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: 458

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.

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

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) Trough serum concentration at steady-state (Cminss) <br>;Timepoint(s) of evaluation of this end point: Time-averaged serum concentration over 28 days (Cavgd28) [ Time Frame: Up to 28 days ]<br>Trough serum concentration at steady-state (Cminss) [ Time Frame: Up to 4 months ]

Secondary Outcome Measures

Name	Time	Method

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