Neoplasms Clinical Trial
Official title:
A Phase l/ll Study of Varlilumab in Combination With Sunitinib in Patients With Metastatic Clear Cell Renal Cell Carcinoma
This is a study to determine the clinical benefit (how well the drug works), safety, and tolerability of combining varlilumab and sunitinib. The study will enroll patients with metastatic clear cell renal cell carcinoma.
Varlilumab is a fully human monoclonal antibody that binds to a molecule called CD27 found on
certain immune cells and may act to promote anti-tumor effects.
Sunitinib is a small molecule that inhibits multiple receptor tyrosine kinases (RTKs) some of
which play a role in tumor growth and progression of cancer.
This study will evaluate the safety, tolerability and efficacy of the anti-CD27 antibody
varlilumab in combination with sunitinib.
Eligible patients that enroll in the dose escalation portion of the study will be assigned to
one of three dose levels of varlilumab in combination with 50 mg of sunitinib. The first
phase of the study will test the safety profile of the combination and determine which dose
of varlilumab will be studied in Phase ll* of the overall study.
*Note: This Study was terminated prior to initiation of Phase II.
All patients enrolled in the study will be closely monitored to determine if there is a
response to the treatment as well as for any side effects that may occur.
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