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:

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, contact Anne Erwin, RN or Betsy Harper, LPN at (225) 765-7650 or 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, contact Becky Toler, RN at (225) 765-7650 or 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, contact Gretchen Figarola, RN at (225) 765-7650 or 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, contact Gretchen Figarola, RN at (225) 765-7650 or 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, contact Melissa Hughes, LPN at (225) 765-7650 or 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, contact Gretchen Figarola, RN at (225) 765-7650 or research@fmolhs.org

Open for 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, contact Betsy Harper, LPN at (225) 765-7650 or research@fmolhs.org

Open for Enrollment

Title: DIAMOND. Patiromer for the Management of Hyperkalemia in Subjects Receiving RAASi Medications for the Treatment of Heart Failure

Purpose: The purpose of this study is to determine if patiromer treatment of subjects who developed hyperkalemia while receiving RAASi medications will result in continued use of RAASi medications in accordance with heart failure (HF) treatment guidelines and thereby decrease the occurrence of the combined endpoint of cardiovascular (CV) death and CV hospitalization events compared with placebo treatment.

Principle Investigator: Dr. Tara Jarreau

Contact: For more information, contact Gretchen Figarola, RN, BSN at (225) 765-7659

Open to Enrollment

Title: GUIDE-HF. Hemodynamic-GUIDEd Management of Heart Failure

Purpose: The GUIDE-HF IDE clinical trial is intended to demonstrate the effectiveness of the CardioMEMS™ HF System in an expanded patient population including HF patients outside of the present indication, but at risk for future HF events or mortality. The trial includes patients with New York Heart Association (NYHA) Class II, III, or IV HF who have an elevated N-terminal pro-Brain Natriuretic Peptide (NT-proBNP) (or an elevated Brain Natriuretic Peptide (BNP)) and/or a prior HF hospitalization (HFH). The GUIDE-HF IDE trial will include approximately 3600 subjects at approximately 140 North American sites and consists of two arms: a Randomized Arm and a Single Arm.

Principle Investigator: Dr. David Moll

Contact: For more information, contact Anne Erwin, MSN, RN, CCRP at (225) 765-7659

Opening to Enrollment

Title: Multi-center cross-sectional epidemiological study to characterize the prevalence and distribution of lipoprotein(a) levels among patients with established cardiovascular disease

Purpose: The purpose of this study is to improve knowledge about the epidemiology of Lp(a) in patients with established cardiovascular disease (CVD).

Principle Investigator: Dr. Denzil Moraes

Contact: For more information, contact Julie Doyle at (225) 765-7660

Open to Enrollment

Title: Lp(a)HORIZON. Assessing the Impact of Lipoprotein (a) Lowering With TQJ230 on Major Cardiovascular Events in Patients With CVD

Purpose: Study TQJ230A12301 is a pivotal phase 3 study designed to test the hypothesis that treatment with TQJ230 80 mg s.c QM will significantly reduce the risk of CV deaths, nonfatal myocardial infarction (MI), non-fatal stroke and urgent coronary re-vascularization in patients with established CVD and elevated levels of Lp(a) who are treated for CV risk factors other than Lp(a) according to local guidelines for the reduction of cardiovascular risk in patients with established CVD and elevated Lp(a). TQJ230 is a N-acetyl galactosamine (GalNAc) conjugated 2 ́-O-(2-methoxyethyl) (2 ́-MOE) chimeric second-generation antisense oligonucleotide (ASO) drug targeted to apolipoprotein(a), [apo(a)].

Principle Investigator: Dr. Denzil Moraes

Contact: For more information, contact Anne Erwin, MSN, RN, CCRP at (225) 765-7659

Opening Soon

Title: PARAGLIDE-HF. Changes in NT-proBNP and Outcomes, Safety, and Tolerability in HFpEF Patients With Acute Decompensated Heart Failure (ADHF) Who Have Been Stabilized During Hospitalization and Initiated In-hospital or Within 30 Days Post-discharge

Purpose: The purpose of this study is to assess the effect of sacubitril/valsartan (LCZ696) vs. valsartan on changes in NT-proBNP and outcomes, safety and tolerability in patients with HFpEF (left ventricular ejection fraction (LVEF) > 40%) who have been stabilized during hospitalization for acute decompensated heart failure and initiated in-hospital or within 30 days post discharge. Initial dose for patients randomized to sacubitril/valsartan (LCZ696) will be determined by patient's previous dose of ACEi/ARB immediately prior to hospital admission for acute decompensated heart failure. Study treatment will be titrated to the target dose of sacubitril/valsartan (LCZ696) 97/103 mg twice daily (Dose Level 3). Patients will be randomized in a 1:1 ratio of sacubitril/valsartan to valsartan for up to approximately 20 months of double-blind treatment.

Principle Investigator: Dr. Denzil Moraes

Contact: For more information, contact Anne Erwin, BSN, RN, CCRP at (225) 765-7659

Open to Enrollment

Title: PSR. Product Surveillance Registry

Purpose: The purpose of the registry is to provide continuing evaluation and periodic reporting of safety and effectiveness of market-released products for their intended use.

Principle Investigator: Dr. Henry Patrick

Contact: For more information, contact Gretchen Figarola, RN, BSN at (225) 765-7659

Open to Enrollment

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.

Clinical Trials in the Baton Rouge area:

Title: MODIFYIII. Bezlotoxumab (MK-6072) Versus Placebo in Children With Clostridium Difficile Infection (CDI)

Purpose: The purpose of this study is to determine the safety and effectiveness of the monoclonal antibody bezlotoxumab in children ages 1 to 17 who have a Clostridium difficile infection.

Principal Investigator: Dr. Michael Bolton

Contact: For more information, contact JoAnne Hollingsworth, BSN at (225) 765-4073

Open to enrollment

There are no genetic studies open at this time.

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, contact Jen Daigle, RN at (225) 765-7650 or research@fmolhs.org

Open for Enrollment

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

Purpose: This is a randomized, open-label, multi-center, comparative trial to assess the efficacy and safety in immunocompromised subjects with acyclovir resistant mucocutaneous HSV infection, treated with pritelivir 100 mg qd (following a loading dose of 400 mg as first dose to rapidly reach steady-state plasma concentration) or foscarnet 40 mg/kg iv tid/60mg/kg iv bid.

Principal Investigator: Dr. Bud O'Neal

Contact: For more information, contact Jennifer Daigle, BSN at (225) 939-0779

Open to enrollment

Title: A Phase 1, Open-Label, Two-Part Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of a Single Dose of Intravenous Lefamulin In Hospitalized Pediatric Subjects Receiving Standard of Care Antibiotic Therapy for Confirmed or Suspected Infection

Purpose: The purpose of this study is to characterize the safety, tolerability, and pharmacokinetics of lefamulin after a single IV dose in pediatric subjects (birth to < 18 years) who are receiving systemic antibiotic therapy for the prevention or treatment of a confirmed or suspected bacterial infection.

Principal Investigator: Dr. Michael Bolton

Contact: For more information, contact JoAnne Hollingsworth, BSN at (225) 765-4073

Open to Enrollment

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, contact JoAnne Hollingsworth, BSN at (225) 765-4073

Open to Enrollment

Title: Lamprene Multiple Patient Program

Purpose: Lamprene®/Clofazimine, is a product of the pharmaceutical company named Novartis Pharmaceuticals Corporation. Lamprene®/Clofazimine is approved by FDA (the U.S Food and Drug Administration) for the treatment of leprosy. It is no longer available through pharmacies in the US. It is being tested in non-Novartis clinical studies for drug resistant tuberculosis and non-tuberculous mycobacteria (NTM). To be eligible for participation in this expanded access program, patients must have an NTM diagnosis. The treating physician has decided that this infection can be treated with Lamprene®/Clofazimine. This medicine is provided to the physician in an expanded access program. This means that this medicine is not registered for the treatment of NTM, but it can be used in special situations where there are no other possible treatments. For example, this may be because the patient has a type of Mycobacterial infection that is resistant or failed to respond optimally to other drugs, or because the patient has had side effects that prevent the use of other drugs. The physician must submit a patient registration form to initiate the patient approval process.

