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

• Register: ClinicalTrials.gov
• Last refreshed on: 22 January 2024
• Main ID: NCT03141177
• Date of registration: 03/05/2017
• Prospective Registration: Yes
• Primary sponsor: Bristol-Myers Squibb
• Public title: A Study of Nivolumab Combined With Cabozantinib Compared to Sunitinib in Previously Untreated Advanced or Metastatic Renal Cell Carcinoma CheckMate 9ER
• Scientific 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
• Date of first enrolment: August 22, 2017
• Target sample size: 701
• Recruitment status: Active, not recruiting
• URL: https://clinicaltrials.gov/ct2/show/NCT03141177
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 3

Countries of recruitment

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

Contacts

• Name: Bristol-Myers Squibb
• Affiliation: Bristol-Myers Squibb

Key inclusion & exclusion criteria

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



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Renal Cell Carcinoma

Intervention(s)

Drug: Sunitinib

Biological: Nivolumab

Drug: Cabozantinib

Biological: Ipilimumab

Primary Outcome(s)

Progression Free Survival (PFS) [Time Frame: From randomization date to date of first documented tumor progression or death, whichever occurs first (Up to 31 months)]

Secondary Outcome(s)

Number of Participants Experiencing Adverse Events (AEs) [Time Frame: From first dose to 100 days following last dose (Up to 32 Months)]

Number of Participants Experiencing Serious Adverse Events (SAEs) [Time Frame: From first to dose to 100 days following last dose (Up to 32 months)]

Number of Participants With Laboratory Values Grade Shifting From Baseline [Time Frame: From first dose to 30 days following last dose (Up to 30 Months)]

Number of Deaths [Time Frame: From first dose to (up to 31 months) following first dose]

Number of Participants With Laboratory Abnormalities [Time Frame: From first dose to 30 days following last dose (Up to 30 Months)]

Objective Response Rate (ORR) [Time Frame: Up to 31 Months]

Overall Survival (OS) [Time Frame: From randomization date to death date (Up to 31 months)]

Number of Participants Experiencing Adverse Events (AEs) Leading to Discontinuation [Time Frame: From first dose to 30 days following last dose (Up to 30 months)]

Secondary ID(s)

CA209-9ER

2017-000759-20

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Ono Pharmaceutical Co. Ltd

Exelixis

Results

• Results available: Yes
• Date Posted: 26/04/2022
• URL: https://clinicaltrials.gov/ct2/show/results/NCT03141177