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A Study of Subcutaneous Nivolumab Versus Intravenous Nivolumab in Participants With Previously Treated Clear Cell Renal Cell Carcinoma That is Advanced or Has Spread (CheckMate-67T)

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ClinicalTrials.gov Identifier: NCT04810078
Recruitment Status : Active, not recruiting
First Posted : March 22, 2021
Last Update Posted : September 21, 2023
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb

Study Description
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Brief Summary:
The purpose of this study is to evaluate the drug levels, efficacy, safety, and tolerability of subcutaneous nivolumab versus intravenous nivolumab in participants with previously treated clear cell renal cell carcinoma that is advanced or has spread.

Condition or disease Intervention/treatment Phase
Clear Cell Renal Cell Carcinoma Biological: Nivolumab and rHuPH20 Biological: Nivolumab Phase 3

Expanded Access : An investigational treatment associated with this study is no longer available outside the clinical trial.   More info ...

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 454 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 3, Open-label, Randomized, Noninferiority Trial of Subcutaneous Formulation of Nivolumab Versus Intravenous Nivolumab in Participants With Advanced or Metastatic Clear Cell Renal Cell Carcinoma Who Have Received Prior Systemic Therapy
Actual Study Start Date : May 24, 2021
Estimated Primary Completion Date : September 8, 2025
Estimated Study Completion Date : January 29, 2026

Resource links provided by the National Library of Medicine

Drug Information available for: Nivolumab

Arms and Interventions
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Arm Intervention/treatment
Experimental: Arm A: Subcutaneous Nivolumab Biological: Nivolumab and rHuPH20
Specified dose on specified days
Other Name: BMS-986298
Active Comparator: Arm B: Intravenous Nivolumab Biological: Nivolumab
Specified dose on specified days
Other Names:
  • Opdivo
  • BMS-936558


Outcome Measures
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Primary Outcome Measures :
  1. Time-averaged serum concentration over 28 days (Cavgd28) [ Time Frame: Up to 28 days ]
  2. Trough serum concentration at steady-state (Cminss) [ Time Frame: Up to 4 months ]

Secondary Outcome Measures :
  1. Objective response rate (ORR) by Blinded Independent Central Review (BICR) with a minimum of 6 months follow-up [ Time Frame: Up to 2 years 6 months ]
  2. Trough serum concentration at day 28 (Cmind28) [ Time Frame: At 28 days ]
  3. Maximum serum concentration after the first dose (Cmax1) [ Time Frame: Up to 7 days ]
  4. Peak serum concentration at steady-state (Cmaxss) [ Time Frame: Up to 4 months ]
  5. Steady-state average serum concentration (Cavgss) [ Time Frame: Up to 4 months ]
  6. Trough concentration (Ctrough) [ Time Frame: At week 17 ]
  7. Incidence of adverse events (AEs) [ Time Frame: Up to 2 years 3 months ]
  8. Incidence of serious adverse events (SAEs) [ Time Frame: Up to 2 years 3 months ]
  9. Incidence of AEs leading to discontinuation [ Time Frame: Up to 2 years ]
  10. Incidence of deaths [ Time Frame: Up to 5 years ]
  11. Incidence of clinically significant changes in clinical laboratory results: Hematology tests [ Time Frame: Up to 2 years 3 months ]
  12. Incidence of clinically significant changes in clinical laboratory results: Chemistry panel tests [ Time Frame: Up to 2 years 3 months ]
  13. Efficacy parameters: disease control rate (DCR) by BICR with a minimum of 6 months follow-up [ Time Frame: Up to 2 years 6 months ]
  14. Efficacy parameters: DCR by BICR with a minimum of 12 months follow-up [ Time Frame: Up to 3 years ]
  15. Efficacy parameters: DCR by BICR at end of study [ Time Frame: Up to 5 years ]
  16. Efficacy parameters: duration of response (DOR) by BICR with a minimum of 6 months follow-up [ Time Frame: Up to 2 years 6 months ]
  17. Efficacy parameters: DOR by BICR with a minimum of 12 months follow-up [ Time Frame: Up to 3 years ]
  18. Efficacy parameters: DOR by BICR at end of study [ Time Frame: Up to 5 years ]
  19. Efficacy parameters: time to objective response (TTR) by BICR with a minimum of 6 months follow-up [ Time Frame: Up to 2 years 6 months ]
  20. Efficacy parameters: TTR by BICR with a minimum of 12 months follow-up [ Time Frame: Up to 3 years ]
  21. Efficacy parameters: TTR by BICR at end of study [ Time Frame: Up to 5 years ]
  22. Efficacy parameters: progression-free survival (PFS) by BICR with a minimum of 6 months follow-up [ Time Frame: Up to 2 years 6 months ]
  23. Efficacy parameters: PFS by BICR with a minimum of 12 months follow-up [ Time Frame: Up to 3 years ]
  24. Efficacy parameters: PFS by BICR at end of study [ Time Frame: Up to 5 years ]
  25. Efficacy parameters: overall survival (OS) with a minimum of 6 months follow-up [ Time Frame: Up to 2 years 6 months ]
  26. Efficacy parameters: OS with a minimum of 12 months follow-up [ Time Frame: Up to 3 years ]
  27. Efficacy parameters: OS at end of study [ Time Frame: Up to 5 years ]
  28. Efficacy parameters: ORR by BICR with a minimum of 12 months follow-up [ Time Frame: Up to 3 years ]
  29. Efficacy parameters: ORR by BICR at end of study [ Time Frame: Up to 5 years ]
  30. Incidence of anaphylactic, hypersensitivity, and systemic infusion reactions/systemic injection reactions [ Time Frame: Up to 2 years 3 months ]
  31. Incidence of local injection- or infusion-site reactions [ Time Frame: Up to 2 years 3 months ]
  32. Percentage of participants who develop anti-nivolumab antibodies, if applicable [ Time Frame: Up to 2 years 3 months ]
  33. Percentage of participants who develop neutralizing antibodies, if applicable [ Time Frame: Up to 2 years 3 months ]

