A Phase 3 Study of Nivolumab plus Ipilimumab Versus Sunitinib in untreated Subjects with Advanced or Metastatic Renal Cell Carcinoma (RCC)
EU CTIS ID: 2023-504761-23-00
What this study is testing
The purpose of this study is to compare the progression free survival and the overall survival of nivolumab combined with ipilimumab to sunitinib monotherapy in patients with previously untreated Renal Cell Cancer
- 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 RCC with a clear-cell component
- Advanced (not amenable to curative surgery or radiation therapy) or metastatic (AJCC Stage IV) RCC
- No prior systemic therapy for RCC with the following exception: a) One prior adjuvant or neoadjuvant therapy for completely resectable RCC if such therapy did not include an agent that targets VEGF or VEGF receptors and if recurrence occurred at least 6 months after the last dose of adjuvant or neoadjuvant therapy.
- Karnofsky Performance Status (KPS) of at least 70%
- Measurable disease as per RECIST 1.1
- Tumor tissue (formalin-fixed paraffin-embedded (FFPE) archival or recent acquisition) must be received in order to randomize a subject to study treatment. (Note: Fine Needle Aspiration [FNA] and bone met by the central vendor (block or unstained slides) astases samples are not acceptable for submission)
You likely can't join if
- Any history of or current CNS metastases. Baseline imaging of the brain is required within 28 days prior to randomization
- Prior systemic treatment with VEGF or VEGF receptor targeted therapy (including, but not limited to, sunitinib, pazopanib, axitinib, tivozanib, and bevacizumab)
- Prior treatment with an anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, or anti-CTLA-4 antibody, or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways
- Any active or recent history of a known or suspected autoimmune disease or recent history of a syndrome that required systemic corticosteroids (> 10 mg daily prednisone equivalent) or immunosuppressive medications except for syndromes which would not be expected to recur in the absence of an external trigger. Subjects with vitiligo or type I diabetes mellitus or residual hypothyroidism due to autoimmune thyroiditis only requiring hormone replacement are permitted to enroll
- Any condition requiring systemic treatment with corticosteroids (> 10 mg daily prednisone equivalents) or other immunosuppressive medication within 14 days prior to first dose of study drug. Inhaled steroids and adrenal replacement steroid doses > 10 mg daily prednisone equivalents are permitted in the absence of active autoimmune disease
The study team makes the final eligibility decision.
Where it's taking place
- Canada
- Argentina
- United Kingdom
- Turkey
- Mexico
- Brazil
- United States
- Australia
- Chile
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 Canada; Argentina; United Kingdom; Turkey; Mexico; Brazil and 3 more location(s). Enter your location above to see the nearest site and check your eligibility.
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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.