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A Study to Evaluate the Efficacy and Safety of Atezolizumab Given in Combination with Cabozantinib Versus Cabozantinib Alone in Patients with Inoperable, Locally Advanced, or Metastatic Renal Cell Carcinoma who Experienced Radiographic Tumor Progression During or After Immune Checkpoint Inhibitor Treatment
EU CTIS ID: 2024-517785-42-00
What this study is testing
To evaluate the efficacy of atezolizumab in combination with cabozantinib (i.e. atezolizumab + cabozantinib arm) compared with cabozantinib alone (cabozantinib arm) in the intent-to-treat population
- 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
- Histologically confirmed locally advanced or metastatic clear cell or non-clear cell RCC (papillary, chromophobe and unclassified only). RCC with sarcomatoid features is allowed. Patients with the chromophobe subtype of non-clear cell RCC must have sarcomatoid differentiation
- Measurable disease per Response Evaluation Criteria in Solid Tumors version 1.1
- Evaluable International Metastatic Renal Cell Carcinoma Database Consortium risk scores
- Radiographic disease progression to prior immune checkpoint inhibitor (ICI) therapy for RCC
- Karnofsky Performance Status score of >= 70
- Adequate hematologic and end-organ function
You likely can't join if
- Treatment with anti-cancer therapy within 14 days prior to initiation of study treatment
- Patients who received cabozantinib at any time prior to screening
- Patients who received more than one ICI treatment in the locally advanced or metastatic setting
- Patients who received more than two prior lines of therapy in the locally advanced or metastatic setting
- Patients who have received a mammalian target of rapamycin inhibitor in any setting
- Symptomatic, untreated, or actively progressing CNS metastases
The study team makes the final eligibility decision.
Where it's taking place
- Japan
- United Kingdom
- Australia
- Argentina
- United States
- Russian Federation
- Korea, Republic of
- Canada
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 Japan; United Kingdom; Australia; Argentina; United States; Russian Federation and 2 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.