Skip to main content

Clinical Trials Search at Vanderbilt-Ingram Cancer Center



Dose Escalation and Expansion Study of GSK3359609 in Subjects With Selected Advanced Solid Tumors (INDUCE-1)

Multiple Cancer Types

GSK3359609 is an anti-Inducible T cell Co-Stimulator (ICOS) receptor agonist antibody intended for the treatment of cancers of different histology. This is a first-time-in-human (FTIH), open-label, multicenter study designed to investigate the safety, pharmacology, and preliminary antitumor activity in subjects with advanced or recurrent solid tumors with the aim to establish recommended dose(s) of GSK3359609 for further exploration as monotherapy and in combination with pembrolizumab or chemotherapy regimens. The study is comprised of two primary parts, each composed of two phases: Part 1: GSK3359609 monotherapy with Part 1A as dose escalation phase and Part 1B as cohort expansion phase; Part 2: GSK3359609 combination therapy with Part 2A pembrolizumab or GSK3174998 combination dose escalation phase and Part 2B expansion phase with pembrolizumab. Part 2A GSK3359609 combinations with chemotherapy will only consist of safety run-in cohorts. Each part and phase of the study includes a screening period, a treatment period, and a follow-up period. The primary objective of the study is to determine the safety, tolerability, maximum tolerated dose or the maximum administered dose of GSK3359609 alone or in combination.
Lung, Non Small Cell, Phase I
I
Horn, Leora
NCT02723955
VICCTHOP17113

Nivolumab and Vorolanib in Treating Participants with Non-Small Cell Lung Cancer and Refractory Thoracic Tumors

Multiple Cancer Types

This phase I / II trial studies the side effects and best does of vorolanib when given in combination with nivolumab in treating participants with non-small cell lung cancer and thoracic tumors that aren't responding to treatment. Immunotherapy with monoclonal antibodies, such as nivolumab, may help the body’s immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Vorolanib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving nivolumab and vorolanib may work better in treating participants with non-small cell lung cancer and thoracic tumors.
Lung, Non Small Cell
I/II
Horn, Leora
NCT03583086
VICCTHO1802

Phase II Umbrella Study of Novel Anti-cancer Agents in Patients With NSCLC Who Progressed on an Anti-PD-1 / PD-L1 Containing Therapy.

Multiple Cancer Types

This is an open-label, multi-centre, umbrella Phase II study in patients with metastatic NSCLC who have progressed on an anti-PD-1 / PD-L1 containing therapy. This study is modular in design, allowing initial assessment of the efficacy, safety, and tolerability of multiple treatment arms.
Lung, Non Small Cell
II
Horn, Leora
NCT03334617
VICCTHO1810

Integrated Telehealth or In-Person Palliative Care in Improving Quality of Life in Patients with Advanced Non-small Cell Lung Cancer

Multiple Cancer Types

This randomized clinical trial studies how well integrated telehealth or in-person palliative care works in improving quality of life in patients with non-small lung cancer that has spread to other places in the body. Early involvement in palliative care may lesson many of the distressing physical and emotional symptoms and help patients and their families cope with serious illness as well as improve patients’ and their loved ones’ experience with cancer. Integrated telehealth palliative care involves patients meeting with palliative care clinicians using secure video-conferencing technology. It is not yet known whether giving integrated telehealth or in-person palliative care works better for patients and their families in improving quality of life.
Lung, Non Small Cell
N/A
Martin, Sara
NCT03375489
VICCTHO1839

Clinical Proteomics Tumor Analysis Consortium CPTAC 3.0 Research Protocol

Lung

Lung
N/A
Massion, Pierre
VICCTHO1850

LIBERTI: Role of Circulating Tumor DNA (ctDNA) from LIquid Biopsy in Early Stage NSCLC Resected Lung Tumor Investigation

Multiple Cancer Types

Lung, Non Small Cell, Phase I
N/A
Massion, Pierre
VICCTHO1868

Collection of Tissue Samples for Cancer Research

Multiple Cancer Types

Background: -Patients who are being evaluated and / or treated at the NIH Clinical Center (pediatric and adult) and adult patients at participating sites will be entered onto this tissue procurement protocol for collection of tissue specimens. Objectives: - To obtain samples from adult and pediatric patients for research purposes from tests and procedures that are done as required by the primary research protocol(s) to which a patient is enrolled or as part of their standard-of-care treatment. - To obtain samples for research purposes from non-surgical procedures, such as percutaneous biopsies, performed for the sole purpose of obtaining tissue specimens or biological fluids for this protocol. Eligibility: -Adult patients (18 years of age and older) and pediatric patients (younger than 18 years of age) who are being evaluated for and / or treated for cancer at the NIH Clinical Center and adult patients from participating sites. Design: - This is a multicenter tissue procurement protocol with NCI as the coordinating center. - For adult patients: specimens for research purposes, as outlined in this protocol, will be obtained from tests and procedures that are done as required by the primary research protocols to which a patient is enrolled or as part of their standard-of-care treatment. Non-surgical procedures, such as percutaneous biopsies, may also be performed for the sole purpose of obtaining tissue specimens or biological fluids for this protocol. Tissues and biological fluids to be procured may include but are not limited to blood, serum, urine, tumor tissue, normal tissue, pleural fluid, CSF, saliva, bronchial alveolar lavage (BAL), circulating tumor cells, hair follicles, and bone marrow. These specimens will be stored with unique identifiers and used to perform only those research studies that are outlined in this protocol. - For pediatric patients: tumor biopsy / resection tissue used for pediatric preclinical model development will only be from tissue already being obtained as part of a procedure necessary for the patient s clinical care or as part of a primary research protocol; blood specimens will be collected as part of a blood collection already scheduled for the patient s clinical care or as part of the planned pre-procedure bloodwork; volumes collected will not exceed institutional research limits. - Given the risks associated with any invasive procedure, such as tumor biopsy, the procedure will be discussed in detail with the patients and their parents / guardian (as indicated), including the side effects, prior to obtaining a separate consent for each procedure. A separate consent will not be signed prior to obtaining samples by minimally invasive measures, such as venipuncture. - This study has three separate consent forms: one for adult patients at the NIH Clinical Center to opt to donate their samples for ongoing research on assay development and studies of molecular pathways; and two for the generation of preclinical models (adult and pediatric). Adult patients at the NIH and participating sites, and also pediatric patients (NIH Clinical Center only), can opt to donate samples to create preclinical models to study tumor biology and genetics, and to develop new therapies for cancer. - Patients may remain on study for the duration of their consent or completion of the planned procedure, whichever comes first.
Lung, Miscellaneous, Small Cell
N/A
Pietenpol, Jennifer
NCT00900198
VICCMD1494

Genetic Testing in Screening Patients with Stage IB-IIIA Non-Small Cell Lung Cancer That Has Been or Will Be Removed by Surgery (The ALCHEMIST Screening Trial)

Multiple Cancer Types

This phase III ALCHEMIST trial studies genetic testing in screening patients with stage IB-IIIA non-small cell lung cancer that has been or will be removed by surgery. Studying the genes in a patient’s tumor cells may help doctors select the best treatment for patients that have certain genetic changes.
Lung, Non Small Cell
III
York, Sally
NCT02194738
ECOGTHOA151216

Trial of Brigatinib After Treatment With Next-Generation ALK Inhibitors

Multiple Cancer Types

The purpose of this study is to evaluate the safety and effectiveness of this investigational drug, brigatinib (AP261136) in patients with advanced non-small cell lung cancer Non-small cell lung cancer (NSCLC) who have had first-line treatment for their cancer and it still got worse, even after, or while taking drugs called ALK inhibitors, or anti-cancer drugs that act on tumors. Some examples of these anti-cancer drugs are: KEYTRUDA® or ALECENSA®).
Lung, Non Small Cell
II
Horn, Leora
NCT02706626
VICCTHO1736

Phase 1b Multi-indication Study of Anetumab Ravtansine in Mesothelin Expressing Advanced Solid Tumors

Multiple Cancer Types

The key purpose of the main part of the study is to assess efficacy and safety of anetumab ravtansine as monotherapy or combination therapy for mesothelin expressing advanced solid tumors. The main purpose of the safety lead-in (dose-finding) part of the study is to determine the safety and tolerability of anetumab ravtansine in combination with cisplatin and in combination with gemcitabine, and to determine the MTD of anetumab ravtansine in combination with cisplatin for mesothelin expressing advanced cholangiocarcinoma and in combination with gemcitabine for mesothelin expressing advanced adenocarcinoma of the pancreas. Patients will receive anetumab ravtansine every three weeks in monotherapy for most indications. In cholangiocarinoma and adenocarinoma of the pancreas, 3-weekly anetumab ravtansine is administered in combination with cisplatin or gemcitabine respectively (both administered in a 2 week on / 1 week off schedule). Treatment will continue until disease progression or until another criterion for withdrawal is met. .Efficacy will be measured by evaluating the tumor's objective response rate. Radiological tumor assessments will be performed at defined time points until the patient's disease progresses. Blood samples will be collected for safety, pharmacokinetic and biomarker analysis. Archival or fresh biopsy tissue will also be collected for mesothelin expression testing and biomarker analyses.
Breast, Endocrine, Esophageal, Gastrointestinal, Lung, Non Small Cell, Pancreatic
I
Horn, Leora
NCT03102320
VICCPHI1742

To learn more about any of our clinical
trials, call 1-800-811-8480 or complete
the online Self-Referral Form here: