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Clinical Trials Search at Vanderbilt-Ingram Cancer Center



Safety and Efficacy of ALLO-715 BCMA Allogenic CAR T Cells in in Adults With Relapsed or Refractory Multiple Myeloma (UNIVERSAL)

Multiple Cancer Types

The purpose of the UNIVERSAL study is to assess the safety, efficacy, cell kinetics, and immunogenicity of ALLO-715 with or without Nirogacestat in adults with relapsed or refractory multiple myeloma after a lymphodepletion regimen of ALLO-647 in combination with fludarabine and / or cyclophosphamide, or ALLO-647 alone.
Multiple Myeloma, Phase I
I
Oluwole, Olalekan
NCT04093596
VICCCTTP1955

A Multi-Center, Open-Label Study of Fruquintinib in Solid Tumors, Colorectal, and Breast Cancer

Multiple Cancer Types

An open-label, dose escalation and expansion clinical trial to evaluate the safety, tolerability, and PK of fruquintinib in patients with advanced solid tumors, metastatic colorectal cancer and metastatic breast cancer.
Colon, Miscellaneous, Phase I, Rectal
I
Eng, Cathy
NCT03251378
VICCGIP1965

A Study of TAK-169 in Participants With Relapsed or Refractory Multiple Myeloma

Multiple Cancer Types

Multiple Myeloma is a type of blood cancer in cells made in the bone marrow. Relapsed means the previous cancer treatment worked for a while but stopped working, over time. Refractory means people did not respond to previous cancer treatment. TAK-169 is a medicine that binds to the surface of multiple myeloma cells called CD38 cells. It delivers a dose of chemotherapy to the CD38 cells. This study is in 2 parts. The main aims of Part 1 of the study are to check how much TAK-169 a person can receive without getting side effects from it, and to work out the best dose of TAK-169 to give people to treat their cancer. The main aim of Part 2 of the study is to learn if the condition of people with multiple myeloma improves after treatment with TAK-169. Another aim is to check for side effects from TAK-169. In Part 1, at the first visit, the study doctor will check who can take part. Participants who can take part will receive TAK-169 slowly through the vein (infusion). This will happen once a week during a 28-day cycle. Different small groups of participants will receive lower to higher doses of TAK-169. The study doctors will check for side effects after each dose of TAK 169. In this way, researchers can work out the best dose of TAK-169 to give participants in Part 2 of the study. Each participant will stay in the clinic for at least 24 hours after they have received their first infusion of TAK-169. Once the best dose has been worked out, different small groups of participants will receive lower to higher doses of TAK-169 every 2 weeks, starting at the best dose. In Part 2, at the first visit, the study doctor will check who can take part, as only some participants with multiple myeloma can take part. Participants who previously did not respond to daratumumab or it worked for a while but stopped working, over time will have 1 of 2 treatments. - Some will receive TAK-169 once a week. - Others will receive TAK-169 every 2 weeks. Participants who have never previously received other medicines that bind to the multiple myeloma CD38 cells can also take part. They will receive TAK-169 once a week. All participants in Part 2 will receive the best dose of TAK-169 worked out in Part 1. In both parts of the study, participants can receive TAK-169 for up to 1 year. They could receive TAK-169 for longer than 1 year if their multiple myeloma continues to improve or remains stable during treatment. After treatment has finished, participants will visit the clinic for a check-up every 12 weeks.
Multiple Myeloma, Phase I
I
Dholaria, Bhagirathbhai
NCT04017130
VICCHEMP1975

Safety, Tolerability and Pharmacokinetics of an Anti-PD-1 Monoclonal Antibody in Subjects With Advanced Malignancies

Multiple Cancer Types

The primary objective is to assess the safety and tolerability of Toripalimab in subjects with various advanced malignancies and to evaluate the recommended Phase 2 dose. The secondary objectives are to: 1) describe the pharmacokinetic (PK) profile of Toripalimab, 2) evaluate antitumor activity of Toripalimab; 3) determine the immunogenicity of Toripalimab; 4) evaluate overall survival. The exploratory objectives are to: 1) evaluate biomarkers that may correlate with activity of Toripalimab, 2) evaluate pharmacodynamic effects of Toripalimab on its target receptor, programmed cell death 1 (PD-1), as well as effects on the immune system. 3) evaluate the utility of PD-L1 & additional exploratory markers as biomarkers that could aid in selection of appropriate subjects for TAB001 therapy, and 4) identification of additional biomarkers correlating with response to treatment with TAB001.
Miscellaneous, Phase I
I
Davis, Elizabeth
NCT03474640
VICCPHI18174

