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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/ |
A First-in-human Study of PRTH-101 Monotherapy +/- Pembrolizumab in Subjects With Advanced Malignancies
The goal of this Open-Label Study is to evaluate the safety and tolerability of PRTH-101
alone or in combination with pembrolizumab in adults with advance or metastatic solid tumors.
alone or in combination with pembrolizumab in adults with advance or metastatic solid tumors.
Not Available
I
Berlin, Jordan
NCT05753722
VICC-DTPHI23182
Genetic Testing to Select Therapy for the Treatment of Advanced or Metastatic Kidney Cancer, OPTIC RCC Study
Kidney (Renal Cell)
Kidney (Renal Cell)
This phase II trial tests whether using genetic testing of tumor tissue to select the optimal treatment regimen works in treating patients with clear cell renal cell (kidney) cancer that has spread to other places in the body (advanced or metastatic). The current Food and Drug Administration (FDA)-approved regimens for advanced kidney cancer fall into two categories. One treatment combination includes two immunotherapy drugs (nivolumab plus ipilimumab), which are delivered by separate intravenous infusions into a vein. The other combination is one immunotherapy drug (nivolumab infusion) plus an oral pill taken by mouth (cabozantinib). Nivolumab and ipilimumab are immunotherapies which release the brakes of the immune system, thus allowing the patient's own immune system to better kill cancer cells. Cabozantinib is a targeted therapy specifically designed to block certain biological mechanisms needed for growth of cancer cells. In kidney cancer, cabozantinib blocks a tumors blood supply. The genetic (DNA) makeup of the tumor may affect how well it responds to therapy. Testing the makeup (genes) of the tumor, may help match a treatment (from one of the above two treatment options) to the specific cancer and increase the chance that the disease will respond to treatment. The purpose of this study is to learn if genetic testing of tumor tissue may help doctors select the optimal treatment regimen to which advanced kidney cancer is more likely to respond.
Kidney (Renal Cell)
II
Rini, Brian
NCT05361720
VICCURO21103
A Study of Immune Checkpoint Inhibitor Combinations With Axitinib in Participants With Untreated Locally Advanced Unresectable or Metastatic Renal Cell Carcinoma
Kidney (Renal Cell)
Kidney (Renal Cell)
This study will evaluate the efficacy, safety, and pharmacokinetics of tobemstomig (also
known as RO7247669) in combination with axitinib alone or with tiragolumab (anti-TIGIT) and
axitinib, as compared to pembrolizumab and axitinib in participants with previously
untreated, unresectable locally advanced or metastatic clear-cell renal cell carcinoma
(ccRCC).
known as RO7247669) in combination with axitinib alone or with tiragolumab (anti-TIGIT) and
axitinib, as compared to pembrolizumab and axitinib in participants with previously
untreated, unresectable locally advanced or metastatic clear-cell renal cell carcinoma
(ccRCC).
Kidney (Renal Cell)
II
Rini, Brian
NCT05805501
VICCURO22113
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
A Study to Evaluate MEDI5752 and Axitinib in Subjects With Advanced Renal Cell Carcinoma
Multiple Cancer Types
The purpose of this study is to evaluate MEDI5752 in combination with Lenvatinib (or
Axitinib), in subjects with advanced renal cell carcinoma.
Axitinib), in subjects with advanced renal cell carcinoma.
Kidney (Renal Cell),
Phase I
I
Rini, Brian
NCT04522323
VICCUROP2043
Rigosertib Plus Pembrolizumab in Treating Patients with Unresectable/Metastatic Melanoma Refractory to PD-1 Inhibitors
Melanoma
Melanoma
This phase II clinical trial tests how well rigosertib plus pembrolizumab workings in treating patients with melanoma which cannot be removed by surgery (unresectable) or that has spread from where it first started (primary site) to other places in the body (metastatic), and that has not responded to previous treatment with PD-1 or PD-L1 inhibitors (refractory). Rigosertib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and may change the immune system to make immunotherapy more effective. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving rigosertib in combination with pembrolizumab may be more effective in treating patients with unresectable metastatic melanoma that has not responded to previous treatment with PD-1 or PD-L1 inhibitors than giving either drug alone.
Melanoma
II
Johnson, Douglas
NCT05764395
VICCMEL2218
Ipilimumab, Nivolumab, and Ciforadenant as First-Line Therapy for Stage IV Renal Cell Carcinoma
Multiple Cancer Types
This phase 1b/2 trial tests the safety, side effects, and best dose of ciforadenant in combination with ipilimumab and nivolumab as initial (first-line) therapy for patients with stage IV renal cell carcinoma. Ciforadenant may stimulate the immune system in different ways and stop tumor cells from growing. Immunotherapy with monoclonal antibodies, such as ipilimumab and nivolumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving ciforadenant in combination with ipilimumab and nivolumab may help control the disease.
Kidney (Renal Cell),
Phase I
I/II
Beckermann, Kathryn
NCT05501054
VICCUROP22122
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
Itacitinib for the Treatment Steroid Refractory Immune Related Adverse Events Arising from Immune Checkpoint Inhibitors
Miscellaneous
Miscellaneous
This phase II trial tests how well itacitinib works in in patients with immune related adverse events (irAEs) arising from immune checkpoint inhibitors (ICI) that do not respond to steroids (steroid refractory). Steroids are the usual treatment for these side effects. However, sometimes steroids do not improve or fix the side effects. Giving itacitinib may be effective in treating patients with known or suspected problems coming from ICIs, that do not resolve or improve with steroids, by reducing the patient's immune system response that can cause the irAEs.
Miscellaneous
II
Johnson, Douglas
NCT05660421
VICCCTT2193
Study of DF1001 in Patients With Advanced Solid Tumors
Multiple Cancer Types
DF1001-001 is a study of a new molecule that targets natural killer (NK) cells and T-cell
activation signals to specific receptors on cancer cells. The study will occur in two phases.
The first phase will be a dose escalation phase, enrolling patients with various types of
solid tumors that express human epidermal growth factor receptor 2 (HER2). The second phase
will include a dose expansion using the best dose selected from the first phase of the study.
Multiple cohorts will be opened with eligible patients having either HER2 activated non-small
cell lung cancer, hormone receptor (HR) positive HER2 negative metastatic breast cancer, or
HER2 positive metastatic breast cancer. DF1001-001 will be administered as monotherapy or in
combination; combinations are DF1001 + nivolumab, DF1001 + Nab paclitaxel, and DF1001 +
sacituzumab govitecan-hziy.
activation signals to specific receptors on cancer cells. The study will occur in two phases.
The first phase will be a dose escalation phase, enrolling patients with various types of
solid tumors that express human epidermal growth factor receptor 2 (HER2). The second phase
will include a dose expansion using the best dose selected from the first phase of the study.
Multiple cohorts will be opened with eligible patients having either HER2 activated non-small
cell lung cancer, hormone receptor (HR) positive HER2 negative metastatic breast cancer, or
HER2 positive metastatic breast cancer. DF1001-001 will be administered as monotherapy or in
combination; combinations are DF1001 + nivolumab, DF1001 + Nab paclitaxel, and DF1001 +
sacituzumab govitecan-hziy.
Miscellaneous,
Phase I
I/II
Berlin, Jordan
NCT04143711
VICCPHI2064
