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Borderline Resectable Pancreatic AdenocarcinomaPhase 2PaTK02NCT02446093

Neoadjuvant CAN-2409 in Combination With Chemoradiation or SBRT for Borderline Resectable Pancreatic Adenocarcinoma

A Phase 2 study testing Aglatimagene besadenovec, Chemoradiation and Stereotactic body radiation therapy in people with Borderline Resectable Pancreatic Adenocarcinoma, run by Candel Therapeutics, Inc. at 3 sites in 2 countries.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Aglatimagene besadenovec, Chemoradiation and Stereotactic body radiation therapy
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
54 participants
Where
3 sitesin 2 countries
Study dates
Oct 2015to Jul 2026
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
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  • 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

Who cannot join

  • 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
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  • 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

Trial locations and contacts

3 sites in 2 countries.

3 sites in 2 countries

United States2 sites

  • Ohio State University

    Columbus, Ohio, 43210

  • Lee Health/Regional Cancer Center

    Fort Myers, Florida, 33905

Other trials in United States

Mexico1 site

  • Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

    Mexico City, 14080

Other trials in Mexico

About this study

Official title: Neoadjuvant CAN-2409 Plus Prodrug in Combination With Chemoradiation or Stereotactic Body Radiation Therapy for Borderline Resectable Pancreatic Adenocarcinoma

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.

Read the 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.

Being tested
Aglatimagene besadenovec, Chemoradiation, Stereotactic body radiation therapy, Surgery
Keywords
Borderline resectable pancreatic adenocarcinoma, Immunotherapy, Aglatimagene besadenovec, Neoadjuvant, CAN-2409

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Aglatimagene besadenovecBiological

    Also called CAN-2409, AdV-tk

    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.

  • ChemoradiationRadiation

    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.

  • Stereotactic body radiation therapyRadiation

    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.

  • SurgeryProcedure or surgery

    Surgical resection should be performed within 8 weeks after completing CR or SBRT.

Study groups in NCT02446093
Study groupRoleWhat they receive
Test ArmExperimentalCAN-2409 + prodrug (valacylovir or acyclovir) in combination with neoadjuvant chemoradiation or SBRT + Surgery
Receives: Biological: Aglatimagene besadenovec; Radiation: Chemoradiation; Radiation: Stereotactic body radiation therapy; Procedure: Surgery
Control ArmActive comparatorNeoadjuvant chemoradiation or SBRT + Surgery
Receives: Radiation: Chemoradiation; Radiation: Stereotactic body radiation therapy; Procedure: Surgery

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Safety grade by CTCAE version 4.0

    Frequency of adverse events.

    Measured: From the time of CAN-2409 administration to 30 days after the last dose of valacyclovir.

  2. Survival Rate

    All eligible subjects will be followed for at least 2 additional years from the completion of primary treatment window.

    Measured: 24 months

Secondary outcomes (7)

  1. Overall survival (OS) from time of diagnosis

    Time from diagnosis until death from any cause.

    Measured: 60 months

  2. Overall survival (OS) from time of study enrollment

    Time from enrollment until death from any cause.

    Measured: 60 months

  3. Progression free survival (PFS) from time of diagnosis

    Time from diagnosis until first objective documentation of progression (local or distant) or death from any cause.

    Measured: 60 months

  4. Progression free survival (PFS) from time of study enrollment

    Time from study enrollment to documented disease progression or death from any cause.

    Measured: 60 months

  5. Resection rate

    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.

    Measured: 12 weeks

  6. Disease free survival (DFS) in subjects with R0 resection

    Disease-free survival (DFS) will be measured from R0 resection until first objective documentation of recurrence or death from any cause.

    Measured: 60 months

  7. Immunological biomarker characterization in tumor and peripheral blood

    Immunophenotyping in the blood and in the tissue.

    Measured: 24 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 May 2015 (estimated)
  2. Study startOct 2015
  3. Primary completionDec 2025 (estimated)
  4. Study completionJul 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
54 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02446093
Sponsor's protocol ID
PaTK02
Acronym
PaTK02
Status last verified
May 2023
First submitted
14 Apr 2015
Last updated
8 Jan 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Aglatimagene besadenovec, Chemoradiation and Stereotactic body radiation therapy in people with Borderline Resectable Pancreatic Adenocarcinoma, run by Candel Therapeutics, Inc. at 3 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 20 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 8 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in United States, Mexico. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02446093.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jan 2024.

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