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Clinical Trials Search at Vanderbilt-Ingram Cancer Center

Biomarker Verification in Pediatric Chronic GvHD: ABLE 2.0 / PTCTC GVH 1901 Study

This study will validate a previously developed pediatric prognostic biomarker algorithm
aimed at improving prediction of risk for the later development of chronic graft-versus-host
disease (cGvHD) in children and young adults undergoing allogeneic hematopoietic stem cell

By developing an early risk stratification of patients into low-, intermediate-, and
high-risk for future cGvHD development (based upon their biomarker profile, before the onset
of cGvHD), pre-emptive therapies aimed at preventing the onset of cGvHD can be developed
based upon an individual's biological risk profile.

This study will also continue research into diagnostic biomarkers of cGvHD, and begin work
into biomarker models that predict clinical response to cGvHD therapies.
Not Available
Kitko, Carrie

A Study of miRNA 371 in Patients with Germ Cell Tumors


This trial studies whether the blood marker micro ribonucleic acid (miRNA) 371 can predict the chance of cancer returning in patients with germ cell cancers. Studying samples of blood from patients with germ cell cancers in the laboratory may help doctors predict how likely the cancer will come back.
Davis, Nancy

Evaluation of Immunologic Response following COVID-19 Vaccination in Children, Adolescents, and Young Adults with Cancer


This study evaluates immunologic response following COVID-19 vaccination in children, adolescents, and young adults with cancer. Vaccines work by stimulating the bodys immune cells to respond against a specific disease. The immune response produces protection from that disease. Effects from cancer and from treatments for cancer can reduce the bodys natural disease fighting ability (called immunity). Factors such as vaccine type, timing of vaccine dosing related to treatment for cancer and number of vaccine doses or boosts (extra vaccine shots) may strengthen or diminish the bodys protective immune response. This study may help researchers learn more about how the bodys immune system responds to the COVID-19 vaccine when the vaccination is given during or after cancer treatment.
Esbenshade, Adam

A Study Evaluating an Advanced Pneumatic Compression Device Versus Usual Care for Treatment of Head and Neck Lymphedema


To compare the effectiveness of an APCD to Usual Care in the management of lymphedema and
fibrosis (LEF) in head and neck cancer (HNC) survivors.
Murphy, Barbara

Study of INCA 0186 in Subjects With Advanced Solid Tumors

Multiple Cancer Types

This is an open-label, nonrandomized, multicenter, dose escalation, and dose expansion
first-in human (FIH) Phase 1 study to determine the safety, tolerability, PK,
pharmacodynamics, and preliminary efficacy of INCA00186 when given alone or in combination
with INCB106385 and/or retifanlimab in participants with specific advanced solid tumors;
squamous cell carcinoma of the head and neck (SCCHN) and specified gastrointestinal (GI)
malignancies have been selected as indications of interest for this study. Participants with
CD8 T-cell-positive tumors will be selected as these tumors are more likely to respond to
Miscellaneous, Phase I
Berlin, Jordan

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.
Head/Neck, Lung, Non Small Cell, Phase I
Iams, Wade

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.
Pediatric Leukemia, Pediatrics
Zarnegar-Lumley, Sara

Strata PATH (Precision Indications for Approved Therapies)


StrataPATH is a non-randomized, open-label trial designed to explore efficacy and safety of
multiple FDA-approved and commercially available cancer therapies in new, biomarker-guided
patient populations.
Berlin, Jordan

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.
Miscellaneous, Phase I
Berlin, Jordan

A Study of HC-7366 to Establish the Maximum Tolerated Dose (MTD) and Recommended Phase 2 Dose (RP2D)

Multiple Cancer Types

This is a first in human, multicenter, open label, Phase 1a/b dose escalation and dose
expansion study to establish the maximum tolerated dose (MTD), recommended Phase 2 dose
(RP2D), and evaluate the safety and tolerability of QD oral dosing of HC 7366 in a dose
escalating fashion in subjects with advanced solid tumors. Up to 36 subjects will be enrolled
into the Phase 1a dose escalation part of the study. Every effort will be made to ensure
approximately 50% of all subjects enrolled in this study will be subjects with the tumors of
special interest such as squamous cell carcinoma of the head and neck (SCCHN), colorectal
cancer (CRC), non-small cell lung cancer (NSCLC), and transitional cell carcinoma of the
bladder (TCC). Subjects with other solid tumor types are also eligible provided study
selection criteria are met and they do not exceed 50% of all enrolled subjects. The study
will be conducted in the United States at approximately 3 to 5 sites. This Phase 1a/b study
will follow a traditional 3+3 design. The starting dose level will be 10 mg QD, escalating to
20, 40, 75, 125, and 150 mg QD as safety allows. All doses are to be administered in the
fasting state with water at least 1 hour before food or at least 2 hours after food. The
Phase 1b dose expansion part will involve cohort expansion at up to 2 dose levels selected
from the dose escalation data by the safety monitoring committee (SMC), to obtain additional
safety and preliminary efficacy information. Each cohort in Phase 1b will enroll 15 subjects.
The study will be expanded into a Phase 2 study via protocol amendment which will then assess
the dose and tumor type(s) selected in Phase 1a/b as the most appropriate for further
clinical development. Subjects will be dosed until unacceptable toxicity, disease progression
per immune-related Response Evaluation Criteria in Solid Tumors (iRECIST), discontinuation of
treatment for other protocol allowed reason (eg, subject refusal), any other administrative
reasons, or after 2 years of treatment, whichever occurs first. For scheduling purposes,
dosing will occur in 3 week cycles and computed tomography (CT) scans will be conducted once
every 6 weeks with the first postbaseline scan after 6 weeks of dosing (precycle 3).
Miscellaneous, Phase I
Berlin, Jordan

To learn more about any of our clinical
trials, call 615-936-8422.