Neoadjuvant GMCI Plus Chemoradiation for Advanced Non-Metastatic Pancreatic Adenocarcinoma
- Pathological diagnosis of pancreatic adenocarcinoma adequately treated with induction chemotherapy for at least 2 months such that they are a candidate for localized therapy with chemoradiation followed by surgery with or without major vascular resection.
- Patients must be deemed to be in adequate health to undergo major surgery (pancreaticoduodenectomy)
- Tumor accessible for injection that is classified as borderline-resectable or locally advanced but considered potentially resectable after central review by surgical investigators (based upon pre-induction chemotherapy imaging). Resection may include major vascular resection with reconstruction as needed.
- Age 18-76 years
- Performance status ECOG 0-1
- SGOT (AST)<3x upper limit of normal
- Total bilirubin ≤2mg/dl
- Calculated creatinine clearance >30ml/m
- Absolute neutrophil count (ANC)>1500/mm3
- Hemoglobin > 9 g/dL.
- Patients must give study specific informed consent prior to enrollment
- Primary hepatic dysfunction including known cirrhosis or active hepatitis. Patients with biliary obstruction must be stented prior to initiating treatment.
- Evidence of clinically significant pancreatitis as determined by the investigator
- Evidence of significant ascites as determined by the investigator
- Patients on systemic corticosteroids (>10 mg prednisone per day or equivalent) or other systemic immunosuppressive drugs
- Known to be HIV+
- Pregnant or breast-feeding. Female patients of childbearing age must have negative serum or urine pregnancy test within 1 week of beginning therapy.
- Other current malignancy (except squamous or basal cell skin cancers)
- Other serious co-morbid illness or compromised organ function
- Known sensitivity or allergic reactions to acyclovir or valacyclovir
GMCI involves the injection of aglatimagene besadenovec (AdV-tk) into the tumor followed by
oral valacyclovir pills to kill tumor cells and stimulate a cancer vaccine effect. The
current protocol is designed to deliver multiple courses of GMCI in combination with standard
of care chemoradiation and surgery to capitalize on the synergies with the different
This protocol includes two phases:
- Phase 1b - completed.
- The Phase 2 is a randomized study comparing a test group receiving GMCI added to
chemoradiation and surgery to a control arm receiving chemoradiation followed by
surgery. Participants will be randomized in a 1:1 ratio to GMCI plus standard of care or
standard of care alone. Both arms receive standard of care treatment and evaluations.
Trial Phase Phase II
Trial Type Treatment
Candel Therapeutics, Inc.
- Primary ID PaTK02
- Secondary IDs NCI-2015-00859
- Clinicaltrials.gov ID NCT02446093