Clinical Trial Details

NCT ID: NCT03122548
Date Last Changed: October 9, 2017

Overview

Research Study Summary

A clinical trial seeking patients for a research study for the treatment of Gastric Adenocarcinoma, Gastroesophageal Junction Adenocarcinoma or Esophageal Adenocarcinoma

Research Study Title

A Phase 2, Open-label Evaluation of CRS-207 and Pembrolizumab in Adults With Recurrent or Metastatic Gastric, Gastroesophageal Junction, or Esophageal Adenocarcinomas

Purpose

The purpose of this study is to determine whether CRS-207 in combination with pembrolizumab is safe and effective in adults with recurrent or metastatic gastric, gastroesophageal junction, or esophageal cancer who have received one or two prior systemic chemotherapy treatment regimens for advanced disease.

To Learn more

Recruitment Details

Phase
2
Gender
All
Age
18 and up
Overall Status
Recruiting
Lead Sponsor
Aduro Biotech, Inc.
Duration
14 Months
Facility Type
N/A
Compensation

Eligibility

All ages 18 Years and up

Inclusion Criteria:

  1. Diagnosis with confirmed histology of one or more of the following:

  2. Histologically-confirmed gastric or GEJ adenocarcinoma (Siewert type II/III classification) Or

  3. Histologically-confirmed inoperable superior, medial, or distal third esophageal adenocarcinoma (Siewert type I classification may be included, provided there is no mixed histology)

  4. Confirmed recurrent or metastatic disease

  5. Received and experienced disease progression on, or following one or two prior chemotherapy regimens for advanced disease.

  6. HER-2/neu negative or, if HER-2/neu positive, disease must have previously progressed on treatment with trastuzumab

  7. Measurable/assessable disease, as defined by RECIST v1.1.

  8. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1

  9. Can provide tissue for PD-L1 and mesothelin biomarker analysis

Exclusion Criteria:

  1. Diagnosis of squamous or undifferentiated gastric cancer

  2. Individuals with inaccessible tumors or for whom biopsy is contraindicated

  3. Participated in any other study in which receipt of an investigational new drug or investigational device occurred within 28 days of first dose of study drug

  4. Receiving TNF pathway inhibitors, PI3 kinase inhibitors, systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of study drug

  5. Clinical evidence of ascites by physical exam

  6. Prior anti-cancer monoclonal antibody within 4 weeks prior to first dose of study drug or has not recovered from adverse effects due to agents administered more than 4 weeks earlier

  7. Prior chemotherapy, targeted small molecule therapy, or radiation therapy within 2 weeks prior to first dose of study drug, or has not recovered from adverse effects due to a previously-administered agent

  8. Subjects who have implanted medical devices that pose high risks for colonization and cannot be easily removed (e.g. artificial heart valves, pacemakers, prosthetic joints, orthopedic screw(s), metal plate(s)) if infection occurs. Other common devices such as venous access devices (e.g. Port-a-Cath or Mediport) may be permitted as well as arterial and venous stents and dental and breast implants that were placed more than 3 months prior to first dose of study drug.

Site Locations (7)

Country State City Zip Facility and Contact
United States California Los Angeles 90095 UCLA Medical Center
Lisa Yonemoto
310-582-4069
LYonemoto@mednet.ucla.edu

Zev Wainberg, MD
Principal Investigator
United States Colorado Aurora 80045 University of Colorado
Zachary George
720-848-9352
zachary.george@ucdenver.edu

Wells Messersmith, MD
Principal Investigator
United States Illinois Chicago 60637 University of Chicago Medical Center
Syed Abdur-Rahman
773-834-7188
sabdurrahman@medicine.bsd.uchicago.edu

Daniel Catenacci, MD
Principal Investigator
United States Maryland Baltimore 21287 Johns Hopkins University
Rosa Sebree
410-502-2645
Rsebree1@jhmi.edu

Ronan Kelly, MD
Principal Investigator
United States New York New York 10065 Memorial Sloan Kettering Cancer Center
Matt Margolis
646-888-4588
margolim@mskcc.org

Geoffrey Ku, MD
Principal Investigator
United States Texas Dallas 75230 Mary Crowley Cancer Research
Catherine Raj
972-566-3000
craj@marycrowley.org

John J Nemunaitis, MD
Principal Investigator
United States Washington Seattle 98101 Virginia Mason Medical Center
Leslie Lee
206-223-6193
Leslie.Lee@virginiamason.org

Bruce Lin, MD
Principal Investigator

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