NCT04810078 · CITED IN SOURCE DOCUMENTS

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

An NCI or FDA source cites this study. A citation does not establish that it applies to an individual diagnosis.

Phase: PHASE3
Status at capture: ACTIVE NOT RECRUITING
Registry last update: 2025-10-09

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. The purpose of this study's substudy is to evaluate drug level biocomparability of subcutaneous nivolumab manufactured using two different manufacturing processes.

Open the original ClinicalTrials.gov record → · Download preserved record

What did the study report?

Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.

No posted result sections were captured. Registered plans do not establish that a treatment works.

Who could take part

eligibility 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 * 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
healthy Volunteers: false
minimum Age: 18 Years
sex: ALL
std Ages: ADULT
OLDER_ADULT

Treatment arms and interventions

arm Groups

intervention Names
Biological: Nivolumab and rHuPH20
label
Arm A
type
EXPERIMENTAL
intervention Names
Biological: Nivolumab
label
Arm B
type
ACTIVE_COMPARATOR
intervention Names
Biological: Nivolumab and rHuPH20
label
Arm C
type
EXPERIMENTAL
intervention Names
Biological: Nivolumab and rHuPH20
label
Arm D
type
EXPERIMENTAL

interventions

arm Group Labels
Arm A
Arm C
Arm D
description
Specified dose on specified days
name
Nivolumab and rHuPH20
other Names
BMS-986298
type
BIOLOGICAL
arm Group Labels
Arm B
description
Specified dose on specified days
name
Nivolumab
other Names
Opdivo
BMS-936558
type
BIOLOGICAL

Study design

allocation

RANDOMIZED

intervention Model

PARALLEL

masking Info

masking: QUADRUPLE
who Masked: PARTICIPANT
CARE_PROVIDER
INVESTIGATOR
OUTCOMES_ASSESSOR

primary Purpose

TREATMENT

Enrollment

count: 681
type: ACTUAL

Registered outcome plans (not posted results)

primary Outcomes

measure
Time-averaged serum concentration over 28 days (Cavgd28)
time Frame
Up to 28 days
measure
Trough serum concentration at steady-state (Cminss)
time Frame
Up to 4 months

secondary Outcomes

measure
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
measure
Trough serum concentration at day 28 (Cmind28)
time Frame
At 28 days
measure
Maximum serum concentration after the first dose (Cmax1)
time Frame
Up to 7 days
measure
Peak serum concentration at steady-state (Cmaxss)
time Frame
Up to 4 months
measure
Steady-state average serum concentration (Cavgss)
time Frame
Up to 4 months
measure
Trough concentration (Ctrough)
time Frame
At week 17
measure
Incidence of adverse events (AEs)
time Frame
Up to 2 years 3 months
measure
Incidence of serious adverse events (SAEs)
time Frame
Up to 2 years 3 months
measure
Incidence of AEs leading to discontinuation
time Frame
Up to 2 years
measure
Incidence of deaths
time Frame
Up to 5 years
measure
Incidence of clinically significant changes in clinical laboratory results: Hematology tests
time Frame
Up to 2 years 3 months
measure
Incidence of clinically significant changes in clinical laboratory results: Chemistry panel tests
time Frame
Up to 2 years 3 months

Full study description

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. The purpose of this study's substudy is to evaluate drug level biocomparability of subcutaneous nivolumab manufactured using two different manufacturing processes.

Source references

references

citation
Albiges L, Bourlon MT, Chacon M, Cutuli HJ, Chuken YAL, Zurawski B, Mota JM, Magri I, Burotto M, Luz M, de Menezes J, Ruiz EPY, Fu S, Richardet M, Valderrama BP, Maruzzo M, Bracarda S, Breckenridge M, Vezina HE, Rathod D, Yu Z, Zhao Y, Dixon M, Perumal D, George S. Subcutaneous versus intravenous nivolumab for renal cell carcinoma. Ann Oncol. 2025 Jan;36(1):99-107. doi: 10.1016/j.annonc.2024.09.002. Epub 2024 Sep 15.
pmid
39288844
type
DERIVED