A Study of MPDL3280A in Combination With Avastin (Bevacizumab) or With Avastin Plus Chemotherapy in Patients With Advanced Solid Tumors

Status: Recruiting
Phase:
Diagnosis: Melanoma
NCT ID: NCT01633970 (View complete trial on ClinicalTrials.gov)
DFCI Protocol ID: 12-252

 

The primary aim of the study is to assess the safety, pharmacology and preliminary efficacy of MPDL3280A [a monoclonal antibody that targets programmed cell death-1 ligand 1 (PD-L1)] administered with bevacizumab (Arm A) and with bevacizumab plus chemotherapy (Arm B) in patients with advanced solid tumors.

 

Conducting Institutions:
Beth-Israel Deaconess Medical Center, Brigham and Women's Hospital, Dana-Farber Cancer Institute, Massachusetts General Hospital

Overall PI:
David McDermott, MD, Beth Israel Deaconess Medical Center

Site-responsible Investigators:
Frank Stephen Hodi, MD, Dana-Farber Cancer Institute
Janet Murphy, MD, MPH, Massachusetts General Hospital

Contacts:
Beth-Israel Deaconess Medical Center: Cancer Trials Call Center, 617-667-3060
Massachusetts General Hospital: Cancer Trials Call Center, 877-789-6100
Dana-Farber Cancer Institute: Susan Song, 617-632-6287, susan_song@dfci.harvard.edu

Eligibility Criteria

Inclusion Criteria: - Adult patients, >/= 18 years of age - Histologically or cytologically documented advanced solid tumors - Adequate hematologic and end organ function - Measurable disease by RECIST v1.1 - Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1 - Resolution of any acute, clinically significant treatment-related toxicity from prior therapy to Grade </=1 prior to study entry, with the exception of alopecia Exclusion Criteria: - Any approved anti-cancer therapy, including chemotherapy, hormonal therapy, radiotherapy, or herbal therapy intended as anti-cancer therapy, within 3 weeks prior to initiation of study treatment; the following are allowed: hormonal therapy with gonadotropin-releasing hormone agonists or antagonists for prostate cancer, hormone-replacement therapy, and palliative radiotherapy for bone metastases > 2 weeks prior to Day 1 - Biphosphonate therapy for symptomatic hypercalcemia - Known clinically significant liver disease - Known primary central nervous (CNS) malignancy or active CNS metastases (progressing or requiring anticonvulsants or corticosteroids for symptomatic control) - Pregnant or lactating women - Known hypersensitivity to Chinese hamster ovary cell products or other recombinant human antibodies - History of autoimmune disease - History of idiopathic pulmonary fibrosis - History of HIV or hepatitis C infection; history of hepatitis B is allowed if infection has resolved (absence of HBsAg) - Severe infections within 4 weeks prior to Day 1, or signs or symptoms of significant infection within 2 weeks prior to Day 1 - Initiation of oral antibiotics < 7 days prior to Day 1 - Administration of a live, attenuated vaccine within 4 weeks before Day 1 or anticipation that such a live attenuated vaccine will be required during the study - Any bevacizumab-specific exclusion criteria
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