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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT07000149
Registration number
NCT07000149
Ethics application status
Date submitted
23/05/2025
Date registered
2/06/2025
Date last updated
27/08/2025
Titles & IDs
Public title
A Study to Investigate the Efficacy and Safety of Volrustomig ± Casdatifan vs Nivolumab + Ipilimumab as 1L Treatment for Advanced ccRCC
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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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Secondary ID [1]
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2024-519865-23-00
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Secondary ID [2]
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D798NC00001
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Universal Trial Number (UTN)
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Trial acronym
eVOLVE-RCC02
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Advanced Clear Cell Renal Cell Carcinoma
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Condition category
Condition code
Cancer
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Kidney
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Volrustomig
Treatment: Drugs - Casdatifan
Treatment: Drugs - Nivolumab
Treatment: Drugs - Ipilimumab
Experimental: Arm 1A (Volrustomig Dose 1 + Casdatifan) - Participants will receive dose 1 of volrustomig in combination with casdatifan.
Experimental: Arm 1B (Volrustomig Dose 2 + Casdatifan) - Participants will receive dose 2 of volrustomig in combination with casdatifan.
Experimental: Arm 3A (Volrustomig Dose X + Casdatifan) - Participants will receive Volrustomig at the dose to be determined in the Phase Ib part of the study, in combination with casdatifan.
Experimental: Arm 3B (Volrustomig Dose 1) - Participants will receive dose 1 of volrustomig.
Active comparator: Arm 3C (Nivolumab + Ipilimumab) - Participants will receive nivolumab plus ipilimumab as standard of care treatment.
Treatment: Drugs: Volrustomig
Volrustomig will be administered as an intravenous (IV) infusion.
Treatment: Drugs: Casdatifan
Casdatifan will be administered orally.
Treatment: Drugs: Nivolumab
Nivolumab will be administered as an IV infusion.
Treatment: Drugs: Ipilimumab
Ipilimumab will be administered as an IV infusion.
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Phase Ib: Number of participants with adverse events (AEs) and serious adverse events (SAEs)
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Assessment method [1]
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Number of participants who received at least one dose of study treatment will be assessed.
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Timepoint [1]
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Approximately 39 months
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Primary outcome [2]
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Phase III: Progression-free Survival (PFS)
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Assessment method [2]
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The PFS is defined as the time from randomization until radiological progression or death due to any cause (in the absence of progression).
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Timepoint [2]
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Approximately 38 months
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Primary outcome [3]
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Phase III: Overall Survival (OS)
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Assessment method [3]
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The OS is defined as the time from randomization until the date of death due to any cause.
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Timepoint [3]
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Approximately 67 months
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Secondary outcome [1]
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Phase Ib: Objective Response rate (ORR)
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Assessment method [1]
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The ORR is defined as the proportion of participants who have a confirmed complete response (CR) or confirmed partial response (PR).
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Timepoint [1]
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Approximately 39 months
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Secondary outcome [2]
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Phase Ib: Duration of Response (DoR)
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Assessment method [2]
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The DoR is defined as the time from the date of first documented confirmed response until date of documented progression or death due to any cause.
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Timepoint [2]
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Approximately 39 months
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Secondary outcome [3]
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Phase Ib: Progression-free Survival (PFS)
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Assessment method [3]
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The PFS is defined as the time from randomization until radiological progression or death due to any cause (in the absence of progression).
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Timepoint [3]
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Approximately 39 months
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Secondary outcome [4]
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Phase Ib: Disease Control Rate (DCR)
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Assessment method [4]
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The DCR is defined as the percentage of participants who have a confirmed CR or PR or who have stable disease (SD) after randomization.
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Timepoint [4]
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Approximately 39 months
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Secondary outcome [5]
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Phase Ib: Volrustomig concentration in serum
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Assessment method [5]
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To assess the serum concentration of volrustomig when administered concomitantly with casdatifan.
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Timepoint [5]
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Up to 27 months
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Secondary outcome [6]
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Phase Ib: Casdatifan concentration in plasma
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Assessment method [6]
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To assess the plasma concentration of casdatifan when administered concomitantly with volrustomig.
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Timepoint [6]
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Up to 27 months
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Secondary outcome [7]
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Phase Ib: Time to Response (TTR)
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Assessment method [7]
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The TTR is defined as the time from randomization until the first documentation of a subsequently confirmed objective response.
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Timepoint [7]
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Approximately 39 months
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Secondary outcome [8]
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Phase III: Overall Survival
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Assessment method [8]
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The OS is defined as the time from randomization until the date of death due to any cause.
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Timepoint [8]
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Approximately 67 months
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Secondary outcome [9]
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Phase III: Number of participants with AEs and SAEs
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Assessment method [9]
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Number of participants who received at least one dose of study treatment will be assessed.
