A Phase 1b Study of Demcizumab Plus Pembrolizumab in Locally Advanced or Metastatic Solid Tumors

Therapuetic Areas:Oncology
Age Range:21 - Any
Start Date:January 2016
End Date:May 19, 2017

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A Phase 1b, Open-Label, Dose Escalation and Expansion Study of Demcizumab Plus Pembrolizumab in Patients With Locally Advanced or Metastatic Solid Tumors

The purpose of this study is to test the efficacy and safety of an experimental drug,
demcizumab, when given in combination with pembrolizumab. Demcizumab is a humanized
monoclonal antibody and was developed to target cancer stem cells. Demcizumab may block the
growth of cancer stem cells, the remaining cancer cells, and it may also impair the
productive growth of new blood vessels, which tumors need to grow and spread.

This study is sponsored by OncoMed Pharmaceuticals, which is referred to as OncoMed or the
Sponsor in this consent form.

This is an open-label, Phase 1b dose escalation and expansion study of demcizumab plus
pembrolizumab designed to evaluate the safety, efficacy and pharmacokinetics of demcizumab in
combination with pembrolizumab in patients with advanced or metastatic solid tumors. This
study consists of a screening period, a treatment period and a post-treatment follow up
period in which patients will be followed for survival for approximately 12 months. Patients
will be enrolled in two stages: a dose-escalation stage and an expansion phase.

Approximately 42 patients will be enrolled in this study at approximately 10 study centers in
the United States (U.S) and Europe.

Inclusion Criteria:

1. Measurable disease per response evaluation criteria in solid tumors (RECIST) v1.1

2. Availability of formalin-fixed paraffin-embedded (FFPE) tumor tissue, either fresh
core-needle-biopsied or archived

3. Age >21 years

4. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1

5. Adequate organ and marrow function

6. For women of childbearing potential and men with partners of childbearing potential,
agreement (by patient and/or partner) to use two effective forms of contraception from
study entry through at least 6 months after the termination visit.

7. Ability to understand and the willingness to sign a written informed consent document

Exclusion Criteria:

1. Treatment with any anti-cancer therapy, including radiotherapy, chemotherapy, biologic
therapy, or herbal therapy within 3 weeks or 5 half-lives (for systemic agents)
whichever is shorter

2. Receiving any other investigational agents or any other anti-cancer therapy

3. Active infections requiring antibiotics

4. Patients with brain metastases (treated or untreated) leptomeningeal disease,
uncontrolled seizure disorder, or active neurologic disease

5. History of interstitial lung disease or active, non-infectious pneumonitis that
required oral or intravenous corticosteroids

6. Prior radiation to the chest wall or mediastinum if the radiation field involves the

7. Significant intercurrent illness that will limit the patient's ability to participate
in the study or may result in their death over the next 18 months

8. Major surgical procedure, open biopsy, or significant traumatic injury within 28 days
prior to enrollment, or anticipation of need for major surgical procedure during the
course of the study

9. Pregnant or nursing women

10. New York Heart Association Classification II, III, or IV

11. Acute prior study treatment related toxicity (except alopecia) that has not resolved
to Grade < or = to 1 unless it has been deemed stable by the investigator

12. Inability to comply with study and follow up procedure
We found this trial at
Denver, Colorado 80218
Denver, CO
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1500 E Medical Center Dr
Ann Arbor, Michigan 48109
(734) 936-4000
Principal Investigator: Bryan Schneider, MD
Phone: 800-865-1125
University of Michigan Health System The University of Michigan is home to one of the...
Ann Arbor, MI
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3322 West End Avenue
Nashville, Tennessee 37203
(615)329-SCRI (7274)
Principal Investigator: Melissa L Johnson, MD
Phone: 877-691-7274
Sarah Cannon Research Institute Sarah Cannon Research Institute (SCRI) is a global strategic research organization...
Nashville, TN
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630 W 168th St
New York, New York
Columbia University Medical Center Situated on a 20-acre campus in Northern Manhattan and accounting for...
New York, NY
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San Antonio, Texas 78229
Principal Investigator: Drew W Rasco, MD
Phone: 210-593-5265
San Antonio, TX
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