A Phase III, Double-blind, Placebo-controlled, Multi-center International Study of Neoadjuvant/Adjuvant Durvalumab for the Treatment of Patients with Resectable Stages II and III Non-small Cell Lung Cancer (AEGEAN) Save

Date Added
September 12th, 2019
PRO Number
Pro00090077
Researcher
John Wrangle

List of Studies

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Keywords
Cancer, Cancer/Lung, Drug Studies, Men's Health, Women's Health
Summary

This study is for patients that have been diagnosed with Resectable Stages II and III Non-small Cell Lung Cancer (NSCLC). The investigational drug in this study is durvalumab. The purpose of this study is to see if durvalumab will work and be safe for the treatment of resectable NSCLC. Participants can expect to be on this study for about 5 years.

Institution
MUSC
Recruitment Contact
HCC Clinical Trials Office
843-792-9321
hcc-clinical-trials@musc.edu

INSIGNA : A Randomized, Phase III Study of Firstline Immunotherapy Alone or in Combination With Chemotherapy in Induction/Maintenance or Postprogression in Advanced Nonsquamous Non-Small Cell Lung Cancer (NSCLC) With Immunobiomarker SIGNature-Driven Analysis Save

Date Added
July 29th, 2019
PRO Number
Pro00089504
Researcher
John Wrangle

List of Studies

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Keywords
Cancer, Cancer/Lung
Summary

This study is for patients that have been diagnosed with non-squamous non-small cell lung cancer. The investigational drug used is MK-3475 (pembrolizumab). The purpose of this study is to compare any good and bad effects of using only the immunotherapy drug, MK-3475 (pembrolizumab), alone first versus the combination of the immunotherapy drug, MK-3475 (pembrolizumab), and chemotherapy. Participants can expect to be on this study for up to 2 years and followed for up to 5 years from when they began taking part in the study.

Institution
MUSC
Recruitment Contact
Nancy McGaha
864-725-7129
nmcgaha@selfregional.org

A Phase 1b Study of ASP1948, Targeting an Immune Modulatory Receptor, as a Single Agent and in Combination with Nivolumab in Subjects with Advanced Solid Tumors Save

Date Added
July 23rd, 2019
PRO Number
Pro00087949
Researcher
John Wrangle

List of Studies

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Keywords
Cancer, Cancer/Breast, Cancer/Genitourinary, Cancer/Gynecological, Cancer/Head & Neck, Cancer/Lung
Summary

The purpose of this study is to determine at what dose the study drug (ASP1948) is safe and tolerated and how it is processed in the blood of patients with tumors that cannot be removed (unresectable) or has spread (metastasized) to a different part of the body. When the safe dose is identified, it will be used to evaluate if the study treatment causes tumors to shrink in patients.The screening period for this study can take up to 28 days. The treatment period consists of up to 48 weeks of initial treatment, followed by up to 45 weeks of follow up. If you quality and are willing to continue in the re-treatment period (receiving the study drug again), you will be in the study for an additional 48 weeks.

Institution
MUSC
Recruitment Contact
HCC Clinical Trials Office
843-792-9321
hcc-clinical-trials@musc.edu

A Phase 1 Study of ALKS 4230 Administered Subcutaneously as Monotherapy and in Combination With Pembrolizumab in Subjects With Advanced Solid Tumors Save

Date Added
July 23rd, 2019
PRO Number
Pro00088438
Researcher
John Wrangle

List of Studies

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Keywords
Cancer, Cancer/Breast, Cancer/Gastrointestinal, Cancer/Lung, Cancer/Skin
Summary

The study will have 2 parts (Part A and Part B). Part A of this research study (the dose escalation phase) will test the safety and effectiveness of the different doses of ALKS 4230 (study drug) to find the one that is the safest and most effective. Part B of this study (the dose expansion phase) will use the safe dosing determined in Part A to see how effectively the combination of ALKS 4230 and pembrolizumab treats your solid tumors.LKS 4230 is an investigational (experimental) drug; this means that is has not been approved by the US Food and Drug Administration (FDA) to treat your disease. This is an open-label study which means that all subjects will be taking the active study drugs.You can be in the study for as long as it is clinically beneficial to you.