Principal Investigator: Dr. Maria Reyes

Contact: For more information, contact Katie Vance, PhD at (225) 765-4365

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, contact Becky Toler, RN at (225) 765-7650 or research@fmolhs.org

Open for Enrollment

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. Karl LeBlanc and Dr. Danielle Cobb

Contact: For more information, contact Leslie Son, PhD at (225) 765-7650 or 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, contact Leslie Son, PhD at (225) 765-7650 or research@fmolhs.org

Open for Enrollment

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, email the Research Department at research@fmolhs.org

Title: EMN29 A Phase 3, Randomized, Open-Label Trial of Selinexor, Pomalidomide, and Dexamethasone versus Elotuzumab, Pomalidomide, and Dexamethasone In Patients with Relapsed or Refractory Multiple Myeloma (RRMM) ex. EMN29

Purpose: This phase 3 randomized, open-label multicenter trial will compare the efficacy, safety and the impact on health-related quality of life (HR-QoL) of SPd versus EloPd in pomalidomide-naïve patients with MM who have received 1 to 4 prior anti-MM regimens and been treated with an immunomodulatory imide drug (IMiD), proteasome inhibitor (PI) and an anti-CD38 monoclonal antibody (mAb).

Principle Investigator: Stagg, Marshall BS, MD

Contact: For more information, email the Research Department 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, email the Research Department at research@fmolhs.org

Title: Pfizer C4971003 - Phase 1b/2 Stud of PF-07901801, Tafasitamab, and Lenalidmide in Transplant Ineligible Relapsed/Refractory Diffuse Large B-cell Lymphoma

Purpose: The purpose of this study is to learn about the effects of three study medicines maplirpacept (PF-07901801), tafasitamab, and lenalidomide] when given together for the treatment of diffuse large B-cell lymphoma (DLBCL) that:

• Is relapsed (has returned after last treatment) or
• is refractory (has not responded to last treatment)

Principle Investigator: Stagg, Marshall BS, MD

Contact: For more information, email the Research Department at research@fmolhs.org

Title: BMS Connect Myeloid Registry

Purpose: The purpose of the Connect® Myeloid disease registry is to provide unique insights into treatment decisions and treatment patterns as they relate to clinical outcomes of patients with myeloid diseases in routine clinical practice. This disease registry will also evaluate molecular and cellular markers that may provide further prognostic classification which may or may not be predictive of therapy and clinical outcomes.

Principle Investigator: Stagg, Marshall BS, MD

Contact: For more information, email the Research Department 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, email the Research Department at research@fmolhs.org

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, email the Research Department at research@fmolhs.org

Title: Tropion Breast 02 – A Phase 3, Open-label, Randomized Study of Datopotamab Deruxtecan (Dato-DXd) versus Investigator’s Choice of Chemotherapy in Patients who are not Candidates for PD-1/PD-:1 Inhibitor Therapy in First Line Locally Recurrent Inoperable or Metastatic Triple-Negative Breast Cancer

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, email the Research Department at research@fmolhs.org

Title: Genentech evERA ML43171 – A Phase III, Randomized, Open-Label Multicenter Study Evaluating the Efficacy and Safety of Giredestrant Plus Everolimus compared with Exemestane Plus Everolimus in Patients with Estrogen Receptor-Positive, Her Negative, Locally Advanced or Metastatic Breast Cancer

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, email the Research Department 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, email the Research Department at research@fmolhs.org

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

Purpose: This phase 3 trial compares the addition of nivolumab to chemotherapy (carboplatin and paclitaxel) versus usual treatment (chemotherapy alone) for the treatment of anal cancer that has spread to other places in the body (metastatic). Immunotherapy with monoclonal antibodies, such as nivolumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Chemotherapy drugs, such as carboplatin and paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving nivolumab together with carboplatin and paclitaxel may help doctors find out if the treatment is better or the same as the usual approach.

Principle Investigator: Stagg, Marshall BS, MD

Contact: For more information, email the Research Department at research@fmolhs.org

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, email the Research Department at research@fmolhs.org

Title: PD-Inhibitor (Nivolumab) and Ipilimumab Followed by Nivolumab vs. VEGF TKI Cabozantinib with Nivolumab: A Phase III Trial in Metastatic Untreated Renal Cell Cancer [PDIGREE]

Purpose: This phase III trial compares the usual treatment (treatment with ipilimumab and nivolumab followed by nivolumab alone) to treatment with ipilimumab and nivolumab, followed by nivolumab with cabozantinib in patients with untreated renal cell carcinoma that has spread to other parts of the body. The addition of cabozantinib to the usual treatment may make it work better. Immunotherapy with monoclonal antibodies, such as nivolumab and ipilimumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Cabozantinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. It is not yet known how well the combination of cabozantinib and nivolumab after initial treatment with ipilimumab and nivolumab works in treating patients with renal cell cancer that has spread to other parts of the body.

