Esophageal Cancer Clinical Trial

Safety and Efficacy of CRS-207 With Pembrolizumab in Gastric, Gastroesophageal Junction or Esophageal Cancers

Summary

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 chemotherapy regimens for advanced disease.

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

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

Histologically-confirmed gastric or gastroesophageal junction (GEJ) adenocarcinoma (Siewert type II/III classification), or
Histologically-confirmed inoperable superior, medial, or distal third esophageal adenocarcinoma (Siewert type I classification may be included, provided there is no mixed histology)
Confirmed recurrent or metastatic disease
Received and experienced disease progression on, or following one or two prior chemotherapy regimens for advanced disease.
HER-2/neu negative or, if HER-2/neu positive, disease must have previously progressed on treatment with trastuzumab; prior treatment must have included a platinum and a fluoropyrimidine.
Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
Can provide tissue for immunotherapy-drugs-are-boosting-survival/" >PD-L1 and mesothelin biomarker analysis
Adequate organ and marrow function at screening

Exclusion Criteria:

Diagnosis of squamous or undifferentiated gastric cancer
Individuals with inaccessible tumors or for whom biopsy is contraindicated
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
Receiving tumor necrosis factor (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
Clinical evidence of ascites by physical exam
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
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
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.

Study is for people with:

Esophageal Cancer

Phase:

Phase 2

Estimated Enrollment:

5

Study ID:

NCT03122548

Recruitment Status:

Terminated

Sponsor:

Aduro Biotech, Inc.

Check Your Eligibility

Let’s see if you might be eligible for this study.

What is your age and gender ?

Submit

There are 8 Locations for this study

See Locations Near You

UCLA Medical Center
Los Angeles California, 90095, United States
University of Colorado
Aurora Colorado, 80045, United States
University of Chicago Medical Center
Chicago Illinois, 60637, United States
Johns Hopkins University
Baltimore Maryland, 21287, United States
Henry Ford Hospital
Detroit Michigan, 48202, United States
Memorial Sloan Kettering Cancer Center
New York New York, 10065, United States
Mary Crowley Cancer Research
Dallas Texas, 75230, United States
Virginia Mason Medical Center
Seattle Washington, 98101, United States

How clear is this clinincal trial information?

Study is for people with:

Esophageal Cancer

Phase:

Phase 2

Estimated Enrollment:

5

Study ID:

NCT03122548

Recruitment Status:

Terminated

Sponsor:


Aduro Biotech, Inc.

How clear is this clinincal trial information?

×

Introducing, the Journey Bar

Use this bar to access information about the steps in your cancer journey.

Please confirm you are a US based health care provider:

Yes, I am a health care Provider No, I am not a health care provider