Clinical Trials Search at Vanderbilt-Ingram Cancer Center
A Study of Ceralasertib Monotherapy and Ceralasertib Plus Durvalumab in Patients With Melanoma and Resistance to PD-(L)1 Inhibition
Melanoma
Melanoma
Main study: This is an open-label, phase 2 study that aims to evaluate the efficacy and
safety/tolerability of ceralasertib, when administered as monotherapy and in combination with
durvalumab in participants with unresectable or advanced melanoma and primary or secondary
resistance to PD-(L)1 inhibition.
safety/tolerability of ceralasertib, when administered as monotherapy and in combination with
durvalumab in participants with unresectable or advanced melanoma and primary or secondary
resistance to PD-(L)1 inhibition.
Melanoma
II
Johnson, Douglas
NCT05061134
VICCMEL2177
Testing Oral Decitabine and Cedazuridine (ASTX727) in Combination with Venetoclax for Higher-Risk Acute Myeloid Leukemia Patients
Leukemia
Leukemia
This phase Ib/II trial studies the effects of ASTX727 (decitabine and cedazuridine) in combination with venetoclax in treating patients with higher-risk acute myeloid leukemia patients who do not have a change in the gene called fms-like tyrosine kinase 3 (FLT3). 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. Cedazuridine is an enzyme inhibitor. It helps to increase the amount of decitabine in the body so that the medication will have a greater effect. Venetoclax is in a class of medications called B-cell lymphoma-2 (BCL-2) inhibitors. Venetoclax may stop the growth of cancer cells by blocking BCL-2, a protein needed for cancer cell survival. Venetoclax and decitabine are commonly given together for older patients with AML ASTX727 (a pill form of decitabine + cedazuridine) has been found to be equal to decitabine (given intravenously), and this part of the study is to confirm that venetoclax and ASTX727 is as safe as venetoclax and decitabine given intravenously. This study allows for lowering doses of study drugs to assure the dose chosen for the randomized study (second portion of this trial) is safe and tolerable for people. Giving ASTX727 in combination with venetoclax may help in the treatment of patients with higher-risk acute myeloid leukemia.
Leukemia
I/II
Savona, Michael
NCT04817241
VICCNCIHEM10417
Avelumab or Hydroxychloroquine with or without Palbociclib for the Treatment of Stage II-III Breast Cancer, PALAVY Study
Breast
Breast
This phase II trial investigates the effect of avelumab or hydroxychloroquine sulfate with or without palbociclib in treating patients with stage II-III breast cancer that is positive for disseminated tumor cells (DTCs) after curative therapy. DTCs are breast cancer cells that are asleep (dormant) in the bone marrow. There are multiple ways in which these cells stay alive, and three of these mechanisms are inhibited by the drugs in this trial. First, dormant cancer cells need a protein signal pathway involving CDK 4/6 to start dividing once they wake up in order to survive as an active cancer cell. Palbociclib works by blocking the CDK 4/6 protein and by doing so may limit the dormant cancer cell from being able to survive. In addition, palbociclib may also help both of the other drugs in the trial to work better. Second, dormant cancer cells also use a process called autophagy to generate their own nutrition, which can allow them to stay asleep. Hydroxychloroquine has been shown to block autophagy, which leads to starvation of the cells. Third, dormant cancer cells are able to hide from the bodys immune system. The immune system sends a type of cell called T cells throughout the body to detect and fight infections and diseasesincluding cancers. One way the immune system controls the activity of T cells is through the PD-1/PD-L1 (programmed cell death protein-1) pathway. However, some cancer cells hide from T-cell attack by taking control of the PD-1/PD-L1 interaction and this stops T cells from attacking cancer cells. Avelumab is an antibody designed to block the PD-1/PD-L1 pathway and helps the immune system in detecting and fighting dormant cancer cells. Because palbociclib, hydroxychloroquine, and avelumab work on the mechanisms that keep the dormant cells alive, taking one or a combination of these drugs may be able to eliminate DTCs.
Breast
II
Reid, Sonya
NCT04841148
VICCBRE2161
LUMINOS-102: Lerapolturev With or Without Immune Checkpoint Blockade in Advanced PD-1 Refractory Melanoma
Melanoma
Melanoma
A Phase 2 study to investigate the efficacy and safety of lerapolturev alone or in
combination with a programmed death receptor-1 (anti-PD-1) inhibitor.
combination with a programmed death receptor-1 (anti-PD-1) inhibitor.
Melanoma
II
Johnson, Douglas
NCT04577807
VICCMEL20109
A Study of Evorpacept (ALX148) in Patients With Advanced HER2+ Gastric Cancer (ASPEN-06)
Gastric/Gastroesophageal
Gastric/Gastroesophageal
A Phase 2/3 Study of Evorpacept (ALX148) in Combination With Trastuzumab, Ramucirumab, and
Paclitaxel in Patients With Advanced HER2-overexpressing gastric/GEJ adenocarcinoma.
Paclitaxel in Patients With Advanced HER2-overexpressing gastric/GEJ adenocarcinoma.
Gastric/Gastroesophageal
II/III
Gibson, Mike
NCT05002127
VICCGI2174
A Study to Evaluate Safety and Efficacy of Selinexor in Combination With Ruxolitinib in Participants With Myelofibrosis
Multiple Cancer Types
This is a global, Phase 1/2, multicenter, open-label study to evaluate the safety and
efficacy of selinexor plus ruxolitinib in treatment nave myelofibrosis (MF) participants.
The study will be conducted in two phases: Phase 1a/1b and Phase 2. The Phase 1a of the study
will be dose escalation (non-randomized dose finding study) to determine the maximum
tolerated dose [MTD], recommended Phase 2 dose (RP2D), and evaluate safety and preliminary
efficacy and will follow a standard 3+3 design. The Phase 1b of the study will be dose
expansion (non-randomized efficacy exploration) at the determined RP2D to further assess the
safety and preliminary efficacy at this dose level. The Phase 2 (randomized efficacy
exploration) of the study will include MF participants who are treatment nave randomized 1:1
to receive the combination therapy of selinexor and ruxolitinib versus (vs) ruxolitinib
monotherapy.
efficacy of selinexor plus ruxolitinib in treatment nave myelofibrosis (MF) participants.
The study will be conducted in two phases: Phase 1a/1b and Phase 2. The Phase 1a of the study
will be dose escalation (non-randomized dose finding study) to determine the maximum
tolerated dose [MTD], recommended Phase 2 dose (RP2D), and evaluate safety and preliminary
efficacy and will follow a standard 3+3 design. The Phase 1b of the study will be dose
expansion (non-randomized efficacy exploration) at the determined RP2D to further assess the
safety and preliminary efficacy at this dose level. The Phase 2 (randomized efficacy
exploration) of the study will include MF participants who are treatment nave randomized 1:1
to receive the combination therapy of selinexor and ruxolitinib versus (vs) ruxolitinib
monotherapy.
Hematologic,
Phase I
I/II
Mohan, Sanjay
NCT04562389
VICCHEMP2130
A Study of Belzutifan (MK-6482) in Participants With Advanced Clear Cell Renal Cell Carcinoma (MK-6482-018)
Multiple Cancer Types
The goal of this study is to evaluate the safety, tolerability and pharmacokinetics of
escalating doses of belzutifan as second line positive (2L+) treatment in participants with
advanced clear cell renal cell carcinoma (ccRCC).
escalating doses of belzutifan as second line positive (2L+) treatment in participants with
advanced clear cell renal cell carcinoma (ccRCC).
Kidney (Renal Cell),
Phase I
I
Beckermann, Kathryn
NCT04846920
VICCUROP2127
Study of SQZ-eAPC-HPV in Patients With HPV16+ Recurrent, Locally Advanced or Metastatic Solid Tumors
This is a Phase 1/2, first-in-human, open label, multicenter study to assess safety and
tolerability, antitumor activity, and immunogenic and pharmacodynamic effects of SQZ-eAPC-HPV
as monotherapy and in combination with pembrolizumab in patients with recurrent, locally
advanced, or metastatic HPV16+ solid tumors. The study includes patients with head and neck,
cervical, anal, vulvar, or penile cancer.
tolerability, antitumor activity, and immunogenic and pharmacodynamic effects of SQZ-eAPC-HPV
as monotherapy and in combination with pembrolizumab in patients with recurrent, locally
advanced, or metastatic HPV16+ solid tumors. The study includes patients with head and neck,
cervical, anal, vulvar, or penile cancer.
Not Available
I/II
Iams, Wade
NCT05357898
VICCPHI2264
A Study for Subjects With Prostate Cancer Who Previously Participated in an Enzalutamide Clinical Study
Prostate
Prostate
The purpose of this study is to collect long term safety data in subjects who are continuing
to derive clinical benefit from treatment with Enzalutamide from the subjects participation
in an enzalutamide clinical study sponsored by Astellas or Medivation (i.e., parent study)
which has completed, at a minimum, the primary analysis or the study specified evaluation
period.
to derive clinical benefit from treatment with Enzalutamide from the subjects participation
in an enzalutamide clinical study sponsored by Astellas or Medivation (i.e., parent study)
which has completed, at a minimum, the primary analysis or the study specified evaluation
period.
Prostate
II
Moses, Kelvin
NCT02960022
VICCURO2210
Sparing Bone Marrow in Patients with Stage III-IV Lung Cancer, VMAT Trial
Lung
Lung
This phase II trial tests whether designing radiation to avoid bone marrow in the spine (vertebral bone marrow) leads to less reduction of white blood cell counts (lymphopenia) in patients with lung cancer. This sparing technique could lead to better disease control and outcome.
Lung
N/A
Osmundson, Evan
NCT05248256
VICCRAD2189
