A Phase II, Randomized Study of MPDL3280A Administered as Monotherapy or in Combination with Avastin (Bevacizumab) versus Sunitinib in Patients with Untreated Advanced Renal Cell Carcinoma

Diseases and Conditions Researched

Kidney

What is the purpose of this trial?

This multicenter, randomized, open-label study will evaluate the efficacy and safety of MPDL3280A as monotherapy or in combination with Avastin (bevacizumab) versus sunitinib in patients with previously untreated locally advanced or metastatic renal cell carcinoma. Patients in Arm A will receive MPDL3280A 1200 mg IV every 3 weeks (eight 6-week cycles or up to 1 year) plus Avastin 15 mg/kg IV until disease progression. Patients in Arm B will receive MPDL3280A alone (up to 1 year), and patients in Arm C will receive sunitinib 50 mg orally daily for 4 weeks followed by 2 weeks rest until disease progression. Following disease progression, patients in Arms B and C will be given the option to receive combination treatment with MPDL3280A and Avastin.


Participation Guidelines

Age: Any

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Sponsor: Hoffman-La Roche
Dates:
Last Updated:
Study HIC#: 1311013090