CAN-2409 + Chemoradiation/SBRT for Pancreatic Cancer

(PaTK02 Trial)

Recruiting at 7 trial locations

Overseen By Andrea Manzanera, MD, MPH

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Candel Therapeutics, Inc.

Must not be taking: Corticosteroids, Immunomodulators, Immunosuppressives

Disqualifiers: Hepatic dysfunction, Pancreatitis, Ascites, HIV, others

Stay on Your Current Meds You can continue your current medications while participating

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 12 weeks

54 Participants Needed

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. ^{1 2 3 4 5}

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. ^{1 5 6 7 8}

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. ^{1 2 9 10 11}

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.

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+

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

Group I: Test Arm Experimental Treatment 4 Interventions

CAN-2409 + prodrug (valacylovir or acyclovir) in combination with neoadjuvant chemoradiation or SBRT + Surgery

Group II: Control Arm Active Control 3 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)

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Stereotactic body radiation therapy in pancreatic cancer: the new frontier. Moningi, S., Marciscano, AE., Rosati, LM., et al.[2014]

Stereotactic body radiation therapy (SBRT) shows promising efficacy for patients with locally advanced pancreatic cancer, with a pooled 1-year overall survival rate of 51.6% and a median overall survival of 17 months based on a systematic review of 19 studies involving 1009 patients.

The treatment also demonstrated a 1-year locoregional control rate of 72.3%, with severe adverse events occurring in less than 10% of patients, suggesting that SBRT is a safe and effective option for inoperable pancreatic cancer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Stereotactic Body Radiation Therapy for Locally Advanced Pancreatic Cancer: A Systematic Review and Pooled Analysis of 19 Trials. Petrelli, F., Comito, T., Ghidini, A., et al.[2023]

Patients with unresectable pancreatic carcinoma have very low survival rates, with less than 5% overall survival at 5 years, even with standard treatments like chemotherapy and radiation.

Stereotactic body radiation therapy (SBRT) offers a promising alternative, delivering treatment in just 3-5 days with minimal disruption to chemotherapy, showing excellent local control and acceptable toxicity, suggesting it could improve patient outcomes and warrants further research.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Stereotactic Body Radiation Therapy (SBRT) for Unresectable Pancreatic Carcinoma. Stauder, MC., Miller, RC.[2021]

Stereotactic body radiation therapy (SBRT) for unresectable pancreatic cancer showed similar overall survival and disease control outcomes compared to conventional intensity modulated radiation therapy (IMRT), based on a retrospective review of 270 patients (44 SBRT and 226 IMRT).

SBRT was associated with significantly lower rates of acute gastrointestinal toxicity, fatigue, and hematologic toxicity compared to IMRT, indicating that SBRT may be a safer and more tolerable treatment option for patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Stereotactic body radiation vs. intensity-modulated radiation for unresectable pancreatic cancer. Park, JJ., Hajj, C., Reyngold, M., et al.[2022]

Stereotactic body radiation therapy (SBRT) combined with chemotherapy for unresectable pancreatic cancer showed a median overall survival of 14.3 months and a local control rate of 79%, indicating its effectiveness in managing this challenging condition.

The treatment was generally well tolerated, with minimal acute toxicity, although there were some severe late toxicities, suggesting that while SBRT is a promising option, careful monitoring for side effects is necessary.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Stereotactic Body Radiation Therapy (SBRT) Combined With Chemotherapy for Unresected Pancreatic Adenocarcinoma. Gurka, MK., Kim, C., He, AR., et al.[2022]

References

1. Singapore pubmed.ncbi.nlm.nih.gov

Stereotactic body radiotherapy in pancreatic adenocarcinoma. [2023]

2. England pubmed.ncbi.nlm.nih.gov

Neoadjuvant stereotactic body radiation therapy for nonmetastatic pancreatic adenocarcinoma. [2023]

3. United States pubmed.ncbi.nlm.nih.gov

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]

4. England pubmed.ncbi.nlm.nih.gov

Stereotactic body radiation therapy in pancreatic cancer: the new frontier. [2014]

5. United States pubmed.ncbi.nlm.nih.gov

Stereotactic body radiation therapy boost in locally advanced pancreatic cancer. [2018]

6. England pubmed.ncbi.nlm.nih.gov

Stereotactic body radiation therapy with concurrent full-dose gemcitabine for locally advanced pancreatic cancer: a pilot trial demonstrating safety. [2022]

7. United States pubmed.ncbi.nlm.nih.gov

Patient-reported outcomes of a multicenter phase 2 study investigating gemcitabine and stereotactic body radiation therapy in locally advanced pancreatic cancer. [2022]

8. United States pubmed.ncbi.nlm.nih.gov

Stereotactic Body Radiation Therapy for Locally Advanced Pancreatic Cancer: A Systematic Review and Pooled Analysis of 19 Trials. [2023]

9. Switzerland pubmed.ncbi.nlm.nih.gov

Stereotactic Body Radiation Therapy (SBRT) for Unresectable Pancreatic Carcinoma. [2021]

10. England pubmed.ncbi.nlm.nih.gov

Stereotactic body radiation vs. intensity-modulated radiation for unresectable pancreatic cancer. [2022]

11. United States pubmed.ncbi.nlm.nih.gov

Stereotactic Body Radiation Therapy (SBRT) Combined With Chemotherapy for Unresected Pancreatic Adenocarcinoma. [2022]