A Study of ASP1948, Targeting an Immune Modulatory Receptor as a Single Agent and in Combination With a PD-l Inhibitor (Nivolumab or Pembrolizumab) in Subjects With Advanced Solid Tumors

Multiple Cancer Types

The purpose of this study is to evaluate the tolerability and safety profile of ASP1948 when administered as a single agent and in combination with nivolumab or pembrolizumab in participants with locally advanced (unresectable) or metastatic solid tumors; characterize the pharmacokinetic profile of ASP1948 when administered as a single agent and in combination with nivolumab or pembrolizumab and determine the recommended Phase 2 dose (RP2D) of ASP1948 when administered as a single agent and in combination with nivolumab or pembrolizumab. This study will also evaluate the antitumor effect of ASP1948 when administered as a single agent and in combination with nivolumab or pembrolizumab.
Miscellaneous, Phase I
I
Berlin, Jordan
NCT03565445
VICCPHI1907

A Dose Escalation Study Of PF-06939999 In Participants With Advanced Or Metastatic Solid Tumors

Multiple Cancer Types

This is a Phase 1, open label, multi center, dose escalation and expansion, safety, tolerability, PK, and pharmacodynamics study of PF 06939999 in previously treated patients with advanced or metastatic cancer.
Bladder, Cervical, Esophageal, Head/Neck, Lung, Non Small Cell, Phase I, Uterine
I
Berlin, Jordan
NCT03854227
VICCPHI1909

Testing the Combination of Anetumab Ravtansine With Either Nivolumab, Nivolumab and Ipilimumab, or Gemcitabine and Nivolumab in Advanced Pancreatic Cancer

Multiple Cancer Types

This phase I trial studies the side effects and best dose of anetumab ravtansine when given together with nivolumab, ipilimumab and gemcitabine hydrochloride in treating patients with mesothelin positive pancreatic cancer that has spread to other places in the body (advanced). Anetumab ravtansine is a monoclonal antibody, called anetumab ravtansine, linked to a chemotherapy drug called DM4. Anetumab attaches to mesothelin positive cancer cells in a targeted way and delivers DM4 to kill them. 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. Chemotherapy drugs, such as gemcitabine hydrochloride, 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. Giving anetumab ravtansine together with nivolumab, ipilimumab, and gemcitabine hydrochloride may work better in treating patients with pancreatic cancer.
Pancreatic, Phase I
I
Cardin, Dana
NCT03816358
VICCGIP1931ET-CT

Venetoclax and Selinexor in Treating Patients with Relapsed or Refractory High Risk Hematologic Malignancies

Multiple Cancer Types

This phase Ib trial studies the side effects and best dose of venetoclax and selinexor and how well they work in treating patients with high risk hematologic malignancies such as diffuse large B-cell lymphoma, multiple myeloma, or acute myeloid leukemia that have come back (recurrent) or do not respond to treatment (refractory). Venetoclax functions by inhibiting or slowing down a protein in the body called bcl-2, which is involved in slowing down the normal process by which old cells in the body are cleared (called apoptosis). Selinexor functions by trapping “tumor suppressing proteins” within the cell and causing the cancer cells to die or stop growing. This study examines the effects, if any, of selinexor and venetoclax on high risk hematologic malignancies and on the body, including any side-effects.
Hematologic, Leukemia, Lymphoma, Multiple Myeloma, Myelodysplastic Syndrome, Phase I
I
Byrne, Michael
NCT03955783
VICCHEM1755

A Safety Study of NUC-3373 in Combination With Standard Agents Used in Colorectal Cancer Treatment

Multiple Cancer Types

This is a three-part study of NUC-3373 administered by intravenous (IV) infusion across two administration schedules, in separate combinations with leucovorin (LV), oxaliplatin, oxaliplatin and VEGF pathway inhibitors, oxaliplatin and EGFR inbibitors, irinotecan, irinotecan and VEGF pathway inhibitors, and irinotecan and EGFR inhibitors. The primary objective is to identify a recommended dose for NUC-3373 when combined with these agents.
Colon, Phase I, Rectal
I
Ciombor, Kristen
NCT03428958
VICCGIP1851

Capecitabine and Radiation Therapy after Surgery in Treating Patients with Non-Metastatic Invasive Breast cancer

Multiple Cancer Types

This phase I trial studies how well capecitabine and radiation therapy after surgery work in treating patients with invasive breast cancer that has not spread to other places in the body. Drugs used in chemotherapy, such as 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. Radiation therapy uses high-energy x-rays to kill tumor cells and shrink tumors. Giving capecitabine and radiation therapy together may kill more tumor cells in patients with invasive breast cancer compared to capecitabine or radiation therapy alone.
Breast, Phase I
I
Chak, Bapsi
NCT03958721
VICCBREP1898

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