Clinical Trials Search at Vanderbilt-Ingram Cancer Center

A Phase 3 study to evaluate the efficacy and safety of birtamimab plus standard of care
compared to placebo plus standard of care in Mayo Stage IV patients with AL amyloidosis.

This is a prospective, multi-center, Phase II study of hematopoietic cell transplantation
(HCT) using human leukocyte antigen (HLA)-mismatched unrelated donors (MMUD) for peripheral
blood stem cell transplant in adults and bone marrow stem cell transplant in children.
Post-transplant cyclophosphamide (PTCy), tacrolimus and mycophenolate mofetil (MMF) will be
used for for graft versus host disease (GVHD) prophylaxis. This trial will study how well
this treatment works in patients with hematologic malignancies.

This phase II trial studies the effect of hormonal therapy given after (adjuvant) combination pertuzumab/trastuzumab in treating patients with hormone receptor positive, HER2 positive breast cancer. The drugs trastuzumab and pertuzumab are both monoclonal antibodies, which are disease-fighting proteins made by cloned immune cells. Estrogen can cause the growth of breast cancer cells. Hormonal therapy, such as letrozole, anastrozole, exemestane, and tamoxifen, block the use of estrogen by the tumor cells. Giving hormonal therapy after pertuzumab and trastuzumab may kill any remaining tumor cells in patients with breast cancer.

This phase II trial studies the effect of lutetium Lu 177 dotatate compared to the usual treatment (everolimus) in treating patients with somatostatin receptor positive bronchial neuroendocrine tumors that have spread to other places in the body (advanced). Radioactive drugs, such as lutetium Lu 177 dotatate, may carry radiation directly to tumor cells and may reduce harm to normal cells. Lutetium Lu 177 dotatate may be more effective than everolimus in shrinking or stabilizing advanced bronchial neuroendocrine tumors.

This is a Phase III, randomized, open-label, 3-arm, multicenter, international study
assessing the efficacy and safety of Dato-DXd with or without durvalumab compared with ICT in
participants with stage I to III TNBC with residual invasive disease in the breast and/or
axillary lymph nodes at surgical resection following neoadjuvant systemic therapy.

The Phase 1 portion of this study is a single-arm, open-label, multicenter, non-randomized
interventional study to evaluate the pharmacokinetic (PK) interaction, safety, and efficacy
of ASTX727 when given in combination with venetoclax for the treatment of newly diagnosed
acute myeloid leukemia (AML) in adults who are age 75 years or older, or who have
comorbidities that preclude use of intensive induction chemotherapy. The primary purpose of
the study is to rule out drug-drug interactions between ASTX727 and venetoclax combination
therapy by evaluating area under the curve (AUC) and maximum plasma concentration (Cmax)
exposure. The Phase 2 portion of the study is to assess the efficacy of ASTX727 and
venetoclax when given in combination and to evaluate potential PK interactions. Phase 2 will
follow the same overall study design as Phase 1 and has two parts, Part A and Part B.

This is a Phase 1/2 study to assess the safety and efficacy of ELI-002 7P immunotherapy (a
lipid-conjugated immune-stimulatory oligonucleotide [Amph-CpG-7909] plus a mixture of
lipid-conjugated peptide-based antigens [Amph-Peptides 7P]) as adjuvant treatment in subjects
with solid tumors with mutated KRAS/NRAS. This study builds on the experience obtained with
related product ELI-002 2P, which was studied in protocol ELI-002-001 under IND 26909.

This is a multicenter, Phase 1b/2 trial. The phase 1b part of the trial aims to determine the
RP2D of elacestrant when administered in combination with alpelisib, everolimus, palbociclib,
and ribociclib. The Phase 2 part of the trial will evaluate the efficacy and safety of the
various combinations in patients with ER+/HER2- advanced/metastatic breast cancer.

This phase III trial studies how well lenalidomide and dexamethasone works with or without daratumumab-hyaluronidase in treating patients with high-risk smoldering myeloma. Drugs used in chemotherapy, such as lenalidomide, 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. Anti-inflammatory drugs, such as dexamethasone lower the bodys immune response and are used with other drugs in the treatment of some types of cancer. Daratumumab-hyaluronidase is a monoclonal antibody, daratumumab, that may interfere with the ability of cancer cells to grow and spread, and hyaluronidase, which may help daratumumab work better by making cancer cells more sensitive to the drug. Giving lenalidomide and dexamethasone with daratumumab-hyaluronidase may work better in treating patients with smoldering myeloma.

This phase III trial studies rituximab after stem cell transplant and to see how well it works compared with rituximab alone in treating patients with in minimal residual disease-negative mantle cell lymphoma in first complete remission. Immunotherapy with rituximab, may induce changes in bodys immune system and may interfere with the ability of tumor cells to grow and spread. Giving chemotherapy before a stem cell transplant helps kill any cancer cells that are in the body and helps make room in the patients bone marrow for new blood-forming cells (stem cells) to grow. After treatment, stem cells are collected from the patient's blood and stored. More chemotherapy is then given to prepare the bone marrow for the stem cell transplant. The stem cells are then returned to the patient to replace the blood-forming cells that were destroyed by the chemotherapy. Giving rituximab with or without stem cell transplant may work better in treating patients with mantle cell lymphoma.