Intratumoral Gene Mediated Cytotoxic Immunotherapy in Patients With Resectable Non-Small Cell Lung Cancer
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|ClinicalTrials.gov Identifier: NCT03131037|
Recruitment Status : Unknown
Verified January 2021 by Candel Therapeutics, Inc..
Recruitment status was: Active, not recruiting
First Posted : April 27, 2017
Last Update Posted : January 27, 2021
|Condition or disease||Intervention/treatment||Phase|
|Lung Cancer||Biological: AdV-tk (aglatimagene besadenovec) + valacyclovir||Phase 1|
The purpose of this open-label, dose escalation clinical trial is to investigate the safety of GMCI prior to surgery in patients with NSCLC. GMCI involves the use of aglatimagene besadenovec (AdV-tk) injected into the tumor followed by oral valacyclovir prodrug to kill tumor cells and stimulate a cancer vaccine effect. Killing tumor cells in an immune stimulatory environment induces the body's immune system to detect and destroy cancer cells. GMCI has been well tolerated in previous trials in multiple tumor types with clinical, pathologic and immune responses.
AdV-tk will be injected intratumorally on day 0 during a standard of care staging procedure. The prodrug, valacyclovir, will be administered orally at a fixed dose for 14 days following the AdV-tk injection. Then standard of care surgical resection will be performed about 3 weeks after the AdV-tk injection. Chemotherapy and/or radiation may begin 6-8 weeks after resection surgery. Choice of chemotherapy depends on the treating oncologist.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||12 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Masking Description:||Open Label|
|Official Title:||Intratumoral Gene Mediated Cytotoxic Immunotherapy (GMCI) For Resectable Non-Small Cell Lung Cancer|
|Actual Study Start Date :||May 4, 2017|
|Estimated Primary Completion Date :||December 2021|
|Estimated Study Completion Date :||May 2022|
Experimental: Study Arm
AdV-tk (aglatimagene besadenovec) + valacyclovir
Biological: AdV-tk (aglatimagene besadenovec) + valacyclovir
AdV-tk will be administered intratumorally followed by oral valacyclovir. Valacyclovir will be administered orally at a fixed dose for 14 days after each AdV-tk administration.
- Safety [ Time Frame: 6 weeks ]Safety based on standard laboratory and clinical adverse event monitoring.
- Immunologic changes [ Time Frame: 12 months ]The effect of GMCI on the histology and immune profile of the resected tumor. Systemic and intratumoral cytokine responses will also be assessed.
- Progression free survival (PFS) [ Time Frame: 5 years ]The PFS curves will be estimated using the Kaplan-Meier method.
- Overall survival (OS) [ Time Frame: 5 years ]The OS curves will be estimated using the Kaplan-Meier method.
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): NCT03131037
|United States, Pennsylvania|
|University of Pennsylvania|
|Philadelphia, Pennsylvania, United States, 19104|