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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

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

A Trial of TAK-788 (AP32788) in Non-small Cell Lung Cancer (NSCLC)

Multiple Cancer Types

The purpose of this phase 1 / 2 study is to evaluate the safety, recommended phase 2 dose (RP2D), dose limiting toxicities (DLTs), maximum tolerated dose (MTD), pharmacokinetics of oral TAK-788 and its active metabolites, anti-tumor activity of TAK-788 in participants with NSCLC with epidermal growth factor receptor (EGFR) or human epidermal growth factor 2 (HER2) mutations, and anti-tumor activity of TAK-788 in participants with solid tumors other than NSCLC with EGFR or HER2 mutations, and to explore relationship between tumor and / or plasma biomarkers, and TAK-788 efficacy, safety, and / or cytochrome P450 3A (CYP3A) induction. The study will also determine the efficacy of TAK-788 in participants with locally advanced or metastatic NSCLC harboring EGFR in-frame exon 20 insertion mutations who have received at least 1 prior line of therapy for locally advanced or metastatic NSCLC.
Lung, Non Small Cell
I/II
Horn, Leora
NCT02716116
VICCTHO1614

An Open-Label, Dose-Escalation / Dose-Expansion Safety Study of INCB059872 in Subjects With Advanced Malignancies

Multiple Cancer Types

This is an open-label, dose-escalation / dose-expansion study of INCB059872 in subjects with advanced malignancies. The study will be conducted in 4 parts. Part 1 (mono therapy dose escalation) will determine the recommended dose(s) of INCB059872 for dose expansion, based on maximum tolerated dose and / or a tolerated pharmacologically active dose. Part 2 (dose expansion) will further determine the safety, tolerability, efficacy, PK, and PD of the selected monotherapy dose(s) in AML / MDS, SCLC, myelofibrosis, Ewing sarcoma, and poorly differentiated neuroendocrine tumors. Part 3 will determine the recommended dose(s) of INCB059872 in combination with azacitadine and all-trans retinoic acid in AML and in combination with nivolumab in SCLC. Part 4 will further determine the safety, tolerability, efficacy, PK, and PD of the selected combination dose(s) in Part 3.
Hematologic, Leukemia, Lung, Miscellaneous, Small Cell
I/II
Savona, Michael
NCT02712905
VICCHEMP1615

Afatinib and Necitumumab in Treating Patients with EGFR Mutation Positive Advanced or Metastatic Non-small Cell Lung Cancer

Multiple Cancer Types

This phase I trial studies the side effects and best dose of afatinib and necitumumab and to see how well they work in treating patients with EGFR mutation positive non-small cell lung cancer that has spread to other places in the body. Afatinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Monoclonal antibodies, such as necitumumab, may interfere with the ability of tumor cells to grow and spread. Giving afatinib and necitumumab may work better in treating patients with EGFR mutation positive non-small cell lung cancer.
Lung, Non Small Cell
I
Horn, Leora
NCT03054038
VICCTHO1684

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