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).
Study details:
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.
Eligibility criteria
Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.
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.
Eligibility
Age eligible for study : NA
Healthy volunteers accepted : No
Gender eligible for study: ALL
Things to know
Study dates
Study start:
Primary completion:
Study completion finish:
Study type
TREATMENT
Phase
- PHASE1
Study ID
NCT07000149
Intervention or treatment
DRUG: Volrustomig
DRUG: Casdatifan
DRUG: Nivolumab
DRUG: Ipilimumab
Conditions
- Advanced Clear Cell Renal Cell Carcinoma
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Research sites nearby
Closest Location:
Research Site
Select from list below to view details:
Research Site
East Melbourne, Australia
Research Site
Elizabeth Vale, Australia
Research Site
Nedlands, Australia
Research Site
North Adelaide, Australia
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Who is running the clinical trial?
AstraZeneca
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
| Participant Group/Arm | Intervention/Treatment |
|---|---|
EXPERIMENTAL: Arm 1A (Volrustomig Dose 1 + Casdatifan)
| Drug: Volrustomig, Drug: Casdatifan |
EXPERIMENTAL: Arm 1B (Volrustomig Dose 2 + Casdatifan)
| Drug: Volrustomig, Drug: Casdatifan |
What is the study measuring?
Primary Outcome
| Measure | Description | Time Frame |
|---|---|---|
| Phase Ib: 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. | Approximately 39 months |
| Phase III: Progression-free Survival (PFS) | The PFS is defined as the time from randomization until radiological progression or death due to any cause (in the absence of progression). | Approximately 38 months |
| Phase III: Overall Survival (OS) | The OS is defined as the time from randomization until the date of death due to any cause. | Approximately 67 months |
Secondary Outcome
| Measure | Description | Time Frame |
|---|---|---|
| Phase Ib: Objective Response rate (ORR) | The ORR is defined as the proportion of participants who have a confirmed complete response (CR) or confirmed partial response (PR). | Approximately 39 months |
| Phase Ib: Duration of Response (DoR) | 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. | Approximately 39 months |
| Phase Ib: Progression-free Survival (PFS) | The PFS is defined as the time from randomization until radiological progression or death due to any cause (in the absence of progression). | Approximately 39 months |
| Phase Ib: Disease Control Rate (DCR) | The DCR is defined as the percentage of participants who have a confirmed CR or PR or who have stable disease (SD) after randomization. | Approximately 39 months |
| Phase Ib: Volrustomig concentration in serum | To assess the serum concentration of volrustomig when administered concomitantly with casdatifan. | Up to 27 months |
| Phase Ib: Casdatifan concentration in plasma | To assess the plasma concentration of casdatifan when administered concomitantly with volrustomig. | Up to 27 months |
| Phase Ib: Time to Response (TTR) | The TTR is defined as the time from randomization until the first documentation of a subsequently confirmed objective response. | Approximately 39 months |
| Phase III: Overall Survival | The OS is defined as the time from randomization until the date of death due to any cause. | Approximately 67 months |
| Phase III: Number of participants with AEs and SAEs | Number of participants who received at least one dose of study treatment will be assessed. | Approximately 67 months |
| Phase III: Time to second progression or death (PFS2) | 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. | Approximately 67 months |
| Phase III: Objective Response rate (ORR) | The ORR is defined as the proportion of participants who have a confirmed CR or confirmed PR. | Approximately 67 months |
| Phase III: Duration of Response (DoR) | 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. | Approximately 67 months |
| Phase III: Progression-free Survival | The PFS is defined as the time from randomization until radiological progression or death due to any cause (in the absence of progression). | Approximately 67 months |
References
Clinical Trials Gov: A Study to Investigate the Efficacy and Safety of Volrustomig ± Casdatifan vs Nivolumab + Ipilimumab as 1L Treatment for Advanced ccRCCOther trials to consider
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