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Clinical Trials Search at Vanderbilt-Ingram Cancer Center



A Safety and Efficacy Study of Treatment Combinations With and Without Chemotherapy in Adult Participants With Advanced Upper Gastrointestinal Tract Malignancies

Multiple Cancer Types

This is a Phase 2, open-label, parallel 3-cohort, multicenter study to evaluate the safety
and preliminary clinical activity of treatment combinations with and without chemotherapy in
participants with locally advanced unresectable or metastatic gastric, GEJ, and esophageal
adenocarcinoma. Chemotherapy will consist of FOLFOX (oxaliplatin, leucovorin, fluorouracil).
Esophageal, Gastric/Gastroesophageal, Gastrointestinal
II
Gibson, Mike
NCT05329766
VICCGI2240

pB1-11 and TA-HPV Vaccines Combined with Pembrolizumab for the Treatment of Recurrent or Metastatic PD-L1 and HPV Positive Oropharyngeal Cancer

Head/Neck

This phase II trial tests how well pB1-11 and human papillomavirus tumor antigen (TA-HPV) vaccines in combination with pembrolizumab work in treating patients with oropharyngeal cancer that has come back (recurrent) or that has spread from where it first started (primary site) to other places in the body (metastatic) and that is PD-L1 and human papillomavirus (HPV) positive. Oropharyngeal cancer is a type of head and neck cancer involving structures in the back of the throat (the oropharynx), such as the non-bony back roof of the mouth (soft palate), sides and back wall of the throat, tonsils, and back third of the tongue. Scientists have found that some strains or types of a virus called HPV can cause oropharyngeal cancer. pBI-11 is a circular deoxyribonucleic acid (DNA) (plasmid) vaccine that promotes antibody, cytotoxic T cell, and protective immune responses. TA-HPV is an investigational recombinant vaccina virus derived from a strain of the vaccina virus which was widely used for smallpox vaccination. Vaccination with this TA-HPV vaccine may stimulate the immune system to mount a cytotoxic T cell response against tumor cells positive for HPV, resulting in decreased tumor growth. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread by inhibiting the PD-1 receptor. These investigational vaccines could cause or enhance an immune response in the body against HPV, during which time the activity of pembrolizumab against oropharyngeal cancer associated with HPV may be strengthened. These drugs in combination may be more effective in increasing the ability of the immune system to fight oropharyngeal cancer than pembrolizumab alone.
Head/Neck
II
Gibson, Mike
NCT05799144
VICCHN2208

Ramucirumab and Trifluridine/Tipiracil or Paclitaxel for the Treatment of Patients with Previously Treated Advanced Gastric or Gastroesophageal Junction Cancer

Gastric/Gastroesophageal

This phase II trial studies the effect of the combination of ramucirumab and trifluridine/tipiracil or paclitaxel in treating patients with previously treated gastric or gastroesophageal junction cancer that has spread to other places in the body (advanced). Ramucirumab may damage tumor cells by targeting new blood vessel formation. Trifluridine/tipiracil is a chemotherapy pill and that may damage tumor cells by damaging their deoxyribonucleic acid (DNA). Paclitaxel may block cell growth by stopping cell division which may kill tumor cells. Giving ramucirumab and trifluridine/tipiracil will not be worse than ramucirumab and paclitaxel in treating gastric or gastroesophageal junction cancer.
Gastric/Gastroesophageal
II
Gibson, Mike
NCT04660760
VICCGI2168

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