Principle Investigator: Stagg, Marshall BS, MD

Contact: For more information, email the Research Department at research@fmolhs.org

Title: 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, email the Research Department 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, email the Research Department at research@fmolhs.org

Title: A092104 A Randomized Phase 2/3 Study of Olaparib plus Temozolomide versus Investigator’s Choice for the Treatment of Patients with Advanced Uterine Leiomyosarcoma after Progression of Prior Chemotherapy

Purpose: This phase II/III trial compares the effect of the combination of olaparib and temozolomide to the usual treatment (trabectedin and pazopanib) for uterine leiomyosarcoma that has spread to other places in the body (advanced) after initial chemotherapy has stopped working. Olaparib is a PARP inhibitor. PARP is a protein that helps repair damaged deoxyribonucleic acid (DNA). Blocking PARP may prevent tumor cells from repairing their damaged DNA, causing them to die. PARP inhibitors are a type of targeted therapy. Temozolomide is in a class of medications called alkylating agents. It works by slowing or stopping the growth of tumor cells in the body. The combination of olaparib and temozolomide may work better than the usual treatment in shrinking or stabilizing advanced uterine leiomyosarcoma after initial chemotherapy has stopped working.

Principle Investigator: Stagg, Marshall, BS, MD

Contact: For more information, email the Research Department at research@fmolhs.org

Title: Merck Leap 7902-009 A Phase 2, open-label three arm clinical study to evaluate the safety and efficacy of Lenvatinib in combination with Pembrolizumab versus Standard of Care Chemotherapy and Lenvatinib Monotherapy in Participants with Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma that have Progressed after Platinum Therapy and Immunotherapy

Purpose: This study is designed to assess the safety and efficacy of lenvatinib in combination with pembrolizumab versus standard of care (SOC) chemotherapy, and to also assess the safety and efficacy of lenvatinib monotherapy in participants with recurrent/metastatic head and neck squamous cell carcinoma (R/M HNSCC) that have progressed after platinum therapy and a programmed cell death protein 1 (PD-1) or anti-programmed death ligand 1 (PD-L1) inhibitor. The primary hypothesis is that lenvatinib + pembrolizumab is superior to SOC chemotherapy with respect to ORR per modified Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 as assessed by blinded independent central review.

Principle Investigator: Stagg, Marshall BS, MD

Contact: For more information, email the Research Department at research@fmolhs.org

Title: 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. Drugs used in chemotherapy such as cisplatin work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Radiation therapy uses high energy rays to kill tumor cells and shrink tumors. Immunotherapy with monoclonal antibodies, such as nivolumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. It is not yet known whether chemotherapy and radiation therapy followed by maintenance nivolumab therapy works better than chemotherapy and radiation therapy alone in treating patients with HPV positive oropharyngeal cancer.

Principle Investigator: Stagg, Marshall BS, MD

Contact: For more information, email the Research Department at research@fmolhs.org

Title: A Randomized Phase III Trial of Induction/Consolidation Atezolizumab (NSC #783608) + SBRT Versus SBRT Alone in High Risk, Early Stage NSCLC

Purpose:This phase III trial studies how well atezolizumab added to the usual radiation therapy works in treating patients with stage I-IIA non-small cell lung cancer. Immunotherapy with monoclonal antibodies, such as atezolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Radiation therapy, such as stereotactic body radiation therapy, uses special equipment to position a patient and deliver radiation to tumors with high precision. This method can kill tumor cells with fewer doses over a shorter period and cause less damage to normal tissue. Giving atezolizumab and radiation therapy may work better than radiation therapy alone in treating patients with early non-small cell lung cancer.

Principle Investigator: Stagg, Marshall BS, MD

Contact: For more information, email the Research Department at research@fmolhs.org

Title: 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, email the Research Department at research@fmolhs.org

Title: Avanzar D926NC00001 A Phase III, Randomized, Open-Label, Multicentre Global Study of Datopotamab Deruxtecan in Combination with Durvalumab and Carboplatin versus Pembrolizumab in Combination with Platinum based Chemotherapy for the First-line Treatment of Patients with Locally Advanced or Metastatic NSCLC Without Actionable Genomic Alterations

Purpose: Participants with locally advanced or metastatic NSCLC without actionable tumor tissue genomic alterations and confirmed to meet all eligibility criteria will be randomized in a 1:1 ratio to Dato-DXd in combination with durvalumab and carboplatin versus pembrolizumab in combination with histology-specific platinum-based chemotherapy as first-line treatment. The primary objectives of the study are to demonstrate superiority of Dato-DXd in combination with durvalumab and carboplatin relative to pembrolizumab in combination with platinum-based chemotherapy by assessment of Progression Free Survival (PFS) by BICR and Overall Survival (OS) in first-line treatment of TROP2 biomarker positive participants.

Contact: For more information, email the Research Department 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, email the Research Department at research@fmolhs.org

Title: Amgen 757-20210004 A Randomized, Open-label, Phase 3 Study of Tarlatamab Compared with Standard of Care in Subjects with Relapsed Small Cell Lung Cancer After Platinum-based First Line Chemotherapy

Purpose: PThe main objective is to compare the efficacy of tarlatamab with standard of care (SOC) on prolonging overall survival (OS).

Contact: For more information, email the Research Department 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, email the Research Department at research@fmolhs.org

Title: Adjuvant Lung Cancer Enrichment Marker Identification and Sequencing Trial (ALCHEMIST)

Purpose: This ALCHEMIST trial studies genetic testing in screening patients with stage IB-IIIA non-small cell lung cancer that has been or will be removed by surgery. Studying the genes in a patient's tumor cells may help doctors select the best treatment for patients that have certain genetic changes.

Principle Investigator: Stagg, Marshall BS, MD

Contact: For more information, email the Research Department at research@fmolhs.org

Title: A Randomized Phase II Trial of Cabozantinib and Cabozantinib Plus Nivolumab Versus Standard Chemotherapy in Patients with Previously Treated Non-Squamous NSCLC

Purpose: This phase II trial compares cabozantinib alone and the combination of cabozantinib and nivolumab to standard chemotherapy in the treatment of patients with non-squamous non-small cell lung cancer (NSCLC). Cabozantinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Immunotherapy with monoclonal antibodies, such as nivolumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Ramucirumab is a monoclonal antibody that may interfere with the ability of tumor cells to grow and spread. Chemotherapy drugs, such as docetaxel, gemcitabine hydrochloride, paclitaxel, and nab-paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving cabozantinib alone or in combination with nivolumab may be more effective than standard chemotherapy in treating patients with non-small cell lung cancer.

Principle Investigator: Stagg, Marshall BS, MD

Contact: For more information, email the Research Department at research@fmolhs.org

Title: 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, email the Research Department at research@fmolhs.org

Title: A Phase III Trial of Perioperative versus Adjuvant Chemotherapy for Resectable Pancreatic Cancer

Purpose: This phase III trial compares perioperative chemotherapy (given before and after surgery) versus adjuvant chemotherapy (given after surgery) for the treatment of pancreatic cancer that can be removed by surgery (removable/resectable). Chemotherapy drugs, such as fluorouracil, irinotecan, leucovorin, and oxaliplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving chemotherapy before and after surgery (perioperatively) may work better in treating patients with pancreatic cancer compared to giving chemotherapy after surgery (adjuvantly).

Principle Investigator: Stagg, Marshall BS, MD

Contact: For more information, email the Research Department at research@fmolhs.org

Title: 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, email the Research Department at research@fmolhs.org

Title: REtroperitoneal SArcoma Registry: an International Prospective Initiative (RESAR)

Purpose: Surgery is currently the only potentially curative treatment modality for localized retroperitoneal sarcoma (RPS). Available studies regarding oncologic outcomes are mainly retrospective in nature, and RPS are recognized as a rare disease. Therefore, prospective analysis of high quality data is a top priority.

Principle Investigator: Lyons, John MD

Contact: For more information, email the Research Department at research@fmolhs.org

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

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, email the Research Department at research@fmolhs.org

Title: 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). Immunotherapy with monoclonal antibodies, such as ipilimumab and nivolumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Colony-stimulating factors, such as sargramostim, may increase the production of white blood cells. It is not yet known whether nivolumab and ipilimumab are more effective with or without sargramostim in treating patients with melanoma.

