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:
Dana-Farber Cancer Institute:
Deborah Doss, 617-632-5672,
ddoss@partners.org
Beth-Israel Deaconess Medical Center:
Cancer Trials Call Center, 617-667-3060
Massachusetts General Hospital:
Cancer Trials Call Center, 877-789-6100
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