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

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 495

Inclusion Criteria

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.
- Karnofsky PS = 70 at screening.
- Must agree to follow specific methods of contraception, if applicable.
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 216
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 279

Exclusion Criteria

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 healthcare 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 a 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 co stimulation or checkpoint pathways.

- Treatment with any live attenuated vaccine within 30 days of first study treatment.

- Other protocol-defined inclusion/exclusion criteria apply.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.<br>2. To evaluate efficacy of SC nivolumab over 12 months.<br>3. To evaluate PK of SC nivolumab and IV nivolumab administration.<br>4. To evaluate the safety profile of SC nivolumab and IV nivolumab administration.;Primary end point(s): Time-averaged serum concentration over 28 days (Cavgd28)<br>Trough serum concentration at steady-state (Cminss);Timepoint(s) of evaluation of this end point: Time-averaged serum concentration over 28 days (Cavgd28) [ Time<br>Frame: Up to 28 days ]<br>Trough serum concentration at steady-state (Cminss) [ Time Frame: Up<br>to 4 months ]

Secondary Outcome Measures

Name	Time	Method

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