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:
Genentech
Information provided by (Responsible Party):
Genentech
ClinicalTrials.gov Identifier:
NCT01633970
First received: June 22, 2012
Last updated: April 12, 2013
Last verified: April 2013
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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