A Study of Subcutaneous Nivolumab in Previously Treated Advanced or Metastatic Clear Cell Renal Cell Carcinoma

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. - A Study of Subcutaneous Nivolumab in Previously Treated Advanced or Metastatic Clear Cell Renal Cell

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2020-003655-15-FR

Enrollment

458

Registered

2021-02-22

Start date

2021-06-02

Completion date

Unknown

Last updated

2024-08-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Metastatic Clear Cell Renal Cell Carcinoma MedDRA version: 21.1 Level: LLT Classification code 10050076 Term: Metastatic renal carcinoma System Organ Class: 100000004864

Interventions

Product Name: Nivolumab Subcutaneous coformulated with excipient rHuPH20 Product Code: BMS-986298-01 Pharmaceutical Form: Solution for injection INN or Proposed INN: NIVOLUMAB CAS Number: 946414-94-4

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - Histological confirmation of renal cell carcinoma (RCC) - 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 - Received no more than 2 prior systemic treatment regimens - Progression or intolerance on or after the last treatment regimen received Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 275 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 183

Exclusion criteria

Exclusion criteria: - Untreated, symptomatic central nervous system (CNS) metastases. - Prior immunotherapy (medications which are target the immune system) known as PDL1 or CTLA4 or any other medications working similarly 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

Design outcomes

Primary

Measure	Time frame
Main Objective: To demonstrate PK noninferiority of SC nivolumab vs IV nivolumab administration;Secondary Objective: 1. To demonstrate the ORR noninferiority of SC nivolumab vs IV nivolumab administration. 2. To evaluate efficacy of SC nivolumab over 12 months. 3. To evaluate PK of SC nivolumab and IV nivolumab administration. 4. To evaluate the safety profile of SC nivolumab and IV nivolumab administration.;Primary end point(s): Cmind28 ;Timepoint(s) of evaluation of this end point: Minimum of 06 months	—

Measure

Time frame

Main Objective: To demonstrate PK noninferiority of SC nivolumab vs IV nivolumab administration;Secondary Objective: 1. To demonstrate the ORR noninferiority of SC nivolumab vs IV nivolumab administration. 2. To evaluate efficacy of SC nivolumab over 12 months. 3. To evaluate PK of SC nivolumab and IV nivolumab administration. 4. To evaluate the safety profile of SC nivolumab and IV nivolumab administration.;Primary end point(s): Cmind28 ;Timepoint(s) of evaluation of this end point: Minimum of 06 months

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Secondary

Measure	Time frame
Secondary end point(s): 1 - ORR by BICR, with a minimum of 6 months follow-up. 2 - Efficacy parameters (ORR, DCR, DOR, TTR, PFS, OS) with a minimum of 12 months follow-up. 3 - Cavgd28, Cmax1, Tmax, Cavgss, and Cminss. 4 - Incidence of AEs, SAEs, AEs leading to discontinuation, deaths, and laboratory abnormalities.;Timepoint(s) of evaluation of this end point: minimum of 06 months for end points 1 and 3 above minimum of 12 months for end points 2 and 4 above	—

Measure

Time frame

Secondary end point(s): 1 - ORR by BICR, with a minimum of 6 months follow-up. 2 - Efficacy parameters (ORR, DCR, DOR, TTR, PFS, OS) with a minimum of 12 months follow-up. 3 - Cavgd28, Cmax1, Tmax, Cavgss, and Cminss. 4 - Incidence of AEs, SAEs, AEs leading to discontinuation, deaths, and laboratory abnormalities.;Timepoint(s) of evaluation of this end point: minimum of 06 months for end points 1 and 3 above minimum of 12 months for end points 2 and 4 above

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Countries

Argentina, Brazil, Chile, Czechia, Czech Republic, Finland, France, Ireland, Italy, Mexico, New Zealand, Poland, Portugal, Romania, Russian Federation, Spain, Turkey, United States

Contacts

Public ContactGSM-CT

Bristol-Myers Squibb International Corporation

clinical.trials@bms.com

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026