QUILT-3.055: A Phase IIb, Single-Arm, Open-Label Study of ALT-803 in Combination with Pembrolizumab or Nivolumab in Patients with Advanced or Metastatic Non-Small Cell Lung Cancer who have Disease Progression Following an Initial Response to Treatment with PD-1 Checkpoint Inhibitor Therapy Save

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

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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 advanced or metastatic non-small cell lung cancer (NSCLC) whose disease improved or remained unchanged after receiving nivolumab or pembrolizumab and whose disease has now worsened. The investigational drug in this study is called ALT-803. Participants can expect to receive the study drug ALT-803 in combination with an approved drug called pembrolizumab or they will receive ALT-803 in combination with an approved drug called nivolumab. Participants will receive ALT-803 in combination with pembrolizumab if they have previously received pembrolizumab. They will receive ALT-803 in combination with nivolumab if they have previously received nivolumab. The purpose of this research study is to test the effectiveness of the study drug, ALT-803, in combination with either pembrolizumab or nivolumab in patients with advanced or metastatic NSCLC that initially had improvement or no change in disease after receiving pembrolizumab or nivolumab 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 1/2 Study on the Safety of Rovalpituzumab Tesirine Administered in Combination with Nivolumab or Nivolumab and Ipilimumab for Adults with Extensive-Stage Small Cell Lung Cancer Save

Date Added
June 27th, 2017
PRO Number
Pro00065422
Researcher
John Wrangle

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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 extensive-stage small cell lung cancer (SCLC). This study is being conducted to test whether or not rovalpituzumab tesirine (SC16LD6.5) combined with nivolumab alone or with nivolumab and ipilimumab are useful treatments for small cell lung cancer, after at least one prior treatment has failed.The investigational drugs in this study are Rovalpituzumab Tesirine (SC16LD6.5), Nivolumab (BMS-936558, MDX1106, ONO-4538, Opdivo®), and Ipilimumab (MDX-010, Yervoy®) . If participants agree to take part in this study, their involvement will last for as long as their study doctor confirms their cancer is not getting worse and there have been no significant side effects. There is no limit to the number of cycles of study treatment participants can receive.

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

An Open-label, Single-Arm, Phase 2 Study Evaluating the Efficacy, Safety and Pharmacokinetics of Rovalpituzumab Tesirine (SC16LD6.5) for Third-line and Later Treatment of Subjects with Relapsed or Refractory Delta-Like Protein 3-Expressing Small Cell Lung Cancer (TRINITY) Save

Date Added
February 9th, 2016
PRO Number
Pro00051442
Researcher
John Wrangle

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

This study is for participants who have been diagnosed with small cell lung cancer. You are being invited to take part in a research study to test an investigational drug called rovalpituzumab tesirine (SC16LD6.5, also known as the "study drug") for the treatment of small cell lung cancer. The purpose of this research study is to determine if rovalpituzumab tesirine can be administered safely and if rovalpituzumab tesirine is an effective treatment for small cell lung cancer that produces DLL3. Participants can expect to be in this study for up to 4 years.

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

An open label Phase Ib dose escalation study to evaluate the safety, tolerability, pharmacokinetics, immunogenicity and maximum tolerated dose of anetumab ravtansine in combination with pemetrexed 500 mg/m2 and cisplatin 75 mg/m2 in subjects with mesothelin-expressing predominantly epithelial mesothelioma or nonsquamous non-small-cell lung cancer Save

Date Added
February 9th, 2016
PRO Number
Pro00051011
Researcher
John Wrangle

Silhouette
Keywords
Cancer, Cancer/Lung, Drug Studies
Summary

This study is for subjects who have been diagnosed with peritoneal or pleural mesothelioma or nonsquamous non-small-cell lung cancer(NSCLC) cancer that cannot be cured by standard treatment. If you do participate in this study, you will receive BAY 94-9343, an investigational (experimental) anti-cancer medication. The purpose of this study is to evaluate safety, tolerability (the effect of the drug on your body), maximum tolerated dose, pharmacokinetics (the effect of your body on the drug), and immunogenicity (induce a mediated immune response) of BAY 94-9343 when given in combination with Pemetrexed and Cisplatin in subjects with advance or refractory (has not responded to other treatment) mesothelioma or nonsquamous non-small-cell lung cancer (NSCLC). Another purpose of the study is what effects (both good and bad) it has on you and your cancer. Study duration will vary with each participant.

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

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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