Safety and Efficacy of CRS-207 With Pembrolizumab in Gastric, Gastroesophageal Junction or Esophageal Cancers
Condition: Gastric Adenocarcinoma; Gastroesophageal Junction Adenocarcinoma; Esophageal Adenocarcinoma
MeSH terms: Adenocarcinoma; Esophageal Neoplasms
Intervention: CRS-207; Pembrolizumab
Intervention description: Administered by IV infusion over 1 hour.; Administered by IV infusion over 30 minutes.
Intervention MeSH terms: Pembrolizumab
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 5.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: stomach cancer; gastric cancer; esophageal cancer; digestive system diseases; gastrointestinal diseases; stomach diseases

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.
    

Eligibility criteria:

        Inclusion Criteria:

          1. 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)

          2. Confirmed recurrent or metastatic disease

          3. Received and experienced disease progression on, or following one or two prior
             chemotherapy regimens for advanced disease.

          4. 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.

          5. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1

          6. Can provide tissue for PD-L1 and mesothelin biomarker analysis

          7. Adequate organ and marrow function at screening

        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 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

          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.