A Phase Ib Study of the Safety and Pharmacology of MPDL3280A Administered With Bevacizumab or With Bevacizumab Plus Chemotherapy in Patients With Advanced Solid Tumors
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