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

Completed · Phase 1

Conditions studied: Locally Advanced or Metastatic Solid Tumors

In brief

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.

Key facts

Study ID

NCT02722954

Run by

OncoMed Pharmaceuticals, Inc.

People needed

29

Starts

2016-01-01

Expected to finish

2017-05-19

Last updated by the study team

2020-08-11

Who can join

Age: 21 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Measurable disease per response evaluation criteria in solid tumors (RECIST) v1.1
• Availability of formalin-fixed paraffin-embedded (FFPE) tumor tissue, either fresh core-needle-biopsied or archived
• Age >21 years
• Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
• Adequate organ and marrow function
• 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.
• Ability to understand and the willingness to sign a written informed consent document

You may not qualify if…

• 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
• Receiving any other investigational agents or any other anti-cancer therapy
• Active infections requiring antibiotics
• Patients with brain metastases (treated or untreated) leptomeningeal disease, uncontrolled seizure disorder, or active neurologic disease
• History of interstitial lung disease or active, non-infectious pneumonitis that required oral or intravenous corticosteroids
• Prior radiation to the chest wall or mediastinum if the radiation field involves the heart
• 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
• 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
• Pregnant or nursing women
• New York Heart Association Classification II, III, or IV
• 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
• Inability to comply with study and follow up procedure

Where it is running

• Rocky Mountain Cancer Center — Denver, Colorado, United States
• University of Michigan Health System — Ann Arbor, Michigan, United States
• Columbia University Medical Center — New York, New York, United States
• Sarah Cannon Research Institute — Nashville, Tennessee, United States
• The START Center for Cancer Care — San Antonio, Texas, United States
• The Royal Marsden NHS Foundation Trust — Sutton, Surrey, United Kingdom

Full record on ClinicalTrials.gov

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