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Inclusion Criteria:

  • Histological confirmation of renal cell carcinoma (RCC) with a clear cell component, including participants who may also have sarcomatoid features
  • Advanced RCC (not amenable to curative surgery or radiation therapy) or metastatic RCC (Stage IV)
  • Measurable disease as defined by Response Evaluation Criteria in Solid Tumor (RECIST) v1.1 criteria within 28 days prior to randomization
  • Received no more than 2 prior systemic treatment regimens
  • Intolerance or progression on or after the last treatment regimen received and within 6 months prior to randomization on the study
  • Karnofsky PS ≥ 70 at screening
  • Must agree to follow specific methods of contraception, if applicable

Exclusion Criteria:

  • Untreated, symptomatic central nervous system (CNS) metastases
  • Concurrent malignancy (present during screening) requiring treatment or history of prior malignancy active within 2 years prior to randomization
  • Active, known, or suspected autoimmune disease

  • Known human immunodeficiency virus (HIV) positive with an acquired immunodeficiency syndrome (AIDS) defining opportunistic infection within the last year, or a current CD4 count < 350 cells/μL. Participants with HIV are eligible if:

    1. They have received established antiretroviral therapy (ART) for at least 4 weeks prior to randomization
    2. They continue on ART as clinically indicated while enrolled on study
    3. CD4 counts and viral load are monitored per standard of care by a local health care provider
    4. Inclusion of participants with HIV should be based on Investigator clinical judgment in consultation with the Medical Monitor NOTE: Testing for HIV must be performed at sites where mandated locally. HIV-positive participants must be excluded where mandated locally
  • Serious or uncontrolled medical disorders including for example, active severe acute respiratory syndrome coronavirus 2 (SAR-CoV-2) infection within approximately 4 weeks prior to screening. In the case of prior SARS-CoV-2 infection, acute symptoms must have resolved based on investigator clinical judgment and, in consultation with Medical Monitor, there are no sequelae that would place the participant at a higher risk of receiving investigational treatment to be eligible
  • Prior treatment with an programmed death receptor-1 (anti-PD-1), programmed death ligand-1 (anti-PD-L1), or cytotoxic T-lymphocyte-associated antigen-4 (anti-CTLA-4) antibody, or any other antibody or drug specifically targeting T-cell costimulation or checkpoint pathways
  • Treatment with any live attenuated vaccine within 30 days of first study treatment

Other protocol-defined inclusion/exclusion criteria apply

Contacts and Locations
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Information from the National Library of Medicine

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): NCT04810078


Locations
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Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
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Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
More Information
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Additional Information:

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Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT04810078    
Other Study ID Numbers: CA209-67T
2020-003655-15 ( EudraCT Number )
U1111-1255-9514 ( Registry Identifier: WHO )
First Posted: March 22, 2021    Key Record Dates
Last Update Posted: September 21, 2023
Last Verified: September 2023

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Bristol-Myers Squibb:
BMS-936558
BMS-986298
Clear cell renal cell carcinoma
ccRCC
 Nivolumab
Opdivo
rHuPH20
Subcutaneous
Additional relevant MeSH terms:
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Carcinoma
Carcinoma, Renal Cell
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Adenocarcinoma
Kidney Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Female Urogenital Diseases
 Female Urogenital Diseases and Pregnancy Complications
Urogenital Diseases
Kidney Diseases
Urologic Diseases
Male Urogenital Diseases
Nivolumab
Antineoplastic Agents, Immunological
Antineoplastic Agents
Immune Checkpoint Inhibitors
Molecular Mechanisms of Pharmacological Action