Trial record 2 of 2 for:
candel | Pancreatic Cancer
Neoadjuvant GMCI Plus Chemoradiation for Advanced Non-Metastatic Pancreatic Adenocarcinoma (PaTK02)
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| ClinicalTrials.gov Identifier: NCT02446093 |
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Recruitment Status :
Recruiting
First Posted : May 18, 2015
Last Update Posted : December 7, 2020
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Sponsor:
Candel Therapeutics, Inc.
Collaborator:
Ohio State University
Information provided by (Responsible Party):
Candel Therapeutics, Inc.
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Brief 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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Pancreatic Adenocarcinoma | Biological: GMCI (aglatimagene besadenovec + valacyclovir) Drug: Chemotherapy Radiation: Radiation Procedure: Surgery | Phase 2 |
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.
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 38 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | Neoadjuvant GMCI Plus Chemoradiation for Advanced Non-Metastatic Pancreatic Adenocarcinoma |
| Study Start Date : | October 2015 |
| Estimated Primary Completion Date : | December 2021 |
| Estimated Study Completion Date : | December 2022 |
Resource links provided by the National Library of Medicine
| Arm | Intervention/treatment |
|---|---|
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Experimental: Test Arm
GMCI + chemoradiation + surgery
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Biological: GMCI (aglatimagene besadenovec + valacyclovir)
Three courses of GMCI each involving aglatimagene besadenovec injection into the tumor site followed by 14 days of oral valacyclovir.
Other Names:
Drug: Chemotherapy Standard of care chemotherapy given with radiation Radiation: Radiation Other Name: Standard of care radiation given with chemotherapy Procedure: Surgery Pancreaticoduodenectomy (Whipple)
Other Name: Pancreatic cancer resection |
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Active Comparator: Control Arm
Chemoradiation + surgery
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Drug: Chemotherapy
Standard of care chemotherapy given with radiation Radiation: Radiation Other Name: Standard of care radiation given with chemotherapy Procedure: Surgery Pancreaticoduodenectomy (Whipple)
Other Name: Pancreatic cancer resection |
Primary Outcome Measures :
- Resection rate [ Time Frame: 4 months ]The percentage of patients receiving an R0 resection will be compared between the two arms.
- Safety graded by CTC ver4.0 [ Time Frame: 6 months ]Frequency of adverse events will be compared between the two arms
Secondary Outcome Measures :
- Overall survival [ Time Frame: 2 years ]The percentage of patients alive at 2 years will be compared between the two arms.
- Progression-free survival [ Time Frame: 2 years ]The PFS curves will be estimated using the Kaplan-Meier method.
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| Ages Eligible for Study: | 18 Years to 76 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
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
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02446093
Locations
| United States, Florida | |
| Lee Health/Regional Cancer Center | Recruiting |
| Fort Myers, Florida, United States, 33905 | |
| Contact: Alina A Ward 239-343-9547 alina.ward@LeeHealth.org | |
| Contact: Mark Bloomston, MD (239) 333-0995 mark.bloomston@21co.com | |
| Principal Investigator: Mark Bloomston, M.D | |
| United States, Ohio | |
| Ohio State University | Recruiting |
| Columbus, Ohio, United States, 43210 | |
| Contact: Shona Taylor 614-685-4337 ext 8230 Shona.Taylor@osumc.edu | |
| Contact: Mary Dillhoff, MD 614-293-4583 Mary.Dillhoff@osumc.edu | |
| Principal Investigator: Mary Dillhoff, MD | |
| United States, Virginia | |
| University of Virginia | Recruiting |
| Charlottesville, Virginia, United States, 22903 | |
| Contact: Sallie Mannen 434-297-5724 sbm8qz@virginia.edu | |
| Principal Investigator: Tri M Le, MD | |
| Mexico | |
| Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran | Recruiting |
| Mexico City, Mexico, 14080 | |
| Contact: Luis Uscanga, M.D +52 (55)54870900 ext 4401 luis.uscangad@gmail.com | |
Sponsors and Collaborators
Candel Therapeutics, Inc.
Ohio State University
| Responsible Party: | Candel Therapeutics, Inc. |
| ClinicalTrials.gov Identifier: | NCT02446093 |
| Other Study ID Numbers: |
PaTK02 |
| First Posted: | May 18, 2015 Key Record Dates |
| Last Update Posted: | December 7, 2020 |
| Last Verified: | December 2020 |
Keywords provided by Candel Therapeutics, Inc.:
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pancreas cancer immunotherapy GMCI AdV-tk aglatimagene besadenovec |
Additional relevant MeSH terms:
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Adenocarcinoma Carcinoma Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type |
Neoplasms Valacyclovir Antiviral Agents Anti-Infective Agents |