A Study of Nivolumab Combined With Cabozantinib Compared to Sunitinib in Previously Untreated Advanced or Metastatic Renal Cell Carcinoma

Renal Cell Carcinoma Clinical Trial

— CheckMate 9ER  

Official 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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03141177
• Other study ID #: CA209-9ER
• Secondary ID: 2017-000759-20
• Status: Active, not recruiting
• Phase: Phase 3
• Start date: August 22, 2017
• Est. completion date: April 17, 2024

Study information

• Verified date: January 2024
• Source: Bristol-Myers Squibb
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 701
• Est. completion date: April 17, 2024
• Est. primary completion date: February 12, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com

Inclusion Criteria:

• 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

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

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Renal Cell
• Renal Cell Carcinoma

Intervention

Biological:
• Nivolumab
Specified dose on specified day

Drug:
• Cabozantinib
Specified dose on specified days
• Sunitinib
Specified dose on specified days.

Biological:
• Ipilimumab
Specified dose on specified days

Locations

Country	Name	City	State
Argentina	Local Institution - 0046	Caba	Buenos Aires
Argentina	Local Institution - 0138	Caba
Argentina	Local Institution - 0048	Ciudad Autonoma De Buenos Aire	Buenos Aires
Argentina	Local Institution - 0049	Cordoba
Argentina	Local Institution - 0050	Cordoba
Argentina	Local Institution - 0047	Tucuman
Argentina	Local Institution - 0114	Viedma	RIO Negro
Australia	Local Institution - 0007	Doubleview	Western Australia
Australia	Local Institution - 0004	Elizabeth Vale	South Australia
Australia	Local Institution - 0006	Herston	Queensland
Australia	Local Institution - 0005	Malvern	Victoria
Australia	Local Institution - 0002	North Ryde	New South Wales
Australia	Local Institution - 0129	South Brisbane
Australia	Local Institution - 0001	Southport	Queensland
Australia	Local Institution - 0008	Sydney	New South Wales
Australia	Local Institution - 0009	Sydney	New South Wales
Australia	Local Institution - 0073	Westmead	New South Wales
Brazil	Local Institution - 0058	Barretos	Sao Paulo
Brazil	Local Institution - 0057	Belo Horizonte	Minas Gerais
Brazil	Local Institution - 0119	Ijui	RIO Grande DO SUL
Brazil	Local Institution - 0056	Porto Alegre	RIO Grande DO SUL
Brazil	Local Institution - 0060	Porto Alegre	RIO Grande DO SUL
Brazil	Local Institution - 0066	Rio De Janeiro
Brazil	Local Institution - 0061	Sao Paulo
Brazil	Local Institution - 0074	Sao Paulo
Chile	Local Institution - 0045	Santiago	Metropolitana
Czechia	Local Institution - 0034	Hradec Kralove
Czechia	Local Institution - 0033	Olomouc
Germany	Local Institution - 0013	Aachen
Germany	Local Institution - 0016	Bonn
Germany	Local Institution - 0117	Essen
Germany	Local Institution - 0023	Jena
Germany	Local Institution - 0010	Muenchen
Germany	Local Institution - 0014	Nuernberg
Germany	Local Institution - 0011	Tuebingen
Greece	Local Institution - 0082	Athens
Greece	Local Institution - 0083	Thessaloniki
Israel	Local Institution - 0072	Haifa
Israel	Local Institution - 0070	Kfar Saba
Israel	Local Institution - 0071	Petah Tikva
Israel	Local Institution - 0069	Ramat Gan
Italy	Local Institution - 0054	Arezzo
Italy	Local Institution - 0052	Milano
Italy	Local Institution - 0055	Napoli
Italy	Local Institution - 0053	Padova
Italy	Local Institution - 0051	Pavia
Italy	Local Institution - 0147	Pavia
Italy	Local Institution - 0172	Terni
Japan	Local Institution - 0152	Adachi-ku	Tokyo
Japan	Local Institution - 0148	Akita-shi	Akita
Japan	Local Institution - 0156	Aomori
Japan	Local Institution - 0151	Bunkyo-ku	Tokyo
Japan	Local Institution - 0158	Bunkyo-ku	Tokyo
Japan	Local Institution - 0167	Chiba
Japan	Local Institution - 0161	Fukuoka
Japan	Local Institution - 0155	Hidaka-shi	Saitama
Japan	Local Institution - 0168	Kobe	Hyogo
Japan	Local Institution - 0173	Minato-ku	Tokyo
Japan	Local Institution - 0159	Morioka	Iwate
Japan	Local Institution - 0162	Nagasaki
Japan	Local Institution - 0150	Niigata-shi	Niigata
Japan	Local Institution - 0169	Okayama-shi	Okayama
Japan	Local Institution - 0154	Osaka	Osaka-shi
Japan	Local Institution - 0170	Osaka-shi	Osaka
Japan	Local Institution - 0160	Osakasayamashi	Osaka
Japan	Local Institution - 0164	Sapporo	Hokkaido
Japan	Local Institution - 0157	Sapporo-shi	Hokkaido
Japan	Local Institution - 0163	Suita-shi	Osaka
Japan	Local Institution - 0153	Tokushima-shi	Tokushima
Japan	Local Institution - 0149	Tokyo
Japan	Local Institution - 0165	Yamagata
Japan	Local Institution - 0166	Yokohama	Kanagawa
Japan	Local Institution - 0171	Yokohama	Kanagawa
Mexico	Local Institution - 0062	Ciudad de Mexico	Distrito Federal
Mexico	Local Institution - 0136	Merida	Yucatan
Mexico	Local Institution - 0116	Mexico	Distrito Federal
Mexico	Local Institution - 0064	Monterrey	Nuevo Leon
Mexico	Local Institution - 0065	Monterrey	Nuevo Leon
Mexico	Local Institution - 0143	Monterrey	Nuevo LEON
Mexico	Local Institution - 0063	Queretaro
Mexico	Local Institution - 0115	Tlalpan	Distrito Federal
Mexico	Local Institution - 0108	Zapopan	Jalisco
Poland	Local Institution - 0084	Biala Podlaska
Poland	Local Institution - 0130	Bydgoszcz
Poland	Local Institution - 0085	Gdansk
Romania	Local Institution - 0021	Cluj-Napoca
Romania	Local Institution - 0022	Craiova
Russian Federation	Local Institution - 0020	Moscow
Russian Federation	Local Institution - 0099	Saint-Petersburg
Spain	Local Institution - 0125	Barcelona
Spain	Local Institution - 0120	Madrid
Spain	Local Institution - 0121	Madrid
Spain	Local Institution - 0144	Santander
Spain	Local Institution - 0124	Sevilla
Spain	Local Institution - 0123	Valencia
Turkey	Local Institution - 0094	Ankara
Turkey	Local Institution - 0107	Ankara
Turkey	Local Institution - 0139	Ankara
Turkey	Local Institution - 0096	Antalya
Turkey	Local Institution - 0097	Denizli
Turkey	Local Institution - 0095	Edirne
Turkey	Local Institution - 0146	Istanbul
United Kingdom	Local Institution - 0111	London
United Kingdom	Local Institution - 0109	Manchester
United Kingdom	Local Institution - 0140	Truro
United States	Local Institution - 0135	Allentown	Pennsylvania
United States	Local Institution - 0127	Athens	Georgia
United States	Local Institution - 0103	Aurora	Colorado
United States	Local Institution - 0133	Bakersfield	California
United States	Local Institution - 0037	Boston	Massachusetts
United States	Local Institution - 0113	Boston	Massachusetts
United States	Local Institution - 0040	Buffalo	New York
United States	Local Institution - 0036	Chicago	Illinois
United States	Local Institution - 0075	Dallas	Texas
United States	Local Institution - 0077	Daphne	Alabama
United States	Local Institution - 0091	Fort Wayne	Indiana
United States	Local Institution - 0044	Goodyear	Arizona
United States	Local Institution - 0068	Houston	Texas
United States	Local Institution - 0106	Kansas City	Missouri
United States	Local Institution - 0102	Las Vegas	Nevada
United States	Local Institution - 0093	Los Angeles	California
United States	Local Institution - 0105	Nashville	Tennessee
United States	Local Institution - 0017	New York	New York
United States	Local Institution - 0086	Newnan	Georgia
United States	Local Institution - 0131	Norfolk	Virginia
United States	Local Institution - 0067	Portland	Oregon
United States	Local Institution - 0090	Redondo Beach	California
United States	Local Institution - 0035	Saint Louis	Missouri
United States	Local Institution - 0080	San Antonio	Texas
United States	Local Institution - 0088	San Luis Obispo	California
United States	Central Coast Medical Oncology Corporation	Santa Maria	California
United States	Local Institution - 0078	Sherman	Texas
United States	Local Institution - 0132	Tucson	Arizona
United States	Local Institution - 0087	Wichita	Kansas
United States	Local Institution - 0042	Zion	Illinois

