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Clinical Trials Search at Vanderbilt-Ingram Cancer Center



A Study of E7386 in Combination With Other Anticancer Drug in Participants With Solid Tumor

Multiple Cancer Types

The primary objective of this study is to assess the safety and tolerability and to determine
the recommended Phase 2 dose (RP2D) of E7386 in combination with other anticancer drug(s).
Gynecologic, Liver, Phase I
I
Goff, Laura
NCT04008797
VICC-DTPHI23106

Evorpacept (ALX148) in Combination With Pembrolizumab in Patients With Advanced Head and Neck Squamous Cell Carcinoma (ASPEN-03)

Head/Neck

A Phase 2 Study of Evorpacept (ALX148) in Combination With Pembrolizumab in Patients With
Advanced Head and Neck Squamous Cell Carcinoma.
Head/Neck
II
Choe, Jennifer
NCT04675294
VICCHN20127

Conditioning SCID Infants Diagnosed Early

Multiple Cancer Types

The investigators want to study if lower doses of chemotherapy will help babies with SCID to
achieve good immunity with less short and long-term risks of complications after
transplantation. This trial identifies babies with types of immune deficiencies that are most
likely to succeed with this approach and offers them transplant early in life before they get
severe infections or later if their infections are under control. It includes only patients
receiving unrelated or mismatched related donor transplants.

The study will test if patients receiving transplant using either a low dose busulfan or a
medium dose busulfan will have immune recovery of both T and B cells, measured by the ability
to respond to immunizations after transplant. The exact regimen depends on the subtype of
SCID the patient has. Donors used for transplant must be unrelated or half-matched related
(haploidentical) donors, and peripheral blood stem cells must be used. To minimize the chance
of graft-versus-host disease (GVHD), the stem cells will have most, but not all, of the T
cells removed, using a newer, experimental approach of a well-established technology. Once
the stem cell transplant is completed, patients will be followed for 3 years. Approximately
9-18 months after the transplant, vaccinations will be administered, and a blood test
measuring whether your child's body has responded to the vaccine will be collected.
Hematologic, Pediatrics
II
Connelly, James
NCT03619551
VICCNCPED18122

Ramucirumab and Trifluridine/Tipiracil or Paclitaxel for the Treatment of Patients with Previously Treated Advanced Gastric or Gastroesophageal Junction Cancer

Gastric/Gastroesophageal

This phase II trial studies the effect of the combination of ramucirumab and trifluridine/tipiracil or paclitaxel in treating patients with previously treated gastric or gastroesophageal junction cancer that has spread to other places in the body (advanced). Ramucirumab may damage tumor cells by targeting new blood vessel formation. Trifluridine/tipiracil is a chemotherapy pill and that may damage tumor cells by damaging their deoxyribonucleic acid (DNA). Paclitaxel may block cell growth by stopping cell division which may kill tumor cells. Giving ramucirumab and trifluridine/tipiracil will not be worse than ramucirumab and paclitaxel in treating gastric or gastroesophageal junction cancer.
Gastric/Gastroesophageal
II
Gibson, Mike
NCT04660760
VICCGI2168

Niraparib and Dostarlimab as Neoadjuvant Treatment for Patients with BRCA-Mutated or PALB2-Mutated Stage I-III Breast Cancer

Breast

This phase II trial studies the effects of niraparib in combination with dostarlimab prior to surgery in treating BRCA-mutated or PALB2-mutated stage I-III breast cancer. Niraparib is a PARP inhibitor, which means that it blocks an enzyme (proteins that help chemical reactions in the body occur) in cells called PARP. PARP helps repair deoxyribonucleic acid (DNA) when it becomes damaged. Blocking PARP may help keep cancer cells from repairing their damaged DNA, causing them to die. PARP inhibitors are a type of targeted therapy. Dostarlimab stimulates the immune system by blocking the PD-1 pathway. The PD-1 pathway controls the bodys natural immune response, but for some types of cancer, the immune system does not work as it should and is prevented from attacking tumors. Dostarlimab works by blocking the PD-1 pathway, which may help your immune system identify and catch tumor cells. Giving niraparib in combination with dostarlimab may work better against the tumor and maximize tumor shrinkage before surgery.
Breast
II
Abramson, Vandana
NCT04584255
VICCBRE2190

