Advanced Clear Cell Renal Cell Carcinoma
Conditions
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)
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). 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.
Interventions
DRUGVolrustomig
Volrustomig will be administered as an intravenous (IV) infusion.
DRUGCasdatifan
Casdatifan will be administered orally.
Sponsors
AstraZeneca
Arcus Biosciences, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of participants with adverse events (AEs) and serious adverse events (SAEs) | Up to Day 90 (+7) post last dose | Number of participants who received at least one dose of study treatment will be assessed. |
Countries
Australia, South Korea
Outcome results
None listed