Clinical Trials

Clinical research studies are designed to answer specific medical questions. Some clinical research studies test new drugs or new combinations of drugs, new surgical procedures or devices or new ways to use existing treatments. Other research studies might involve long-term observation of patients to better understand how health or diseases progress. The goal of clinical research is to discover better ways to treat, prevent, diagnose or understand human disease.

Both healthy patients and patients with an illness or disease can volunteer to be in a clinical trial. Franciscan Missionaries of Our Lady Health System offers clinical trials for adult and pediatric patients in several of the regions we serve. Patients who decide to participate in a research study usually must complete the informed consent process before they participate in the clinical trial.

During the informed consent process, patients are provided with the information they need to make their decision about participating in a clinical trial. Members of the research team meet with the patient and provides them with an informed consent form that explains the details of the study, including the purpose, duration, required procedures, potential risks and benefits, and contact information for the research team. Patients are given time to ask questions, consult with their family, or talk to their doctors before they sign the informed consent document. Participating in a clinical trial is voluntary. Patients can refuse to participate or can withdraw from the study at any time without the loss of any medical benefit to which the patient is entitled.

You can sign up for a clinical trial by:

• Physician Referral: Ask your doctor about participating in one of our trials.
• Phone: In the Baton Rouge area, call our clinical research department at (225) 765-7659.
• Email: Contact our clinical research department at research@fmolhs.org.

If you are a patient at a Franciscan Missionaries of Our Lady Health System hospital or clinic, you might be asked to participate in a research study.

Clinical trials are funded by different sources, including pharmaceutical companies, device companies, the National Institutes of Health or other sponsors. FMOLHS is committed to ensuring that financial interests or other conflicts of interest do not compromise the protection of research subjects or the integrity of the research findings.

NIH Clinical Research Trials and You

There are currently no active clinical trials. Talk with your specialist about other trial options and check here again in the future as new trials are added regularly.

Clinical Trials in the Baton Rouge area:

There are currently no active clinical trials. Talk with your specialist about other trial options and check here again in the future as new trials are added regularly.

Clinical Trials in the Baton Rouge area:

There are currently no active clinical trials. Talk with your specialist about other trial options and check here again in the future as new trials are added regularly.

Clinical Trials in the Baton Rouge area:

There are currently no active clinical trials. Talk with your specialist about other trial options and check here again in the future as new trials are added regularly.

There are no genetic studies open at this time.

Clinical Trials in the Baton Rouge area:

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. 

Open to enrollment

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

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. 

Open for Enrollment

Title: The STOP AF First Post Approval Study (PAS) is a sub-study to the Cryo Global Registry

Purpose: The STOP AF First PAS is a prospective, global, multi-center, observational trial. The purpose of the study is to describe long-term clinical performance and safety data in the recurrent symptomatic paroxysmal AF population treated with Arctic Front™ and Freezor™ MAX Families of cardiac cryoablation catheters (hereafter referred to as Arctic Front™ Cardiac Cryoablation Catheter System) as an alternative to antiarrhythmic drug therapy as an initial rhythm control strategy. This PAS is a condition of the pre-market approval order (P100010/S110) by the U.S. Food and Drug Administration.

Principle Investigator: Dr. Kenneth Civello

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

Open for 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. 

Open for 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. 

Open for Enrollment

Title: Product Surveillance Registry (PSR)

Purpose: The purpose of the Registry is to provide continuing evaluation and periodic reporting of safety and effectiveness of Medtronic market-released products. The Registry data is intended to benefit and support interests of patients, hospitals, clinicians, regulatory bodies, payers, and industry by streamlining the clinical surveillance process and facilitating leading edge performance assessment via the least burdensome approach.

Principle Investigator: Dr. Henry Patrick

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: 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: Catalyst Trial - Study Details | Amplatzer Amulet LAAO vs. NOAC | ClinicalTrials.gov

Purpose: A prospective, randomized, controlled, unblinded, multicenter clinical trial of the Amplatzer™ Amulet™ device in patients with non-valvular atrial fibrillation who are at increased risk for cardioembolic events. The objective of this trial is to evaluate the safety and effectiveness of the Amulet LAA occluder compared to NOAC therapy in patients with non-valvular AF at increased risk for ischemic stroke and who are recommended for long-term NOAC therapy.

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

Clinical Trials in the Jackson, Mississippi area:

Title: The CORCINCH-HF Study

Purpose: This is a prospective, randomized, open-label, multicenter, international, clinical safety and efficacy investigation of the AccuCinch Ventricular Restoration System. The objective of this study is to evaluate the safety and efficacy of the AccuCinch Ventricular Restoration System in patients with symptomatic heart failure with reduced ejection fraction (HFrEF).

Study Location: Jackson Heart Clinic and St. Dominic Jackson Memorial Hospital.

Principle Investigator: Dr. William Crowder

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

Open for Enrollment

Title: Encore PFO Closure Device U.S. IDE Randomized Trial: The PerFOrm Trial

Purpose: This is a prospective, multicenter, randomized clinical study. The Encore PFO closure device is indicated for percutaneous, transcatheter closure of a patent foramen ovale (PFO) in patients, predominantly between the ages of 18 and 60 years, who have had a cryptogenic stroke due to a presumed paradoxical embolism.

Study Location: Jackson Heart Clinic and St. Dominic Jackson Memorial Hospital.

Principle Investigator: Dr. William Crowder

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

Open for Enrollment

Title: Catalyst Trial - Study Details | Amplatzer Amulet LAAO vs. NOAC | ClinicalTrials.gov

Purpose: A prospective, randomized, controlled, unblinded, multicenter clinical trial of the Amplatzer™ Amulet™ device in patients with non-valvular atrial fibrillation who are at increased risk for cardioembolic events. The objective of this trial is to evaluate the safety and effectiveness of the Amulet LAA occluder compared to NOAC therapy in patients with non-valvular AF at increased risk for ischemic stroke and who are recommended for long-term NOAC therapy.

Study Location: Jackson Heart Clinic and St. Dominic Jackson Memorial Hospital.

Principle Investigator: Dr. William Crowder

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

Open for Enrollment

Clinical Trials in the Baton Rouge area:

There are currently no active clinical trials. Talk with your specialist about other trial options and check here again in the future as new trials are added regularly.

Clinical Trials in the Baton Rouge area:

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

Clinical Trials in the Baton Rouge area:

Title: Trial on Efficacy and Safety of Pritelivir Tablets for Treatment of Acyclovir-resistant Mucocutaneous HSV (Herpes Simplex Virus) Infections in Immunocompromised Subjects (PRIOH-1)

Purpose: A randomized, open label, multi-center, comparative trial, to assess the efficacy and safety of pritelivir versus foscarnet for the treatment of acyclovir-resistant mucocutaneous HSV infections in immunocompromised adults (PRIOH-1)

Principle Investigator: Dr. Hollis O’Neal Jr.

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

Open for Enrollment

Title:Single-dose PK Study of Ceftazidime-Avibactam In Hospitalized Children Receiving Systemic Antibiotics for Nosocomial Pneumonia

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

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

Open to Enrollment

Clinical Trials in the Baton Rouge area:

Title: A Prospective, Multicenter study to Evaluate the Performance and Safety of the CerebroFlo® EVD Catheter

Purpose: The primary goal of this study is to assess the occurrence of flushing interventions to address occlusions during the treatment of interventricular hemorrhage (spontaneous primary IVH or secondary IVH due to ruptured aneurysm).

Principle Investigator: Dr. Allen Joseph

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

Open for Enrollment

Clinical Trials in the Baton Rouge area:

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

Clinical Trials in the Baton Rouge area:

Title: M20-638 - Study of Subcutaneous Epcoritamab in Combination With Intravenous Rituximab and Oral Lenalidomide (R2) to Assess Adverse Events and Change in Disease Activity in Adult Participants With Follicular Lymphoma (EPCORE FL-1)

Purpose: This study will assess how safe and effective epcoritamab is in combination with lenalidomide and rituximab (R2) in treating adult participants with relapsed or refractory (R/R) FL.

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: M23-362 A Phase 2, Open-Label Trial to Evaluate Safety of Eporitamab Monotherapy in Subjects with Relapsed or Refractory diffuse Large B-Cell Lymphoma and Classic Follicular Lymphoma when Administered in the Outpatient Setting

Purpose: The purpose of this study is to assess the safety of epcoritamab in adult participants in relapsed or refractory (R/R) diffuse large b-cell lymphoma (DLBCL) who have received at least 1 prior line of systemic antilymphoma therapy including at least 1 anti-CD20 monoclonal antibody-containing therapy or R/R classic follicular lymphoma (cFL).

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: 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: 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: S1803 - Phase III Study of Daratumumab/rHuPH20 (NSC- 810307) + Lenalidomide or Lenalidomide as Post-Autologous Stem Cell Transplant Maintenance Therapy in Patients with Multiple Myeloma (MM) Using Minimal Residual Disease to Direct Therapy Duration (DRAMMATIC Study)

Purpose: To provide a maintenance therapy for Post-Autologous Stem Cell Transplant patients with Multiple Myeloma.

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.

Clinical Trials in the Jackson, Mississippi area:

Title: Exact Sciences 2021-05 Tissue and Blood Biomarker Study

Purpose: This is a prospective, observational blood and formalin-fixed paraffin-embedded (FFPE) tumor tissue specimen collection study to evaluate biomarkers in subjects with cancer.

Study Location: Jackson Heart Clinic and St. Dominic Jackson Memorial Hospital.

Principle Investigator: Dr. Donald Seago and Dr. Christy Haygood

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

Open for Enrollment

Title: CAMBRIA-1 A Study of Camizestrant in ER+/HER2- Early Breast Cancer After at Least 2 Years of Standard Adjuvant Endocrine Therapy

Purpose: Phase III, randomised, open-label, 2 arm, multicentre, international study assessing the efficacy and safety of Dato-DXd compared with ICC in participants with locally recurrent inoperable or metastatic TNBC who are not candidates for PD-1/PD-L1 inhibitor therapy.

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: 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: 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: 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: A Phase II Study of Gemcitabine Plus Cisplatin Chemotherapy in Patients with Muscle-Invasive Bladder Cancer with Bladder Preservation for Those Patients Whose Tumors Harbor Deleterious DNA Damage Response (DDR) Gene Alterations

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

Clinical Trials in the Baton Rouge area:

Title: GOG 3083/XPORT-EC-042 A Phase 3, Randomized, Placebo-Controlled, Double-Blind, Multi-Center Trial of Selinexor in Maintenance Therapy after Systemic Therapy for Patients with P53 Wild-Type Advanced or Recurrent Endometrial Carcinoma

Purpose: The purpose of this study is to evaluate the efficacy and safety of Selinexor as a maintenance treatment in patients with p53 wt endometrial carcinoma (EC), who have achieved a partial response (PR) or complete response (CR) (per Response Evaluation Criteria in Solid Tumors version 1.1 [RECIST v 1.1]) after completing at least 12 weeks of platinum-based therapy.

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.

Clinical Trials in the Jackson, Mississippi area:

Title: GOG 3083- Karyopharm XPORT-EC-042

Purpose: A Phase 3, Randomized, Placebo-Controlled, Double-Blind, Multicenter Trial. The purpose of this study is to evaluate the efficacy and safety of selinexor as a maintenance treatment in patients with p53 wt endometrial carcinoma (EC), who have achieved a partial response (PR) or complete response (CR) (per Response Evaluation Criteria in Solid Tumors version 1.1 [RECIST v 1.1]) after completing at least 12 weeks of platinum-based therapy.

Study Location: Jackson Heart Clinic and St. Dominic Jackson Memorial Hospital.

Principle Investigator: Dr. Donald Seago and Dr. Christy Haygood

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

Open for Enrollment

Title: GOG 3041- DUO-E AstraZeneca Study

Purpose: A Phase III study to assess the efficacy and safety of durvalumab in combination with platinum-based chemotherapy (paclitaxel + carboplatin) followed by maintenance durvalumab with or without olaparib for patients with newly diagnosed advanced or recurrent endometrial cancer.

Study Location: Jackson Heart Clinic and St. Dominic Jackson Memorial Hospital.

Principle Investigator: Dr. Donald Seago and Dr. Christy Haygood

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

Open for Enrollment

Title: Merck- GOG 3036 Study

Purpose: A Randomized Phase 3, Double-Blind Study to assess the efficacy and safety of treatment with carboplatin/paclitaxel* PLUS pembrolizumab (MK-3475) and maintenance olaparib (MK-7339) in women with epithelial ovarian cancer (EOC), fallopian tube cancer, or primary peritoneal cancer.

Study Location: Jackson Heart Clinic and St. Dominic Jackson Memorial Hospital.

Principle Investigator: Dr. Donald Seago and Dr. Christy Haygood

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

Open for Enrollment

There are currently no active clinical trials. Talk with your specialist about other trial options and check here again in the future as new trials are added regularly.

Title: Amgen 20200041 - A Phase 3, Open-label, Multicenter, Randomized Study of Tarlatamab in Combination With Durvalumab vs Durvalumab Alone in Subjects With Extensive-Stage Small-Cell Lung Cancer Following Platinum, Etoposide and Durvalumab (DeLLphi-305)

Purpose:The primary objective of this study is to compare the efficacy of tarlatamab plus durvalumab with durvalumab alone on prolonging overall survival (OS).

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.

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

Title: Merck MK3475-D46 EVOKE An Open-label, Multicenter, Phase 3 Randomized, Active-Comparator-Controlled Clinical Study of Pembrolizumab in Combination with Sacituzumab Govitecan versus MK-3475 Monotherapy as Frist-line Treatment in Participants with PD-L1 TPS Greater than or Equal to 50% Metastatic Non-small Cell Lung Cancer

Purpose: The purpose of this study is to compare pembrolizumab (MK-3475) in combination with sacituzumab govitecan with pembrolizumab alone with respect to progression-free survival (PFS) and overall survival (OS) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as assessed by blinded independent central review (BICR) among adults with metastatic non-small cell lung cancer (NSCLC) with programmed cell death ligand 1 (PD-L1) tumor proportion score (TPS) ≥50%).

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

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

Title: EAA7211 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.

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

Title: Amgen 20210031 - A Randomized, Double-Blind Study Evaluating the Efficacy, Safety, and Immunogenicity of ABP206 Compared with OPDIVO (Nivolumab) in Subjects with treatment-Naïve Unresectable or Metastatic Melanoma

Purpose:The purpose of this study is to assess the efficacy, safety, and immunogenicity of ABP 206 compared with Nivolumab in Subjects with Treatment-Naïve Unresectable or Metastatic Melanoma.

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: 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.

Title: GBT021601-021 A Phase 2/3 Randomized, Multicenter Study of GBT021601 Administered Orally to Participants with Sickle Cell Disease and an Open-Label Pharmacokinetics Study in Pediatric Participants with Sickle Cell Disease

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.

Title: DCP-001 Use of a Clinical Trial Screening Selection Tool to Address Cancer Health Disparities in the NCI Community Oncology Research Program (NCORP)

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: ES 2021-05 Specimen Collection Study to Evaluate Biomarkers in Subjects with Cancer

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.

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

Title: A Randomized Trial Addressing Cancer-Related Financial Hardship Through Delivery of a Proactive Financial Navigation Intervention (CREDIT)

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

Title: Disparities in REsults of Immune Checkpoint Inhibitor Treatment (DiRECT): A Prospective Cohort Study of Cancer Survivors Treated with anti-PD-1/anti-PD-L1 Immunotherapy in a Community Oncology Setting

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

Title: Fulcrum 6058-SCD-101 - A Phase 1 Open-Label, Multiple-Dose Study to Evaluate Safety and Tolerability, Pharmacokinetics and Pharmacodynamics of FTX-6058 in Subjects With Sickle Cell Disease (SCD)

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.

There are currently no active clinical trials at this time.

There are currently no active clinical trials at this time.

There are currently no active clinical trials at this time.

There are currently no active clinical trials at this time.