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Timepoint [9]
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Approximately 67 months
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Secondary outcome [10]
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Phase III: Time to second progression or death (PFS2)
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Assessment method [10]
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The PFS2 is defined as the time from randomization to the earliest progression event after the start of the first subsequent therapy, or death from any cause, whichever occurs first.
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Timepoint [10]
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Approximately 67 months
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Secondary outcome [11]
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Phase III: Objective Response rate (ORR)
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Assessment method [11]
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The ORR is defined as the proportion of participants who have a confirmed CR or confirmed PR.
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Timepoint [11]
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Approximately 67 months
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Secondary outcome [12]
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Phase III: Duration of Response (DoR)
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Assessment method [12]
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The DoR is defined as the time from the date of first documented confirmed response until date of documented progression or death due to any cause.
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Timepoint [12]
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Approximately 67 months
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Secondary outcome [13]
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Phase III: Progression-free Survival
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Assessment method [13]
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The PFS is defined as the time from randomization until radiological progression or death due to any cause (in the absence of progression).
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Timepoint [13]
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Approximately 67 months
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Eligibility
Key inclusion criteria
* 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.
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
* 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.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people assessing the outcomes
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
28/07/2025
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
29/07/2032
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Actual
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Sample size
Target
1116
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
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Recruitment hospital [1]
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Research Site - East Melbourne
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Recruitment hospital [2]
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Research Site - Elizabeth Vale
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Recruitment hospital [3]
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Research Site - Nedlands
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Recruitment hospital [4]
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Research Site - North Adelaide
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Recruitment hospital [5]
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Research Site - Syndey
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Recruitment postcode(s) [1]
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3002 - East Melbourne
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Recruitment postcode(s) [2]
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5112 - Elizabeth Vale
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Recruitment postcode(s) [3]
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6009 - Nedlands
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Recruitment postcode(s) [4]
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5000 - North Adelaide
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Recruitment postcode(s) [5]
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4032 - Syndey
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Recruitment outside Australia
Country [1]
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United States of America
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State/province [1]
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California
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Country [2]
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United States of America
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State/province [2]
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Colorado
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Country [3]
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United States of America
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State/province [3]
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Massachusetts
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Country [4]
0
0
United States of America
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State/province [4]
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New York
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Country [5]
0
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United States of America
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State/province [5]
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Ohio
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Country [6]
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United States of America
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State/province [6]
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Tennessee
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Country [7]
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United States of America
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State/province [7]
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Texas
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Country [8]
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China
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State/province [8]
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Beijing
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Country [9]
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China
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State/province [9]
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Guangzhou
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Country [10]
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China
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State/province [10]
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Nanjing
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Country [11]
0
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China
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State/province [11]
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Nanning
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Country [12]
0
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China
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State/province [12]
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Shanghai
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Country [13]
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China
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State/province [13]
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Xiamen
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Country [14]
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Georgia
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State/province [14]
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Batumi
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Country [15]
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Georgia
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State/province [15]
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Tbilisi
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Country [16]
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South Korea
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State/province [16]
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Busan
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Country [17]
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South Korea
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State/province [17]
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Seongnam-si
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Country [18]
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South Korea
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State/province [18]
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Seoul
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Country [19]
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Taiwan
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State/province [19]
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Kaohsiung City
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Country [20]
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Taiwan
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State/province [20]
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Taichung
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Country [21]
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Taiwan
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State/province [21]
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Tainan City
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
AstraZeneca
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Address
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Country
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Other collaborator category [1]
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Commercial sector/industry
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Name [1]
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Arcus Biosciences, Inc.
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Address [1]
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Country [1]
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Ethics approval
Ethics application status
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Summary
Brief summary
This is a Phase Ib/III, randomized, multicenter, global study evaluating the efficacy and safety of volrustomig in combination with casdatifan for the first-line (1L) treatment of participants with advanced clear cell renal cell carcinoma (ccRCC).
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Trial website
https://clinicaltrials.gov/study/NCT07000149
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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AstraZeneca Clinical Study Information Center
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Address
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Country
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Phone
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1-877-240-9479
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Fax
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Email
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[email protected]
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Contact person for scientific queries
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
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What data in particular will be shared?
Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal Vivli.org. All requests will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.
Supporting document/s available: Study protocol, Statistical analysis plan (SAP)
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When will data be available (start and end dates)?
AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA PhRMA Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
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Available to whom?
When a request has been approved AstraZeneca will provide access to the anonymized individual patient-level data via secure research environment Vivli.org. Signed Data Usage Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information.
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Available for what types of analyses?
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How or where can data be obtained?
IPD available at link: https://vivli.org/
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What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT07000149
Download to PDF