- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02446093
Neoadjuvant CAN-2409 in Combination With Chemoradiation or SBRT for Borderline Resectable Pancreatic Adenocarcinoma (PaTK02)
Neoadjuvant CAN-2409 Plus Prodrug in Combination With Chemoradiation or Stereotactic Body Radiation Therapy for Borderline Resectable Pancreatic Adenocarcinoma
Study Overview
Status
Detailed Description
Study Type
Enrollment (Estimated)
Phase
- Phase 2
Contacts and Locations
Study Contact
- Name: Garrett Nichols, MD, MS
- Phone Number: (617)916-5445
- Email: gnichols@candeltx.com
Study Contact Backup
- Name: Andrea Manzanera, MD, MPH
- Phone Number: (617)916-5445
- Email: andrea@Candeltx.com
Study Locations
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-
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Mexico City, Mexico, 14080
- Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
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-
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Florida
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Fort Myers, Florida, United States, 33905
- Lee Health/Regional Cancer Center
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Ohio
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Columbus, Ohio, United States, 43210
- Ohio State University
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Pathological diagnosis of pancreatic adenocarcinoma adequately treated with a FOLFIRINOX based induction chemotherapy for at least 4 months such that they are a candidate for localized therapy with CR or SBRT followed by surgery with or without major vascular resection.
- Subjects must be deemed to be in adequate health to undergo major surgery (e.g., pancreaticoduodenectomy).
Tumor accessible for injection by EUS or CT-guidance, considered potentially resectable at time of diagnosis, and classified as borderline resectable based on central radiologic review of CT scans performed following completion of FOLFIRINOX based induction chemotherapy. Resection may include major vascular resection with reconstruction as needed.
Criteria for borderline resectable disease status:
- No distant metastasis or lymph node involvement outside the planned resection field.
- Venous involvement of the superior mesenteric vein (SMV) or portal view (PV) with distortion or narrowing of the vein or occlusion of the vein with suitable vessel proximal and distal, allowing for safe resection and replacement
- Gastroduodenal artery encasement up to the hepatic artery with either short segment encasement or direct tumor abutment of the hepatic artery, without extension to the celiac axis
- Tumor abutment of the superior mesenteric artery (SMA) not to exceed > 180 degrees of the circumference of the vessel wall
- Age > 18 years at the time of consent
- Performance status ECOG 0 or 1
- SGOT (AST) <3x upper limit normal
Total bilirubin <2mg/dl
- Subjects with biliary obstruction can be enrolled if AST and bilirubin do not meet criteria but must meet the criteria after stenting before starting treatment
- Creatinine <2mg/dl
- Calculated creatinine clearance > 30ml/min
- WBC > 3000/mm^3
- Absolute neutrophil count (ANC) > 1000/mm^3
- Platelets > 100,000/mm^3
- Hemoglobin > 9g/dl
- Signed, written informed consent
Exclusion Criteria:
- Primary hepatic dysfunction including known cirrhosis or active hepatitis. Subjects with biliary obstruction must be stented prior to initiating treatment
- Evidence of clinically significant pancreatitis as determined by the investigator
- Evidence of significant ascites as determined by investigator
- Subjects on systemic corticosteroid (>10 mg prednisone per day or equivalent), systemic immunomodulators, or other systemic immunosuppressive drugs
- Known to be HIV+
- Pregnant or breast-feeding. Female subjects of childbearing age must have negative serum or urine pregnancy test within 2 weeks of beginning protocol therapy
- Other current malignancy (except squamous or basal cell skill cancers)
- Other serious co-morbid illnesses or compromised organ function
- Known sensitivity or allergic reactions to acyclovir or valacyclovir
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Test Arm
CAN-2409 + prodrug (valacylovir or acyclovir) in combination with neoadjuvant chemoradiation or SBRT + Surgery
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Three courses of CAN-2409 + prodrug (valacylovir or acyclovir) will be delivered and timed with different phases of therapy: 1) after induction chemotherapy 2) during CR or post-SBRT, and 3) at time of surgery.
Up to 2 additional courses of CAN-2409 + prodrug, if feasible, for subjects with disease progression or metastases.
Other Names:
CR will start not more than 2 months after completion of induction chemotherapy.
The chemotherapy component of CR may be selected as per institutional standard of care (SOC) and protocols for administration, and may include capecitabine, 5-FU, or gemcitabine.
Radiation should consist of a total dose of 45-54 Gy in 1.8-2.0
Gy fractions concurrent with chemotherapy over 3-5.5 weeks.
SBRT should start no more than 2 months after completion of induction chemotherapy.
For SBRT, the radiation should consist of a total dose of 25-50 Gy in divided fractions over 1-2 weeks.
Surgical resection should be performed within 8 weeks after completing CR or SBRT.
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Active Comparator: Control Arm
Neoadjuvant chemoradiation or SBRT + Surgery
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CR will start not more than 2 months after completion of induction chemotherapy.
The chemotherapy component of CR may be selected as per institutional standard of care (SOC) and protocols for administration, and may include capecitabine, 5-FU, or gemcitabine.
Radiation should consist of a total dose of 45-54 Gy in 1.8-2.0
Gy fractions concurrent with chemotherapy over 3-5.5 weeks.
SBRT should start no more than 2 months after completion of induction chemotherapy.
For SBRT, the radiation should consist of a total dose of 25-50 Gy in divided fractions over 1-2 weeks.
Surgical resection should be performed within 8 weeks after completing CR or SBRT.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Safety grade by CTCAE version 4.0
Time Frame: From the time of CAN-2409 administration to 30 days after the last dose of valacyclovir.
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Frequency of adverse events.
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From the time of CAN-2409 administration to 30 days after the last dose of valacyclovir.
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Survival Rate
Time Frame: 24 months
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All eligible subjects will be followed for at least 2 additional years from the completion of primary treatment window.
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24 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Overall survival (OS) from time of diagnosis
Time Frame: 60 months
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Time from diagnosis until death from any cause.
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60 months
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Overall survival (OS) from time of study enrollment
Time Frame: 60 months
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Time from enrollment until death from any cause.
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60 months
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Progression free survival (PFS) from time of diagnosis
Time Frame: 60 months
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Time from diagnosis until first objective documentation of progression (local or distant) or death from any cause.
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60 months
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Progression free survival (PFS) from time of study enrollment
Time Frame: 60 months
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Time from study enrollment to documented disease progression or death from any cause.
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60 months
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Resection rate
Time Frame: 12 weeks
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Subjects will be considered to have R0 resection if all lesions are removed with negative microscopic surgical margins.
Subjects will be considered to have R1 resection if all lesions are removed with any positive microscopic surgical margins.
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12 weeks
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Disease free survival (DFS) in subjects with R0 resection
Time Frame: 60 months
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Disease-free survival (DFS) will be measured from R0 resection until first objective documentation of recurrence or death from any cause.
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60 months
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Immunological biomarker characterization in tumor and peripheral blood
Time Frame: 24 months
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Immunophenotyping in the blood and in the tissue.
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24 months
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Collaborators and Investigators
Sponsor
Collaborators
Study record dates
Study Major Dates
Study Start
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- PaTK02
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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