Clinical Trials Logo

Clinical 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 (SBRT). The Standard of Care (SOC) Control arm will be used as a benchmark for informal comparisons of efficacy, safety, and biomarkers.


Clinical Trial 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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT02446093
Study type Interventional
Source Candel Therapeutics, Inc.
Contact
Status Active, not recruiting
Phase Phase 2
Start date October 2015
Completion date July 2026

See also
  Status Clinical Trial Phase
Recruiting NCT04940286 - Gemcitabine, Nab-paclitaxel, Durvalumab, and Oleclumab Before Surgery for the Treatment of in Resectable/Borderline Resectable Primary Pancreatic Cancer Phase 2
Completed NCT02394535 - Nab-Paclitaxel, Capecitabine, and Radiation Therapy Following Induction Chemotherapy in Treating Patients With Locally Advanced Pancreatic Cancer Phase 1
Suspended NCT05688215 - Zimberelimab and Quemliclustat in Combination With Chemotherapy for the Treatment of Patients With Borderline Resectable and Locally Advanced Pancreatic Adenocarcinoma Phase 1/Phase 2
Recruiting NCT05083247 - Preoperative mFOLFIRINOX (or Gem-Nab-P) +/- Isotoxic High-dose SBRT for Borderline Resectable Pancreatic Adenocarcinoma Phase 2
Recruiting NCT03970252 - Nivolumab in Combination With Chemotherapy Pre-Surgery in Treating Patients With Borderline Resectable Pancreatic Cancer Early Phase 1
Recruiting NCT04484909 - NBTXR3 Activated by Radiation Therapy for the Treatment of Locally Advanced or Borderline-Resectable Pancreatic Cancer Phase 1
Terminated NCT05546411 - A Trial of NIS793 With FOLFIRINOX in Pancreatic Cancer Phase 2
Active, not recruiting NCT04423731 - Neoadjuvant Chemotherapy in Borderline Resectable and Locally Advanced Pancreatic Cancer
Active, not recruiting NCT04669197 - Study of Paclitaxel Protein Bound + Gemcitabine + Cisplatin + Hydrochloroquine as Treatment in Untreated Pancreas Cancer Phase 2
Active, not recruiting NCT04106856 - Losartan and Hypofractionated Rx After Chemo for Tx of Borderline Resectable or Locally Advanced Unresectable Pancreatic Cancer (SHAPER) Phase 1
Recruiting NCT05825066 - Neoadjuvant Chemotherapy for Borderline Resectable and Locally Advanced Pancreatic Adenocarcinoma Phase 2
Not yet recruiting NCT04915417 - Neoadjuvant Stereotactic Ablative Radiotherapy for Pancreatic Ductal Adenocarcinoma N/A
Recruiting NCT05356039 - Survival, Quality of Life and Resectability in Locally Advanced Pancreatic Cancer
Active, not recruiting NCT04481204 - New and Emerging Therapies for the Treatment of Resectable, Borderline Resectable, or Locally Advanced Pancreatic Cancer, PIONEER-Panc Study Phase 2