Neoadjuvant CAN-2409 in Combination With Chemoradiation or SBRT for Borderline Resectable Pancreatic Adenocarcinoma (PaTK02)
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ClinicalTrials.gov Identifier: NCT02446093 |
Recruitment Status :
Recruiting
First Posted : May 18, 2015
Last Update Posted : December 9, 2022
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Condition or disease | Intervention/treatment | Phase |
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Borderline Resectable Pancreatic Adenocarcinoma | Biological: Aglatimagene besadenovec Radiation: Chemoradiation Radiation: Stereotactic body radiation therapy Procedure: Surgery | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 54 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Neoadjuvant CAN-2409 Plus Prodrug in Combination With Chemoradiation or Stereotactic Body Radiation Therapy for Borderline Resectable Pancreatic Adenocarcinoma |
Study Start Date : | October 2015 |
Estimated Primary Completion Date : | December 2025 |
Estimated Study Completion Date : | July 2026 |
Arm | Intervention/treatment |
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Experimental: Test Arm
CAN-2409 + prodrug (valacylovir or acyclovir) in combination with neoadjuvant chemoradiation or SBRT + Surgery
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Biological: Aglatimagene besadenovec
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:
Radiation: Chemoradiation 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. Radiation: Stereotactic body radiation therapy 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. Procedure: Surgery Surgical resection should be performed within 8 weeks after completing CR or SBRT. |
Active Comparator: Control Arm
Neoadjuvant chemoradiation or SBRT + Surgery
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Radiation: Chemoradiation
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. Radiation: Stereotactic body radiation therapy 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. Procedure: Surgery Surgical resection should be performed within 8 weeks after completing CR or SBRT. |
- 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. ]Frequency of adverse events.
- Survival Rate [ Time Frame: 24 months ]All eligible subjects will be followed for at least 2 additional years from the completion of primary treatment window.
- Overall survival (OS) from time of diagnosis [ Time Frame: 60 months ]Time from diagnosis until death from any cause.
- Overall survival (OS) from time of study enrollment [ Time Frame: 60 months ]Time from enrollment until death from any cause.
- Progression free survival (PFS) from time of diagnosis [ Time Frame: 60 months ]Time from diagnosis until first objective documentation of progression (local or distant) or death from any cause.
- Progression free survival (PFS) from time of study enrollment [ Time Frame: 60 months ]Time from study enrollment to documented disease progression or death from any cause.
- Resection rate [ Time Frame: 12 weeks ]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.
- Disease free survival (DFS) in subjects with R0 resection [ Time Frame: 60 months ]Disease-free survival (DFS) will be measured from R0 resection until first objective documentation of recurrence or death from any cause.
- Immunological biomarker characterization in tumor and peripheral blood [ Time Frame: 24 months ]Immunophenotyping in the blood and in the tissue.

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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).
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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
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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

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): NCT02446093
Contact: Garrett Nichols, MD, MS | (617)916-5445 | gnichols@candeltx.com | |
Contact: Andrea Manzanera, MD, MPH | (617)916-5445 | andrea@Candeltx.com |
United States, Florida | |
Lee Health/Regional Cancer Center | Active, not recruiting |
Fort Myers, Florida, United States, 33905 | |
Mayo Clinic | Not yet recruiting |
Jacksonville, Florida, United States, 32224 | |
Contact: Kristin East East.Kristen@mayo.edu | |
Principal Investigator: John Stauffer, MD | |
AdventHealth | Not yet recruiting |
Orlando, Florida, United States, 32803 | |
Contact: Rebecca Iorio, MS Rebecca.Iorio@AventHealth.com | |
Principal Investigator: Mohamedtaki Tejani, MD | |
Moffitt Cancer Center | Not yet recruiting |
Tampa, Florida, United States, 33612 | |
Contact: Erin Scott erin.scott@moffitt.org | |
Principal Investigator: Dae Won Kim, MD | |
Sub-Investigator: Jason Fleming, MD | |
Sub-Investigator: Sarah Hoffe, MD | |
United States, Minnesota | |
Mayo Clinic | Not yet recruiting |
Rochester, Minnesota, United States, 55906 | |
Contact: Lisa Seymour Seymour.Lisa@mayo.edu | |
Principal Investigator: Susanne Warner, MD | |
United States, Ohio | |
Ohio State University | Active, not recruiting |
Columbus, Ohio, United States, 43210 | |
United States, Virginia | |
University of Virginia | Recruiting |
Charlottesville, Virginia, United States, 22903 | |
Contact: Sallie Mannen 434-297-5724 sbm8qz@virginia.edu | |
Principal Investigator: Tri M Le, MD | |
Mexico | |
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran | Active, not recruiting |
Mexico City, Mexico, 14080 |
Responsible Party: | Candel Therapeutics, Inc. |
ClinicalTrials.gov Identifier: | NCT02446093 |
Other Study ID Numbers: |
PaTK02 |
First Posted: | May 18, 2015 Key Record Dates |
Last Update Posted: | December 9, 2022 |
Last Verified: | December 2022 |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
Borderline resectable pancreatic adenocarcinoma Immunotherapy Aglatimagene besadenovec Neoadjuvant CAN-2409 |
Adenocarcinoma Carcinoma Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms |