Clinical Trials
As an academic medical center, Our Lady of the Lake is committed to the advancement of healthcare through clinical innovation, medical education and scientific research. We participate in a wide range of clinical trials that are used to determine whether new drugs or treatments are both safe and effective.
Be sure to consult with your physician before participating in a clinical trial.
Clinical Trials by Specialty
Purpose: The goal of the study is to compare the efficacy and safety of crizanlizumab + standard of care to standard of care alone on renal function in sickle cell disease patients ≥ 16 years with chronic kidney disease due to sickle cell nephropathy.
Principle Investigator: Dr. Vince Cataldo
Contact: For more information, contact JoAnne Hollingsworth, BSN at (225) 765-4073
Open to Enrollment
Title: HOPE Kids. Study to Evaluate the Effect of GBT440 in Pediatrics with Sickle Cell Disease
Purpose: This study consists of four parts, Parts A, B, C, and D. Part A is a single dose pharmacokinetic (PK) study in pediatric participants with Sickle Cell Disease. Part B is a multiple dose, safety, exploratory, efficacy, and PK study in adolescent Sickle Cell Disease participants who were 12-17 years of age. Part C is a multiple dose, safety, tolerability, and PK study, which includes the assessment of hematological effects and the effect on TCD flow velocity of voxelotor in pediatric participants with Sickle Cell Disease who are 4 to 17 years of age. Part D is a multiple dose, safety, tolerability, and PK study, which will examine the hematological effects of voxelotor in pediatric participants with Sickle Cell Disease who are between 9 months to less than 4 years of age.
Principle Investigator: Dr. Kacie Sims
Contact: For more information, contact JoAnne Hollingsworth, BSN at (225) 765-4073
Closed to Enrollment
Purpose: Randomized pivotal study to evaluate the safety and efficacy of the nContact EPi-Sense®-AF Guided Coagulation System with VisiTrax® to treat symptomatic persistent Atrial Fibrillation (AF) patients who are refractory or intolerant to at least one Class I and/or III anti-arrhythmic drug.
Principle Investigator: Dr. Kenneth Civello
Contact: For more information, contact Becky S. Toler, RN, BSN at (225) 765-7659
Closed to Enrollment
Purpose: The purpose of this study is to determine if patiromer treatment of subjects who developed hyperkalemia while receiving RAASi medications will result in continued use of RAASi medications in accordance with heart failure (HF) treatment guidelines and thereby decrease the occurrence of the combined endpoint of cardiovascular (CV) death and CV hospitalization events compared with placebo treatment.
Principle Investigator: Dr. Tara Jarreau
Contact: For more information, contact Gretchen Figarola, RN, BSN at (225) 765-7659
Open to Enrollment
Title: GREAT. Global Registry for Endovascular Aortic Treatment Outcomes Evaluation
Purpose: Prospective observational cohort registry designed to obtain data on device performance and clinical outcomes of patients treated with Gore endovascular aortic products in the United States.
Principle Investigator: Dr. Paul Michael Davis
Contact: For more information, contact Becky S. Toler, RN, BSN at (225) 765-7659.
Closed to Enrollment
Title: GUIDE-HF. Hemodynamic-GUIDEd Management of Heart Failure
Purpose: The GUIDE-HF IDE clinical trial is intended to demonstrate the effectiveness of the CardioMEMS™ HF System in an expanded patient population including HF patients outside of the present indication, but at risk for future HF events or mortality. The trial includes patients with New York Heart Association (NYHA) Class II, III, or IV HF who have an elevated N-terminal pro-Brain Natriuretic Peptide (NT-proBNP) (or an elevated Brain Natriuretic Peptide (BNP)) and/or a prior HF hospitalization (HFH). The GUIDE-HF IDE trial will include approximately 3600 subjects at approximately 140 North American sites and consists of two arms: a Randomized Arm and a Single Arm.
Principle Investigator: Dr. David Moll
Contact: For more information, contact Anne Erwin, MSN, RN, CCRP at (225) 765-7659
Opening to Enrollment
Title: Multi-center cross-sectional epidemiological study to characterize the prevalence and distribution of lipoprotein(a) levels among patients with established cardiovascular disease
Purpose: The purpose of this study is to improve knowledge about the epidemiology of Lp(a) in patients with established cardiovascular disease (CVD).
Principle Investigator: Dr. Denzil Moraes
Contact: For more information, contact Julie Doyle at (225) 765-7660
Open to Enrollment
Purpose: Study TQJ230A12301 is a pivotal phase 3 study designed to test the hypothesis that treatment with TQJ230 80 mg s.c QM will significantly reduce the risk of CV deaths, nonfatal myocardial infarction (MI), non-fatal stroke and urgent coronary re-vascularization in patients with established CVD and elevated levels of Lp(a) who are treated for CV risk factors other than Lp(a) according to local guidelines for the reduction of cardiovascular risk in patients with established CVD and elevated Lp(a). TQJ230 is a N-acetyl galactosamine (GalNAc) conjugated 2 ́-O-(2-methoxyethyl) (2 ́-MOE) chimeric second-generation antisense oligonucleotide (ASO) drug targeted to apolipoprotein(a), [apo(a)].
Principle Investigator: Dr. Denzil Moraes
Contact: For more information, contact Anne Erwin, MSN, RN, CCRP at (225) 765-7659
Opening Soon
Purpose: Observational, post-market, real world study to assess outcomes of patients treated with the AFX System compared to other EVAR devices for Endovascular Abdominal Aortic Aneurysm Repair.
Principle Investigator: Dr. James Craven
Contact: For more information, contact Becky S. Toler, RN, BSN at (225) 765-7659
Closed to Enrollment
Purpose: The purpose of this study is to evaluate whether the early introduction of Entresto compared to Ramipril will reduce the effects of heart failure in patients following acute MI, when taken in addition to conventional MI treatment.
Principle Investigator: Dr. Andrew Rees
Contact: For more information, contact Anne Erwin, BSN, RN, CCRP at (225) 765-7659
Closed to Enrollment
Purpose: The purpose of this study is to assess the effect of sacubitril/valsartan (LCZ696) vs. valsartan on changes in NT-proBNP and outcomes, safety and tolerability in patients with HFpEF (left ventricular ejection fraction (LVEF) > 40%) who have been stabilized during hospitalization for acute decompensated heart failure and initiated in-hospital or within 30 days post discharge. Initial dose for patients randomized to sacubitril/valsartan (LCZ696) will be determined by patient's previous dose of ACEi/ARB immediately prior to hospital admission for acute decompensated heart failure. Study treatment will be titrated to the target dose of sacubitril/valsartan (LCZ696) 97/103 mg twice daily (Dose Level 3). Patients will be randomized in a 1:1 ratio of sacubitril/valsartan to valsartan for up to approximately 20 months of double-blind treatment.
Principle Investigator: Dr. Denzil Moraes
Contact: For more information, contact Anne Erwin, BSN, RN, CCRP at (225) 765-7659
Open to Enrollment
Title: PSR. Product Surveillance Registry
Purpose: The purpose of the registry is to provide continuing evaluation and periodic reporting of safety and effectiveness of market-released products for their intended use.
Principle Investigator: Dr. Henry Patrick
Contact: For more information, contact Gretchen Figarola, RN, BSN at (225) 765-7659
Open to Enrollment
Title: Passive Immunity Trial for Our Nation to Treat COVID-19 in Hospitalized Adults (PassItOn)
Purpose: The purpose of this study is to test the safety and efficacy of convalescent donor plasma to treat COVID-19 in hospitalized adults in a randomized, placebo-controlled setting. The effect of convalescent plasma will be compared to placebo on clinical outcomes, measured using the COVID-19 7-point Ordinal Clinical Progression Outcomes Scale at Day 15, among adults with COVID-19 requiring hospitalization. Convalescent plasma or placebo will be given as a single infusion to randomized patients.
Principle Investigator: Dr. Vince Cataldo
Contact: For more information, contact JoAnne Hollingsworth, BSN at (225) 765-4073
Open to Enrollment
Title: Study of Efficacy and Safety of MAS825 in Patients With COVID-19 (MAS-COVID)
Purpose: The purpose of this study is to evaluate the efficacy and safety of MAS825 in addition to current standard of care compared to placebo and standard of care in controlling the inflammatory syndrome and resultatnt acute respiratory distress syndrome in hospitalized patients presenting with COVID-19 pneumonia and impaired respiratory function. MAS825 is an anti-IL-1b/IL-18 monoclonal antibody.
Principle Investigator: Dr. Bud O'Neal
Contact: For more information, contact Jennifer Daigle, BSN at (225) 939-0779
Closed to Enrollment
Title: Dociparstat for the Treatment of Severe COVID-19 in Adults at High Risk of Respiratory Failure
Purpose: This is a randomized, double-blind, placebo-controlled Phase 2/3 study to evaluate the safety and efficacy of dociparstat (DSTAT) in patients with Acute Lung Injury (ALI) due to COVID-19. This study is designed to determine if DSTAT can accelerate recovery and prevent progression to mechanical ventilation in patients severely affected by COVID-19. Dociparstat is a glycosaminoglycan derived from porcine heparin. The pharmacologic activity profile of dociparstat retains the polyanionic and anti-inflammatory activities of unfractionated heparin with substantially reduced anticoagulant activity.
Principle Investigator: Dr. Brad Vincent
Contact: For more information, contact Anne Erwin, MSN, RN, CCRP at (225) 765-7659
Closed to Enrollment
Title: A Phase 1, Open-Label, Two-Part Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of a Single Dose of Intravenous Lefamulin In Hospitalized Pediatric Subjects Receiving Standard of Care Antibiotic Therapy for Confirmed or Suspected Infection
Purpose: Multicenter, double blind randomized controlled trial of fentanyl vs. fentanyl + dexmedetomidine as the initial regimen for maintenance of sedation in mechanically-ventilated, critically ill children. This trial will evaluate the opioid-sparing effect of dexmedetomidine when administered with fentanyl to mechanically ventilated, critically ill children. Study drug or placebo will be administered with fentanyl, which will be titrated to achieve sedation scores consistent with response to light touch. Plasma samples and bedside assessments for pain, sedation, and delirium will be collected.
Principle Investigator: Dr. Kelechi Iheagwara
Contact: For more information, contact JoAnne Hollingsworth, BSN at (225) 765-4073
Closed to Enrollment
Title: Natural History of the Development of Type 1 Diabetes
Purpose: The purpose of this study is to learn more about how Type 1 Diabetes occurs.
Principle Investigator: Dr. James Garner
Contact: For more information, contact Christine LeBoeuf, MSN, RN, OCN, CCRC at (225) 765-5956
Open to Enrollment
Purpose: The purpose of this study is to determine the safety and effectiveness of the monoclonal antibody bezlotoxumab in children ages 1 to 17 who have a Clostridium difficile infection.
Principal Investigator: Dr. Michael Bolton
Contact: For more information, contact JoAnne Hollingsworth, BSN at (225) 765-4073
Open to enrollment
There are no Genetic studies open at this time.
Purpose: This is a randomized, open-label, multi-center, comparative trial to assess the efficacy and safety in immunocompromised subjects with acyclovir resistant mucocutaneous HSV infection, treated with pritelivir 100 mg qd (following a loading dose of 400 mg as first dose to rapidly reach steady-state plasma concentration) or foscarnet 40 mg/kg iv tid/60mg/kg iv bid.
Principal Investigator: Dr. Bud O'Neal
Contact: For more information, contact Jennifer Daigle, BSN at (225) 939-0779
Open to enrollment
Title: A Phase 1, Open-Label, Two-Part Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of a Single Dose of Intravenous Lefamulin In Hospitalized Pediatric Subjects Receiving Standard of Care Antibiotic Therapy for Confirmed or Suspected Infection
Purpose: The purpose of this study is to characterize the safety, tolerability, and pharmacokinetics of lefamulin after a single IV dose in pediatric subjects (birth to < 18 years) who are receiving systemic antibiotic therapy for the prevention or treatment of a confirmed or suspected bacterial infection.
Principal Investigator: Dr. Michael Bolton
Contact: For more information, contact JoAnne Hollingsworth, BSN at (225) 765-4073
Open to Enrollment
Purpose: This is a multicenter, multinational, open label single dose pharmacokinetic (PK) study enrolling at least 32 subjects. The study aims to characterize the pharmacokinetics (PK) of a single intravenous dose of CAZ AVI in pediatric subjects aged 3 months to less than 18 years who are receiving systemic antibiotic therapy for suspected or confirmed nosocomial pneumonia, including ventilator associated pneumonia.
Principal Investigator: Dr. Michael Bolton
Contact: For more information, contact JoAnne Hollingsworth, BSN at (225) 765-4073
Open to Enrollment
Title: Lamprene Multiple Patient Program
Purpose: Lamprene®/Clofazimine, is a product of the pharmaceutical company named Novartis Pharmaceuticals Corporation. Lamprene®/Clofazimine is approved by FDA (the U.S Food and Drug Administration) for the treatment of leprosy. It is no longer available through pharmacies in the US. It is being tested in non-Novartis clinical studies for drug resistant tuberculosis and non-tuberculous mycobacteria (NTM). To be eligible for participation in this expanded access program, patients must have an NTM diagnosis. The treating physician has decided that this infection can be treated with Lamprene®/Clofazimine. This medicine is provided to the physician in an expanded access program. This means that this medicine is not registered for the treatment of NTM, but it can be used in special situations where there are no other possible treatments. For example, this may be because the patient has a type of Mycobacterial infection that is resistant or failed to respond optimally to other drugs, or because the patient has had side effects that prevent the use of other drugs. The physician must submit a patient registration form to initiate the patient approval process.
Principal Investigator: Dr. Maria Reyes
Contact: For more information, contact Katie Vance, PhD at (225) 765-4365
Open to Enrollment
There are no Neurological studies open at this time.
Purpose: This phase III trial studies how well carvedilol works in preventing cardiac toxicity in patients with human epidermal growth factor receptor (HER)-2-positive breast cancer that has spread to other places in the body. A beta-blocker, such as carvedilol, is used to treat heart failure and high blood pressure, and it may prevent the heart from side effects of chemotherapy.
Principle Investigator: Stagg, Marshall BS, MD
Contact: For more information, email the Research Department at research@fmolhs.org
Purpose: Patients with HER2-positive primary breast cancer (BC) who do not achieve complete response after appropriate neoadjuvant therapy are at higher risk of disease recurrence. More effective treatment options are needed for this patient population. This study will examine the efficacy and safety of trastuzumab deruxtecan (T-DXd) compared with trastuzumab emtansine (T-DM1) in high-risk patients with residual invasive breast cancer following neoadjuvant therapy.
Principle Investigator: Zatarain, Lauren
Contact: For more information, email the Research Department at research@fmolhs.org
Purpose: This phase II/III trial studies the best dose of duloxetine and how well it works in preventing pain, tingling, and numbness (peripheral neuropathy) caused by treatment with oxaliplatin in patients with stage II-III colorectal cancer. Duloxetine increases the amount of certain chemicals in the brain that help relieve depression and pain. Giving duloxetine in patients undergoing treatment with oxaliplatin for colorectal cancer may help prevent peripheral neuropathy.
Principle Investigator: Stagg, Marshall BS, MD
Contact: For more information, email the Research Department at research@fmolhs.org
Purpose: This phase III trial studies how well vitamin D3 given with standard chemotherapy and bevacizumab works in treating patients with colorectal cancer that has spread to other parts of the body. Vitamin D3 helps the body use calcium and phosphorus to make strong bones and teeth. Drugs used in chemotherapy, such as leucovorin calcium, fluorouracil, oxaliplatin, and irinotecan hydrochloride, work in different ways to stop the growth of tumor cells by killing the cells, by stopping them from dividing, or by stopping them from spreading. Immunotherapy with monoclonal antibodies, such as bevacizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving vitamin D3 with chemotherapy and bevacizumab may work better in shrinking or stabilizing colorectal cancer. It is not yet known whether giving high-dose vitamin D3 in addition to chemotherapy and bevacizumab would extend patients' time without disease compared to the usual approach (chemotherapy and bevacizumab).
Principle Investigator: Stagg, Marshall BS, MD
Contact: For more information, email the Research Department at research@fmolhs.org
Purpose: This phase III trial studies combination chemotherapy and atezolizumab to see how well it works compared with combination chemotherapy alone in treating patients with stage III colon cancer and deficient deoxyribonucleic acid (DNA) mismatch repair. Drugs used in combination chemotherapy, such as oxaliplatin, leucovorin calcium, and fluorouracil, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Immunotherapy with monoclonal antibodies, such as atezolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving combination chemotherapy with atezolizumab may work better than combination chemotherapy alone in treating patients with colon cancer.
Principle Investigator: Stagg, Marshall BS, MD
Contact: For more information, email the Research Department at research@fmolhs.org
Purpose: This phase II/III trial studies how well circulating tumor deoxyribonucleic acid (ctDNA) testing in the blood works in predicting treatment for patients with stage IIA colon cancer after surgery. ctDNA are circulating tumor cells that are shed by tumors into the blood. Finding ctDNA in the blood means that there is very likely some small amounts of cancer that remain after surgery. However, this cancer, if detected, cannot be found on other tests usually used to find cancer, as it is too small. Testing for ctDNA levels may help identify patients with colon cancer after surgery who do benefit, and those who do not benefit, from receiving chemotherapy.
Principle Investigator: Stagg, Marshall BS, MD
Contact: For more information, email the Research Department at research@fmolhs.org
Purpose: This phase 3 trial compares the addition of nivolumab to chemotherapy (carboplatin and paclitaxel) versus usual treatment (chemotherapy alone) for the treatment of anal cancer that has spread to other places in the body (metastatic). 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. Chemotherapy drugs, such as carboplatin and paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving nivolumab together with carboplatin and paclitaxel may help doctors find out if the treatment is better or the same as the usual approach.
Principle Investigator: Stagg, Marshall BS, MD
Contact: For more information, email the Research Department at research@fmolhs.org
Purpose: This phase II trial studies how well gemcitabine hydrochloride and cisplatin work in treating participants with invasive bladder urothelial cancer. Drugs used in chemotherapy, such as gemcitabine hydrochloride and cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading.
Principle Investigator: Stagg, Marshall BS, MD
Contact: For more information, email the Research Department at research@fmolhs.org
Purpose: This phase III trial compares the usual treatment (treatment with ipilimumab and nivolumab followed by nivolumab alone) to treatment with ipilimumab and nivolumab, followed by nivolumab with cabozantinib in patients with untreated renal cell carcinoma that has spread to other parts of the body. The addition of cabozantinib to the usual treatment may make it work better. Immunotherapy with monoclonal antibodies, such as nivolumab and ipilimumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Cabozantinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. It is not yet known how well the combination of cabozantinib and nivolumab after initial treatment with ipilimumab and nivolumab works in treating patients with renal cell cancer that has spread to other parts of the body.
Principle Investigator: Stagg, Marshall BS, MD
Contact: For more information, email the Research Department at research@fmolhs.org
Title: A Randomized Phase II Trial of Triplet Therapy (A PD-L1 Inhibitor Durvalumab (MEDI4736) in Combination with Olaparib and Cediranib) Compared to Olaparib and Cediranib or Durvalumab (MEDI4736) and Cediranib or Standard of Care Chemotherapy in Women with Platinum-Resistant Recurrent Epithelial Ovarian Cancer, Primary Peritoneal or Fallopian Cancer who have Received Prior Bevacizumab
Purpose: This phase II trial studies the possible benefits of treatment with different combinations of the drugs durvalumab, olaparib and cediranib vs. the usual treatment in patients with ovarian, primary peritoneal, or fallopian tube cancer that has come back after a period of improvement with platinum therapy (recurrent platinum resistant). Usual treatment is the type of treatment most patients with this condition receive if they are not part of a clinical study. Combination therapies studied in this trial include MEDI4736 (durvalumab) plus olaparib and cediranib, durvalumab and cediranib, or olaparib and cediranib. Monoclonal antibodies, such as durvalumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumors cells to grow and spread. Olaparib is an inhibitor of PARP, an enzyme that helps repair deoxyribonucleic acid (DNA) when it becomes damaged. Blocking PARP may help keep cancer cells from repairing their damaged DNA, causing them to die. PARP inhibitors are a type of targeted therapy. Cediranib may stop the growth of tumor cells by blocking VEGF (an enzyme). needed for cell growth. Giving different combinations of durvalumab, olaparib and cediranib may work better in increasing the duration of time that the cancer does not progress compared to the usual treatment.
Principle Investigator: Stagg, Marshall BS, MD
Contact: For more information, email the Research Department at research@fmolhs.org
Purpose: The purpose of this study is to evaluate the efficacy and safety of pembrolizumab plus concurrent chemoradiotherapy compared to placebo plus concurrent chemoradiotherapy in participants with locally advanced cervical cancer. The primary hypotheses are that pembrolizumab plus concurrent chemoradiotherapy is superior to placebo plus concurrent chemoradiotherapy with respect to progression-free survival and overall survival. Once the study objectives have been met or the study has ended, participants will be discontinued from this study and will be enrolled in an extension study to continue protocol-defined assessments and treatment.
Principle Investigator: Ozair, Sobia
Contact: For more information, email the Research Department at research@fmolhs.org
Purpose: This phase III trials studies whether maintenance immunotherapy (nivolumab) following definitive treatment with radiation and chemotherapy (cisplatin) result in significant improvement in overall survival (time being alive) and progression-free survival (time being alive without cancer) for patients with intermediate risk human papillomavirus (HPV) positive oropharynx cancer (throat cancer) that has spread to nearby tissue or lymph nodes. Drugs used in chemotherapy such as cisplatin work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Radiation therapy uses high energy rays to kill tumor cells and shrink tumors. 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. It is not yet known whether chemotherapy and radiation therapy followed by maintenance nivolumab therapy works better than chemotherapy and radiation therapy alone in treating patients with HPV positive oropharyngeal cancer.
Principle Investigator: Stagg, Marshall BS, MD
Contact: For more information, email the Research Department at research@fmolhs.org
Purpose: This screening and multi-sub-study randomized phase II/III trial will establish a method for genomic screening of similar large cancer populations followed by assigning and accruing simultaneously to a multi-sub-study hybrid Master Protocol (Lung-MAP). The type of cancer trait (biomarker) will determine to which sub-study, within this protocol, a participant will be assigned to compare new targeted cancer therapy, designed to block the growth and spread of cancer, or combinations to standard of care therapy with the ultimate goal of being able to approve new targeted therapies in this setting. In addition, the protocol includes non-match sub-studies which will include all screened patients not eligible for any of the biomarker-driven sub-studies.
Principle Investigator: Stagg, Marshall BS, MD
Contact: For more information, email the Research Department at research@fmolhs.org
Purpose: This phase II trial studies whether atezolizumab in combination with talazoparib works better than atezolizumab alone as maintenance therapy for patients with SLFN11-positive extensive-stage small cell lung cancer. Immunotherapy with monoclonal antibodies, such as atezolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. PARPs are proteins that help repair damage to DNA, the genetic material that serves as the body's instruction book. Changes (mutations) in DNA can cause tumor cells to grow quickly and out of control, but PARP inhibitors like talazoparib may keep PARP from working, so tumor cells can't repair themselves, and they stop growing. Giving atezolizumab in combination with talazoparib may help lower the chance of extensive-stage small cell lung cancer growing and spreading compared to atezolizumab alone.
Principle Investigator: Stagg, Marshall BS, MD
Contact: For more information, email the Research Department at research@fmolhs.org
Purpose: This trial studies how well atezolizumab added to the usual radiation therapy works in treating patients with stage I-IIA non-small cell lung cancer. Immunotherapy with monoclonal antibodies, such as atezolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Radiation therapy, such as stereotactic body radiation therapy, uses special equipment to position a patient and deliver radiation to tumors with high precision. This method can kill tumor cells with fewer doses over a shorter period and cause less damage to normal tissue. Giving atezolizumab and radiation therapy may work better than radiation therapy alone in treating patients with early non-small cell lung cancer.
Principle Investigator: Stagg, Marshall BS, MD
Contact: For more information, email the Research Department at research@fmolhs.org
Title: Adjuvant Lung Cancer Enrichment Marker Identification and Sequencing Trial (ALCHEMIST)
Purpose: This 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.
Principle Investigator: Stagg, Marshall BS, MD
Contact: For more information, email the Research Department at research@fmolhs.org
Purpose: This 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.
Principle Investigator: Stagg, Marshall BS, MD
Contact: For more information, email the Research Department at research@fmolhs.org
Purpose: This phase II trial compares cabozantinib alone and the combination of cabozantinib and nivolumab to standard chemotherapy in the treatment of patients with non-squamous non-small cell lung cancer (NSCLC). Cabozantinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. 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. Ramucirumab is a monoclonal antibody that may interfere with the ability of tumor cells to grow and spread. Chemotherapy drugs, such as docetaxel, gemcitabine hydrochloride, paclitaxel, and nab-paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving cabozantinib alone or in combination with nivolumab may be more effective than standard chemotherapy in treating patients with non-small cell lung cancer.
Principle Investigator: Stagg, Marshall BS, MD
Contact: For more information, email the Research Department at research@fmolhs.org
Title: Predictive Assay for Decision Making in Adjuvant Therapy (PADMA)
Purpose: Prospective Registrational Trial to Define Real World Outcomes of Patients with Completely Resected Stage I or IIA (tumor < or = 5cm, node negative) Non-squamous Non-Small Lung Cancer (NSCLC) Identified as High, Intermediate, or Low Risk by a 14-Gene Prognostic Assay DetermaRx being Considered for Adjuvant Platinum-based chemotherapy or other adjuvant therapy versus Observation
Principle Investigator: Cassidy, Emily MD
Contact: For more information, email the Research Department at research@fmolhs.org
Purpose: This randomized phase III trial studies cabozantinib to see how well it works compared with placebo in treating patients with neuroendocrine or carcinoid tumors that have spread to other places in the body (advanced). Cabozantinib is a chemotherapy drug known as a tyrosine kinase inhibitor, and it targets specific tyrosine kinase receptors, that when blocked, may slow tumor growth.
Principle Investigator: Stagg, Marshall BS, MD
Contact: For more information, email the Research Department at research@fmolhs.org
Purpose: This phase II/III trial compares the effect of immunotherapy with atezolizumab in combination with standard chemotherapy with a platinum drug (cisplatin or carboplatin) and etoposide versus standard therapy alone for the treatment of poorly differentiated extrapulmonary (originated outside the lung) small cell neuroendocrine cancer. The other aim of this trial is to compare using atezolizumab just at the beginning of treatment versus continuing it beyond the initial treatment. Immunotherapy with monoclonal antibodies, such as atezolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Cisplatin and carboplatin are in a class of medications known as platinum-containing compounds that work by killing, stopping or slowing the growth of cancer cells. Etoposide is in a class of medications known as podophyllotoxin derivatives. It blocks a certain enzyme needed for cell division and DNA repair, and it may kill cancer cells. Giving atezolizumab in combination with a platinum drug (cisplatin or carboplatin) and etoposide may work better in treating patients with poorly differentiated extrapulmonary small cell neuroendocrine cancer compared to standard therapy with a platinum drug (cisplatin or carboplatin) and etoposide alone.
Principle Investigator: Stagg, Marshall BS, MD
Contact: For more information, email the Research Department at research@fmolhs.org
Title: A Phase III Trial of Perioperative versus Adjuvant Chemotherapy for Resectable Pancreatic Cancer
Purpose: This phase III trial compares perioperative chemotherapy (given before and after surgery) versus adjuvant chemotherapy (given after surgery) for the treatment of pancreatic cancer that can be removed by surgery (removable/resectable). Chemotherapy drugs, such as fluorouracil, irinotecan, leucovorin, and oxaliplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving chemotherapy before and after surgery (perioperatively) may work better in treating patients with pancreatic cancer compared to giving chemotherapy after surgery (adjuvantly).
Principle Investigator: Stagg, Marshall BS, MD
Contact: For more information, email the Research Department at research@fmolhs.org
Title: Comparing the Clinical Impact of Pancreatic Cyst Surveillance Programs
Purpose: The purpose of this study is to compare the two approaches for monitoring pancreatic cysts. The study doctors want to compare more frequent monitoring vs less frequent monitoring in order to learn which monitoring method leads to better outcome for patients with pancreatic cysts.
Principle Investigator: Stagg, Marshall BS, MD
Contact: For more information, email the Research Department at research@fmolhs.org
Purpose: This phase II trial compares two treatment combinations: gemcitabine hydrochloride and nab-paclitaxel, or fluorouracil, leucovorin calcium, and liposomal irinotecan in older patients with pancreatic cancer that has spread to other places in the body (metastatic). Drugs used in chemotherapy, such as gemcitabine hydrochloride, nab-paclitaxel, fluorouracil, leucovorin calcium, and liposomal irinotecan, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. This study may help doctors find out which treatment combination is better at prolonging life in older patients with metastatic pancreatic cancer.
Principle Investigator: Stagg, Marshall BS, MD
Contact: For more information, email the Research Department at research@fmolhs.org
Title: REtroperitoneal SArcoma Registry: an International Prospective Initiative (RESAR)
Purpose: Surgery is currently the only potentially curative treatment modality for localized retroperitoneal sarcoma (RPS). Available studies regarding oncologic outcomes are mainly retrospective in nature, and RPS are recognized as a rare disease. Therefore, prospective analysis of high quality data is a top priority.
Principle Investigator: Lyons, John MD
Contact: For more information, email the Research Department at research@fmolhs.org
Purpose: This phase II trial studies how pembrolizumab works before and after surgery in treating patients with stage III-IV high-risk melanoma. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving pembrolizumab before and after surgery may work better compared to after surgery alone in treating melanoma.
Principle Investigator: Stagg, Marshall BS, MD
Contact: For more information, email the Research Department at research@fmolhs.org
Purpose: This phase II/III trial studies the side effects of nivolumab and ipilimumab when given together with or without sargramostim and to see how well they work in treating patients with stage III-IV melanoma that cannot be removed by surgery (unresectable). Immunotherapy with monoclonal antibodies, such as ipilimumab and nivolumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Colony-stimulating factors, such as sargramostim, may increase the production of white blood cells. It is not yet known whether nivolumab and ipilimumab are more effective with or without sargramostim in treating patients with melanoma.
Principle Investigator: Stagg, Marshall BS, MD
Contact: For more information, email the Research Department at research@fmolhs.org
Title: Use of a Clinical Trial Screening Tool to Address Cancer Health Disparities in the NCI Community Oncology Research Program (NCORP)
Purpose: In an effort to broaden the understanding of who is screened for NCI clinical trials and the barriers to clinical trial participation, NCORP has developed a clinical trials screening tool. The NCORP Clinical Trials Screening Tool will provide a unique opportunity to collect expanded demographic and clinical data to increase our understanding of who is or is not enrolled in NCI-sponsored trials and address research questions related to disparities in cancer care and cancer care delivery.
Principle Investigator: Stagg, Marshall BS, MD
Contact: For more information, email the Research Department at research@fmolhs.org
Purpose: This clinical trial examines a financial navigation program in helping patients and their spouses understand and better manage the financial aspects of cancer care. Cancer patients and their spouses may be at high risk for financial problems because of the cost of cancer treatment. A financial navigator is a person or team who work with patients and their families to help them reduce stress or hardship related to the cost of cancer treatment. Financial navigators help patients understand their out-of-pocket expenses and what their health insurance plans may cover. Financial navigation may also help patients set up payment plans, find cost-saving methods for treatments, and improve access to healthcare services that the patient needs. Providing financial navigation to patients may help reduce financial worries and improve quality of life.
Principle Investigator: Stagg, Marshall BS, MD
Contact: For more information, email the Research Department at research@fmolhs.org
Title: Molecular Analysis for Therapy Choice (MATCH)
Purpose: This phase II MATCH trial studies how well treatment that is directed by genetic testing works in patients with solid tumors or lymphomas that have progressed following at least one line of standard treatment or for which no agreed upon treatment approach exists. Genetic tests look at the unique genetic material (genes) of patients' tumor cells. Patients with genetic abnormalities (such as mutations, amplifications, or translocations) may benefit more from treatment which targets their tumor's particular genetic abnormality. Identifying these genetic abnormalities first may help doctors plan better treatment for patients with solid tumors, lymphomas, or multiple myeloma.
Principle Investigator: Stagg, Marshall BS, MD
Contact: For more information, email the Research Department at research@fmolhs.org
Title: Immune Checkpoint Inhibitor Toxicity (I-CHECKIT): A Prospective Observational Study
Purpose: This study examines how certain risk factors (such as age, gender, other medical conditions, and the type of immunotherapy used to treat the cancer) affect whether a patient with a malignant solid tumor will develop mild or serious side effects from the immunotherapy medications. Immunotherapy is the type of treatment that helps the body's immune system fight cancer. In the future, this information may help doctors make better decisions about cancer treatments.
Principle Investigator: Stagg, Marshall BS, MD
Contact: For more information, email the Research Department at research@fmolhs.org
Title: Establishment of a National Biorepository to Advance Studies of Immune-Related Adverse Events
Purpose: This trial collects research data and samples from patients who experience immunotherapy side effects to store for use in future research studies. Studying research data and samples from patients who experience immunotherapy side effects may help researchers better understand how to predict, prevent, and treat these side effects.
Principle Investigator: Stagg, Marshall BS, MD
Contact: For more information, email the Research Department at research@fmolhs.org
Purpose: This study compares treatment outcomes between patients of African American/Black (AA) ancestry and European American/White (EA) ancestry currently receiving immune checkpoint inhibitor treatment. Collecting samples of blood and saliva and health and treatment information from racially diverse patients receiving immune checkpoint inhibitor treatment over time may help doctors better understand health care disparities among all cancer patients.
Principle Investigator: Stagg, Marshall BS, MD
Contact: For more information, email the Research Department at research@fmolhs.org
Title: Post Market Study of Parietene™ DS Composite Mesh in Ventral Hernia Repair
Purpose: This is a multi-center post-market single arm prospective study of Parietene™ DS Composite Mesh in subjects undergoing ventral hernia repair to confirm its clinical safety and performance in the short (1, 3 months), mid (12 months) and long term (24 months). 125 male or female adults subjects will be enrolled in a minimum of 4 USA sites who are undergoing elective ventral hernia repair (primary or incisional)
Principle Investigator: Dr. Karl LeBlanc
Contact: For more information contact Tina Martinez at (225) 765-6547
Closed to Enrollment
Purpose: The purpose of this prospective, multi-center post-market study is to prospectively collect uniform, evidence based outcomes for patients undergoing open, laparoscopic or robotic assisted hernia repair.
Principle Investigator: Dr. Karl LeBlanc
Contact: For more information contact Tina Martinez at (225) 765-6547
Closed to Enrollment
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As an academic medical center, Our Lady of the Lake is committed to the advancement of healthcare through clinical innovation, medical education and scientific research. We participate in a wide range of clinical trials that are used to determine whether new drugs or treatments are both safe and effective.
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