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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

Randomized, Open Label, Clinical Study of the Targeted Therapy, Palbociclib, to Treat Metastatic Breast Cancer

Breast

The primary objective of this study is to demonstrate that the combination of palbociclib with anti-HER2 therapy plus endocrine therapy is superior to anti-HER2-based therapy plus endocrine therapy alone in improving the outcomes of subjects with hormone receptor-positive, HER2+ metastatic breast cancer.
Breast
III
Mayer, Ingrid
NCT02947685
VICCBRE17118

Targeted Therapy Directed by Genetic Testing in Treating Pediatric Patients with Relapsed or Refractory Advanced Solid Tumors, Non-Hodgkin Lymphomas, or Histiocytic Disorders (The Pediatric MATCH Screening Trial)

Multiple Cancer Types

This Pediatric MATCH screening and multi-sub-study phase II trial studies how well treatment that is directed by genetic testing works in pediatric patients with solid tumors, non-Hodgkin lymphomas, or histiocytic disorders that have progressed following at least one line of standard systemic therapy and / or for which no standard treatment exists that has been shown to prolong survival. Genetic tests look at the unique genetic material (genes) of patients' tumor cells. Patients with genetic changes or abnormalities (mutations) may benefit more from treatment which targets their tumor's particular genetic mutation, and may help doctors plan better treatment for patients with solid tumors or non-Hodgkin lymphomas.
Lymphoma, Miscellaneous, Pediatric Solid Tumors
N/A
Borinstein, Scott
NCT03155620
COGAPEC1621SC

REVEAL 1 (Evaluation of VGX-3100 and Electroporation for the Treatment of Cervical HSIL)

HPV-301 is a prospective, randomized, double-blind, placebo controlled Phase 3 study to determine the efficacy, safety, and tolerability of VGX-3100 administered by intramuscular (IM) injection followed by electroporation (EP) delivered with CELLECTRA™ 5PSP in adult women with histologically confirmed cervical high grade squamous intraepithelial lesion (HSIL) (cervical intraepithelial neoplasia grade 2 [CIN2] or grade 3 [CIN3]) associated with human papillomavirus (HPV) 16 and / or HPV-18.
Not Available
III
Alvarez, Ronald
NCT03185013
VICCGYN1801

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

A Study To Assess The Tolerability And Clinical Activity Of Gedatolisib In Combination With Palbociclib / Letrozole Or Palbociclib / Fulvestrant In Women With Metastatic Breast Cancer

Multiple Cancer Types

This is a multicenter, open label, Phase 1b study in patients with mBC. This study will have a dose escalation to identify the maximum tolerated dose (MTD) of the combination of gedatolisib plus palbociclib / fulvestrant and gedatolisib plus palbociclib / letrozole and expansion to estimate the objective response rate (OR) of the combination of gedatolisib plus palbociclib / letrozole or palbociclib / fulvestrant.
Breast, Phase I
I
Mayer, Ingrid
NCT02684032
VICCBRE1804

Carboplatin with or without Pembrolizumab in Treating Patients with Advanced Breast Cancer with Locally Recurrent Chest Wall Disease That Cannot Be Removed by Surgery

Breast

This randomized phase II trial studies how well carboplatin with or without pembrolizumab work in treating patients with breast cancer that has spread to other places in the body with chest wall disease that has come back and cannot be removed by surgery. Monoclonal antibodies, such as carboplatin and pembrolizumab, may interfere with the ability of tumor cells to grow and spread.
Breast
II
Abramson, Vandana
NCT03095352
VICCBRE1808

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

Nivolumab and Ipilimumab in Estimating Anti-Tumor Activity and Identifying Potential Predictors of Response in Patients with Melanoma That is Metastatic or Cannot Be Removed by Surgery

Melanoma

This phase II trial studies how well nivolumab and ipilimumab work in estimating anti-tumor activity and identifying potential predictors of response in patients with melanoma that is spreading to other places in the body or that cannot be removed by surgery. Monoclonal antibodies, such as nivolumab and ipilimumab, may interfere with the ability of tumor cells to grow and spread.
Melanoma
N/A
Johnson, Douglas
NCT02978443
VICCMEL1816

Iodine I-131 with or without Selumetinib in Treating Patients with Recurrent or Metastatic Thyroid Cancer

This randomized phase II trial studies how well iodine I-131 works with or without selumetinib in treating patients with thyroid cancer that has returned or has spread from where it started to other places in the body. Many thyroid cancers absorb iodine. Due to this, doctors often give radioactive iodine (iodine I-131) alone to treat thyroid cancer as part of standard practice. It is thought that the more thyroid tumors are able to absorb radioactive iodine, the more likely it is that the radioactive iodine will cause those tumors to shrink. Selumetinib may help radioactive iodine work better in patients whose tumors still absorb radioactive iodine. It is not yet known whether iodine I-131 is more effective with or without selumetinib in treating thyroid cancer.
Not Available
II
Gilbert, Jill
NCT02393690
VICCHN1817

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