Study Stopped
Low enrollment and lack of clinical activity in other CRS-207 studies.
Safety and Efficacy of CRS-207 With Pembrolizumab in Gastric, Gastroesophageal Junction or Esophageal Cancers
A Phase 2, Open-label Evaluation of CRS-207 and Pembrolizumab in Adults With Recurrent or Metastatic Gastric, Gastroesophageal Junction, or Esophageal Adenocarcinomas
2 other identifiers
interventional
5
1 country
8
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2
Started Aug 2017
Shorter than P25 for phase_2
8 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 4, 2017
CompletedFirst Posted
Study publicly available on registry
April 21, 2017
CompletedStudy Start
First participant enrolled
August 14, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 27, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
January 31, 2018
CompletedResults Posted
Study results publicly available
February 20, 2019
CompletedApril 4, 2019
March 1, 2019
5 months
April 4, 2017
January 26, 2019
March 22, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Objective Response Rate (ORR)
ORR was evaluated based upon the best overall response (BOR) for individual study subjects. BOR was determined by the highest post-baseline qualitative response value for each evaluable subject as measured by Response Evaluation Criteria in Solid Tumors (RECIST v1.1) and given the following hierarchy of overall response results: complete response (CR) \> partial response (PR) \> stable disease (SD) \> progressive disease (PD) \> not evaluable (NE). The protocol-specified ORR was defined as the percentage of evaluable subjects with a BOR of CR or PR; however, this percentage was not calculated per the final study Statistical Analysis Plan (SAP). Therefore, the number of evaluable subjects with BOR RECIST v1.1 values of CR, PR, SD, PD, and NE are provided for this outcome measure. .
BOR was assessed from the first post-baseline tumor assessment until documented disease progression, starting of a new cancer treatment, death, or study termination, whichever is earlier, assessed up to 15 weeks.
Secondary Outcomes (4)
Disease Control Rate (DCR)
BOR was assessed from the first post-baseline tumor assessment until documented disease progression, starting of a new cancer treatment, death, or study termination, whichever is earlier, assessed up to 15 weeks.
Progression-Free Survival (PFS)
Subjects followed for disease progression from first dose of study treatment until documented disease progression, initiation of new cancer treatment, death, or study termination, whichever is earlier, assessed up to 15 weeks.
Duration of Response (DOR)
DOR assessed from the date of a post-baseline tumor assessment of CR or PR per RECIST v1.1 until the date of documented disease progression, starting of a new cancer treatment, death, or study termination, whichever is earlier, assessed up to 15 weeks.
Overall Survival (OS)
OS was assessed from the first dose of study treatment until death or study termination, whichever is earlier, assessed up to 15 weeks.
Study Arms (1)
CRS-207 + Pembrolizumab
EXPERIMENTALCRS-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 Ă— 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.
Interventions
Administered by IV infusion over 30 minutes.
Eligibility Criteria
You may qualify if:
- 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 PD-L1 and mesothelin biomarker analysis
- Adequate organ and marrow function at screening
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Aduro Biotech, Inc.lead
- Merck Sharp & Dohme LLCcollaborator
Study Sites (8)
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
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Limitations and Caveats
Study was terminated early and included a small number of subjects, and insufficient data were available to evaluate the clinical activity of the study treatment. Due to low enrollment, some protocol-specified outcome measures were not evaluated.
Results Point of Contact
- Title
- Medical Affairs
- Organization
- Aduro Biotech, Inc.
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 4, 2017
First Posted
April 21, 2017
Study Start
August 14, 2017
Primary Completion
December 27, 2017
Study Completion
January 31, 2018
Last Updated
April 4, 2019
Results First Posted
February 20, 2019
Record last verified: 2019-03
Data Sharing
- IPD Sharing
- Will not share