A Study of Nivolumab Combined With Cabozantinib Compared to Sunitinib in Previously Untreated Advanced or Metastatic Renal Cell Carcinoma (CheckMate 9ER)
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT03141177 |
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Recruitment Status :
Active, not recruiting
First Posted : May 4, 2017
Last Update Posted : February 12, 2021
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Renal Cell Carcinoma | Biological: Nivolumab Drug: Cabozantinib Drug: Sunitinib Biological: Ipilimumab | Phase 3 |
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 638 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| 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 |
| Actual Study Start Date : | July 11, 2017 |
| Actual Primary Completion Date : | February 12, 2020 |
| Estimated Study Completion Date : | May 14, 2024 |
| Arm | Intervention/treatment |
|---|---|
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Experimental: Doublet
Nivolumab and Cabozantinib
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Biological: Nivolumab
Specified dose on specified day
Other Names:
Drug: Cabozantinib Specified dose on specified days
Other Name: Cabometyx |
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Active Comparator: Monotherapy
Sunitinib
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Drug: Sunitinib
Specified dose on specified days.
Other Name: Sutent |
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Experimental: Triplet
Nivolumab, Ipilimumab, Cabozantinib *Enrollment to the triplet arm was discontinued by protocol amendment |
Biological: Ipilimumab
Specified dose on specified days
Other Names:
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- Progression Free Survival (PFS) per blinded independent central review (BICR) [ Time Frame: Up to 29 months ]
- Overall Survival (OS) [ Time Frame: Up to 40 months ]
- Objective Response Rate (ORR) [ Time Frame: up to 29 months ]
- Incidence of adverse events (AEs) [ Time Frame: Up to 40 months ]
- Incidence of Serious Adverse Events (SAEs) [ Time Frame: Up to 40 months ]
- Incidence of AEs leading to discontinuation [ Time Frame: Up to 40 months ]
- Incidence of Deaths [ Time Frame: Up to 40 months ]
- Incidence of laboratory abnormalities [ Time Frame: Up to 40 months ]
- Change from baseline in Laboratory values [ Time Frame: Up to 40 Months ]
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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
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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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03141177
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| Study Director: | Bristol-Myers Squibb | Bristol-Myers Squibb |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Bristol-Myers Squibb |
| ClinicalTrials.gov Identifier: | NCT03141177 |
| Other Study ID Numbers: |
CA209-9ER 2017-000759-20 ( EudraCT Number ) |
| First Posted: | May 4, 2017 Key Record Dates |
| Last Update Posted: | February 12, 2021 |
| Last Verified: | February 2021 |
| Studies a U.S. FDA-regulated Drug Product: | Yes |
| Studies a U.S. FDA-regulated Device Product: | No |
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Carcinoma Carcinoma, Renal Cell Kidney Neoplasms Kidney Diseases Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms Adenocarcinoma Urologic Neoplasms Urogenital Neoplasms Neoplasms by Site Urologic Diseases Nivolumab |
Ipilimumab Sunitinib Antineoplastic Agents, Immunological Antineoplastic Agents Angiogenesis Inhibitors Angiogenesis Modulating Agents Growth Substances Physiological Effects of Drugs Growth Inhibitors Protein Kinase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |