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

Q: What medical condition is GMCI (aglatimagene besadenovec + valacyclovir) primarily designed to address?

<p>GMCI has been proven to successfully treat <a href="https://www.withpower.com/clinical-trials/genital-herpes">genital herpes</a>, <a href="https://www.withpower.com/clinical-trials/hiv">HIV</a>-1 infection, and the oral affliction known as herpes labialis.</p>

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 60 months

Awards & highlights

PaTK02 Trial 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.Check my eligibility

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.See study design

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.

PaTK02 Trial 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.

PaTK02 Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 60 months

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Safety grade by CTCAE version 4.0

Survival Rate

Secondary outcome measures

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

PaTK02 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

Chemoradiation

2006

Completed Phase 3

~990

Surgery

2000

Completed Phase 3

~2550

Stereotactic body radiation therapy

2017

Completed Phase 1

~30

0 / 9Eligibility criteria met

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

3,205 Previous Clinical Trials

3,766,730 Total Patients Enrolled

Ohio State UniversityOTHER

827 Previous Clinical Trials

502,697 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Could you please elaborate on the research that has been conducted in regard to combining aglatimagene besadenovec and valacyclovir?

"Since its initial exploration in 2006 at the University of Texas MD Anderson Cancer Center, GMCI (aglatimagene besadenovec + valacyclovir) has been studied in 307 separate trials. Presently there are 13 active studies being conducted across numerous cities, with a concentration near Jacksonville, Minnesota."

Answered by AI

What goals is this investigation endeavoring to accomplish?

"This clinical trial will evaluate the 30-day Survival Rate following CAN-2409 administration with valacyclovir. Secondary endpoints include Progression Free Survival (PFS) from time of diagnosis, Overall Survival (OS) from enrollment in the study and PFS from when participants join the program."

Answered by AI

Does this trial introduce any groundbreaking procedures?

"Since the initial 2006 study conducted by Millennium Pharmaceuticals, Inc., GMCI (aglatimagene besadenovec + valacyclovir) has been subject to 13 trials in 126 cities across 4 nations. After its successful Phase 2 drug approval following that first research project, further investigation into this compound is ongoing."

Answered by AI

How many healthcare facilities are involved in executing this trial?

"There are 5 clinical trial sites participating in this study, located in Jacksonville, Rochester and Tampa among other localities. It is advised that participants choose the site nearest to them to reduce travel demands."

Answered by AI

Has the Federal Drug Administration sanctioned the use of GMCI therapy?

"There is evidence to suggest the safety of GMCI (aglatimagene besadenovec + valacyclovir), thus, it was given a rating of 2. This score is based on the fact that this drug has completed Phase 2 trials but have yet to demonstrate efficacy."

Answered by AI

Does this trial take into consideration individuals under 35 years of age?

"This study requires that participants are aged between 18 and 76."

Answered by AI

What medical condition is GMCI (aglatimagene besadenovec + valacyclovir) primarily designed to address?

"GMCI has been proven to successfully treat genital herpes, HIV-1 infection, and the oral affliction known as herpes labialis."

Answered by AI

Are there any eligibility criteria for me to be included in this trial?

"Eligibility requirements for this study include adenocarcinoma and ages 18-76, with a goal of enrolling 54 participants."

Answered by AI

Is this experiment still welcoming participants?

"Affirmative. The information posted on clinicaltrials.gov shows that this trial is actively recruiting participants, having first been put up for public scrutiny on October 1st 2015 and being edited as recently as December 4th 2022. 54 volunteers are needed from 5 different medical sites to participate in the study."

Answered by AI

How many individuals are taking part in this medical experiment?

"54 fitting individuals must be found to join this experiment. Mayo Clinic in Jacksonville, Minnesota and Moffitt Cancer Center in Rochester, Virginia are two of the many potential study sites for those looking to participate."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2015. "Neoadjuvant CAN-2409 in Combination With Chemoradiation or SBRT for Borderline Resectable Pancreatic Adenocarcinoma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02446093.

All > Adenocarcinoma > Virginia