Clinical Trials Using Aglatimagene Besadenovec
Clinical trials are research studies that involve people. The clinical trials on this list are studying Aglatimagene Besadenovec. All trials on the list are supported by NCI.
NCI’s basic information about clinical trials explains the types and phases of trials and how they are carried out. Clinical trials look at new ways to prevent, detect, or treat disease. You may want to think about taking part in a clinical trial. Talk to your doctor for help in deciding if one is right for you.
Phase 3 Study of ProstAtak® Immunotherapy With Standard Radiation Therapy for Localized Prostate Cancer
The purpose of this study is to evaluate the effectiveness of ProstAtak® immunotherapy in combination with radiation therapy for patients with intermediate-high risk localized prostate cancer. ProstAtak kills tumor cells and stimulates a cancer vaccine effect. Killing tumor cells in an immune stimulatory environment induces the body's immune system to detect and destroy cancer cells. ProstAtak has shown synergy with radiation without added toxicity and lower than expected recurrence rates in previous clinical trials. The hypothesis is that ProstAtak can lead to improvement in the clinical outcome for patients with prostate cancer. Participants will be randomized to the ProstAtak or control arm at a 2:1 ratio. Both arms receive standard external beam radiation therapy. Short-term androgen deprivation therapy may be given but is not required.
Location: 8 locations
GMCI, Nivolumab, Radiation Therapy, and Temozolomide in Treating Patients with Newly Diagnosed High-Grade Gliomas
This phase I trial studies the side effects and best dose of aglatimagene besadenovec and valacyclovir (gene mediated cytotoxic immunotherapy [GMCI]), nivolumab, radiation therapy, and temozolomide in treating patients with newly diagnosed high-grade gliomas. Aglatimagene besadenovec and valacyclovir may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors. Drugs used in chemotherapy, such as temozolomide, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving GMCI, nivolumab, radiation therapy, and temozolomide may work better in treating patients with high-grade gliomas.
Location: 7 locations
GMCI Plus Standard of Care Immune Checkpoint Inhibitor for Stage III / IV NSCLC
The purpose of this phase 2 multi-site trial is to evaluate the safety and efficacy of adding Gene Mediated Cytotoxic Immunotherapy (GMCI™) to standard of care in patients with stage III / IV NSCLC that are not responding to a first line immune checkpoint inhibitor (ICI). 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. Patients will receive two courses of GMCI with aglatimagene besadenovec injected into an accessible involved tumor site followed by 14 days of oral valacyclovir. Patients will continue with standard of care ICI, plus chemotherapy if indicated. The hypothesis is that the combination of GMCI and ICI may improve the response rate and overall clinical long-term benefit for NSCLC patients.
Location: Laura and Isaac Perlmutter Cancer Center at NYU Langone, New York, New York
Neoadjuvant GMCI Plus Chemoradiation for Advanced Non-Metastatic Pancreatic Adenocarcinoma
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.
Location: Ohio State University Comprehensive Cancer Center, Columbus, Ohio