NCT04810078 - A Study of Subcutaneous Nivolumab Versus Intravenous Nivolumab in Participants With Previously Treated Clear Cell Renal Cell Carcinoma That is Advanced or Has Spread | Crick

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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 * 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

Outcomes

Primary Outcomes

Adjusted Geometric Mean Serum Concentration of Nivolumab Over 28 Days (Cavgd28) on Original Scale

Plasma samples were collected to assess the serum concentration.

Time frame: Pre-dose (Day 1 to Day 28)

Adjusted Geometric Mean of Nivolumab Trough Serum Concentration at Steady State (Cminss) on Original Scale

Plasma samples were collected to assess the serum concentration.

Time frame: Pre-dose (Day 1 to Day 28)

Secondary Outcomes

Objective Response Rate (ORR) Per BICR

Objective response rate (ORR) is defined as the percentage of participants who achieve a best overall response (BOR) of confirmed complete response (CR) or confirmed partial response (PR), based on blinded independent central review (BICR) assessments using Response Evaluation Criteria in Solid Tumors (RECIST 1.1), divided by the number of all randomized participants. Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm. Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.

Time frame: From first dose to the date of first objectively documented progression, per RECIST v1.1, or death due to any cause, whichever occurred first (up to approximately 26 months)

Trough Serum Concentration of Nivolumab at Day 28 (Cmind28)