Avelumab with Binimetinib, Sacituzumab Govitecan, or Liposomal Doxorubicin in Treating Patients with Stage IV or Unresectable, Recurrent Triple Negative Breast Cancer

Breast

This phase II trial studies how well the combination of avelumab with liposomal doxorubicin with or without binimetinib, or the combination of avelumab with sacituzumab govitecan works in treating patients with triple negative breast cancer that is stage IV or is not able to be removed by surgery (unresectable) and has come back (recurrent). Immunotherapy with checkpoint inhibitors like avelumab require activation of the patient's immune system. This trial includes a two week induction or lead-in of medications that can stimulate the immune system. It is our hope that this induction will improve the response to immunotherapy with avelumab. One treatment, sacituzumab govitecan, is a monoclonal antibody called sacituzumab linked to a chemotherapy drug called SN-38. Sacituzumab govitecan is a form of targeted therapy because it attaches to specific molecules (receptors) on the surface of tumor cells, known as TROP2 receptors, and delivers SN-38 to kill them. Another treatment, liposomal doxorubicin, is a form of the anticancer drug doxorubicin that is contained in very tiny, fat-like particles. It may have fewer side effects and work better than doxorubicin, and may enhance factors associated with immune response. The third medication is called binimetinib, which may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth, and may help activate the immune system. It is not yet known whether giving avelumab in combination with liposomal doxorubicin with or without binimetinib, or the combination of avelumab with sacituzumab govitecan will work better in treating patients with triple negative breast cancer.
Breast
II
Abramson, Vandana
NCT03971409
VICCBRE1987

Study to Evaluate Safety, Tolerability, and Optimal Dose of Candidate GBM Vaccine VBI-1901 in Recurrent GBM Subjects

Neuro-Oncology

The purpose of this study is to assess the safety and tolerability of VBI-1901 in subjects
with recurrent malignant gliomas (glioblastoma, or GBM).
Neuro-Oncology
I/II
Merrell, Ryan
NCT03382977
VICCNEUP2234

Ruxolitinib in Preventing Breast Cancer in Patients with High Risk and Precancerous Breast Lesions

Breast

This phase II trial studies how well ruxolitinib before surgery works in preventing breast cancer in patients with high risk and precancerous breast conditions. Ruxolitinib may changes the breast cell when administered to participants with precancerous breast conditions. Ruxolitinib may stop the growth of cells by blocking some of the enzymes needed for cell growth.
Breast
II
Meszoely, Ingrid
NCT02928978
VICCBRE1904

A Study of ASP3082 in Adults With Previously Treated Solid Tumors

Phase I

Genes contain genetic code which tell the body which proteins to make. Many types of cancer
are caused by changes, or mutations, in a gene called KRAS. Researchers are looking for ways
to stop the actions of abnormal proteins made from the mutated KRAS gene. The so-called G12D
mutation in the KRAS gene is common in people with some solid tumors.

ASP3082 is a potential new treatment for certain solid tumors in people who have the G12D
mutation in their KRAS gene. Before ASP3082 is available as a treatment, the researchers need
to understand how it is processed by and acts upon the body. This information will help find
a suitable dose and to check for potential medical problems from the treatment.

People in this study will be adults with locally advanced, unresectable or metastatic solid
tumors with the G12D mutation in their KRAS gene (G12D mutation). Locally advanced means the
cancer has spread to nearby tissue. Unresectable means the cancer cannot be removed by
surgery. Metastatic means the cancer has spread to other parts of the body. They will have
been previously treated with standard therapies or refused to receive those treatments. In
the European Union (EU) and South Korea, people who have refused to receive treatment with
standard therapies cannot take part.

The main aims of the study are: to check the safety of ASP3082 by itself and together with
cetuximab (a common cancer medicine), how well it is tolerated, and to find a suitable dose
of ASP3082 by itself and together with cetuximab.

This is an open-label study. This means that people in this study and clinic staff will know
that they will receive ASP3082.

