Clinical trial · Interventional
A Study to Investigate the Efficacy and Safety of Volrustomig ± Casdatifan vs Nivolumab + Ipilimumab as 1L Treatment for Advanced ccRCC
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)
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Advanced Clear Cell Renal Cell Carcinoma | Clear Cell Renal Cell Carcinoma | CURATED_BROADER | 0.78 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Casdatifan | Drug | — | UNRESOLVED |
| Volrustomig | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Arm 1A (Volrustomig Dose 1 + Casdatifan)
- description
- Participants will receive dose 1 of volrustomig in combination with casdatifan.
- interventionNames
- Drug: Volrustomig
- Drug: Casdatifan
- type
- EXPERIMENTAL
- label
- Arm 1B (Volrustomig Dose 2 + Casdatifan)
- description
- Participants will receive dose 2 of volrustomig in combination with casdatifan.
- interventionNames
- Drug: Volrustomig
- Drug: Casdatifan
Primary outcomes (1)
- measure
- Number of participants with adverse events (AEs) and serious adverse events (SAEs)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available