Clinical Trials Search at Vanderbilt-Ingram Cancer Center
A Clinical Study of Ifinatamab Deruxtecan (I-DXd) in People With Metastatic Prostate Cancer (MK-2400-001)
Prostate
Prostate
Researchers are looking for new ways to treat metastatic castration-resistant prostate cancer (mCRPC). Researchers have designed a study medicine called ifinatamab deruxtecan (also called I-DXd or MK-2400) to treat mCRPC. The goal of this study is to learn if people who receive I-DXd live longer overall and live longer without the cancer growing or spreading than people who receive chemotherapy.
Prostate
III
Schaffer, Kerry
NCT06925737
VICCURO24539
Evexomostat Plus PI3K or AKT Inhibitor and Fulvestrant in Patients With a PI3K Alteration and HR+/Her2- Breast Cancer
This is a Phase 1b/2, open-label, parallel-arms pilot study in men and post-menopausal women with hormone receptor positive (HR+), HER2- advanced or metastatic breast cancer with an alteration in the PI3K pathway, including a mutation of the PIK3CA gene, PTEN loss, or AKT1 mutation, designed to determine the safety of evexomostat (SDX-7320) plus standard of care treatment alpelisib (BYL-719) or capivasertib and fulvestrant (each combined, the 'triplet therapy'), to measure the severity and number of hyperglycemic events, and to assess clinical, anti-tumor benefit of the triplet therapy.
The purpose of this study is:
* to characterize the safety of the triplet drug combination consisting of either alpelisib or capivasertib (per the treating oncologist's choice) and fulvestrant plus evexomostat,
* to test whether evexomostat, when given in combination with either alpelisib or capivasertib and fulvestrant will reduce the number and severity of hyperglycemic events and/or reduce the number or dose of anti-diabetic medications needed to control the hyperglycemia for metabolically normal patients and those deemed at risk for capivasertib and alpelisib-induced hyperglycemia (insulin resistance, as measured by HOMA-IR, baseline elevated HbA1c or well-controlled type 2 diabetes), and
* to assess preliminary anti-tumor efficacy for each combination and changes in key biomarkers and quality of life in this patient population.
The purpose of this study is:
* to characterize the safety of the triplet drug combination consisting of either alpelisib or capivasertib (per the treating oncologist's choice) and fulvestrant plus evexomostat,
* to test whether evexomostat, when given in combination with either alpelisib or capivasertib and fulvestrant will reduce the number and severity of hyperglycemic events and/or reduce the number or dose of anti-diabetic medications needed to control the hyperglycemia for metabolically normal patients and those deemed at risk for capivasertib and alpelisib-induced hyperglycemia (insulin resistance, as measured by HOMA-IR, baseline elevated HbA1c or well-controlled type 2 diabetes), and
* to assess preliminary anti-tumor efficacy for each combination and changes in key biomarkers and quality of life in this patient population.
Not Available
I/II
Rexer, Brent
NCT05455619
VICCBREP2271
Surgical Debulking Prior to Peptide Receptor Radionuclide Therapy in Well Differentiated Gastroenteropancreatic Neuroendocrine Tumors
Multiple Cancer Types
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
Colon,
Esophageal,
Gastric/Gastroesophageal,
Gastrointestinal,
Liver,
Pancreatic,
Rectal
N/A
Idrees, Kamran
NCT06016855
VICCGI2283
A Study to Evaluate Adverse Events and Change in Disease Activity of Intravenous ABBV-706 Versus Standard of Care in Adult Participants With Relapsed/Refractory Small Cell Lung Cancer
Lung
Lung
Small cell lung cancer (SCLC) is characterized by aggressive and rapid growth and a tendency to develop early spread to distant sites including mediastinal lymph nodes, liver, bones, adrenal glands, and brain. The purpose of this study is to assess safety, tolerability, and change in disease activity of ABBV-706 compared to standard of care (SOC) treatment (topotecan, lurbinectedin, or amrubicin).
ABBV-706 is an investigational drug being developed for the treatment of SCLC. There are two treatment arms in this study. Participants will either receive ABBV-706 or SOC. Approximately 531 adult participants will be enrolled in the study across 175 sites worldwide.
Participants with SCLC will receive intravenous (IV) ABBV-706 or SOC \[topotecan (IV or orally), or lubinectedin (IV), or amrubicin (IV)\]. The estimated duration of the study is approximately 53 months.
There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic and may require frequent medical assessments, blood tests, questionnaires, and scans.
ABBV-706 is an investigational drug being developed for the treatment of SCLC. There are two treatment arms in this study. Participants will either receive ABBV-706 or SOC. Approximately 531 adult participants will be enrolled in the study across 175 sites worldwide.
Participants with SCLC will receive intravenous (IV) ABBV-706 or SOC \[topotecan (IV or orally), or lubinectedin (IV), or amrubicin (IV)\]. The estimated duration of the study is approximately 53 months.
There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic and may require frequent medical assessments, blood tests, questionnaires, and scans.
