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CAN-2409 + Chemoradiation/SBRT for Pancreatic Cancer (PaTK02 Trial)

Phase 2
Waitlist Available
Research Sponsored by Candel Therapeutics, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
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
No distant metastasis or lymph node involvement outside the planned resection field
Must not have
Other current malignancy (except squamous or basal cell skill cancers)
Subjects on systemic corticosteroid (>10 mg prednisone per day or equivalent), systemic immunomodulators, or other systemic immunosuppressive drugs
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 60 months
Awards & highlights
No Placebo-Only Group

Summary

This trial is testing a new immunotherapy treatment for pancreatic cancer that has shown promise in earlier trials. The new treatment will be given in combination with standard chemotherapy and radiation, and the goal is to see if it improves outcomes for patients with pancreatic cancer.

Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
Potential side effects may include reactions related to the immune system's activation such as flu-like symptoms, fatigue, allergic reactions to medication components like acyclovir or valacyclovir, and typical risks associated with chemoradiation such as nausea and skin irritation.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My cancer is near the liver artery but hasn't reached the main stomach artery.
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My cancer has not spread to distant areas or lymph nodes outside the surgery area.
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My cancer involves major veins near my intestines but surgery is possible.
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My kidneys are functioning well enough to clear waste.
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My tumor touches less than half of the main artery's outer wall.
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I am older than 18 years.
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I am healthy enough to undergo major surgery.
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I am fully active or can carry out light work.
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I have pancreatic cancer treated with FOLFIRINOX for 4+ months and am now eligible for specific local therapy and possibly surgery.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I do not have any current cancer except for skin cancer.
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I am taking more than 10 mg of prednisone daily or similar drugs.
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My doctor has found a significant buildup of fluid in my abdomen.
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I have liver issues like cirrhosis or hepatitis, or I've had a bile duct blockage treated with a stent.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~60 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 60 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Safety grade by CTCAE version 4.0
Survival Rate
Secondary study objectives
Disease free survival (DFS) in subjects with R0 resection
Immunological biomarker characterization in tumor and peripheral blood
Overall survival (OS) from time of diagnosis
+4 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

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
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Surgery
2000
Completed Phase 3
~2490
Chemoradiation
2006
Completed Phase 3
~990
Stereotactic body radiation therapy
2017
Completed Phase 1
~30

Find a Location

Who is running the clinical trial?

Candel Therapeutics, Inc.Lead Sponsor
11 Previous Clinical Trials
1,219 Total Patients Enrolled
Mayo ClinicOTHER
3,362 Previous Clinical Trials
3,065,907 Total Patients Enrolled
Ohio State UniversityOTHER
871 Previous Clinical Trials
655,678 Total Patients Enrolled

Media Library

Chemoradiation Clinical Trial Eligibility Overview. Trial Name: NCT02446093 — Phase 2
Pancreatic Cancer Research Study Groups: Test Arm, Control Arm
Pancreatic Cancer Clinical Trial 2023: Chemoradiation Highlights & Side Effects. Trial Name: NCT02446093 — Phase 2
Chemoradiation 2023 Treatment Timeline for Medical Study. Trial Name: NCT02446093 — Phase 2
~5 spots leftby Dec 2025
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