Clinical Trials Search at Vanderbilt-Ingram Cancer Center

This open-label, exploratory study is designed to evaluate the safety and efficacy of
targeted therapies or immunotherapy as single agents or combinations, in participants with
metastatic colorectal cancer (mCRC) whose tumors are biomarker positive as per treatment
arm-specific definition. Eligible participants with mCRC will be enrolled into specific
treatment arms based on their biomarker assay results.

This is a multicenter, randomized, open-label, controlled Phase 3 trial of XL092 +
atezolizumab vs regorafenib in subjects with microsatellite stable/microsatellite instability
low (MSS/MSI-low) metastatic colorectal cancer (mCRC) who have progressed during, after or
are intolerant to standard-of-care (SOC) therapy.

The purpose of this study is to evaluate two study medicines (encorafenib plus cetuximab)
taken alone or together with standard chemotherapy for the potential treatment of colorectal
cancer that:

- has spread to other parts of the body (metastatic);

- has a certain type of abnormal gene called "BRAF"; and

- has not received prior treatment.

Participants in this study will receive one of the following study treatments:

- Encorafenib plus cetuximab: These participants will receive encorafenib by mouth at home
every day and cetuximab once every two weeks by intravenous (IV) infusion (an injection
into the vein) at the study clinic.

- Encorafenib plus cetuximab with chemotherapy: These participants will receive
encorafenib and cetuximab in the way described in the bullet above. Additionally, they
will receive standard chemotherapy by IV infusion and oral treatment at home.

- Chemotherapy alone: These participants will receive chemotherapy, the standard treatment
for this condition, by IV infusion at the study clinics and oral treatment at home.

The study team will monitor how each participant responds to the study treatment for up to
about 3 years.

This phase II trial tests whether adding nivolumab to the usual treatment (encorafenib and cetuximab) works better than the usual treatment alone to shrink tumors in patients with colorectal cancer that has spread to other places in the body (metastatic) or that cannot be removed by surgery (unresectable) and whose tumor has a mutation in a gene called BRAF. Encorafenib is in a class of medications called kinase inhibitors. It is used in patients whose cancer has a certain mutation (change) in the BRAF gene. It works by blocking the action of mutated BRAF that signals cancer cells to multiply. This helps to stop or slow the spread of cancer cells. Cetuximab is in a class of medications called monoclonal antibodies. It binds to a protein called EGFR, which is found on some types of cancer cells. This may help keep cancer cells from growing. 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. Giving nivolumab in combination with encorafenib and cetuximab may be more effective than encorafenib and cetuximab alone at stopping tumor growth and spreading in patients with metastatic or unresectable BRAF-mutant colorectal cancer.

This phase II/III trial aims to determine the type of chemotherapy that will benefit patients who have had surgery for their stage II or III colon cancer based on presence or absence of circulating tumor deoxyribonucleic acid (ctDNA). In ctDNA positive patients, this trial compares the effect of usual chemotherapy versus mFOLFIRINOX. In ctDNA negative patients, this trial compares the effect of usual chemotherapy versus ctDNA testing every 3 months to determine which approach might be better to prevent colon cancer from returning. Oxaliplatin is in a class of medications called platinum-containing antineoplastic agents. It works by damaging cells DNA and may kill cancer cells. Leucovorin is in a class of medications called folic acid analogs. It works by protecting healthy cells from the effects of chemotherapy medications while allowing chemotherapy agent to enter and kill cancer cells. Fluorouracil is in a class of medications called antimetabolites. It stops cells from making DNA and may slow or stop the growth of cancer cells. Capecitabine is in a class of medications called antimetabolites. It Is taken up by cancer cells and breaks down to a substance that kills cancer cells. Irinotecan is in a class of antineoplastic medications called topoisomerase I inhibitors. It works by stopping the growth of cancer cells. This trial may help doctors determine what kind of chemotherapy to recommend to colon cancer patients based on the presence or absence of ctDNA after surgery for colon cancer.

This phase IV trial evaluates how well giving standard of care (SOC) peptide receptor radionuclide therapy (PRRT) after SOC surgical removal of as much tumor as possible (debulking surgery) works in treating patients with grade 1 or 2, somatostatin receptor (SSTR) positive, gastroenteropancreatic neuroendocrine tumors (GEP-NETs) that have spread from where they first started (primary site) to the liver (hepatic metastasis). Lutetium Lu 177 dotatate is a radioactive drug that uses targeted radiation to kill tumor cells. Lutetium Lu 177 dotatate includes a radioactive form (an isotope) of the element called lutetium. This radioactive isotope (Lu-177) is attached to a molecule called dotatate. On the surface of GEP-NET tumor cells, a receptor called a somatostatin receptor binds to dotatate. When this binding occurs, the lutetium Lu 177 dotatate drug then enters somatostatin receptor-positive tumor cells, and radiation emitted by Lu-177 helps kill the cells. Giving lutetium Lu 177 dotatate after surgical debulking may better treat patients with grade 1/2 GEP-NETs.

This study will evaluate the safety and tolerability of oral TP-1454 in patients with
advanced metastatic or progressive solid tumors and anal cancer.

This study will evaluate the efficacy, safety, and pharmacokinetics of tobemstomig (also
known as RO7247669) in combination with axitinib alone or with tiragolumab (anti-TIGIT) and
axitinib, as compared to pembrolizumab and axitinib in participants with previously
untreated, unresectable locally advanced or metastatic clear-cell renal cell carcinoma
(ccRCC).

This phase II trial tests whether using genetic testing of tumor tissue to select the optimal treatment regimen works in treating patients with clear cell renal cell (kidney) cancer that has spread to other places in the body (advanced or metastatic). The current Food and Drug Administration (FDA)-approved regimens for advanced kidney cancer fall into two categories. One treatment combination includes two immunotherapy drugs (nivolumab plus ipilimumab), which are delivered by separate intravenous infusions into a vein. The other combination is one immunotherapy drug (nivolumab infusion) plus an oral pill taken by mouth (cabozantinib). Nivolumab and ipilimumab are immunotherapies which release the brakes of the immune system, thus allowing the patient's own immune system to better kill cancer cells. Cabozantinib is a targeted therapy specifically designed to block certain biological mechanisms needed for growth of cancer cells. In kidney cancer, cabozantinib blocks a tumors blood supply. The genetic (DNA) makeup of the tumor may affect how well it responds to therapy. Testing the makeup (genes) of the tumor, may help match a treatment (from one of the above two treatment options) to the specific cancer and increase the chance that the disease will respond to treatment. The purpose of this study is to learn if genetic testing of tumor tissue may help doctors select the optimal treatment regimen to which advanced kidney cancer is more likely to respond.

The purpose of this study is to evaluate MEDI5752 in combination with Lenvatinib (or
Axitinib), in subjects with advanced renal cell carcinoma.