Clinical Trial Details

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


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


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

18 and up
Overall Status
Lead Sponsor
Aduro Biotech, Inc.
14 Months
Facility Type


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

Zev Wainberg, MD
Principal Investigator
United States Colorado Aurora 80045 University of Colorado
Zachary George

Wells Messersmith, MD
Principal Investigator
United States Illinois Chicago 60637 University of Chicago Medical Center
Syed Abdur-Rahman

Daniel Catenacci, MD
Principal Investigator
United States Maryland Baltimore 21287 Johns Hopkins University
Rosa Sebree

Ronan Kelly, MD
Principal Investigator
United States New York New York 10065 Memorial Sloan Kettering Cancer Center
Matt Margolis

Geoffrey Ku, MD
Principal Investigator
United States Texas Dallas 75230 Mary Crowley Cancer Research
Catherine Raj

John J Nemunaitis, MD
Principal Investigator
United States Washington Seattle 98101 Virginia Mason Medical Center
Leslie Lee

Bruce Lin, MD
Principal Investigator

DISCLAIMER: CenterWatch does not conduct clinical research. CenterWatch is a publishing company that posts clinical trials information on behalf of sponsor companies, contract research organizations, clinical research sites and other interested parties. This information is designed to help patients find clinical trials of interest and contact the research centers conducting the trials.