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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02722954
Recruitment Status : Completed
First Posted : March 30, 2016
Last Update Posted : April 9, 2018
Sponsor:
Collaborator:
Celgene Corporation
Information provided by (Responsible Party):
OncoMed Pharmaceuticals, Inc.

Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Locally Advanced or Metastatic Solid Tumors Drug: Demcizumab Drug: Pembrolizumab Phase 1

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 29 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 1b, Open-Label, Dose Escalation and Expansion Study of Demcizumab Plus Pembrolizumab in Patients With Locally Advanced or Metastatic Solid Tumors
Study Start Date : January 2016
Actual Primary Completion Date : May 10, 2017
Actual Study Completion Date : May 19, 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Demcizumab and Pembrolizumab
Demcizumab will be administered prior to pembrolizumab
Drug: Demcizumab
Drug: Demcizumab at starting dose of 2.5mg/kg administered intravenously (IV).
Other Name: OMP-21M18

Drug: Pembrolizumab
Drug: Pembrolizumab administered 2mg/kg IV every 3 weeks




Primary Outcome Measures :
  1. 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) ]
    The maximum tolerated dose (MTD) or maximum administered dose (MAD) will be determined in patients treated with demcizumab in combination with pembrolizumab


Secondary Outcome Measures :
  1. 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 ]
    peak plasma concentration



Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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 heart
  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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02722954


Locations
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United States, Colorado
Rocky Mountain Cancer Center
Denver, Colorado, United States, 80218
United States, Michigan
University of Michigan Health System
Ann Arbor, Michigan, United States, 48109-5848
United States, New York
Columbia University Medical Center
New York, New York, United States, 10032
United States, Tennessee
Sarah Cannon Research Institute
Nashville, Tennessee, United States, 37203
United States, Texas
The START Center for Cancer Care
San Antonio, Texas, United States, 78229
United Kingdom
The Royal Marsden NHS Foundation Trust
Sutton, Surrey, United Kingdom, SM2 5PT
Sponsors and Collaborators
OncoMed Pharmaceuticals, Inc.
Celgene Corporation

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Responsible Party: OncoMed Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT02722954     History of Changes
Other Study ID Numbers: M18-008
First Posted: March 30, 2016    Key Record Dates
Last Update Posted: April 9, 2018
Last Verified: April 2018

Keywords provided by OncoMed Pharmaceuticals, Inc.:
malignancy
metastatic
Demcizumab
Pembrolizumab
Phase 1b

Additional relevant MeSH terms:
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Pembrolizumab
Antineoplastic Agents, Immunological
Antineoplastic Agents