- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03165994
APX005M With Concurrent Chemoradiation for Resectable Esophageal and Gastroesophageal Junction Cancers
A Phase 2 Study of APX005M in Combination With Concurrent Chemoradiation as Neoadjuvant Therapy for Resectable Esophageal and Gastroesophageal Junction Cancers
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Primary Objective:
To assess the efficacy of this novel combination, as measured by the pathologic complete response (pCR) rate.
Secondary Objectives:
- To further characterize the safety and feasibility of combining APX005M with SOC chemoradiation (external beam radiation in daily fractions, with concurrent weekly low-dose carboplatin/paclitaxel) in the neoadjuvant setting for patients with resectable esophageal and GE junction cancers.
- To assess the efficacy of combining APX005M with SOC chemoradiation as measured by rates of R0 resection (microscopically negative margins, i.e., no tumor remains following surgery); and radiographic/metabolic response to neoadjuvant treatment on CT-PET.
Exploratory Objectives:
- To identify possible predictive molecular or immune-based efficacy biomarkers for this novel combination.
- To characterize and assess overall survival.
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
-
-
Arizona
-
Tucson, Arizona, United States, 85719
- University of Arizona
-
-
California
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Duarte, California, United States, 91010
- City of Hope Comprehensive Cancer Center
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San Francisco, California, United States, 94143
- University of California, San Francisco
-
-
District of Columbia
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Washington, District of Columbia, United States, 20007-2113
- MedStar Georgetown University Hospital (MGUH)
-
-
New York
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New York, New York, United States, 10016
- New York University
-
-
North Carolina
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Chapel Hill, North Carolina, United States, 27599-7305
- The University of North Carolina at Chapel Hill
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Winston-Salem, North Carolina, United States, 27157
- Wake Forest School of Medicine
-
-
Ohio
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Cincinnati, Ohio, United States, 45219
- University of Cincinnati Medical Center
-
-
Texas
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The Woodlands, Texas, United States, 77380
- Renovatio Clinical
-
-
Washington
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Seattle, Washington, United States, 98109
- University of Washington
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Age ≥ 18 years of age
- Histologically proven squamous cell carcinoma, adenocarcinoma or undifferentiated carcinoma of the esophagus or GE junction
- Surgically resectable (T1-3 Nx preferably by endoscopic ultrasound [EUS]). (Excluded: T1N0 tumors, cervical esophageal location, tumors invading the tracheobronchial tree or with fistula, distant disease that cannot be included in the radiation field or be resected at the time of esophagectomy)
- Eastern Cooperative Oncology Group (ECOG) performance status 0-1
- Adequate hematological, renal, and hepatic parameters
Exclusion Criteria:
- Any history of or current hematologic malignancy
- History of a second primary cancer is allowed in the event the cancer is curatively resected and there is no evidence of recurrence/metastatic disease x 1 year. Subjects who have a history of cervical or breast carcinoma in situ, localized prostate cancer, adequately treated basal cell or squamous cell carcinoma of the skin, or superficial bladder tumors [Ta, Tis & T1] are also allowed.
- Major surgery within 4 weeks of first dose of investigational product
- Prior or concurrent treatment with any anticancer agent for the same cancer diagnosis
- Prior exposure to any immuno-oncology agents, including CD40/PD-1/PD-L1/CTLA-4 inhibitors (if any ambiguity, should be discussed with study principal investigator)
- History of bone marrow transplantation
- History of autoimmune disorders with the exception of vitiligo or autoimmune thyroid disorders
- Chronic steroid dependency (prednisone equivalent > 10 mg/day). Any steroid use should be discontinued at least 2 weeks prior to initiation of study treatment.
- Congestive heart failure (New York Heart Association Class III to IV), symptomatic ischemia, conduction abnormalities uncontrolled by conventional intervention, or myocardial infarction within 6 months before first dose
- Known human immunodeficiency virus (HIV) infection
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: APX005M with chemoradiation
APX005M: 0.3mg/kg dose intravenously over 1 hour, every 3 weeks x 3 doses (weeks 1, 4, and 7). Treatment begins 2 weeks prior to concurrent chemoradiation (chemoRT); continues during weeks 2 and 5 of chemoRT. Daily radiation therapy (RT): 28 fractions (28 days) Chemotherapy: Carboplatin and paclitaxel will be given intravenously over 1 hour, once weekly, for 5 weeks (days 1, 8, 15 22, and 29 of RT). Carboplatin dose will be area under curve (AUC) 2. Paclitaxel dose will be 50mg/m2. Surgical resection of tumor: between weeks 10-16 |
Carboplatin IV infusion
Other Names:
APX005M intravenous (IV) infusion
Other Names:
Radiation therapy, total dose 5040cGy in 180cGy fractions
Other Names:
Paclitaxel IV infusion
Other Names:
Surgical removal of the tumor will occur between weeks 10-16
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Pathologic complete response (pCR) rate
Time Frame: At time of surgery (at 10-16 weeks)
|
At time of surgery (at 10-16 weeks)
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Rates of R0 resection (microscopically negative margins, i.e., no tumor remains following surgery)
Time Frame: At time of surgery
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At time of surgery
|
Pathologic stage at time of surgery
Time Frame: At time of surgery
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At time of surgery
|
Radiographic/metabolic response to neoadjuvant treatment on Computed Tomography (CT) / CT-Positron Emission Tomography (PET) (CT-PET)
Time Frame: Baseline, then at time of surgery, and 3 and 6 months post-operatively
|
Baseline, then at time of surgery, and 3 and 6 months post-operatively
|
Frequency of adverse events
Time Frame: Up to 5 months for each patient
|
Up to 5 months for each patient
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- APX005M-006
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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