Advanced Clear Cell Renal Cell CarcinomaPhase 1eVOLVE-RCC02NCT07000149
A Study to Investigate the Efficacy and Safety of Volrustomig ± Casdatifan vs Nivolumab + Ipilimumab as 1L Treatment for Advanced ccRCC
A Phase 1 study testing Volrustomig and Casdatifan in people with Advanced Clear Cell Renal Cell Carcinoma, run by AstraZeneca at 3 sites in 2 countries.
Trial 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). The Phase III part of the study will no longer be conducted. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Clear Cell Renal Cell Carcinoma
- What is being tested?
- Volrustomig and Casdatifan
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 3 sitesin 2 countries
- Study dates
- 28 Jul 2025to 29 Jan 2027
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
3 sites in 2 countries.
3 sites in 2 countries
About this study
Official 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)
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).
The Phase III part of the study will no longer be conducted.
Read the detailed description
The primary purpose of this study is to measure the efficacy and safety of volrustomig in combination with casdatifan in participants with advanced ccRCC (as 1L treatment).
The study was planned to comprise of 2 parts - Phase Ib and Phase III.
In Phase 1b part of the study, participants are planned to be randomized in a 1:1 ratio to receive either dose 1 or dose 2 of volrustomig in combination with casdatifan.
The Phase III part of the study will no longer be conducted.
- Conditions
- Advanced Clear Cell Renal Cell Carcinoma
- Being tested
- Volrustomig, Casdatifan
- Keywords
- Programmed cell death-ligand-1, Cytotoxic T-lymphocyte-associated antigen-4 (CTLA-4), First-line treatment (1L), Immunotherapy, Kidney cancer, Clear cell renal carcinoma, Immuno-oncology bispecific (IO-bispecific), Volrustomig, Casdatifan, Hypoxia-inducible factor-2α (HIF-2α)
- Medical subject headings
- Diabetes Mellitus, Insulin-Dependent, 12, Kidney Neoplasms, Carcinoma, Renal Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VolrustomigDrug
Also called MEDI5752
Volrustomig will be administered as an intravenous (IV) infusion.
CasdatifanDrug
Also called AB521
Casdatifan will be administered orally.
| Study group | Role | What they receive |
|---|---|---|
| Arm 1A (Volrustomig Dose 1 + Casdatifan) | Experimental | Participants will receive dose 1 of volrustomig in combination with casdatifan. Receives: Drug: Volrustomig; Drug: Casdatifan |
| Arm 1B (Volrustomig Dose 2 + Casdatifan) | Experimental | Participants will receive dose 2 of volrustomig in combination with casdatifan. Receives: Drug: Volrustomig; Drug: Casdatifan |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with adverse events (AEs) and serious adverse events (SAEs)
Number of participants who received at least one dose of study treatment will be assessed.
Measured: Up to Day 90 (+7) post last dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2025
- Study start28 Jul 2025
- Primary completion29 Jan 2027 (estimated)
- Study completion29 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Clear Cell Renal Cell CarcinomaStudies of the same condition, open and under way.
- More trials run by AstraZenecaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Arcus Biosciences, Inc.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07000149
- Sponsor's protocol ID
- D798NC00001
- Other IDs
- 2024-519865-23-00
- Acronym
- eVOLVE-RCC02
- Status last verified
- Jul 2026
- First submitted
- 23 May 2025
- Last updated
- 3 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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)
- ClinicalTrials.gov ID
- NCT07000149
- Acronym / sponsor ID
- eVOLVE-RCC02 / D798NC00001
- Conditions
- Advanced Clear Cell Renal Cell Carcinoma
- Keywords
- Programmed cell death-ligand-1, Cytotoxic T-lymphocyte-associated antigen-4 (CTLA-4), First-line treatment (1L), Immunotherapy, Kidney cancer, Clear cell renal carcinoma, Immuno-oncology bispecific (IO-bispecific), Volrustomig
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 9 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Collaborators
- Arcus Biosciences, Inc.
- Study start
- 28 Jul 2025 (actual)
- Primary completion
- 29 Jan 2027 (estimated)
- Study completion
- 29 Jan 2027 (estimated)
- First posted
- 2 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
The Phase III part of the study will no longer be conducted.
Detailed description
The primary purpose of this study is to measure the efficacy and safety of volrustomig in combination with casdatifan in participants with advanced ccRCC (as 1L treatment).
The study was planned to comprise of 2 parts - Phase Ib and Phase III.
In Phase 1b part of the study, participants are planned to be randomized in a 1:1 ratio to receive either dose 1 or dose 2 of volrustomig in combination with casdatifan.
The Phase III part of the study will no longer be conducted.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm 1A (Volrustomig Dose 1 + Casdatifan) | Experimental | Drug: Volrustomig, Drug: CasdatifanParticipants will receive dose 1 of volrustomig in combination with casdatifan. |
| Arm 1B (Volrustomig Dose 2 + Casdatifan) | Experimental | Drug: Volrustomig, Drug: CasdatifanParticipants will receive dose 2 of volrustomig in combination with casdatifan. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VolrustomigAlso: MEDI5752Volrustomig will be administered as an intravenous (IV) infusion. | Drug | Arm 1A (Volrustomig Dose 1 + Casdatifan), Arm 1B (Volrustomig Dose 2 + Casdatifan) |
| CasdatifanAlso: AB521Casdatifan will be administered orally. | Drug | Arm 1A (Volrustomig Dose 1 + Casdatifan), Arm 1B (Volrustomig Dose 2 + Casdatifan) |
Primary outcome
Number of participants with adverse events (AEs) and serious adverse events (SAEs)
Time frame: Up to Day 90 (+7) post last dose
Number of participants who received at least one dose of study treatment will be assessed.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2026.
- Individual participant dataSharing planned: Yes. 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.
Related trials for Advanced Clear Cell Renal Cell Carcinoma
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
Active, not recruitingPhase 3
A Study of Belzutifan (MK-6482) in Combination With Lenvatinib Versus Cabozantinib for Treatment of Renal Cell Carcinoma (MK-6482-011)
Carcinoma, Renal Cell
Not yet recruitingPhase 2
Toripalimab and Lenvatinib With or Without SBRT Before Surgery for Non-Clear Cell Kidney Cancer
Nonmetastatic Locally Advanced Non-Clear Cell Renal Cell Carcinoma
Active, not recruitingPhase 1/2
Phase 1b/2 Trial of Ipilimumab, Nivolumab, and Ciforadenant (Adenosine A2a Receptor Antagonist) in First-line Advanced Renal Cell Carcinoma.
Renal Cell Carcinoma
RecruitingPhase 2
At-Home Cancer Directed Therapy Versus in Clinic for the Treatment of Patients With Advanced Cancer
Advanced Anal Carcinoma, Advanced Biliary Tract Carcinoma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Volrustomig and Casdatifan in people with Advanced Clear Cell Renal Cell Carcinoma, run by AstraZeneca at 3 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 3 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in South Korea, Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with adverse events (AEs) and serious adverse events (SAEs) (time frame: Up to Day 90 (+7) post last dose). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Aug 2026.