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AGS-003 (Rocapuldencel-T) + Sunitinib in Advanced RCC
NCT01582672Phase 3
Key facts
- Status
- Terminated
- Start
- Nov 2012
- Primary completion
- Apr 2018
- Countries
- 8
- Sponsor
- Argos Therapeutics
- Modality
- Whole Cell Cancer Vaccines, Dendritic Cell Vaccines
- Drugs
- rocapuldencel-T
- Conditions
- renal cell carcinoma (RCC)
01
Overview
Phase 3, randomised, open-label trial of rocapuldencel-T in renal cell carcinoma (RCC) (2 arms), sponsored by Argos Therapeutics. Primary endpoint: Overall Survival at 42 months. Started Nov 2012; status: terminated.
02
Design
2 arms- Study design
- RandomizedOpen-label
AGS-003 + Standard Treatment
Sunitinib + Autologous Dendritic Cell Immunotherapy (AGS-003)
Standard Treatment
Sunitinib alone
03
Who it enrols
Adults with newly diagnosed, metastatic renal cell carcinoma with clear cell histology who are candidates for nephrectomy and first-line sunitinib treatment.
04
Endpoints
Primary
Overall Survival
Secondary
Progression Free Survival
Tumor Response
Treatment Emergent Adverse Events
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