Conditions: Advanced Renal Cell Carcinoma
Allocation: NON_RANDOMIZED | Intervention model: PARALLEL
Enrollment: 85
Healthy volunteers: no

Brief summary:
This phase 2 study is an open-label, multi-center study to determine the safety and tolerability of AMG 386 in combination with sunitinib in the treatment of subjects with metastatic renal cell carcinoma.

Detailed description:

Arms:
arm 1: Trebananib 10 mg/kg intravenously (IV) once weekly (QW) plus sunitinib 50 mg orally (PO) once daily (QD) 4 weeks on/2 weeks off arm 2: Trebananib 15 mg/kg IV QW plus sunitinib 50 mg PO QD 4 weeks on/2 weeks off

Interventions: intervention 1: Sunitinib intervention 2: Trebananib
Intervention descriptions: intervention 1: Sunitinib will be administered 50 mg QD and is considered to be the background therapy as it is licensed for treatment of reneal cell cancer (RCC) and will be administered to all participants. intervention 2: Administered until a participant develops disease progression, clinical progression, unacceptable toxicity, withdraws consent, or death.

Protocol document: