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A Phase 2 Study of Bevacizumab, Erlotinib and Atezolizumab in Subjects with Advanced Hereditary Leiomyomatosis and Renal Cell Cancer (HLRCC) Associated or Sporadic Papillary Renal Cell Cancer.

Primary Objective:
- To assess the complete response (CR) rate according to standard Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) in patients with 1) advanced RCC associated with HLRCC and 2) advanced sporadic/non-HLRCC papillary renal cell cancer treated with a combination of bevacizumab, erlotinib, and atezolizumab.

Secondary Objectives:
- To determine the safety and tolerability of the combination of bevacizumab, erlotinib, and atezolizumab.

- To determine the objective response rate (ORR) as complete response (CR) + partial
response (PR).

- To determine disease control rate (DCR) - confirmed response, or stable disease (SD) lasting for at least 6 months.

- To assess progression-free survival time (PFS) according to RECIST 1.1.

- To assess overall survival (OS).

- To assess the duration of response.

- To assess response to treatment using iRECIST.

Protocol Number: 082203
Phase: Phase II
Applicable Disease Sites: Kidney
Drugs Involved: ERLOTINIB
Atezolizumab (MPDL3280A)
BEVACIZUMAB
Principal Investigator: Ryan Stephenson
Scope: National
Therapies Involved: Chemotherapy multiple agents systemic
Participating Institutions:
  • Rutgers Cancer Institute of New Jersey
Inclusion & Exclusion Criteria

Please note that we have obtained the inclusion and exclusion criteria information from the National Institutes of Health’s clinical trials web site ClinicalTrials.gov. The listed criteria may not necessarily reflect recent amendments to the protocol and the current criteria.

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