Trial record 1 of 1 for:
NCT03122548
Safety and Efficacy of CRS-207 With Pembrolizumab in Gastric, Gastroesophageal Junction or Esophageal Cancers
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT03122548 |
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Recruitment Status :
Active, not recruiting
First Posted : April 21, 2017
Last Update Posted : February 15, 2018
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Sponsor:
Aduro Biotech, Inc.
Collaborator:
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
Aduro Biotech, Inc.
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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 systemic chemotherapy treatment regimens for advanced disease.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Gastric Adenocarcinoma Gastroesophageal Junction Adenocarcinoma Esophageal Adenocarcinoma | Biological: CRS-207 Biological: Pembrolizumab | Phase 2 |
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 79 participants |
| Intervention Model: | Single Group Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | A Phase 2, Open-label Evaluation of CRS-207 and Pembrolizumab in Adults With Recurrent or Metastatic Gastric, Gastroesophageal Junction, or Esophageal Adenocarcinomas |
| Actual Study Start Date : | August 30, 2017 |
| Estimated Primary Completion Date : | October 2018 |
| Estimated Study Completion Date : | May 2019 |
Resource links provided by the National Library of Medicine
Drug Information available for:
Pembrolizumab
| Arm | Intervention/treatment |
|---|---|
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Experimental: CRS-207 and Pembrolizumab
Treatment cycle is once every 3 weeks. Pembrolizumab: 200 mg administered IV over 30 minutes on Day 1 of each 3 week cycle. CRS-207: starting dose 1×10^9 CFU administered IV over 1 hour on Day 2 of Cycle 1, on Day 1 of Cycles 2, 3, 4; and every 6 weeks thereafter. Treatment cycles will continue up to 24 months as long as there is adequate safety and potential for clinical benefit.
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Biological: CRS-207
via IV infusion Biological: Pembrolizumab via IV infusion
Other Name: MK-3475 |
Primary Outcome Measures :
- Number of patients with treatment-related adverse events as assessed by CTCAE v 4.0 [ Time Frame: Through study completion, an average of 18 months ]CTCAE = Common Terminology Criteria for Adverse Events
Secondary Outcome Measures :
- Tumor response [ Time Frame: Through study completion, an average of 18 months ]RECIST (Response Evaluation Criteria in Solid Tumors) will be used to assess tumor response and progression
- Survival [ Time Frame: From date of enrollment until the date of death or close of study, assessed at least 12 months from study completion ]Subjects will be observed for survival for at least 12 months from last dose of study drug
- Characterization of immune responses [ Time Frame: From study start through study completion, an average of 18 months ]Peripheral blood will be collected to assess immune responses directed against Listeria monocytogenes, mesothelin and other tumor-associated antigens
- Analysis of biomarker expression [ Time Frame: At screening (within 28 days of study start) and through study completion, an average of 19 months ]Tumor tissue samples will be used to analyze PD-L1 status and mesothelin status; phenotyping and characterization of tumor infiltrating lymphocytes and tumor microenvironment, functional genomic analyses and T cell receptor sequencing
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
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Diagnosis with confirmed histology of one or more of the following:
- Histologically-confirmed gastric or 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
- Measurable/assessable disease, as defined by RECIST v1.1.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Can provide tissue for PD-L1 and mesothelin biomarker analysis
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 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.
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03122548
Locations
| United States, California | |
| UCLA Medical Center | |
| Los Angeles, California, United States, 90095 | |
| United States, Colorado | |
| University of Colorado | |
| Aurora, Colorado, United States, 80045 | |
| United States, Illinois | |
| University of Chicago Medical Center | |
| Chicago, Illinois, United States, 60637 | |
| United States, Maryland | |
| Johns Hopkins University | |
| Baltimore, Maryland, United States, 21287 | |
| United States, Michigan | |
| Henry Ford Hospital | |
| Detroit, Michigan, United States, 48202 | |
| United States, New York | |
| Memorial Sloan Kettering Cancer Center | |
| New York, New York, United States, 10065 | |
| United States, Texas | |
| Mary Crowley Cancer Research | |
| Dallas, Texas, United States, 75230 | |
| United States, Washington | |
| Virginia Mason Medical Center | |
| Seattle, Washington, United States, 98101 | |
Sponsors and Collaborators
Aduro Biotech, Inc.
Merck Sharp & Dohme Corp.
| Responsible Party: | Aduro Biotech, Inc. |
| ClinicalTrials.gov Identifier: | NCT03122548 History of Changes |
| Other Study ID Numbers: |
ADU-CL-14 KEYNOTE KN-463 ( Other Identifier: Merck Sharp & Dohme Corp. ) |
| First Posted: | April 21, 2017 Key Record Dates |
| Last Update Posted: | February 15, 2018 |
| Last Verified: | February 2018 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
| Studies a U.S. FDA-regulated Drug Product: | Yes | |
| Studies a U.S. FDA-regulated Device Product: | No | |
Keywords provided by Aduro Biotech, Inc.:
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stomach cancer gastric cancer esophageal cancer |
digestive system diseases gastrointestinal diseases stomach diseases |
Additional relevant MeSH terms:
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Adenocarcinoma Esophageal Neoplasms Carcinoma Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms Gastrointestinal Neoplasms Digestive System Neoplasms |
Neoplasms by Site Head and Neck Neoplasms Digestive System Diseases Esophageal Diseases Gastrointestinal Diseases Pembrolizumab Antineoplastic Agents |