Trial purpose
Cancer treatment
Tumor type
Genitourinary
Age
18+
Trial acronym
eVOLVE-RCC02
Clinical summary
Summary
The purpose of this study is to:
- Determine the recommended Phase III dose (PR3D) of volrustomig immunotherapy.
- Measure the safety and efficacy of volrustomig in combination with casdatifan targeted therapy compared to standard treatment.
The study has 2 parts.
In the Phse Ib part of the study, participants will be randomly allocated (by chance) to receive either dose 1 or dose 2 of volrustomig in combination with casadatifan.
In the Phase III part of the study, participants will be randomly allocated (by chance) to receive either:
- Volrustomig (at the dose to be determined in the Phase Ib) in combination with casdatifan,
- Volrustomig by itself (monotherapy), or
- Standard of care treatment with nivolumab plus ipilimumab combination immunotherapy.
Conditions
This trial is treating people with advanced or metastatic renal cell carcinoma, or recurrent disease that has not previously been treated with systemic therapy for the first-line setting.
Eligibility
Inclusion
- Histologically or cytologically confirmed RCC with clear cell component.
- Advanced/metastatic RCC or recurrent disease that has not previously been treated with systemic therapy in the 1L setting.
- Karnofsky Performance Status ≥ 70%.
- Provision of acceptable tumor sample.
- At least one lesion that can be accurately measured at baseline as ≥ 10 mm in the longest diameter (except lymph nodes, which must have short axis ≥ 15 mm) with computed tomography (CT) or magnetic resonance imaging (MRI) and is suitable for accurate repeated measurements.
Exclusion
- History of leptomeningeal disease or spinal cord compression.
- Symptomatic brain metastases.
- Medical history of severe chronic obstructive pulmonary disease.
- Active or prior documented autoimmune or inflammatory disorders.
- Prior systemic therapy for advanced/metastatic RCC. Note - Other inclusion and exclusion criteria may apply as stated in the protocol.
Inclusion
- You have had treatment, but your cancer has come back (relapsed or recurrent).
- Your cancer has spread to other parts of the body (metastatic) or has grown into nearby parts of the body (locally advanced).
Exclusion
- You have certain types of non-cancer medical conditions.
- You have had certain treatments, surgical procedures or drugs.
Clinical trials have complex eligibility criteria, and other criteria may apply for this trial. Ask your doctor about whether this trial could be right for you.
More information
Trial Identifiers
Information on this page is partially produced from ClinicalTrials.gov *. View further details about this trial on the registry via the links below:
Trial sponsor
AstraZeneca
Scientific Title
A Phase Ib/III Randomized, Multicenter, Global Study of Volrustomig Plus Casdatifan or Volrustomig Monotherapy Versus Nivolumab Plus Ipilimumab as First-line Treatment for Participants With Advanced Clear Cell Renal Cell Carcinoma (ccRCC)
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