Institution
MUSC
Recruitment Contact
HCC Clinical Trials Office
843-792-9321
hcc-clinical-trials@musc.edu

A PHASE 2, OPEN-LABEL, RANDOMIZED STUDY OF ALT-803, A FUSION PROTEIN ACTIVATOR OF NATURAL KILLER AND T CELLS, IN COMBINATION WITH PEMBROLIZUMAB VS PEMBROLIZUMAB ALONE AS FIRST-LINE TREATMENT FOR PATIENTS WITH METASTATIC NON-SMALL CELL LUNG CANCER (NSCLC) Save

Date Added
September 25th, 2018
PRO Number
Pro00080330
Researcher
John Wrangle

List of Studies

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Keywords
Cancer, Cancer/Lung, Drug Studies, Men's Health, Women's Health
Summary

This study is for patients who have been diagnosed with metastatic, non-small cell lung cancer (NSCLC), have not received any prior chemotherapy for metastatic disease, and are eligible to receive pembrolizumab, a FDA approved standard therapy for NSCLC. The investigational drug in this study is ALT-803. In this research study, participants will be selected by chance to receive either the study drug ALT-803 in combination with pembrolizumab or will receive pembrolizumab alone. The purpose of this research study is to test the effectiveness of the study drug, ALT-803, in combination with pembrolizumab compared to pembrolizumab alone. Participants can expect to be in this study for 24 months.

Institution
MUSC
Recruitment Contact
HCC Clinical Trials Office
843-792-9321
hcc-clinical-trials@musc.edu

A Feasibility Trial of Neoadjuvant Cisplatin-Pemetrexed with Atezolizumab in Combination and in Maintenance for Resectable Malignant Pleural Mesothelioma." Save

Date Added
April 24th, 2018
PRO Number
Pro00076862
Researcher
John Wrangle

List of Studies

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Keywords
Cancer, Cancer/Lung, Lung
Summary

This study is for patients that have been diagnosed with mesothelioma. This study is to test whether giving one drug, atezolizumab, along with cisplatin and pemetrexed, before surgery and atezolizumab after surgery by vein is safe. Atezolizumab is the experimental cancer drug in this study, which has already been approved for the treatment of patients with bladder cancer and lung cancer. Participants can expect to be in this study for up to a year and followed for side effect for up to three years after study completion.

Institution
MUSC
Recruitment Contact
HCC Clinical Trials Office
843-792-9321
hcc-clinical-trials@musc.edu

QUILT-3.055: A Phase IIb, Single-Arm, Multicohort, Open-Label Study of ALT-803 in Combination with a PD-1/PD-L1 Checkpoint Inhibitor in Patients who have Disease Progression Following an Initial Response to Treatment with PD-1/PD-L1 Checkpoint Inhibitor Therapy Save

Date Added
August 22nd, 2017
PRO Number
Pro00068710
Researcher
John Wrangle

List of Studies

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Keywords
Cancer, Cancer/Lung, Drug Studies, Men's Health, Women's Health
Summary

This study is for patients who have been diagnosed with an advanced form of cancer and your disease improved or remained unchanged after receiving PD-1/ PD-L1 Checkpoint Inhibitor Therapy. The investigational drug in this study is called ALT-803. Participants will receive the study drug ALT-803 in combination with an approved PD-1/PD-L1 Checkpoint Inhibitor Therapy (Pembrolizumab, Nivolumab, Atezolizumab, or Avelumab). The purpose of this research study is to test the effectiveness of the study drug, ALT-803, in combination with pembrolizumab, nivolumab, atezolizumab, or avelumab in with advanced forms of cancer that initially had improvement or no change in disease after receiving checkpoint inhibitor therapy and who now have disease worsening. Participation in this study should take approximately 24 months.

Institution
MUSC
Recruitment Contact
HCC Clinical Trials Office
843-792-9321
hcc-clinical-trials@musc.edu

A Phase IB/II Study of Nivolumab in Combination with ALT-803 in Patients with Pretreated, Advanced or Metastatic Non-Small Cell Lung Cancer Save

Date Added
October 13th, 2015
PRO Number
Pro00048329
Researcher
John Wrangle

List of Studies

Silhouette
Keywords
Cancer/Lung
Summary

This study is for adult patients with non-small cell lung cancer (NSCLC). The purpose of this study is to look at the safety and tolerability of escalting doses of ALT-803 and Nivolumab. ALT-803 is an investigational drug. Subjects will have screening tests to determine if he or she is eligible to participate in this study. If the subject is eligible and wishes to enroll, he or she will begin treatment with ALT-803 and nivolumab. Study treatment will last until the subject is no longer benefiting from the study drug.

Institution
MUSC
Recruitment Contact
HCC Clinical Trials Office
843-792-9321
hcc-cto-clinops@musc.edu

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