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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
Sponsor:
Collaborator:
Mayo Clinic
Information provided by (Responsible Party):
Candel Therapeutics, Inc.

Brief Summary:
The purpose of this study is to characterize the safety, preliminary efficacy, and immune biologic activity of CAN-2409 + prodrug (valacyclovir or acyclovir) in subjects with borderline resectable pancreatic cancer who are being treated with neoadjuvant chemoradiation (CR) or stereotactic body radiation therapy (SBRT). The Standard of Care (SOC) Control arm will be used as a benchmark for informal comparisons of efficacy, safety, and biomarkers.

Condition or disease Intervention/treatment Phase
Borderline Resectable Pancreatic Adenocarcinoma Biological: Aglatimagene besadenovec Radiation: Chemoradiation Radiation: Stereotactic body radiation therapy Procedure: Surgery Phase 2

Detailed Description:
Study design is an open-label Phase 2 trial that randomizes subjects with borderline resectable pancreatic adenocarcinoma to received SOC with (Test arm) or without (Control arm) the addition of CAN-2409 + prodrug (2:1 randomization, Test: Control), beginning after completion of at least 4 months (8 cycles) of a FOLFIRINOX based induction therapy. Confirmation of borderline resectable status will be based on central radiologic review following completion of FOLFIRINOX based induction regimen. Upon enrollment, eligible subjects will receive three courses of CAN-2409 + prodrug, the first course starting prior to CR or SBRT, the second course concurrent with CR or just following completion of SBRT, and the third at time of resection. Up to 2 additional courses are allowed at the time of disease recurrence.

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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
Experimental: Test Arm
CAN-2409 + prodrug (valacylovir or acyclovir) in combination with neoadjuvant chemoradiation or SBRT + Surgery
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:
  • CAN-2409
  • AdV-tk

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
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.




Primary Outcome Measures :
  1. 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.

  2. 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.


Secondary Outcome Measures :
  1. Overall survival (OS) from time of diagnosis [ Time Frame: 60 months ]
    Time from diagnosis until death from any cause.

  2. Overall survival (OS) from time of study enrollment [ Time Frame: 60 months ]
    Time from enrollment until death from any cause.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. Immunological biomarker characterization in tumor and peripheral blood [ Time Frame: 24 months ]
    Immunophenotyping in the blood and in the tissue.



Information from the National Library of Medicine

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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:

  1. 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.
  2. Subjects must be deemed to be in adequate health to undergo major surgery (e.g., pancreaticoduodenectomy).
  3. 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
  4. Age > 18 years at the time of consent
  5. Performance status ECOG 0 or 1
  6. SGOT (AST) <3x upper limit normal
  7. 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
  8. Creatinine <2mg/dl
  9. Calculated creatinine clearance > 30ml/min
  10. WBC > 3000/mm^3
  11. Absolute neutrophil count (ANC) > 1000/mm^3
  12. Platelets > 100,000/mm^3
  13. Hemoglobin > 9g/dl
  14. Signed, written informed consent

Exclusion Criteria:

  1. Primary hepatic dysfunction including known cirrhosis or active hepatitis. Subjects with biliary obstruction must be stented prior to initiating treatment
  2. Evidence of clinically significant pancreatitis as determined by the investigator
  3. Evidence of significant ascites as determined by investigator
  4. Subjects on systemic corticosteroid (>10 mg prednisone per day or equivalent), systemic immunomodulators, or other systemic immunosuppressive drugs
  5. Known to be HIV+
  6. Pregnant or breast-feeding. Female subjects of childbearing age must have negative serum or urine pregnancy test within 2 weeks of beginning protocol therapy
  7. Other current malignancy (except squamous or basal cell skill cancers)
  8. Other serious co-morbid illnesses or compromised organ function
  9. Known sensitivity or allergic reactions to acyclovir or valacyclovir

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): NCT02446093


Contacts
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Contact: Garrett Nichols, MD, MS (617)916-5445 gnichols@candeltx.com
Contact: Andrea Manzanera, MD, MPH (617)916-5445 andrea@Candeltx.com

Locations
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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
Sponsors and Collaborators
Candel Therapeutics, Inc.
Mayo Clinic
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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

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Candel Therapeutics, Inc.:
Borderline resectable pancreatic adenocarcinoma
Immunotherapy
Aglatimagene besadenovec
Neoadjuvant
CAN-2409
Additional relevant MeSH terms:
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Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms