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| Consuelo Wilkins, MD, MSCI, Senior Vice President for Health Equity and Inclusive Excellence for Vanderbilt University Medical Center (VUMC) and Senior Associate Dean for Health Equity and Inclusive Excellence for Vanderbilt University School of Medicine, always knew she wanted to be a physician. "Health equity was built into everything I did, even if I didn’t know it or recognize it at the time," Wilkins said. "I have always learned and believed that people are the same — everyone deserves to be healthy, and everyone should have the best opportunities to take care of themselves and their families." Click below to learn more about health equity initiatives. https://momentum.vicc.org/2021/09/everyone-deserves-to-be-healthy/ |
Vanderbilt was the lead site for an NIH-funded, phase 2, multicenter influenza vaccine study in pediatric allogeneic hematopoietic stem cell transplant (HCT) recipients that may lead to a change in the current flu vaccine recommendations in this vulnerable population. Natasha Halasa, MD, MPH and colleagues recently published in the New England Journal of Medicine, that two doses of high-dose trivalent flu vaccine resulted in higher amounts of influenza-specific antibodies than two doses of standard dose quadrivalent vaccine. https://news.vumc.org/2023/03/02/high-dose-flu-vaccine-beneficial-for-pediatric-stem-cell-transplant-patients/ |
Savolitinib Plus Osimertinib Versus Platinum-based Doublet Chemotherapy in Participants With Non-Small Cell Lung Cancer Who Have Progressed on Osimertinib Treatment
Multiple Cancer Types
Clinical study to investigate the efficacy and safety of savolitinib in combination with
osimertinib versus platinum-based doublet chemotherapy in participants with EGFR mutated,
MET-overexpressed and/or amplified, locally advanced or metastatic NSCLC who have progressed
on treatment with Osimertinib.
osimertinib versus platinum-based doublet chemotherapy in participants with EGFR mutated,
MET-overexpressed and/or amplified, locally advanced or metastatic NSCLC who have progressed
on treatment with Osimertinib.
Lung,
Non Small Cell
III
Iams, Wade
NCT05261399
VICCTHO2219
FHD-286 as Monotherapy or Combination Therapy in Subjects With Advanced Hematologic Malignancies
Multiple Cancer Types
This Phase 1, multicenter, open-label, dose escalation study is designed to assess the
safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and preliminary clinical
activity of FHD-286 administered orally as monotherapy or combination therapy, in subjects
with advanced hematologic malignancies.
safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and preliminary clinical
activity of FHD-286 administered orally as monotherapy or combination therapy, in subjects
with advanced hematologic malignancies.
Leukemia,
Myelodysplastic Syndrome,
Phase I
I
Kishtagari, Ashwin
NCT04891757
VICCHEMP2138
A Study of Zilovertamab Vedotin (MK-2140) in Combination With Standard of Care in Participants With Relapsed or Refractory Diffuse Large B-Cell Lymphoma (rrDLBCL) (MK-2140-003)
Lymphoma
Lymphoma
The purpose of this Phase 2/3, randomized, multisite, open-label, dose confirmation, and
expansion study is to evaluate the safety, and efficacy of zilovertamab vedotin (ZV) in
combination with standard of care options for the treatment of rrDLBCL. This study will be
divided into 2 parts: Dose Confirmation (Part 1) and Efficacy Expansion (Part 2) and will
enroll participants who are at least 18 years of age with rrDLBCL. The hypotheses are: ZV in
combination with rituximab, gemcitabine, and oxaliplatin (R-GemOx) is superior to R-GemOx
with respect to progression-free survival (PFS) per Lugano response criteria by blinded
independent review committee (BICR); and that ZV in combination with bendamustine rituximab
(BR) is superior to BR with respect to PFS per Lugano response criteria by BICR.
expansion study is to evaluate the safety, and efficacy of zilovertamab vedotin (ZV) in
combination with standard of care options for the treatment of rrDLBCL. This study will be
divided into 2 parts: Dose Confirmation (Part 1) and Efficacy Expansion (Part 2) and will
enroll participants who are at least 18 years of age with rrDLBCL. The hypotheses are: ZV in
combination with rituximab, gemcitabine, and oxaliplatin (R-GemOx) is superior to R-GemOx
with respect to progression-free survival (PFS) per Lugano response criteria by blinded
independent review committee (BICR); and that ZV in combination with bendamustine rituximab
(BR) is superior to BR with respect to PFS per Lugano response criteria by BICR.
Lymphoma
II/III
Morgan, David
NCT05139017
VICCPCL2228
Nilotinib, Trametinib, and Dabrafenib for the Treatment of BRAF V600 Mutant Metastatic or Unresectable Melanoma
Multiple Cancer Types
This phase I trial is to find out the best dose, possible benefits and/or side effects of nilotinib given together with trametinib and dabrafenib in treating patients with BRAF V600 mutant melanoma that has spread to other places in the body (metastatic) or cannot be removed by surgery (unresectable). Nilotinib, trametinib, and dabrafenib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving nilotinib together with trametinib and dabrafenib may lower the chance of cancer growing or spreading.
Melanoma,
Phase I
I
Johnson, Douglas
NCT04903119
VICCMELP2274
Evaluation of SNDX-5613 in Participants With Colorectal Cancer and Other Solid Tumors
Phase I
Phase I
This study will evaluate the safety, tolerability, pharmacokinetics (PK), and anti-tumor
activity of SNDX-5613 in participants with colorectal cancer (CRC) or other solid tumors who
have failed at least 1 prior line of therapy.
activity of SNDX-5613 in participants with colorectal cancer (CRC) or other solid tumors who
have failed at least 1 prior line of therapy.
Phase I
I/II
Ciombor, Kristen
NCT05731947
VICCPHI22111
Evexomostat Plus Alpelisib and Fulvestrant in Women With the PIK3CA Mutation With HR+/Her2- Breast Cancer
The PIK3CA gene is frequently mutated in breast cancer, leading to disease aggressiveness and
patient mortality. Alpelisib, a small molecule that inhibits the activity of the PIK3CA gene
product PI3K, has demonstrated clinical benefit in cancer patients with this gene mutation.
However, hyperglycemia, an on-target toxicity associated with alpelisib that leads to
hyperinsulinemia, limits the drug's clinical efficacy and induces high grade hyperglycemia in
patients with baseline metabolic dysfunction, insulin resistance and/or elevated HbA1c.
Restoring insulin sensitivity and reduction in circulating concentrations of insulin have
been reported to improve the activity of alpelisib.
Evexomostat (SDX-7320) is a polymer-conjugate of a novel small molecule methionine
aminopeptidase 2 (MetAP2) inhibitor that has demonstrated the ability to reduce
alpelisib-induced hyperglycemia in multiple animal experiments and has demonstrated
synergistic anti-tumor activity independent of changes in glucose or insulin. Evexomostat was
well tolerated in a Phase 1 safety study in late-stage cancer patients and showed
improvements in insulin resistance for patients that presented with baseline elevated
insulin. Overall, the most common treatment-emergent adverse events with evexomostat (TEAEs)
were fatigue (44%), decreased appetite (38%), constipation and nausea (each 28%), and
diarrhea (22%). All other TEAEs occurred at an incidence <20%.
The purpose of this study is to characterize the safety of the triplet drug combination
(alpelisib, fulvestrant plus evexomostat), to test whether evexomostat, when given in
combination with alpelisib and fulvestrant will reduce the number and severity of
hyperglycemic events and/or reduce the number of anti-diabetic medications needed to control
the hyperglycemia for patients deemed at risk for alpelisib-induced hyperglycemia (baseline
elevated HbA1c or well-controlled type 2 diabetes), and to assess preliminary anti-tumor
efficacy and changes in key biomarkers and quality of life in this patient population.
patient mortality. Alpelisib, a small molecule that inhibits the activity of the PIK3CA gene
product PI3K, has demonstrated clinical benefit in cancer patients with this gene mutation.
However, hyperglycemia, an on-target toxicity associated with alpelisib that leads to
hyperinsulinemia, limits the drug's clinical efficacy and induces high grade hyperglycemia in
patients with baseline metabolic dysfunction, insulin resistance and/or elevated HbA1c.
Restoring insulin sensitivity and reduction in circulating concentrations of insulin have
been reported to improve the activity of alpelisib.
Evexomostat (SDX-7320) is a polymer-conjugate of a novel small molecule methionine
aminopeptidase 2 (MetAP2) inhibitor that has demonstrated the ability to reduce
alpelisib-induced hyperglycemia in multiple animal experiments and has demonstrated
synergistic anti-tumor activity independent of changes in glucose or insulin. Evexomostat was
well tolerated in a Phase 1 safety study in late-stage cancer patients and showed
improvements in insulin resistance for patients that presented with baseline elevated
insulin. Overall, the most common treatment-emergent adverse events with evexomostat (TEAEs)
were fatigue (44%), decreased appetite (38%), constipation and nausea (each 28%), and
diarrhea (22%). All other TEAEs occurred at an incidence <20%.
The purpose of this study is to characterize the safety of the triplet drug combination
(alpelisib, fulvestrant plus evexomostat), to test whether evexomostat, when given in
combination with alpelisib and fulvestrant will reduce the number and severity of
hyperglycemic events and/or reduce the number of anti-diabetic medications needed to control
the hyperglycemia for patients deemed at risk for alpelisib-induced hyperglycemia (baseline
elevated HbA1c or well-controlled type 2 diabetes), and to assess preliminary anti-tumor
efficacy and changes in key biomarkers and quality of life in this patient population.
Not Available
I/II
Rexer, Brent
NCT05455619
VICCBREP2271
Capecitabine Compared to Endocrine Therapy for the Treatment of Non-luminal A Hormone Receptor-Positive Metastatic Breast Cancer
Breast
Breast
This phase II trial compares the effect of capecitabine to endocrine therapy in patients with non-Luminal A hormone receptor-positive breast cancer that has spread from where it first started (primary site) to other places in the body (metastatic). In this study, patients submit a sample of tumor for testing to determine if their breast cancer is considered non-Luminal A. Only patients with non-Luminal A receive study treatment. In the future, doctors hope that this test can assist in picking the best treatment for patients with this type of cancer. Capecitabine is in a class of medications called antimetabolites. It is taken up by tumor cells and breaks down into fluorouracil, a substance that kills tumor cells. Endocrine therapy is treatment that adds, blocks, or removes hormones. To slow or stop the growth of certain cancers (such as prostate and breast cancer), synthetic hormones or other drugs may be given to block the body's natural hormones. Giving capecitabine as compared to endocrine therapy may kill more tumor cells in patients with metastatic breast cancer.
Breast
II
Reid, Sonya
NCT05693766
VICCBRE2256
Decitabine and Cedazuridine in Combination with Venetoclax for the Treatment of Patients who have Relapsed Acute Myeloid Leukemia after Donor Stem Cell Transplant
Leukemia
Leukemia
This phase II trial tests how well decitabine and cedazuridine (DEC-C) works in combination with venetoclax in treating acute myeloid leukemia (AML) in patients whose AML has come back after a period of improvement (relapse) after a donor stem cell transplant. Cedazuridine is in a class of medications called cytidine deaminase inhibitors. It prevents the breakdown of decitabine, making it more available in the body so that decitabine will have a greater effect. Decitabine is in a class of medications called hypomethylation agents. It works by helping the bone marrow produce normal blood cells and by killing abnormal cells in the bone marrow. Venetoclax is in a class of medications called B-cell lymphoma-2 (BCL-2) inhibitors. It may stop the growth of cancer cells by blocking Bcl-2, a protein needed for cancer cell survival. Giving DEC-C in combination with venetoclax may kill more cancer cells in patients with relapsed AML.
Leukemia
II
Mohan, Sanjay
NCT05799079
VICCHEM2163
Total Body Irradiation and Hypofractionated Radiation Therapy with Atezolizumab and Chemotherapy for the Treatment of Extensive-Stage Small Cell Lung Cancer, TESSERACT Trial
Multiple Cancer Types
This phase I/II trial studies the side effects, safety, and effectiveness of low dose radiation to the entire body (total body irradiation [TBI]) and higher dose radiation to known areas of cancer (hypofractionated radiation therapy [H-RT]) combined with atezolizumab and chemotherapy (carboplatin & etoposide) in treating patients with small cell lung cancer that has spread to disease sites outside of the lung (extensive stage). Extensive stage disease has historically been treated with chemotherapy alone with consideration of chest (thoracic) radiation therapy for those with response to chemotherapy, as well as consideration of preventative radiation therapy to the head (prophylactic cranial irradiation). Emerging evidence supports the synergistic interactions between immunotherapy and radiation therapy. Immunotherapy with monoclonal antibodies, such as atezolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Carboplatin is in a class of medications known as platinum-containing compounds. It works in a way similar to the anticancer drug cisplatin, but may be better tolerated than cisplatin. Carboplatin works by killing, stopping or slowing the growth of tumor cells. Etoposide is in a class of medications known as podophyllotoxin derivatives. It blocks a certain enzyme needed for cell division and DNA repair and may kill tumor cells. Combining TBI and H-RT with atezolizumab and chemotherapy may improve response to treatment.
Lung,
Small Cell
I/II
Osmundson, Evan
NCT06110572
VICCTHOP2206
Active Myeloid Target Compound Decitabine and Cedazuridine in Combination with Itacitinib for the Treatment of Myelodysplastic/Myeloproliferative Neoplasm (MDS/MPN) Overlap Syndromes, ABNL-MARRO Study
Multiple Cancer Types
This phase I/II trial tests the safety, side effects, and best dose of decitabine and cedazuridine (ASTX727) in combination with itacitinib and how well they work in treating patients with myelodysplastic/ myeloproliferative neoplasm. Cedazuridine is in a class of medications called cytidine deaminase inhibitors. It prevents the breakdown of decitabine, making it more available in the body so that decitabine will have a greater effect. Decitabine is in a class of medications called hypomethylation agents. It works by helping the bone marrow produce normal blood cells and by killing abnormal cells in the bone marrow. Itacitinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Giving decitabine and cedazuridine in combination with itacitinib may work better in treating patients with myelodysplastic/myeloproliferative neoplasm.
Hematologic,
Myelodysplastic Syndrome
I/II
Savona, Michael
NCT04061421
VICCHEMP1977
