- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02722954
A Phase 1b Study of Demcizumab Plus Pembrolizumab in Locally Advanced or Metastatic Solid Tumors
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.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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.
Study Type
Enrollment (Actual)
Phase
- Phase 1
Contacts and Locations
Study Locations
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Surrey
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Sutton, Surrey, United Kingdom, SM2 5PT
- The Royal Marsden NHS Foundation Trust
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Colorado
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Denver, Colorado, United States, 80218
- Rocky Mountain Cancer Center
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Michigan
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Ann Arbor, Michigan, United States, 48109-5848
- University of Michigan Health System
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New York
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New York, New York, United States, 10032
- Columbia University Medical Center
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Tennessee
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Nashville, Tennessee, United States, 37203
- Sarah Cannon Research Institute
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Texas
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San Antonio, Texas, United States, 78229
- The START Center for Cancer Care
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Demcizumab and Pembrolizumab
Demcizumab will be administered prior to pembrolizumab
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Drug: Demcizumab at starting dose of 2.5mg/kg administered intravenously (IV).
Other Names:
Drug: Pembrolizumab administered 2mg/kg IV every 3 weeks
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Dose limiting toxicities (DLT) of demcizumab given in combination with pembrolizumab
Time Frame: Subjects will be treated and observed for DLT through the end of the first cycle (Days 1-22)
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The maximum tolerated dose (MTD) or maximum administered dose (MAD) will be determined in patients treated with demcizumab in combination with pembrolizumab
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Subjects will be treated and observed for DLT through the end of the first cycle (Days 1-22)
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Pharmacokinetics (PK) of demcizumab and pembrolizumab
Time Frame: Plasma sample for Pharmacokinetics (PK) analysis to be obtained on Days 1, 22, 43 then at every other cycle (each cycle is 21 days) until 12 weeks post treatment termination, an average of 1 year
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peak plasma concentration
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Plasma sample for Pharmacokinetics (PK) analysis to be obtained on Days 1, 22, 43 then at every other cycle (each cycle is 21 days) until 12 weeks post treatment termination, an average of 1 year
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Collaborators and Investigators
Sponsor
Collaborators
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- M18-008
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Locally Advanced or Metastatic Solid Tumors
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University Medical Center GroningenActive, not recruiting
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Avistone Biotechnology Co., Ltd.Not yet recruitingLocally Advanced or Metastatic Solid TumorsUnited States
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Genexine, Inc.CompletedLocally Advanced or Metastatic Solid TumorsKorea, Republic of
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