Clinical Trials Search at Vanderbilt-Ingram Cancer Center
A Study of TAK-676 With Pembrolizumab After Radiation Therapy to Treat a Number of Cancers
Multiple Cancer Types
In this study, adults with non-small-cell lung cancer (NSCLC), triple-negative breast cancer
(TNBC) and squamous-cell carcinoma of the head and neck (SCCHN) will be treated with TAK-676
and pembrolizumab following radiotherapy. The main aims of this study are to check if people
are improving after treatment with TAK-676, getting side effects from these combined
treatments, and how much TAK-676 people with these cancers can receive without getting
unacceptable side effects from it.
Participants will receive radiotherapy, then at least 40 hours later will receive
pembrolizumab followed by TAK-676 slowly through a vein (infusion). Participants will receive
an infusion of pembrolizumab at the same dose every 3 weeks. Different small groups of
participants will receive lower to higher doses of TAK-676 on specific days of a 21-day
cycle. This study will be happening at sites in North America.
(TNBC) and squamous-cell carcinoma of the head and neck (SCCHN) will be treated with TAK-676
and pembrolizumab following radiotherapy. The main aims of this study are to check if people
are improving after treatment with TAK-676, getting side effects from these combined
treatments, and how much TAK-676 people with these cancers can receive without getting
unacceptable side effects from it.
Participants will receive radiotherapy, then at least 40 hours later will receive
pembrolizumab followed by TAK-676 slowly through a vein (infusion). Participants will receive
an infusion of pembrolizumab at the same dose every 3 weeks. Different small groups of
participants will receive lower to higher doses of TAK-676 on specific days of a 21-day
cycle. This study will be happening at sites in North America.
Head/Neck,
Lung,
Non Small Cell,
Phase I
I
Iams, Wade
NCT04879849
VICCHNP20120
Venetoclax in Children With Relapsed Acute Myeloid Leukemia (AML)
Multiple Cancer Types
A study to evaluate if the randomized addition of venetoclax to a chemotherapy backbone
(fludarabine/cytarabine/gemtuzumab ozogamicin [GO]) improves survival of
children/adolescents/young adults with acute myeloid leukemia (AML) in 1st relapse who are
unable to receive additional anthracyclines, or in 2nd relapse.
(fludarabine/cytarabine/gemtuzumab ozogamicin [GO]) improves survival of
children/adolescents/young adults with acute myeloid leukemia (AML) in 1st relapse who are
unable to receive additional anthracyclines, or in 2nd relapse.
Pediatric Leukemia,
Pediatrics
III
Zarnegar-Lumley, Sara
NCT05183035
VICCPED2237
DAY101 Monotherapy or in Combination With Other Therapies for Patients With Solid Tumors
Multiple Cancer Types
This is a Phase 1b/2, multi-center, open label umbrella study of patients 12 years of age
with recurrent or progressive solid tumors with alterations in the key proteins of the
RAS/RAF/MEK/ERK pathway, referred to as the MAPK pathway.
with recurrent or progressive solid tumors with alterations in the key proteins of the
RAS/RAF/MEK/ERK pathway, referred to as the MAPK pathway.
Miscellaneous,
Phase I
I/II
Berlin, Jordan
NCT04985604
VICCMD2142
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
A Study of MT-0169 in Participants With Relapsed or Refractory Multiple Myeloma or Non-Hodgkin Lymphoma
Multiple Cancer Types
This will be a Phase 1 Open-Label, dose escalation and expansion study of MT-0169 (an
Engineered toxin body (ETB) in patients with relapsed or refractory multiple myeloma or
non-Hodgkin lymphoma. MT-0169 is an investigational drug that recognizes and binds to the
CD38 receptor, which may be found on the surface of multiple myeloma and non-Hodgkin lymphoma
cancer cells. It delivers a dose of a modified toxin that kills these cells.
Engineered toxin body (ETB) in patients with relapsed or refractory multiple myeloma or
non-Hodgkin lymphoma. MT-0169 is an investigational drug that recognizes and binds to the
CD38 receptor, which may be found on the surface of multiple myeloma and non-Hodgkin lymphoma
cancer cells. It delivers a dose of a modified toxin that kills these cells.
Multiple Myeloma,
Phase I
I
Dholaria, Bhagirathbhai
NCT04017130
VICCHEMP1975
Vincristine Pharmacokinetics in Infants
Pediatrics
Pediatrics
This pilot trial compares drug exposure levels using a new method for dosing vincristine in infants and young children compared to the standard dosing method based on body surface area (BSA) in older children. Vincristine is an anticancer drug used to a variety of childhood cancers. The doses anticancer drugs in children must be adjusted based on the size of the child because children vary significantly in size (height, weight, and BSA) and ability to metabolize drugs from infancy to adolescence. The dose of most anticancer drugs is adjusted to BSA, which is calculated from a patients weight and height. However, infants and young children have more severe side effects if the BSA is used to calculate their dose, so new dosing models have to be made to safely give anticancer drugs to the youngest patients. This new method uses a BSA-banded approach to determine the dose. Collecting blood samples before and after a dose of the drug will help researchers determine whether this new vincristine dosing method results in equivalent drug levels in the blood over time in infants and young children compared to older children.
Pediatrics
N/A
Borinstein, Scott
NCT05359237
COGPEPN22P1
Islet Cell and ST2 Axis Dysregulation in Post-Transplant Diabetes Mellitus
Not Available
N/A
Engelhardt, Brian
NCT03415139
VICCCTT1836
