: Spain
facility: Local Institution - 0045
city: Sabadell
country: Spain
facility: Local Institution - 0039
city: Santander
country: Spain
facility: Local Institution - 0043
city: Santiago Compostela
country: Spain
facility: Local Institution - 0044
city: Sevilla
country: Spain
facility: Local Institution - 0041
city: Valencia
country: Spain
facility: Local Institution - 0040
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References: