CLINICAL RESEARCH TRIALS

What is a Clinical Trial?

A clinical trial is carefully supervised research that is done prior to the release of a drug to the general public. Before a drug enters the clinical trial phase, it is extensively tested through basic or preclinical research in the laboratory and with animals.

The type of experiments done depends on which disease is being studied. The process that brings a new drug from the research laboratory to the marketplace is a long and careful one. It takes years to complete all of the testing in the laboratory, animals, and humans.

What Are The Potential Benefits From Participating in a Clinical Trial?

  • The opportunity to become involved in the research of an investigational drug that would otherwise not be available. (Additional treatment options)
  • The possibility of free study medication.
  • Contributing to medical science which may help yourself and other patients now and in the future.

How Do People Become Involved in a Clinical Trial?

One of the most important steps in the development process of clinical trials is for people like you who volunteer to receive the drug and to be observed for its effects. It is through these trials that investigational new drugs are tested to determine whether they can benefit human beings. But before this can happen, people must volunteer and participate – a choice that may benefit not only the individual but many, many others as well.

Whether or not a clinical trial is right for you depends on a number of factors, including your medical condition and/or medical history. Not every disease will have a clinical trial at our office. But this situation is constantly changing.

Stephanie Patel, RN
Clinical Research Coordinator
843.577.6957
researchcoordinator@choasc.com

Wendy Miller
Data Manager
843.577.6957
datamanager@choasc.com

Brandi Risher
Regulatory Manager/ Research Coordinator
843.577.6957
Brandi.risher@choasc.com

Ashley Morrill, MRA
Clinical Research Coordinator
843.577.6957
Ashley.Morrill@choasc.com

We participate in multiple clinical trials in numerous disease states and stages to include:

Click on the Disease Catergory below for more Specifics on what Trials are offered and see if you Qualify.

LUNG:
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  • BMS CA 209-153  Stage 4 NSCLC after progression for Stage 4 disease treatment (had multiple lines of metastatic treatment) Opened 7/30/2014 with our site enrolling 25 patients.  Opdivo FDA approval of this drug in this setting for this patient population was March 4, 2015.  We continue to have patients on this trial that are over 2 years out and continue to have phenomenal results.  – closed to enrollment
  • BMS CA 209-568  1st Line Stage 4 NSCLC combination treatment of Yervoy with Opdivo currently with 8 patients enrolled.  These patients started as early as July 2016 and all the patients continue to have either stable disease or partial responses on their respective CT scans – enrollment on hold and anticipated to reopen this quarter
  • Merck 407 is our 1st line metastatic NSCLC in the squamous cell type with Keytruda.  Currently have 1 patient on treatment with a partial response recorded – Currently enrolling
  • BMS CA 209-370 1st Line metastatic NSCLC with Xalkori and Nivolumab.  Successfully enrolled 1 patient in this cohort with partial response to disease noted.  Patient was on treatment for 3 months however BMS pulled the plug doe to safety signals noted for hepato-toxicity.  Note our patient is the only patient that did not have hepato-toxicity on the combination treatment – Enrollment closed
  • BMS CA 209-370 1st Line Metastatic NSCLC with Nivolumab.  Successfully enrolled 2 patients with both patients having 2 months of stable disease while on treatment.  – Enrollment closed
  • Roche GO 29436  1st Line Stage 4 NSCLC with Atezolizumab – Enrollment closed prior to our site enrolling a patient
  • BMS CA 209 -384 Nivolumab frequency in NSCLC patients – currently enrolling

DLBCL:
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  • MorphoSys AG C203 Relapsed/Refractory DLBCL to Rituxan with 3 screen fail patients due to aggressive disease progression which inhibited these patients from getting past the screening phase – currently enrolling

BREAST:
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  • Celldex which is for our metastatic triple negative breast cancer patients, we successfully had one patient on this trial that had 6 months of responding disease per CT scan results – currently enrolling
  • Merck 355 is our Keytruda based trial for 1st line treatment in the triple negative breast cancer patient – currently enrolling for this trial

COLORECTAL:
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  • XBiotech  which was for our metastatic colorectal patients, we enrolled 3 patients on this trial with either stable disease and currently have 1 patient that remains on treatment – closed to enrollment

GASTRIC:
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  • Gilead 1080 which is for our advanced or metastatic gastric or gastroesophageal junction.  We currently have 2 patients on treatment with one patient status post the 1st CT scan notable for partial response and the 2nd patient is due for her 1st CT scan soon – open to enrollment

HEPATOCELLULAR:
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  • Merck 240 for our Hepatocellular in the 2nd line setting with Keytruda – currently enrolling for this trial (we had one possible patient for this study however the patient was not able to come to the West Ashley office for scheduled visits)

MULTIPLE MYELOMA:
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  • Merck 183 is 3rd line or greater for our Multiple Myeloma patients with Keytruda.  Successfully enrolled 2 patients on this trial with 1 patient remaining on treatment with a partial response recorded for this patient, this same patient has been on treatment for over a year now.  The second patient had recorded stable disease for 6 months while on treatment – currently enrolling
  • Merck 185 is our 1st line Multiple Myeloma study with Keytruda.  Successfully enrolled 1 patient and received cycle 2 of treatment however due to aggressive disease passed away however while on treatment had responding disease – currently enrolling

RENAL:
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  • BMS CA 209-374 Nivolumab after Anti Angiogenic treatment for Renal Cell.  We successfully enrolled 1 patient on this study who had stable disease for over 4 months but discontinued treatment due to possible toxicity – currently enrolling
  • Merck 3475-426 Keytruda for 1st Line Metastatic Renal Cell for Clear Cell Pathology – Site opened December 2016 currently enrolling
  • Merck 3475-427 Keytruda for Advanced or Metastatic Renal Cell for Clear and Non Clear pathology – Site opened December 2016 currently enrolling
  • BMS  CA 209-920 Yervoy with Opdivo for Advanced or Metastatic Renal Cell for Clear and Non Clear Pathology – Site opened January 13, 2017 currently enrolling

PIPELINE:
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  • BMS CA 209 – 816 for our Early Stage NSCLC with Opdivo and Yervoy  vs Chemotherapy in the neoadjuvant setting – anticipated opening this quarter
  • Janssen AML 3002 for our AML patients treatment with JNJ 56022473 (monoclonal antibody) – anticipated opening this quarter

Please note, available trials can change frequently.
Please contact our office for questions regarding available trials.