Lung
III
Wang, Shuai
NCT07365241
VICCTHO26004
A Study of BMS-986340 as Monotherapy and as Combination Therapy in Participants With Advanced Solid Tumors
Multiple Cancer Types
The purpose of this study is to assess the safety, tolerability, and recommended dose(s) of BMS-986340 as monotherapy and in combination with nivolumab, docetaxel, or Pumitamig in participants with advanced solid tumors. This study is a first-in-human (FIH) study of BMS-986340 in participants with advanced solid tumors.
Bladder,
Colon,
Esophageal,
Gastric/Gastroesophageal,
Head/Neck,
Kidney (Renal Cell),
Lung,
Ovarian,
Pancreatic,
Urologic
I/II
Berlin, Jordan
NCT04895709
VICC-DTPHI23183
A Study to Compare Two Surgical Procedures in Individuals With BRCA1 Mutations to Assess Reduced Risk of Ovarian Cancer
Ovarian
Ovarian
This clinical trial evaluates how well two surgical procedures (bilateral salpingectomy and bilateral salpingo-oophorectomy) work in reducing the risk of ovarian cancer for individuals with BRCA1 mutations. Bilateral salpingectomy involves the surgical removal of fallopian tubes, and bilateral salpingo-oophorectomy involves the surgical removal of both the fallopian tubes and ovaries. This study may help doctors determine if the two surgical procedures are nearly the same for ovarian cancer risk reduction for women with BRCA1 mutations.
Ovarian
N/A
Brown, Alaina
NCT04251052
NRGGYNCC008
Tipifarnib and Naxitamab for Relapsed/Refractory Neuroblastoma
Neuroblastoma (Pediatrics)
Neuroblastoma (Pediatrics)
The purpose of this study is to evaluate the investigational drug, tipifarnib (a pill taken by mouth), in combination with the Food and Drug Administration (FDA) approved drug, naxitimab, administered intravenously (IV; a liquid that continuously goes into your body through a tube that has been placed during a surgery into one of your veins). Naxitamab is FDA approved for pediatric patients 1 year of age and older and adult patients with relapsed or refractory high-risk neuroblastoma in the bone or bone marrow who have demonstrated a partial response, minor response, or stable disease to prior therapy, it may not be approved in the type of disease used in this study.
The goals of this part of the study are:
* Test the safety and tolerability of tipifarnib in combination with naxitimab in participants with cancer
* To determine the activity of study treatments chosen based on:
* How each participant responds to the study treatment
* How long a participant lives without their disease returning/progressing
The goals of this part of the study are:
* Test the safety and tolerability of tipifarnib in combination with naxitimab in participants with cancer
* To determine the activity of study treatments chosen based on:
* How each participant responds to the study treatment
* How long a participant lives without their disease returning/progressing
Neuroblastoma (Pediatrics)
II
Benedetti, Daniel
NCT06540963
VICCPED24540
Nemtabrutinib With CAR T Therapy in Relapsed/Refractory Mantle Cell Lymphoma
Lymphoma
Lymphoma
This phase II trial tests the effect of nemtabrutinib in combination with brexucabtagene autoleucel (brexu-cel) in treating patients with mantle cell lymphoma that has come back after a period of improvement (relapsed) or that has not responded to previous treatment (refractory). Nemtabrutinib, a BTK inhibitor, may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Chimeric antigen receptor (CAR) T-cell therapy, such as brexu-cel, is a type of treatment in which a patient's T cells (a type of immune system cell) are changed in the laboratory so they will attack cancer cells. T cells are taken from a patient's blood. Then the gene for a special receptor that binds to a certain protein on the patient's cancer cells is added to the T cells in the laboratory. The special receptor is called a CAR. Large numbers of the CAR T cells are grown in the laboratory and given to the patient by infusion for treatment of certain cancers. Chemotherapy, such as fludarabine and cyclophosphamide, are given before CAR T cell therapy to help kill cancer cells in the body and help make room for the CAR T cells. Giving nemtabrutinib in combination with brexu-cel may be safe, tolerable, and/or effective in treating patients with relapsed or refractory mantle cell lymphoma.
Lymphoma
II
Dholaria, Bhagirathbhai
NCT07673367
VICC-VCCTT23481
Phase II Panitumumab-IRDye800 in Head & Neck Cancer
Head/Neck
Head/Neck
The purpose of this study is to determine if panitumumab-IRDye800 is effective in identifying cancer, compared to surrounding normal tissue, and the further characterize the safety profile of this drug.
Head/Neck
II
Rosenthal, Eben
NCT04511078
VICCHN21109
Carmustine Wafer in Combination With Retifanlimab and Radiation With/Without Temozolomide in Subjects With Glioblastoma
Multiple Cancer Types
The purpose of the study is to evaluate the safety and survival of carmustine wafers and radiation and retifanlimab with or without temozolomide (TMZ) in newly-diagnosed adult subjects with glioblastoma multiform after carmustine wafer placement.
Neuro-Oncology,
Phase I
I
Thompson, Reid
NCT05083754
VICCNEUP22119
