Ended Therapeutic confirmatory (Phase III) Metastatic Clear Cell Renal Cell Carcinoma

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

EU CTIS ID: 2023-503280-42-00

What this study is testing

To demonstrate PK noninferiority of SC nivolumab vs IV nivolumab administration

  • Therapeutic confirmatory (Phase III)

A plain-language read of the study's public EU CTIS listing. The study team confirms the details.

Who can take part

You may be able to join if

  • * 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.

You likely can't join if

  • * 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.
See the full eligibility criteria
Who can join
  • * 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.
What rules you out
  • * 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.

The study team makes the final eligibility decision.

Where it's taking place

  • Argentina
  • Mexico
  • Chile
  • United States
  • New Zealand
  • Brazil
  • Turkey

Questions & answers

Do participants get paid in this trial?

This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.

Is it free to join, and do I need insurance?

Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.

How long does this study last?

The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.

Who can join this trial?

This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.

Where is this trial taking place?

Study sites include Argentina; Mexico; Chile; United States; New Zealand; Brazil and 1 more location(s). Enter your location above to see the nearest site and check your eligibility.

Explore other conditions

BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.