Neoadjuvant GMCI Plus Chemoradiation for Advanced Non-Metastatic Pancreatic Adenocarcinoma (PaTK02)

  • STATUS
    Recruiting
  • End date
    Dec 27, 2022
  • participants needed
    38
  • sponsor
    Candel Therapeutics, Inc.
Updated on 25 January 2022
cancer
neutrophil count
tumor cells
metastatic pancreatic adenocarcinoma

Summary

The purpose of this study is to evaluate Gene Mediated Cytotoxic Immunotherapy (GMCI) in combination with standard of care chemoradiation and surgery for borderline resectable and unresectable locally advanced pancreatic cancer in patients who have completed induction chemotherapy. GMCI kills tumor cells and creates an immune stimulatory environment in the tumor. Killing tumor cells in an immune stimulatory environment induces the body's immune system to detect and destroy cancer cells. GMCI has shown synergy with radiation and surgery without added toxicity. The hypothesis is that GMCI added to standard of care chemoradiation and surgery after completion of induction chemotherapy will be safe and will improve the clinical outcome for patients with pancreatic cancer.

Description

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 treatment modalities.

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.

Details
Condition Pancreatic Adenocarcinoma
Treatment Gemcitabine, Radiation, Surgery, Chemotherapy, GMCI, mFOLFIRINOX, GMCI (aglatimagene besadenovec + valacyclovir)
Clinical Study IdentifierNCT02446093
SponsorCandel Therapeutics, Inc.
Last Modified on25 January 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

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
Creatinine<2mg/dl
Calculated creatinine clearance >30ml/m
WBC>3000/mm3
Absolute neutrophil count (ANC)>1500/mm3
Platelets>100,000/mm3
Hemoglobin > 9 g/dL
Patients must give study specific informed consent prior to enrollment

Exclusion Criteria

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
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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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