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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


Phase 1
18 Years
N/A
Open (Enrolling)
Both
Neoplasms

Thank you

Trial Information

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
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

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Safety: Incidence of adverse events

Outcome Time Frame:

approximately 12 months

Safety Issue:

No

Principal Investigator

Clinical Trials

Investigator Role:

Study Director

Investigator Affiliation:

Genentech

Authority:

United States: Food and Drug Administration

Study ID:

GP28328

NCT ID:

NCT01633970

Start Date:

July 2012

Completion Date:

March 2015

Related Keywords:

  • Neoplasms
  • PD-L1
  • PD-1
  • PDL1
  • antiPD-L1
  • MPDL3280A
  • Solid tumor
  • MPDL320A
  • Neoplasms

Name

Location

Philadelphia, Pennsylvania  19104
Nashville, Tennessee  37203-1632
Boston, Massachusetts  
Charlotte, North Carolina  
Washington, District of Columbia