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NCT Number: NCT07000149

A Study to Investigate the Efficacy and Safety of Volrustomig ± Casdatifan vs Nivolumab + Ipilimumab as 1L Treatment for Advanced ccRCC

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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This study is active but is not currently recruiting participants.

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Key information

Conditions

Advanced Clear Cell Renal Cell Carcinoma Adenocarcinoma Carcinoma Carcinoma, Renal Cell Diabetes Mellitus, Insulin-Dependent, 12 Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Kidney Neoplasms Male Urogenital Diseases Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Urogenital Diseases Urogenital Neoplasms Urologic Diseases Urologic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Research Site, East Melbourne, Australia

Loading trial locations.

About this study

The primary purpose of this study is to determine the recommended Phase III dose (RP3D) of volrustomig and measure the efficacy and safety of volrustomig in combination with casdatifan compared with nivolumab plus ipilimumab in participants with advanced ccRCC (as 1L treatment).

The study comprises of 2 parts -

In Phase 1b part of the study, participants will be randomized in a 1:1 ratio to receive either dose 1 or dose 2 of volrustomig in combination with casdatifan.

In Phase III part of the study, participants will be randomized in 1:1:1 to receive either Volrustomig (at the dose to be determined in the Phase Ib) in combination with casdatifan, volrustomig monotherapy or standard of care (nivolumab plus ipilimumab).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

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.

Treatment and study plan

Volrustomig

Drug

Volrustomig will be administered as an intravenous (IV) infusion.

Other names: MEDI5752

casdatifan

Drug

Casdatifan will be administered orally.

Other names: AB521

Nivolumab

Drug

Nivolumab will be administered as an IV infusion.

Other names: Opdivo

Ipilimumab

Drug

Ipilimumab will be administered as an IV infusion.

Other names: Yervoy

Primary outcomes

  1. Phase Ib: Number of participants with adverse events (AEs) and serious adverse events (SAEs)

    Time frame: Approximately 39 months

    Number of participants who received at least one dose of study treatment will be assessed.

  2. Phase III: Progression-free Survival (PFS)

    Time frame: Approximately 38 months

    The PFS is defined as the time from randomization until radiological progression or death due to any cause (in the absence of progression).

  3. Phase III: Overall Survival (OS)

    Time frame: Approximately 67 months

    The OS is defined as the time from randomization until the date of death due to any cause.

Secondary outcomes

  1. Phase Ib: Objective Response rate (ORR)

    Time frame: Approximately 39 months

    The ORR is defined as the proportion of participants who have a confirmed complete response (CR) or confirmed partial response (PR).

  2. Phase Ib: Duration of Response (DoR)

    Time frame: Approximately 39 months

    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.

  3. Phase Ib: Progression-free Survival (PFS)

    Time frame: Approximately 39 months

    The PFS is defined as the time from randomization until radiological progression or death due to any cause (in the absence of progression).

  4. Phase Ib: Disease Control Rate (DCR)

    Time frame: Approximately 39 months

    The DCR is defined as the percentage of participants who have a confirmed CR or PR or who have stable disease (SD) after randomization.

  5. Phase Ib: Volrustomig concentration in serum

    Time frame: Up to 27 months

    To assess the serum concentration of volrustomig when administered concomitantly with casdatifan.

  6. Phase Ib: Casdatifan concentration in plasma

    Time frame: Up to 27 months

    To assess the plasma concentration of casdatifan when administered concomitantly with volrustomig.

  7. Phase Ib: Time to Response (TTR)

    Time frame: Approximately 39 months

    The TTR is defined as the time from randomization until the first documentation of a subsequently confirmed objective response.

  8. Phase III: Overall Survival

    Time frame: Approximately 67 months

    The OS is defined as the time from randomization until the date of death due to any cause.

  9. Phase III: Number of participants with AEs and SAEs

    Time frame: Approximately 67 months

    Number of participants who received at least one dose of study treatment will be assessed.

  10. Phase III: Time to second progression or death (PFS2)

    Time frame: Approximately 67 months

    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.

  11. Phase III: Objective Response rate (ORR)

    Time frame: Approximately 67 months

    The ORR is defined as the proportion of participants who have a confirmed CR or confirmed PR.

  12. Phase III: Duration of Response (DoR)

    Time frame: Approximately 67 months

    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.

  13. Phase III: Progression-free Survival

    Time frame: Approximately 67 months

    The PFS is defined as the time from randomization until radiological progression or death due to any cause (in the absence of progression).

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Collaborators

  • Arcus Biosciences, Inc.

Registry information

Official study 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)

Acronym: eVOLVE-RCC02

Important dates

Study start
2025
Primary completion
2030
Study completion
2032
First posted
Jun 2, 2025
Registry last updated
Mar 10, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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