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

This study is currently recruiting participants.
Verified April 2013 by Genentech
Sponsor:
Information provided by (Responsible Party):
Genentech
ClinicalTrials.gov Identifier:
NCT01633970
First received: June 22, 2012
Last updated: April 12, 2013
Last verified: April 2013
  Purpose

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.


Condition Intervention Phase
Neoplasms
Drug: MPDL3280A
Drug: bevacizumab [Avastin]
Drug: chemotherapy
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Genentech:

Primary Outcome Measures:
  • Safety: Incidence of adverse events [ Time Frame: approximately 12 months ] [ Designated as safety issue: No ]
  • Dose-limiting toxicities/maximum tolerated dose [ Time Frame: 21 days for Arm A and the 28 days following the first administration of MPDL3280A in Arm B ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Pharmacokinetics: Area under the concentration-time curve [ Time Frame: approximately 12 months ] [ Designated as safety issue: No ]
  • Best overall response (tumor assessments according to RECIST criteria) [ Time Frame: approximately 12 months ] [ Designated as safety issue: No ]
  • Objective response rate (complete response + partial response) [ Time Frame: approximately 12 months ] [ Designated as safety issue: No ]
  • Duration of objective response [ Time Frame: approximately 12 months ] [ Designated as safety issue: No ]
  • Progression-free survival [ Time Frame: approximately 12 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 68
Study Start Date: July 2012
Estimated Study Completion Date: March 2015
Estimated Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A: MPDL3280A + bevacizumab Drug: MPDL3280A
multiple escalating doses IV q3w
Drug: bevacizumab [Avastin]
15 mg/kg iv q3w
Experimental: B: MPDL3280A + bevacizumab + chemotherapy Drug: chemotherapy
q2w
Drug: MPDL3280A
multiple escalating doses IV q2w
Drug: bevacizumab [Avastin]
10 mg/kg q2w

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01633970

Contacts
Contact: Please reference Study ID Number: GP28328 www.roche.com/about_roche/roche_worldwide.htm 888-662-6728 (U.S. Only) genentechclinicaltrials@druginfo.com

Locations
United States, District of Columbia
Recruiting
Washington, District of Columbia, United States, 20007
United States, Massachusetts
Recruiting
Boston, Massachusetts, United States, 02215
Recruiting
Boston, Massachusetts, United States, 02114
United States, North Carolina
Recruiting
Durham, North Carolina, United States, 27705
Recruiting
Huntersville, North Carolina, United States, 28078
United States, Pennsylvania
Recruiting
Willow Grove, Pennsylvania, United States, 80045
United States, Tennessee
Not yet recruiting
Nashville, Tennessee, United States, 37203
Sponsors and Collaborators
Genentech
Investigators
Study Director: Clinical Trials Genentech
  More Information

No publications provided

Responsible Party: Genentech
ClinicalTrials.gov Identifier: NCT01633970     History of Changes
Other Study ID Numbers: GP28328, 2012-001422-10
Study First Received: June 22, 2012
Last Updated: April 12, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Genentech:
PD-L1
PD-1
PDL1
antiPD-L1
MPDL3280A
Solid tumor
MPDL320A

Additional relevant MeSH terms:
Neoplasms
Bevacizumab
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Growth Inhibitors
Antineoplastic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on June 17, 2013