Sponsors (3)

Lead Sponsor	Collaborator
Bristol-Myers Squibb	Exelixis, Ono Pharmaceutical Co. Ltd

Countries where clinical trial is conducted

United States,  Argentina,  Australia,  Brazil,  Chile,  Czechia,  Germany,  Greece,  Israel,  Italy,  Japan,  Mexico,  Poland,  Romania,  Russian Federation,  Spain,  Turkey,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression Free Survival (PFS)	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	From randomization date to date of first documented tumor progression or death, whichever occurs first (Up to 31 months)
Secondary	Overall Survival (OS)	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").	From randomization date to death date (Up to 31 months)
Secondary	Objective Response Rate (ORR)	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.	Up to 31 Months
Secondary	Number of Participants Experiencing Adverse Events (AEs)	Number of participants experiencing various types of any grade adverse events (AEs) during the specified time frame.	From first dose to 100 days following last dose (Up to 32 Months)
Secondary	Number of Participants Experiencing Serious Adverse Events (SAEs)	Number of participants experiencing various types of any grade serious adverse events (SAEs) during the specified time frame.	From first to dose to 100 days following last dose (Up to 32 months)
Secondary	Number of Participants Experiencing Adverse Events (AEs) Leading to Discontinuation	Number of participants experiencing various types of any grade adverse events (AEs) leading to discontinuation during the specified time frame.	From first dose to 30 days following last dose (Up to 30 months)
Secondary	Number of Deaths	Number of deaths due to any cause during the specified time frame.	From first dose to (up to 31 months) following first dose
Secondary	Number of Participants With Laboratory Abnormalities	Number of participants experiencing laboratory abnormalities in hematology, serum chemistry and electrolytes with grade 3 or higher during the specified time frame.	From first dose to 30 days following last dose (Up to 30 Months)
Secondary	Number of Participants With Laboratory Values Grade Shifting From Baseline	Number of participants experiencing worsening shift from baseline in any grade and grade 3-4 of laboratory values during the specified time frame.	From first dose to 30 days following last dose (Up to 30 Months)

External Links

•   BMS Clinical Trial Information
•   BMS Clinical Trial Patient Recruiting