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

NCT02722954 | Completed Phase 1 DMC

• 1 other identifier: M18-008
• Study Type: interventional
• Target: 29
• Locations: 2 countries
• Sites: 6

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.

Conditions

Locally Advanced or Metastatic Solid Tumors

Keywords

malignancy; metastatic; Demcizumab; Pembrolizumab; Phase 1b

Outcome Measures

Primary Outcomes (1)

• Dose limiting toxicities (DLT) of demcizumab given in combination with pembrolizumab

  The maximum tolerated dose (MTD) or maximum administered dose (MAD) will be determined in patients treated with demcizumab in combination with pembrolizumab

  Subjects will be treated and observed for DLT through the end of the first cycle (Days 1-22)

Secondary Outcomes (1)

• Pharmacokinetics (PK) of demcizumab and pembrolizumab

  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

Study Arms (1)

Demcizumab and Pembrolizumab

EXPERIMENTAL

Demcizumab will be administered prior to pembrolizumab

Drug: Demcizumab; Drug: Pembrolizumab

Interventions

Demcizumab DRUG

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

Also known as: OMP-21M18

Demcizumab and Pembrolizumab

Pembrolizumab DRUG

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

Demcizumab and Pembrolizumab

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• OncoMed Pharmaceuticals, Inc.: lead
• Celgene Corporation: collaborator

Study Sites (6)

Rocky Mountain Cancer Center

Denver, Colorado, 80218, United States

Location

University of Michigan Health System

Ann Arbor, Michigan, 48109-5848, United States

Location

Columbia University Medical Center

New York, New York, 10032, United States

Location

Sarah Cannon Research Institute

Nashville, Tennessee, 37203, United States

Location

The START Center for Cancer Care

San Antonio, Texas, 78229, United States

Location

The Royal Marsden NHS Foundation Trust

Sutton, Surrey, SM2 5PT, United Kingdom

Location

MeSH Terms

Conditions

Neoplasms; Neoplasm Metastasis

Interventions

demcizumab; pembrolizumab

Condition Hierarchy (Ancestors)

Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 7, 2016
• First Posted: March 30, 2016
• Study Start: January 1, 2016
• Primary Completion: May 10, 2017
• Study Completion: May 19, 2017
• Last Updated: August 11, 2020

Record last verified: 2020-08

Locations

GB (1); US (5)