54 Participants Needed

CAN-2409 + Chemoradiation/SBRT for Pancreatic Cancer

(PaTK02 Trial)

Recruiting at 7 trial locations
GN
AM
Overseen ByAndrea Manzanera, MD, MPH
Stay on Your Current MedsYou can continue your current medications while participating
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial

Trial Summary

Do I need to stop taking my current medications for the trial?

The trial does not specify if you need to stop taking your current medications, but you cannot participate if you are on systemic corticosteroids, immunomodulators, or immunosuppressive drugs.

What data supports the effectiveness of the treatment CAN-2409 + Chemoradiation/SBRT for Pancreatic Cancer?

Research shows that Stereotactic Body Radiation Therapy (SBRT) can deliver high doses of radiation to pancreatic tumors while sparing surrounding tissues, potentially improving tumor control and patient outcomes. Studies indicate that using SBRT in combination with chemotherapy may lead to better survival rates and higher chances of successful tumor removal compared to chemotherapy alone.12345

Is the combination of CAN-2409 and SBRT safe for humans?

Research on stereotactic body radiation therapy (SBRT) for pancreatic cancer suggests it can be safe, as it delivers high doses of radiation to tumors while sparing surrounding tissues, potentially reducing side effects compared to conventional methods.15678

How is the treatment CAN-2409 + Chemoradiation/SBRT for pancreatic cancer different from other treatments?

The treatment combines CAN-2409 with chemoradiation and stereotactic body radiation therapy (SBRT), which is a novel approach that delivers high doses of radiation precisely to the tumor in a shorter time, minimizing damage to surrounding tissues and allowing for better integration with chemotherapy. This method may improve surgical outcomes and survival rates compared to traditional radiation therapies.1291011

What is the purpose of this trial?

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.

Eligibility Criteria

Adults over 18 with borderline resectable pancreatic cancer, who've had FOLFIRINOX chemotherapy for at least 4 months and are healthy enough for major surgery. They should have no distant metastasis or lymph node involvement outside the planned surgery area, and their tumor must be accessible for injection. Key health metrics like liver function, kidney clearance, blood cell counts need to be within specific ranges.

Inclusion Criteria

My tumor can be reached for treatment and might be removable after specific chemotherapy.
My cancer has not spread to distant areas or lymph nodes outside the surgery area.
My cancer involves major veins near my intestines but surgery is possible.
See 16 more

Exclusion Criteria

I do not have any current cancer except for skin cancer.
Known sensitivity or allergic reactions to acyclovir or valacyclovir
Known to be HIV+
See 6 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Induction Therapy

Participants receive at least 4 months (8 cycles) of a FOLFIRINOX based induction therapy

16 weeks

Treatment

Participants receive three courses of CAN-2409 + prodrug, with 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

12 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

24 months

Long-term Follow-up

Participants are followed for disease-free survival and overall survival

60 months

Treatment Details

Interventions

  • Aglatimagene besadenovec
  • Chemoradiation
  • GMCI (aglatimagene besadenovec + valacyclovir)
  • Stereotactic body radiation therapy
Trial Overview The trial is testing CAN-2409 plus a prodrug (valacyclovir or acyclovir) in patients undergoing neoadjuvant chemoradiation (CR) or stereotactic body radiation therapy (SBRT), followed by surgery. The goal is to assess safety, effectiveness, and immune response compared to standard care.
Participant Groups
2Treatment groups
Experimental Treatment
Active Control
Group I: Test ArmExperimental Treatment4 Interventions
CAN-2409 + prodrug (valacylovir or acyclovir) in combination with neoadjuvant chemoradiation or SBRT + Surgery
Group II: Control ArmActive Control3 Interventions
Neoadjuvant chemoradiation or SBRT + Surgery

Chemoradiation is already approved in China for the following indications:

🇨🇳
Approved in China as Baizean for:
  • Classical Hodgkin’s lymphoma (cHL)
  • Locally advanced or metastatic urothelial carcinoma (UC)
  • Locally advanced or metastatic non-small cell lung cancer (NSCLC)
  • Advanced unresectable or metastatic microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) solid tumors
  • Locally advanced or metastatic esophageal squamous cell carcinoma (ESCC)
  • Recurrent or metastatic nasopharyngeal cancer (NPC)

Find a Clinic Near You

Who Is Running the Clinical Trial?

