test

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

Conditions

Kidney

Trial Phase

Phase II

Trial Purpose and Description

Trial Purpose

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:
Gender:

Eligibility Criteria

Inclusion Criteria:

  • Adult patients >/= 18 years of age
  • Unresectable advanced or metastatic renal cell carcinoma with component of clear cell histology and/or component of sarcomatoid histology that has not been previously treated with any systemic agents, including treatment in the adjuvant setting
  • Measurable disease, as defined by RECIST v1.1
  • Karnofsky performance score >/= 70
  • Adequate hematologic and end-organ function as defined by protocol
  • Women of childbearing potential and male patients must agree to use adequate methods of contraception as defined by protocol during the treatment period and for at least 6 months after the last dose of MPDL3280A or sunitinib

Exclusion Criteria:

  • Radiotherapy for RCC within 28 days prior to Cycle 1, Day 1 with the exception of: Single-fraction radiotherapy given for the indication of pain control
  • Known malignancies or metastasis of the brain or spinal cord or leptomeningeal disease
  • Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures (once monthly or more frequently)
  • Uncontrolled hypercalcemia or symptomatic hypercalcemia
  • Malignancies other than RCC within 5 years prior to Cycle 1, Day 1, with the exception of those with a negligible risk of metastasis or death, treated with expected curative outcome
  • Life expectancy of < 12 weeks
  • Pregnant and lactating women
  • History of severe allergic, anaphylactic, or other hypersensitivity reactions to chimeric or humanized antibodies or fusion proteins
  • History of autoimmune disease (Patients with a history of autoimmune-related hypothyroidism on a stable dose of thyroid replacement hormone may be eligible for this study)

Bevacizumab- and Sunitinib-Specific Exclusions:

  • Inadequately controlled hypertension
  • Prior history of hypertensive crisis or hypertensive encephalopathy
Sponsor:
Hoffman-La Roche
Dates:
04/10/2014
Last Updated:
Study HIC#:
1311013090