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

NCT ID: NCT03122548

Last Updated: 2019-04-04

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 5 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-08-14
• Study Completion Date: 2018-01-31

Brief 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.

Conditions

Gastric Adenocarcinoma; Gastroesophageal Junction Adenocarcinoma; Esophageal Adenocarcinoma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

CRS-207 + Pembrolizumab

CRS-207 and pembrolizumab will be administered in 3-week cycles. For Cycle 1, pembrolizumab (200 mg) will be administered by intravenous (IV) infusion over 30 minutes on Day 1 and CRS-207 (starting dose 1 × 10e9 colony-forming units \[CFU\]) will be administered by IV infusion over 1 hour on Day 2. If the infusions are well tolerated, pembrolizumab and CRS-207 may be administered on the same day (Day 1) for subsequent cycles. After 4 cycles, pembrolizumab will continue to be administered on Day 1 at each treatment cycle (every 3 weeks); CRS-207 will be administered once every 6 weeks (every other cycle). Treatment will continue for up to 35 cycles as long as there is adequate safety and potential for clinical benefit.

Group Type: EXPERIMENTAL

CRS-207

Intervention Type: BIOLOGICAL

Administered by IV infusion over 1 hour.

Pembrolizumab

Intervention Type: BIOLOGICAL

Administered by IV infusion over 30 minutes.

Interventions

CRS-207

Administered by IV infusion over 1 hour.

Intervention Type: BIOLOGICAL

Pembrolizumab

Administered by IV infusion over 30 minutes.

Intervention Type: BIOLOGICAL

Other Intervention Names

MK-3475

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role: collaborator

Aduro Biotech, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

UCLA Medical Center

Los Angeles, California, United States

University of Colorado

Aurora, Colorado, United States

University of Chicago Medical Center

Chicago, Illinois, United States

Johns Hopkins University

Baltimore, Maryland, United States

Henry Ford Hospital

Detroit, Michigan, United States

Memorial Sloan Kettering Cancer Center

New York, New York, United States

Mary Crowley Cancer Research

Dallas, Texas, United States

Virginia Mason Medical Center

Seattle, Washington, United States

Countries

United States

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

KEYNOTE KN-463

Identifier Type: OTHER

Identifier Source: secondary_id

ADU-CL-14

Identifier Type: -

Identifier Source: org_study_id