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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

29 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-01-31

Study Completion Date

2017-05-19

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Locally Advanced or Metastatic Solid Tumors

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Demcizumab and Pembrolizumab

Demcizumab will be administered prior to pembrolizumab

Group Type EXPERIMENTAL

Demcizumab

Intervention Type DRUG

Drug: Demcizumab at starting dose of 2.5mg/kg administered intravenously (IV).

Pembrolizumab

Intervention Type DRUG

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

Interventions

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Demcizumab

Drug: Demcizumab at starting dose of 2.5mg/kg administered intravenously (IV).

Intervention Type DRUG

Pembrolizumab

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

Intervention Type DRUG

Other Intervention Names

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OMP-21M18

Eligibility Criteria

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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

Minimum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No