Clinical Trials in Baton Rouge

Title: TILIA: Efficacy and Safety of Tozorakimab in Patients Hospitalised for Viral Lung Infection Requiring Supplemental Oxygen

Purpose: We are doing this study to find out if the experimental drug called tozorakimab is safe and effective in treating severe viral lung infections with Acute Respiratory Failure (ARF), and also to better understand the studied disease and associated health problems.

Principal Investigator: James Vermaelen, III, MD

Contact: For more information, please contact the research office at (225) 765-7659 or via email at research@fmolhs.org.

Open for Enrollment

Title: PE-TRACT: PULMONARY EMBOLISM - THROMBUS REMOVAL WITH CATHETER-DIRECTED THERAPY

Purpose: The purpose of the study is to determine if patients with submassive PE who are treated with catheter-directed therapy, CDT, have better cardiopulmonary health (peak oxygen consumption at 3 months via cardiopulmonary exercise test (CPET) and patient-reported functional capacity at 12 months via NYHA status) in the year following PE than patients treated with No-CDT.

Principal Investigator: Hollis “Bud” O’Neal, Jr, MD

Contact: For more information, please contact the research office at (225) 765-7659 or via email at research@fmolhs.org.

Open for Enrollment

Title: POST-ICECAP: Patterns of Survivors’ Recovery Trajectories in the ICECAP Trial

Purpose: The purpose of this study is to describe between-patient variability in the improvement of functional, cognitive, and quality of life outcomes from 3 to 12 months after out-of-hospital cardiac arrest.

Principal Investigator: Ahmad Sharayah, MD

Contact: For more information, please contact the research office at (225) 765-7659 or via email at research@fmolhs.org.

Open for Enrollment

Title: FINALITY-HF: A Study to Evaluate Finerenone on Clinical Efficacy and Safety in Patients with Heart Failure Who Are Intolerant or Not Eligible for Treatment with Steroidal Mineralocorticoid Receptor Antagonists

Purpose: The study objective is to examine the effect of finerenone, a next generation (newer) MRA drug developed to avoid or minimize side effects of heart failure. This study will find out whether finerenone can lower the risk of heart failure and death in participants with heart failure who are unable to take the earlier generation MRAs.

Principal Investigator: David Moll, MD

Contact: For more information, please contact the research office at (225) 765-7659 or via email at research@fmolhs.org.

Open for Enrollment

Title: GREAT

Purpose: This is a prospective observational cohort registry designed to obtain data on device performance and clinical outcomes of patients treated with Gore Endovascular Aortic products.

Principal Investigator: Dr. Davis

Contact: For more information, please contact the research office at (225) 765-7659 or via email at research@fmolhs.org.

Follow-up/No longer open to enrollment

Title: TGR 23-02

Purpose: The purpose of the Gore Together Aortic Registry is to collect real-world data (RWD) for Gore aortic endovascular devices. Due to the nature of the program, patient selection, diagnostic imaging, and treatment interventions will be determined by physicians based on standard clinical practice.

Principal Investigator: Dr. Davis

Contact: For more information, please contact the research office at (225) 765-7659 or via email at research@fmolhs.org.

Open to enrollment

Title: Redefine-HF

Purpose: This is an international, randomized, double-blind, placebo-controlled, event-driven trial of finerenone for the treatment hospitalized heart failure patients with mildly reduced or preserved ejection fraction.

Principal Investigator: Dr. Moll

Contact: For more information, please contact the research office at (225) 765-7659 or via email at research@fmolhs.org.

Open to enrollment

Title: LeAPPS

Purpose: The objective of this trial is to evaluate the effectiveness of left atrial appendage exclusion (LAAE) for the prevention of ischemic stroke or systemic arterial embolism in subjects undergoing cardiac surgery who have risk factors for atrial fibrillation and ischemic stroke.

Principal Investigator: Dr. Stelly

Contact: For more information, please contact the research office at (225) 765-7659 or via email at research@fmolhs.org.

Follow-up/No longer open to enrollment

Title: Study of Inclisiran to Prevent Cardiovascular (CV) Events in Participants With Established Cardiovascular Disease (VICTORION-2-PREVENT)

Purpose: Study CKJX839B12302 is a pivotal Phase III trial to evaluate the benefits of inclisiran on major adverse cardiovascular (MACE) events in participants with established cardiovascular disease (CVD).

Principle Investigator: Dr. Denzil Moraes

Contact: For more information, please contact the research office at (225) 765-7659 or via email at research@fmolhs.org.

Follow-up/No longer open to enrollment

Title: AMPLATZER HUD

Purpose: Humanitarian Device Exemption (HDE) Guidance for Healthcare Providers Requesting the AMPLATZER™ Post-Infarct Muscular VSD Occluder

Principle Investigator: Dr. Jorge Castellanos

Contact: For more information, please contact the research office at (225) 765-7659 or via email at research@fmolhs.org.

Open for Enrollment

Title: The ENCIRCLE Trial

Purpose: This study will establish the safety and effectiveness of the SAPIEN M3 System in subjects with symptomatic, at least 3+ mitral regurgitation (MR) for whom commercially available surgical or transcatheter treatment options are deemed unsuitable. Following completion of enrollment, subjects will be eligible for enrollment in the continued access phase of the trial.

Principle Investigator: Dr. Jorge Castellanos

Contact: For more information, please contact the research office at (225) 765-7659 or via email at research@fmolhs.org.

Follow-up/No longer open to enrollment

Title: Clinical Evaluation of the AccuCinch® Ventricular Restoration System in Patients Who Present With Symptomatic Heart Failure With Reduced Ejection Fraction (HFrEF): The CORCINCH-HF Study

Purpose: Prospective, randomized, open-label, international, multi-center clinical study to evaluate the safety and efficacy of the AccuCinch Ventricular Restoration System in patients with heart failure and reduced ejection fraction (HFrEF).

Principle Investigator: Dr. Jorge Castellanos

Contact: For more information, please contact the research office at (225) 765-7659 or via email at research@fmolhs.org.

No longer open to enrollment at Our Lady of the Lake Regional Medical Center

Title: CorMatrix Cor TRICUSPID ECM Valve Replacement Study: The Pivotal Study of the Cor TRICUSPID ECM Valve (or Cor PEDIATRIC Tricuspid ECM Valve).

Purpose: This study follows the EFS and is now to determine the safety and efficacy of the Cormatrix Cor TRICUSPID Valve for any patients requiring surgical replacement of the tricuspid valve.

Principle Investigator: Dr. Terrence Stelly

Contact: For more information, please contact the research office at (225) 765-7659 or via email at research@fmolhs.org.

Open for Enrollment 

Title: Confirmation-HF: COmbiNed eFfIcacy and safety of an eaRly, intensive MAnagement sTrategy with fInerenOne and SGLT2 iNhibitor in patients hospitalized with Heart Failure (CONFIRMATION-HF)

Purpose: The primary study objective is to determine whether a strategy of early, intensive combination therapy with finerenone and empagliflozin provides superior clinical outcomes compared with local standard of care in patients with HHF.

Principle Investigator: David Moll, MD

Contact: For more information, please contact the research office at (225) 765-7659 or via email at research@fmolhs.org.

Open for Enrollment

Title: Maritime-HF: A Phase 3 Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Maridebart Cafraglutide on Mortality and Morbidity in Participants Living With Heart Failure With Preserved or Mildly Reduced Ejection Fraction and Obesity (MARITIME-HF)

Purpose: This study is being done to learn more about the investigational drug called maridebart cafraglutide (MariTide [formerly AMG 133]) in people living with heart failure (HF) and obesity.

Principle Investigator: Denzil Moraes, MD

Contact: For more information, please contact the research office at (225) 765-7659 or via email at research@fmolhs.org.

Open for Enrollment

Title: The Evaluation of Post-operative Pain Control with a TAP Block Using Exparel vs. Marcaine for Hernia Repairs

Purpose: While studies have shown improved postoperative pain control with TAP blocks after inguinal and ventral hernia repair, data comparing Liposomal bupivacaine (Exparel) to bupivacaine alone in formulation of the TAP block is particularly scarce. Therefore, we designed a prospective, randomized trial comparing the postoperative pain control in minimally invasive ventral and inguinal hernia repair patients who receive an Exaparel-based TAP block compared to the traditional bupivacaine (Marcaine) TAP block.

Principle Investigator: Dr. Danielle Cobb

Contact: For more information, please contact the research office at (225) 765-7659 or via email at research@fmolhs.org.

Open for 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, please contact the research office at (225) 765-7659 or via email at research@fmolhs.org.

Open to Enrollment

Title: AMP Extension: Impact of Activity and Mobility Promotion (AMP) on inflammation, cognitive-motor function and fall risk in clinical patients: an observational study

Purpose: The purpose of this project is to assess the associations between metrics of mobility with visuo-motor function, biomarkers of systemic inflammation, balance, and fall risk in hospitalized patients.

Principal Investigator: Guillaume Spielmann, PhD; Richard Lewis, MD

Contact: For more information, please contact the research office at (225) 765-7659 or via email at research@fmolhs.org.

Open for Enrollment

Title: TIVA vs TXA in Sinus Surgery to Evaluate Operative Blood Loss and Surgical Field Quality

Purpose: The goal of this interventional study is to compare the efficacy (surgical field quality and intra-operative blood loss) or cost of TIVA alone to general inhalational anesthetics with intravenous TXA in patient participants who are undergoing endoscopic sinus surgery.

The main questions the study aims to answer are:

• Is the surgical field quality better when using TIVA alone compared to general inhalational anesthetics with intravenous TXA?
• Is one method more financially advantageous to the participant and the institution compared to the other method?

Participants will be randomized into one of the two anesthesia cohorts prior to sinus surgery. One group will be given total intravenous anesthesia (TIVA) alone and the other will be given intravenous tranexamic acid (TXA) followed by general inhalational anesthesia.

Researchers will compare the TIVA group to the TXA group to see if one group exhibits a better surgery field viewing quality through a subjective evaluation and measurement of blood loss and also which anesthesia regimen is most cost effective upon conducting a cost analysis.

Principle Investigator: Dr. Stephen Hernandez

Contact: For more information, please contact the research office at (225) 765-7659 or via email at research@fmolhs.org.

Open for Enrollment

Title: AbbVie M22-574 - A Phase 3, Multicenter, Randomized, Open Label Study of Etentamig Compared With Standard Available Therapies in Subjects With Relapsed or Refractory Multiple Myeloma (3L+ RRMM Monotherapy Study)

Purpose: This is a study to determine change in disease symptoms of etentamig compared to standard available therapies in adult participants with relapsed/refractory (R/R) MM.

Principle Investigator: Safah, Hana MD

Contact: For more information, please contact the research office at (225) 765-7659 or via email at research@fmolhs.org.

Title: BMS 056-025 A Phase 3, Open-Label, Randomized Study to compare the Efficacy and Safety of Luspatercept vs. Epoetin alfa for the Treatment of Anemia Due to Revised International Prognostic Scoring System (IPSS-R) Very Low, Low, or Intermediate-Risk Myelodysplastic Syndrome (MDS) in Erythropoiesis-Stimulating Agent (ESA) Naïve Participants who are Non-Transfusion

Dependent: The ELEMENT MDS Trial

Purpose: The purpose of the study is to compare the efficacy and safety of Luspatercept vs epoetin alfa in the treatment of anemia in adults due to IPSS-R very low, low, intermediate-risk MDS in ESA-naïve participants who are non-transfusion dependent (NTD).

Principle Investigator: Stagg, Marshall BS, MD

Contact: For more information, please contact the research office at (225) 765-7659 or via email at research@fmolhs.org.

Title: EAA181 Effective Quadruplet Utilization After Treatment Evaluation (EQUATE): A Randomized Phase 3 Trial for Newly Diagnosed Multiple Myeloma Not Intended for Early Autologous Transplantation

Purpose: This phase III trial compares the combination of four drugs (daratumumab, bortezomib, lenalidomide and dexamethasone) to the use of a three drug combination (daratumumab, lenalidomide and dexamethasone). Bortezomib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Chemotherapy drugs, such as lenalidomide, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Daratumumab is a monoclonal antibody that may interfere with the ability of cancer cells to grow and spread. Anti-inflammatory drugs, such as dexamethasone lower the body's immune response and are used with other drugs in the treatment of some types of cancer. Adding bortezomib to daratumumab, lenalidomide, and dexamethasone may be more effective in shrinking the cancer or preventing it from returning, compared to continuing on daratumumab, lenalidomide, and dexamethasone.

Principle Investigator: Stagg, Marshall BS, MD

Contact: For more information, please contact the research office at (225) 765-7659 or via email at research@fmolhs.org.

Title: EAA173 - Daratumumab to Enhance Therapeutic Effectiveness of Revlimid in Smoldering Myeloma (DETER-SMM)

Purpose: To compare overall survival in patients with high-risk smoldering multiple myeloma randomized to daratumumab-lenalidomide (revlimid)-dexamethasone or revlimid-dexamethasone.

Principal Investigator: Stagg, Marshall BS, MD

Contact: For more information, please contact the research office at (225) 765-7659 or via email at research@fmolhs.org.

Title: MYELOMATCH – Master Screening and Reassessment Protocol (MSRP) for the NCI MyeloMATCH Clinical Trials

Purpose: Screening and Reassessment (MSRP): To evaluate the feasibility of MATCHBox organizing all specimen testing results needed for assignment to a myeloMATCH clinical trial or Tier Advancement Pathway (TAP) within 72 hours of MDNet receipt of all required specimens for initial therapy and within 10 days for subsequent therapy and Tier Advancement Pathway (TAP): To enable participants who are not matched to an investigational myeloMATCH treatment substudy to receive standard of care (SOC) while remaining on the MSRP to maintain access to later tiers of treatment substudies.

Principal Investigator: Nakhle Saba, M.D.

Contact: For more information, please contact the research office at (225) 765-7659 or via email at research@fmolhs.org.

Title: SWOG S2308 – Randomized Phase III Study of Mosunetuzumab vs. Rituximab for Low Tumor Burden Follicular Lymphoma

Purpose: This phase II trial studies how well OBI-3424 works in treating patients with T-cell acute lymphoblastic leukemia that has come back (relapsed) or does not response to treatment (refractory).

Principal Investigator: Nakhle Saba, M.D.

Contact: For more information, please contact the research office at (225) 765-7659 or via email at research@fmolhs.org.

Title: Alliance A051902 – A Randomized Phase II Study of CHO(E)P Vs CC-486-CHO(E)P Vs Duvelisib-CHO(E)P in Previously Untreated CD30 Negative Peripheral T-Cell Lymphomas

Purpose: This phase II trial studies the effect of duvelisib or CC-486 and usual chemotherapy consisting of cyclophosphamide, doxorubicin, vincristine, etoposide, and prednisone in treating patients with peripheral T-cell lymphoma.

Principal Investigator: Nakhle Saba, M.D.

Contact: For more information, please contact the research office at (225) 765-7659 or via email at research@fmolhs.org.

Title: Alliance A051901 – Phase I Trial of Methotrexate, Rituximab, Lenalidomide, and Nivolumab (Nivo-MR2) Induction Followed by Lenalidomide and Nivolumab Maintenance in Primary CNS Lymphoma

Purpose: This phase I trial tests the safety, side effects, best dose and effectiveness of lenalidomide when added to nivolumab and the usual drugs (rituximab and methotrexate) in patients with primary central nervous system (CNS) lymphoma.

Principal Investigator: Nakhle Saba, M.D.

Contact: For more information, please contact the research office at (225) 765-7659 or via email at research@fmolhs.org.

Title: Poseida CD19CD20-ALLO1 – Open-Label, Multicenter, Phase 1 Study to Assess the Safety of P-CD19CD20-ALLO1 in Subjects With Selected Relapsed/Refractory B Cell Malignancies

Purpose: TP-CD19CD20-ALLO1 has the potential for efficacy against a wide range of B cell malignancies known to express CD19 and CD20. Some of these malignancies include but are not limited to DLBCL NOS (including DLBCL arising from indolent lymphomas), HGBL, PMBCL, and tFL or follicular lymphoma Grade 3B.

Principal Investigator: Nakhle Saba, M.D.

Contact: For more information, please contact the research office at (225) 765-7659 or via email at research@fmolhs.org.

Title: MK-2140-011 - A Randomized, Open-label, Multicenter, Phase 2 Study Evaluating the Efficacy and Safety of Zilovertamab Vedotin (MK-2140) Plus R-CHP Versus Polatuzumab Vedotin Plus R-CHP in Treatment-naïve Participants With GCB Subtype of Diffuse Large B-cell Lymphoma (DLBCL)

Purpose: The goal of this study is to learn if more people who receive zilovertamab vedotin (MK-2140) and R-CHP have the cancer respond (go away) than those who receive polatuzumab vedotin and R-CHP.

Principal Investigator: Nakhle Saba, M.D.

Contact: For more information, please contact the research office at (225) 765-7659 or via email at research@fmolhs.org.

Title: BGB-16673-302 - A Phase 3, Open-Label, Randomized Study of BGB-16673 Compared to Investigator's Choice (Idelalisib Plus Rituximab or Bendamustine Plus Rituximab or Venetoclax Plus Rituximab Retreatment) in Patients With Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma Previously Exposed to Both BTK and BCL2 Inhibitors

Purpose: The purpose of this study is to investigate the efficacy and safety of BGB-16673 compared with investigator's choice (idelalisib plus rituximab [for CLL only] or bendamustine plus rituximab or venetoclax plus rituximab retreatment) in participants with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) previously exposed to both BTK inhibitors (BTKi) and BCL2 inhibitors (BCL2i).

Principal Investigator: Nakhle Saba, M.D.

Contact: For more information, please contact the research office at (225) 765-7659 or via email at research@fmolhs.org.

Title: BGB-16673-304 - A Phase 3, Open-Label, Randomized Study to Evaluate the Safety and Efficacy of BGB-16673 Compared to Pirtobrutinib in Patients With Relapsed/Refractory Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma

Purpose: The purpose of this study is to evaluate the efficacy and safety of BGB-16673 alone compared with pirtobrutinib in patients with relapsed or refractory (R/R) chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) who had been previously treated with a covalent Bruton tyrosine kinase inhibitor (cBTKi).

Principal Investigator: Nakhle Saba, M.D.

Contact: For more information, please contact the research office at (225) 765-7659 or via email at research@fmolhs.org.

Title: TROPION Breast 05 - A Phase III Study of Dato-DXd With or Without Durvalumab Compared with Investigator's Choice of Chemotherapy in Combination with Pembrolizumab in Patients With PD-L1 Positive Locally Recurrent Inoperable or Metastatic Triple-negative Breast Cancer

Purpose: This is a Phase III, randomized, open-label, 3-arm, multicenter, international study assessing the efficacy and safety of Dato-DXd with or without durvalumab compared with investigator's choice chemotherapy in combination with pembrolizumab in participants with PD-L1 positive locally recurrent inoperable or metastatic TNBC.

Principal Investigator: Stagg, Marshall BS, MD

Contact: For more information, please contact the research office at (225) 765-7659 or via email at research@fmolhs.org.

Title: Artios ART0380C001 - A Study of ART0380 for the Treatment of Advanced or Metastatic Colorectal Cancer

Purpose: A Phase I/IIa, Open-label, Multi-center Study to Assess the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of the ATR Kinase Inhibitor ART0380 Administered Orally as Monotherapy and in Combination to Patients With Advanced or Metastatic Solid Tumors

Principle Investigator: Stagg, Marshall BS, MD

Contact: For more information, please contact the research office at (225) 765-7659 or via email at research@fmolhs.org.

Title: NRG GI008 – A Randomized Phase III Study of Immune Checkpoint Inhibition with Chemotherapy in Treatment – Naïve Metastatic Anal Cancer Patients

Purpose: This Phase II/III trial will evaluate the what kind of chemotherapy to recommend to patients based on the presence or absences of circulating tumor DNA (ctDNA) after surgery for colon cancer.

Principle Investigator: Stagg, Marshall BS, MD

Contact: For more information, please contact the research office at (225) 765-7659 or via email at research@fmolhs.org.

Title: TAK-113-4002 - A Single Arm Phase 4 Trial to Evaluate the Safety and Efficacy of Oral Fruquintinib in the Treatment of Refractory Metastatic Colorectal Cancer in Patients From Minority Populations Underrepresented in Prior Fruquintinib Studies

Purpose: The main aim of this study is to learn how often adults of a minority group such as Black/African American and/or Hispanic/Latino experience hypertension after they have been treated with fruquintinib for refractory metastatic colorectal cancer (mCRC). Other aims are to learn how safe fruquintinib is and how well it is tolerated by participants.

Principle Investigator: Stagg, Marshall BS, MD

Contact: For more information, please contact the research office at (225) 765-7659 or via email at research@fmolhs.org.

Title: NRG GY026 A Phase II/III Study of Paclitaxel/Carboplatin Alone or Combined with Either Trastuzumab and Hyaluronidase-oysk (Herceptin Hylecta) or Pertuzumab, Trastuzamab, and Hyaluronidase-zzxf (PHESGO) in HER2 Positive, Stage I-IV Endometrial Serous Carcinoma or Carcinosarcoma

Purpose: This phase II/III trial tests whether adding trastuzumab and hyaluronidase-oysk (Herceptin HylectaTM) or pertuzumab, trastuzumab and hyaluronidase-zzxf (PhesgoTM) to the usual chemotherapy (paclitaxel and carboplatin) works to shrink tumors in patients with HER2 positive endometrial serous carcinoma or carcinosarcoma. Trastuzumab and pertuzumab are monoclonal antibodies and forms of targeted therapy that attach to specific molecules (receptors) on the surface of tumor cells, known as HER2 receptors. When trastuzumab or pertuzumab attach to HER2 receptors, the signals that tell the cells to grow are blocked and the tumor cell may be marked for destruction by the body's immune system.

Principle Investigator: Stagg, Marshall, BS, MD

Contact: For more information, please contact the research office at (225) 765-7659 or via email at research@fmolhs.org.

Title: NRG-GY036 - A Phase III Trial of One vs. Two Years of Maintenance Olaparib, With or Without Bevacizumab, in Patients With BRCA1/2 Mutated or Homologous Recombination Deficient (HRD+) Ovarian Cancer Following Response to First Line Platinum Based Chemotherapy

Purpose: This phase III trial compares the effect of olaparib for one year versus two years, with or without bevacizumab, for the treatment of BRCA 1/2 mutated or homologous recombination deficient stage III or IV ovarian cancer.

Principle Investigator: Stagg, Marshall BS, MD

Contact: For more information, please contact the research office at (225) 765-7659 or via email at research@fmolhs.org.

Title: ECOG EA3161 - A Phase III Randomized Study of Maintenance Nivolumab Versus Observation in Patients With Locally Advanced, Intermediate Risk HPV Positive OPSCC

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.

Principle Investigator: Stagg, Marshall BS, MD

Contact: For more information, please contact the research office at (225) 765-7659 or via email at research@fmolhs.org.

Title: NRG-HN014 - Randomized Phase III Trial of Perioperative Immunotherapy With Response-Adapted Treatment Versus Standard-of-Care Treatment for Resectable Stage III/IV Cutaneous Squamous Cell Carcinoma

Purpose: This phase III trial compares the effect of adding cemiplimab to standard therapy (surgery with or without radiation) versus standard therapy alone in treating patients with stage III/IV squamous cell skin cancer that is able to be removed by surgery (resectable) and that may have come back after a period of improvement (recurrent).

Principle Investigator: Kansara, Sagar BS, MD

Contact: For more information, please contact the research office at (225) 765-7659 or via email at research@fmolhs.org.

Title: RG-HN006 - Randomized Phase II/III Trial of Sentinel Lymph Node Biopsy Versus Elective Neck Dissection for Early-Stage Oral Cavity Cancer

Purpose: This phase II/III trial studies how well sentinel lymph node biopsy works and compares sentinel lymph node biopsy surgery to standard neck dissection as part of the treatment for early-stage oral cavity cancer.

Principle Investigator: Stagg, Marshall BS, MD

Contact: For more information, please contact the research office at (225) 765-7659 or via email at research@fmolhs.org.

Title: ML44719 - A Phase II, Open-Label, Multi-Cohort, Multicenter Study in Patients with Unresectable Hepatocellular Carcinoma and Child-Pugh B7 and B8 Cirrhosis

Purpose: The purpose of this study is to assess the safety and efficacy of atezolizumab and bevacizumab, or atezolizumab alone, as first-line treatment in participants with unresectable, locally advanced or metastatic hepatocellular carcinoma (HCC) with Child-Pugh B7 or B8 cirrhosis.

Principle Investigator: Stagg, Marshall BS, MD

Contact: For more information, please contact the research office at (225) 765-7659 or via email at research@fmolhs.org.

Title: AZ LIVER-R Icon HCC Registry – An Observational Multi-Center Study to Evaluate Real World Treatment Outcomes of Durvalumab Based Regimens in Hepatobiliary Cancers

Purpose: The primary objective of this study is to evaluate the effectiveness of durvalumab-based regimens in real-world settings as measured by real-world overall survival.

Principle Investigator: Stagg, Marshall BS, MD

Contact: For more information, please contact the research office at (225) 765-7659 or via email at research@fmolhs.org.

Title: MK-2870-019 - A Phase 3 Randomized Open-Label Study of Adjuvant Pembrolizumab With or Without MK-2870 in Participants With Resectable Stage II to IIIB (N2) NSCLC Not Achieving pCR After Receiving Neoadjuvant Pembrolizumab With Platinum-based Doublet Chemotherapy Followed by Surgery

Purpose: This study will assess if adding sacituzumab tirumotecan with pembrolizumab after surgery is effective in treating NSCLC for participants not achieving pathological complete response.

Principle Investigator: Stagg, Marshall, BS, MD

Contact: For more information, please contact the research office at (225) 765-7659 or via email at research@fmolhs.org.

Title: EGFR + Lung - Utilizing Long-read Sequencing to Investigate the EGFR Landscape of EGFR Positive Lung Cancer Patients

Purpose: The aim of this study is to collect blood from both those diagnosed with EGFR positive lung cancer and healthy individuals, evaluate their gene sequence surrounding the EGFR landscape and use the cancer positive and healthy sequences to validate the risk assessment model, which may one day be used to provide insight on susceptibility of getting EGFR positive lung cancer or potentially other cancer types.

Principle Investigator: Stagg, Marshall, BS, MD

Contact: For more information, please contact the research office at (225) 765-7659 or via email at research@fmolhs.org.

Title: Hummingbird - Diagnostic performance of small RNA blood test in patients undergoing follow-up imaging after positive low dose CT screening for cancer of the lung “Early Detection of Lung Cancer based on small RNA signatures - Boston II

Purpose: The study is a prospective, longitudinal, observational study to evaluate the performance of a novel diagnostic test for early-stage lung cancer.

Principle Investigator: Cassidy, Emily, MD

Contact: For more information, please contact the research office at (225) 765-7659 or via email at research@fmolhs.org.

Title: Amgen 20230016 - A Phase 3, Randomized, Double-blind, Placebo-controlled, Multicenter Study of Tarlatamab Therapy in Subjects with Limited-Stage Small-Cell Lung Cancer (LS-SCLC) Who Have Not Progressed Following Concurrent Chemoradiation Therapy

Purpose: The primary objective of this study is to compare the efficacy of Tarlatamab with placebo as assessed by progression free survival (PFS).

Principle Investigator: Stagg, Marshall BS, MD

Contact: For more information, please contact the research office at (225) 765-7659 or via email at research@fmolhs.org.

Title: A081801 Integration of Immunotherapy into Adjuvant Therapy for Resected NSCLC ALCHEMIST Chemo-IO

Purpose: This phase III ALCHEMIST trial tests the addition of pembrolizumab to usual chemotherapy for the treatment of stage IIA, IIB, IIIA or IIIB non-small cell lung cancer that has been removed by surgery. 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. Chemotherapy drugs, such as cisplatin, pemetrexed, carboplatin, gemcitabine hydrochloride, 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 pembrolizumab with usual chemotherapy may help increase survival times in patients with stage IIA, IIB, IIIA or IIIB non-small cell lung cancer.

Principle Investigator: Stagg, Marshall BS, MD

Contact: For more information, please contact the research office at (225) 765-7659 or via email at research@fmolhs.org.

Title: A Master Protocol to Evaluate Biomarker-Driven Therapies and Immunotherapies in Previously-Treated Non-Small Cell Lung Cancer (Lung-MAP Screening Study)

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, please contact the research office at (225) 765-7659 or via email at research@fmolhs.org.

Title: AstraZeneca ARTEMIDE-Lung02 - A Phase III, Randomized, Double-blind, Multicenter, Global Study of Rilvegostomig or Pembrolizumab in Combination With Platinum-based Chemotherapy for the First-line Treatment of Patients With Metastatic Squamous Non-small Cell Lung Cancer Whose Tumors Express PD-L1 (ARTEMIDE-Lung02)

Purpose: The purpose of ARTEMIDE-Lung02 is to assess the efficacy and safety of rilvegostomig in combination with platinum-based chemotherapy for the first-line (1L) treatment of patients with metastatic squamous non-small cell lung cancer (mNSCLC) whose tumors express programmed death-ligand 1 (PD-L1).

Principle Investigator: Stagg, Marshall BS, MD

Contact: For more information, please contact the research office at (225) 765-7659 or via email at research@fmolhs.org.

Title: Merck V940-002 - A Phase 3, Randomized, Double-blind, Placebo- and Active-Comparator Controlled clinical Study of Adjuvant V940 (mRNA-4157) Plus Pembrolizumab Versus Adjuvant Placebo Plus Pembrolizumab in Participants With Resected Stage II, IIIA, IIIB (N2) Non-small Cell Lung Cancer (INTerpath-002)

Purpose: The goal of this study is to evaluate intismeran autogene plus pembrolizumab versus placebo plus pembrolizumab for the adjuvant treatment of margin negative, completely resected Stage II, IIIA, IIIB (with nodal involvement [N2]) non-small cell lung cancer (NSCLC).

Principle Investigator: Stagg, Marshall BS, MD

Contact: For more information, please contact the research office at (225) 765-7659 or via email at research@fmolhs.org.

Title: S2012 Randomized Phase II/III Trial of First Line Platinum/Etoposide with or without Atezolizumab (NSC #783608) in Patients with Poorly Differentiated Extrapulmonary Small Cell Neuroendocrine Carcinomas (NEC)

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, please contact the research office at (225) 765-7659 or via email at research@fmolhs.org.

Title: Artios ART0380C001 - A Study of ART0380 for the Treatment of Metastatic or Locally Advanced Pancreatic Ductal Carcinoma

Purpose: A Phase I/IIa, Open-label, Multi-center Study to Assess the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of the ATR Kinase Inhibitor ART0380 Administered Orally as Monotherapy and in Combination to Patients With Advanced or Metastatic Solid Tumors

Principle Investigator: Stagg, Marshall BS, MD

Contact: For more information, please contact the research office at (225) 765-7659 or via email at research@fmolhs.org.

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, please contact the research office at (225) 765-7659 or via email at research@fmolhs.org.

Purpose: The objective of the proposed research study is to train a machine learning algorithm to distinguish between normal and cancerous tissue in pancreatic adenocarcinoma specimens with the use of a Raman spectroscopy imaging system.

Principle Investigator: Michael Dunham, MD-LSUHSC Dept. Of Otolaryngology

Contact: For more information, please contact the research office at (225) 765-7659 or via email at research@fmolhs.org.

Title: S2312 - A Phase III Study of Cabazitaxel With or Without Carboplatin in Patients With Metastatic Castrate-Resistant Prostate Cancer (mCRPC), Stratified by Aggressive Variant Signature

Purpose: This phase III trial compares the effect of adding carboplatin to the standard of care chemotherapy drug cabazitaxel versus cabazitaxel alone in treating prostate cancer that keeps growing even when the amount of testosterone in the body is reduced to very low levels (castrate-resistant) and that has spread from where it first started (primary site) to other places in the body (metastatic).

Principle Investigator: Stagg, Marshall BS, MD

Contact: For more information, please contact the research office at (225) 765-7659 or via email at research@fmolhs.org.

Purpose: This phase III trial tests two questions by two separate comparisons of therapies. The first question is whether enhanced therapy (apalutamide in combination with abiraterone + prednisone) added to standard of care (prostate radiation therapy and short term androgen deprivation) is more effective compared to standard of care alone in patients with prostate cancer who experience biochemical recurrence (a rise in the blood level of prostate specific antigen [PSA] after surgical removal of the prostate cancer). A second question tests treatment in patients with biochemical recurrence who show prostate cancer spreading outside the pelvis (metastasis) by positron emission tomography (PET) imaging.

Principle Investigator: Stagg, Marshall BS, MD

Contact: For more information, please contact the research office at (225) 765-7659 or via email at research@fmolhs.org.

Purpose:This phase III trial studies whether adding apalutamide to the usual treatment improves outcome in patients with lymph node positive prostate cancer after surgery.

Principle Investigator: Stagg, Marshall BS, MD

Contact: For more information, please contact the research office at (225) 765-7659 or via email at research@fmolhs.org.

Title: EA7211 A Randomized Phase III Study of Neoadjuvant Chemotherapy followed by Surgery versus Surgery Alone for Patients with High Risk Retroperitoneal Sarcoma (STRASS 2)

Purpose: This is a multicenter, randomized, open label phase lll trial to assess whether preoperative chemotherapy, as an adjunct to curative-intent surgery, improves the prognosis of high risk DDLPS (dedifferentiated Liposarcoma) and LMS (Leiomyosarcoma) patients as measured by disease free survival. After confirmation of eligibility criteria, patients will be randomized to either the standard arm or experimental arm.

Principle Investigator: Stagg, Marshall, BS, MD

Contact: For more information, please contact the research office at (225) 765-7659 or via email at research@fmolhs.org.

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, please contact the research office at (225) 765-7659 or via email at research@fmolhs.org.

Title: EA6141 Randomized Phase II/III Study of Nivolumab Plus Ipilimumab Plus Sargramostim Versus Nivolumab Plus Ipilimumab in Patients With Unresectable Stage III or Stage IV Melanoma

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) and that may have spread from where it first started to nearby tissue, lymph nodes, or distant parts of the body (advanced). 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.

Principle Investigator: Stagg, Marshall BS, MD

Contact: For more information, please contact the research office at (225) 765-7659 or via email at research@fmolhs.org.

Title: Cancer Moonshot Biobank Research Protocol

Purpose: This trial collects multiple tissue and blood samples, along with medical information, from cancer patients. The "Cancer Moonshot Biobank" is a longitudinal study. This means it collects and stores samples and information over time, throughout the course of a patient's cancer treatment. By looking at samples and information collected from the same people over time, researchers hope to better understand how cancer changes over time and over the course of medical treatments.

Principle Investigator: Dr. Cataldo

Contact: For more information, please contact the research office at (225) 765-7659 or via email at research@fmolhs.org.

Purpose: The purpose of this study is to evaluate the safety, tolerability, efficacy, pharmacokinetics and pharmacodynamics of GBT021601. This is a three-part, multicenter, Phase 2/3 study of orally administered GBT021601 in participants with sickle cell disease (SCD). Part A will evaluate the safety, tolerability, and efficacy of GBT021601 in adult participants with SCD to determine an optimal dose. Part B will evaluate the efficacy of GBT021601 versus placebo in adult and pediatric participants with SCD for 48 weeks. Part C will evaluate the pharmacokinetics (PK) and safety of single and multiple doses (MD) of open-label single arm GBT021601 administered to pediatric participants.

Principle Investigator: Stagg, Marshall BS, MD

Contact: For more information, please contact the research office at (225) 765-7659 or via email at research@fmolhs.org.

Purpose: To collect clinically characterized, whole blood and FFPE tumor tissue specimens from subjects who either have a diagnosis of cancer or recurrent cancer to evaluate biomarkers that may be associated with cancer, including tumor burden and/or tumor characteristics and to support subsequent assay development activities.

Principle Investigator: Cataldo, Vince, MD

Contact: For more information, please contact the research office at (225) 765-7659 or via email at research@fmolhs.org.

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, please contact the research office at (225) 765-7659 or via email at research@fmolhs.org.

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, M

Contact: For more information, please contact the research office at (225) 765-7659 or via email at research@fmolhs.org.

Purpose: To evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of FTX-6058 in participants with sickle cell disease.

Principal Investigator: Stagg, Marshall BS, MD

Contact: For more information, please contact the research office at (225) 765-7659 or via email at research@fmolhs.org.

Purpose: The purpose is to provide ulixertinib for compassionate use in advanced cancer patients with a MAPK pathway-altered solid tumor(s) who have exhausted available therapies.

Principal Investigator: Greg Bizette, MD

Contact: For more information, please contact the research office at (225) 765-7659 or via email at research@fmolhs.org.

Title: EP0239: Sleep disturbances, behavior, activities of daily living, and caregiver burden among patients diagnosed with Dravet Syndrome and Lennox-Gastaut Syndrome initiating treatment with fenfluramine (Fintepla®): a prospective multicenter study

Purpose: The objective of this study is to describe sleep disturbances (patient and caregiver), behavior, activities of daily living, and caregiver burden among patients diagnosed with Dravet Syndrome (DS) or Lennox-Gastaut Syndrome (LGS) and newly initiating treatment with fenfluramine.

Principal Investigator: Yash Shah, MD

Contact: For more information, please contact the research office at (225) 765-7659 or via email at research@fmolhs.org.

Open for Enrollment

Title: The Pathogenesis of Respiratory Syncytial Virus Infection: Interactions of Immune Responses, Viral Load and Disease Severity

Purpose: The focus of this study is to develop respiratory syncytial viral (RSV) specific immunological methodologies for use in subsequent studies, evaluating the relationship between immune pathology, viral load and disease severity of childhood RSV infection.

Principal Investigator: Dr. Andres Carrion-Vargas, MD (OLOLCH) and Dr. Stephania Cormier, PhD (LSU A&M)

Contact: For more information, please contact the research office at (225) 765-7659 or via email at research@fmolhs.org.

Open for Enrollment