Clinical Trials Search at Vanderbilt-Ingram Cancer Center

The goal of this clinical study is to compare the study drug, axicabtagene ciloleucel, versus
standard of care (SOC) in first-line therapy in participants with high-risk large B-cell
lymphoma.

The purpose of this study is to find out whether the study drug, LY3537982, is safe and
effective in cancer patients who have a specific genetic mutation (KRAS G12C). Patients must
have already received or were not able to tolerate the standard of care, except for specific
groups who have not had cancer treatment. The study will last up to approximately 4 years.

This study is a Phase 1/2, multicenter, dose-escalation, open-label trial to assess safety,
tolerability, pharmacokinetics and pharmacodynamics of TP-3654 in patients with intermediate
or high-risk primary or secondary MF.

This phase II trial tests the safety, side effects, best dose and activity of tovorafenib (DAY101) in treating patients with Langerhans cell histiocytosis that is growing, spreading, or getting worse (progressive), has come back (relapsed) after previous treatment, or does not respond to therapy (refractory). Langerhans cell histiocytosis is a type of disease that occurs when the body makes too many immature Langerhans cells (a type of white blood cell). When these cells build up, they can form tumors in certain tissues and organs including bones, skin, lungs and pituitary gland and can damage them. This tumor is more common in children and young adults. DAY101 may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Using DAY101 may be effective in treating patients with relapsed or refractory Langerhans cell histiocytosis.

This phase II trial studies how well stopping anti-HER2 therapy works in improving outcomes of patients with HER2-positive breast cancer that has spread from where it first started (primary site) to other places in the body (metastatic) and have experienced long-term benefit from first-line treatment (exceptional responders). Patients with metastatic HER2-positive breast cancer are currently treated with systemic drugs indefinitely. These drugs include chemotherapy and/or biological agents targeting the HER2 protein. The first drug combination administered after diagnosis of metastatic spread (i.e., first-line treatment) usually combines chemotherapy with anti-HER2 agents (trastuzumab with or without pertuzumab). Chemotherapy is administered for a limited number of months, and anti-HER2 agents are continued indefinitely as maintenance therapy. Some of these patients experience a long-term benefit from first-line treatment without cancer growth and can be defined as exceptional responders. Nevertheless, all patients with this type of tumor typically continue maintenance treatment with anti-HER2 therapy indefinitely. Exceptional responders usually receive treatment for many years. Information learned from this trial may help researchers understand whether maintenance anti-HER2 treatment can be safely stopped in patients with exceptional response to first-line therapy.

This phase II/III trial tests the role of DNA released from tumor cells into the blood in guiding the use of immunotherapy (nivolumab alone or with relatlimab) after surgical removal of the bladder for bladder cancer treatment. DNA is material found inside all of our cells that acts as a blueprint for how cells function. Tumor cells often have abnormal DNA that looks different than DNA in normal cells. A new test called Signatera has been developed that can detect bladder cancer DNA in the blood which might indicate the presence of bladder tumor cells somewhere in the body. Immunotherapy with monoclonal antibodies, such as nivolumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Relatlimab is a monoclonal antibody that may interfere with the ability of tumor cells to grow and spread. This trial may help doctors determine if the Signatera test can better identify which patients need an additional treatment with immunotherapy to help prevent bladder cancer from coming back after surgery.

This phase III trial studies how well the addition of radiotherapy to the usual treatment (chemotherapy) works compared to the usual treatment alone in treating patients with esophageal and gastric cancer that has spread to a limited number of other places in the body (oligometastatic disease). Radiotherapy uses high energy x-rays, gamma rays, or protons to kill tumor cells and shrink tumors. Drugs used in usual chemotherapy, such as leucovorin, 5-fluorouracil, oxaliplatin, and capecitabine 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. Immunotherapy with monoclonal antibodies, such as nivolumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Adding radiotherapy to the usual chemotherapy may work better compared to the usual chemotherapy alone in treating patients with esophageal and gastric cancer.

This phase III trial compares the addition of total ablative therapy to the usual systemic therapy versus the usual systemic therapy alone in treating patients with advanced colorectal cancer that has spread to up to 4 body sites (limited metastatic). The usual approach for patients who are not participating in a study is treatment with intravenous (through a vein) and/or oral medications (systemic therapy) to help stop the cancer sites from getting larger and the spread of the cancer to additional body sites. The ablative local therapy will consist of very focused, intensive radiotherapy called stereotactic ablative radiotherapy (SABR) with or without surgical resection and/or microwave ablation, which is a procedure where a needle is temporarily inserted in the tumor and heat is used to destroy the cancer cells. The addition of ablative local therapy to the usual approach of systemic therapy could be more effective than usual chemotherapy alone by increasing the life of patients with limited metastatic colorectal cancer.

This phase II trial studies how well cabozantinib works in combination with nivolumab and ipilimumab in treating patients with rare genitourinary (GU) tumors that that has spread from where it first started (primary site) to other places in the body. Cabozantinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Immunotherapy with monoclonal antibodies, such as nivolumab and ipilimumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving cabozantinib, nivolumab, and ipilimumab may work better in treating patients with genitourinary tumors that have no treatment options compared to giving cabozantinib, nivolumab, or ipilimumab alone.

This phase III trial compares standard chemotherapy to therapy with liposome-encapsulated daunorubicin-cytarabine (CPX-351) and/or gilteritinib for patients with newly diagnosed acute myeloid leukemia with or without FLT3 mutations. Drugs used in chemotherapy, such as daunorubicin, cytarabine, and gemtuzumab ozogamicin, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. CPX-351 is made up of daunorubicin and cytarabine and is made in a way that makes the drugs stay in the bone marrow longer and could be less likely to cause heart problems than traditional anthracycline drugs, a common class of chemotherapy drug. Some acute myeloid leukemia patients have an abnormality in the structure of a gene called FLT3. Genes are pieces of DNA (molecules that carry instructions for development, functioning, growth and reproduction) inside each cell that tell the cell what to do and when to grow and divide. FLT3 plays an important role in the normal making of blood cells. This gene can have permanent changes that cause it to function abnormally by making cancer cells grow. Gilteritinib may block the abnormal function of the FLT3 gene that makes cancer cells grow. The overall goals of this study are, 1) to compare the effects, good and/or bad, of CPX-351 with daunorubicin and cytarabine on people with newly diagnosed AML to find out which is better, 2) to study the effects, good and/or bad, of adding gilteritinib to AML therapy for patients with high amounts of FLT3/ITD or other FLT3 mutations and 3) to study changes in heart function during and after treatment for AML. Giving CPX-351 and/or gilteritinib with standard chemotherapy may work better in treating patients with acute myeloid leukemia compared to standard chemotherapy alone.