Candel Therapeutics, Inc.

Lead Sponsor

Trials
12
Recruited
1,300+

Mayo Clinic

Collaborator

Trials
3,427
Recruited
3,221,000+

Ohio State University

Collaborator

Trials
891
Recruited
2,659,000+

Findings from Research

Stereotactic body radiotherapy (SBRT) is an effective treatment for pancreatic cancer, showing good tolerance and disease control, and may become a standard treatment option alongside chemoradiotherapy (CRT).
The combination of SBRT with chemotherapy could enhance treatment effects, although optimal doses and fractionation schedules for SBRT have yet to be established.
Stereotactic body radiotherapy in pancreatic adenocarcinoma.de la Pinta, C.[2023]
The use of neoadjuvant stereotactic body radiation therapy (SBRT) for pancreatic cancer is on the rise, increasing from 0% in 2004 to 9.5% in 2015, particularly in patients with more advanced disease.
Patients receiving neoadjuvant chemo-SBRT showed improved overall survival rates and higher rates of R0 resection compared to those receiving chemotherapy or conventional radiation therapy, suggesting that SBRT may offer significant benefits in treatment outcomes.
Neoadjuvant stereotactic body radiation therapy for nonmetastatic pancreatic adenocarcinoma.Jiang, W., Haque, W., Verma, V., et al.[2023]
Stereotactic body radiation therapy (SBRT) is emerging as a promising treatment for pancreatic cancer (PCA), particularly for patients with locally advanced, unresectable disease, offering potentially better tumor control compared to traditional chemotherapy and chemoradiation.
Early studies of SBRT using multiple doses (3-5) have shown favorable outcomes with improved tumor control and manageable toxicity rates, suggesting it may be a viable alternative to current standard treatments.
Stereotactic body radiation therapy in pancreatic cancer: the new frontier.Moningi, S., Marciscano, AE., Rosati, LM., et al.[2014]

References

Stereotactic body radiotherapy in pancreatic adenocarcinoma. [2023]
Neoadjuvant stereotactic body radiation therapy for nonmetastatic pancreatic adenocarcinoma. [2023]
Pattern of Marginal Local Failure in a Phase II Trial of Neoadjuvant Chemotherapy and Stereotactic Body Radiation Therapy for Resectable and Borderline Resectable Pancreas Cancer. [2019]
Stereotactic body radiation therapy in pancreatic cancer: the new frontier. [2014]
Stereotactic body radiation therapy boost in locally advanced pancreatic cancer. [2018]
Stereotactic body radiation therapy with concurrent full-dose gemcitabine for locally advanced pancreatic cancer: a pilot trial demonstrating safety. [2022]
Patient-reported outcomes of a multicenter phase 2 study investigating gemcitabine and stereotactic body radiation therapy in locally advanced pancreatic cancer. [2022]
Stereotactic Body Radiation Therapy for Locally Advanced Pancreatic Cancer: A Systematic Review and Pooled Analysis of 19 Trials. [2023]
Stereotactic Body Radiation Therapy (SBRT) for Unresectable Pancreatic Carcinoma. [2021]
Stereotactic body radiation vs. intensity-modulated radiation for unresectable pancreatic cancer. [2022]
11.United Statespubmed.ncbi.nlm.nih.gov
Stereotactic Body Radiation Therapy (SBRT) Combined With Chemotherapy for Unresected Pancreatic Adenocarcinoma. [2022]
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