This study will be in 2 parts. In Part 1, different small groups of people will receive lower
to higher doses of ASP3082, by itself, or together with cetuximab. Only people with
colorectal cancer will receive ASP3082 together with cetuximab. Any medical problems will be
recorded at each dose. This is done to find suitable doses of ASP3082 by itself or together
with cetuximab to use in Part 2 of the study. The first group will receive the lowest dose of
ASP3082. A medical expert panel will check the results from this group and decide if the next
group can receive a higher dose of ASP3082. The panel will do this for each group until all
groups have received ASP3082 (by itself or together with cetuximab) or until suitable doses
have been selected for Part 2.

In Part 2, other different small groups of people will receive ASP3082 by itself or together
with cetuximab, with the most suitable doses worked out from Part 1. This will help find a
more accurate dose of ASP3082 to use in future studies.

ASP3082, and cetuximab (if used), will be given through a vein. This is called an infusion.
Each treatment cycle is 21 days long. They will continue treatment until: they have medical
problems from the treatment they can't tolerate; their cancer gets worse; they start other
cancer treatment; they ask to stop treatment; they do not come back for treatment.

People will visit the clinic on certain days during their treatment, with extra visits during
the first 2 cycles of treatment. During these visits, the study doctors will check for any
medical problems from ASP3082 by itself or together with cetuximab. At some visits, other
checks will include a medical examination, echocardiogram (ECHO) or multigated acquisition
(MUGA) scan, blood and urine tests and vital signs. Vital signs include temperature, pulse,
breathing rate, and blood pressure. (Blood oxygen levels will also be checked for people
treated with ASP3082 together with cetuximab.) Tumor samples will be taken during certain
visits during treatment and when treatment has finished.

People will visit the clinic within 7 days after stopping treatment. The study doctors will
check for any medical problems from ASP3082 by itself or together with cetuximab. Other
checks will include a medical examination, echocardiogram (ECHO) or multigated acquisition
(MUGA) scan, urine and blood tests and vital signs. After this, people will continue to visit
the clinic every 9 weeks. This is to check the condition of their cancer. They will do this
until 45 weeks after treatment stopped, or if their cancer is worse, they start other cancer
treatment, they ask to stop treatment, or they do not come back for treatment.

Also, people may visit the clinic at 30 days and 90 days after stopping treatment. At the
30-day visit, the study doctors will check for any medical problems from ASP3082 by itself or
together with cetuximab. People will have their vital signs checked and have some bloo
Phase I
I
Berlin, Jordan
NCT05382559
VICCPHI2207

A Study to Assess the Adverse Events and Change in Disease Activity in Adult Participants With Relapsed or Refractory Multiple Myeloma Receiving Oral ABBV-453 Tablets

Multiple Cancer Types

Multiple myeloma (MM) is a plasma cell disease characterized by the growth of clonal plasma
cells in the bone marrow. The purpose of this study is to assess the safety and toxicity of
ABBV-453 in adult participants with relapsed/refractory (R/R) MM. Adverse events and change
in disease activity will be assessed.

ABBV-453 is an investigational drug being developed for the treatment of R/R MM. Part 1 will
be a monotherapy dose escalation phase to determine the best dose of ABBV-453. In Part 2,
participants are placed in 1 of 3 groups called treatment arms. Each group receives a
different treatment. Approximately 28 to 48 adult participants in Part 1 and 150 to 312 adult
participants in Part 2 with R/R MM will be enrolled in the study in approximately 70 sites
worldwide.

In Part 1 and the Japan Cohort, Participants will receive oral ABBV-453 tablets once daily
(QD) in 28-day cycles. In Part 2, Arm 1, participants will receive continuous doses of oral
ABBV-453 tablets QD in combination with oral dexamethasone tablets once weekly in 28-day
cycles. In Part 2, Arm 2, participants will receive continuous doses of oral ABBV-453 tablets
QD in combination with subcutaneous injections of daratumumab every 1 to 4 weeks and oral
dexamethasone tablets once weekly in, 28-day cycles. In Part 2, Arm 3, participants will
receive continuous doses of oral ABBV-453 tablets QD in combination with subcutaneous
injections of daratumumab every 1 to 4 weeks, oral lenalidomide capsules QD on Days 1-21, and
oral dexamethasone tablets once weekly, in 28-day cycles.

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 an approved
institution (hospital or clinic). The effect of the treatment will be frequently checked by
medical assessments, blood tests, and side effects.
Multiple Myeloma, Phase I
I
Baljevic, Muhamed
NCT05308654
VICCHEMP2230

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