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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| ClinicalTrials.gov Identifier: NCT03141177 |
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Recruitment Status :
Recruiting
First Posted : May 4, 2017
Last Update Posted : November 20, 2018
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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 : | 630 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 |
| Estimated Primary Completion Date : | September 22, 2019 |
| Estimated Study Completion Date : | April 22, 2023 |
| 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 21 months ]
- Overall Survival (OS) [ Time Frame: Up to 64 months ]
- Objective Response Rate (ORR) [ Time Frame: Approximately 16 months ]
- Incidence of adverse events (AEs) [ Time Frame: Up to 64 months ]Safety and Tolerability
- Incidence of Serious Adverse Events (SAEs) [ Time Frame: Up to 64 months ]Safety and Tolerability
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| 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
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
| Contact: Recruiting sites have contact information. Please contact the sites directly. If there is no contact information, | please email: | Clinical.Trials@bms.com | |
| Contact: First line of the email MUST contain NCT # and Site #. |
Show 158 Study Locations
| Study Director: | Bristol-Myers Squibb | Bristol-Myers Squibb |
Additional Information:
| Responsible Party: | Bristol-Myers Squibb |
| ClinicalTrials.gov Identifier: | NCT03141177 History of Changes |
| Other Study ID Numbers: |
CA209-9ER 2017-000759-20 ( EudraCT Number ) |
| First Posted: | May 4, 2017 Key Record Dates |
| Last Update Posted: | November 20, 2018 |
| Last Verified: | November 2018 |
| Studies a U.S. FDA-regulated Drug Product: | Yes | |
| Studies a U.S. FDA-regulated Device Product: | No | |
Additional relevant MeSH terms:
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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 Sunitinib Antibodies, Monoclonal Antineoplastic Agents Immunologic Factors Physiological Effects of Drugs Angiogenesis Inhibitors Angiogenesis Modulating Agents Growth Substances Growth Inhibitors |