Principle Investigator: Stagg, Marshall BS, MD

Contact: For more information, email the Research Department at research@fmolhs.org

Title: 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: Stagg, Marshall BS, MD

Contact: For more information, email the Research Department 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, email the Research Department at research@fmolhs.org

Title: GBT021601-022 An Open-label Extension Study to Evaluate the Long-term Safety of GBT021601 Administered to Participants with Sickle Cell Disease Who Have Participated in a GBT021601 Clinical Trial

Purpose: An Open-label Extension Study to Evaluate the Long-term Safety and Efficacy of GBT021601 Administered to Participants with Sickle Cell Disease Who Have Participated in a GBT021601 Clinical Trial.

Principle Investigator: Stagg, Marshall BS, MD

Contact: For more information, email the Research Department 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, email the Research Department 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, email the Research Department at research@fmolhs.org

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

Purpose: In an effort to broaden the understanding of who is screened for NCI clinical trials and the barriers to clinical trial participation, NCORP has developed a clinical trials screening tool. The NCORP Clinical Trials Screening Tool will provide a unique opportunity to collect expanded demographic and clinical data to increase our understanding of who is or is not enrolled in NCI-sponsored trials and address research questions related to disparities in cancer care and cancer care delivery.

Principle Investigator: Stagg, Marshall BS, MD

Contact: For more information, email the Research Department at research@fmolhs.org

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, email the Research Department at research@fmolhs.org

Title: Molecular Analysis for Therapy Choice (MATCH)

Purpose: This phase II MATCH trial studies how well treatment that is directed by genetic testing works in patients with solid tumors or lymphomas that have progressed following at least one line of standard treatment or for which no agreed upon treatment approach exists. Genetic tests look at the unique genetic material (genes) of patients' tumor cells. Patients with genetic abnormalities (such as mutations, amplifications, or translocations) may benefit more from treatment which targets their tumor's particular genetic abnormality. Identifying these genetic abnormalities first may help doctors plan better treatment for patients with solid tumors, lymphomas, or multiple myeloma.

Principle Investigator: Stagg, Marshall BS, MD

Contact: For more information, email the Research Department at research@fmolhs.org

Title: Immune Checkpoint Inhibitor Toxicity (I-CHECKIT): A Prospective Observational Study

Purpose: This study examines how certain risk factors (such as age, gender, other medical conditions, and the type of immunotherapy used to treat the cancer) affect whether a patient with a malignant solid tumor will develop mild or serious side effects from the immunotherapy medications. Immunotherapy is the type of treatment that helps the body's immune system fight cancer. In the future, this information may help doctors make better decisions about cancer treatments.

Principle Investigator: Stagg, Marshall BS, MD

Contact: For more information, email the Research Department at research@fmolhs.org

Title: Establishment of a National Biorepository to Advance Studies of Immune-Related Adverse Events

Purpose: This trial collects research data and samples from patients who experience immunotherapy side effects to store for use in future research studies. Studying research data and samples from patients who experience immunotherapy side effects may help researchers better understand how to predict, prevent, and treat these side effects.

Principle Investigator: Stagg, Marshall BS, MD

Contact: For more information, email the Research Department at research@fmolhs.org

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

Clinical Trials in the Baton Rouge area:

Title: GBT HOPE. Study to Evaluate the Effect of GBT440 Administered Orally to Patients With Sickle Cell Disease

Purpose: The purpose is to assess the efficacy of GBT440 in adolescents and adults with sickle cell disease as measured by improvement in anemia.

Principle Investigator: Dr. J. Ryan Shows

Contact: For more information contact Allie Piehet, BS at (225) 215-5909

Clinical Trials in the Baton Rouge area:

Title:  MODIFYIII. Bezlotoxumab (MK-6072) Versus Placebo in Children With Clostridium Difficile Infection (CDI)

Purpose: The purpose of this study is to determine the safety and effectiveness of the monoclonal antibody bezlotoxumab in children ages 1 to 17 who have a Clostridium difficile infection.

Principal Investigator: Dr. Michael Bolton

Contact: For more information, contact Katie Vance, Ph.D. at (225) 765-4365

Clinical Trials in the Baton Rouge area:

Title: Pediatric Obesity Weight Evaluation Registry (POWER) Study (POWER)

Purpose: The main objective of this study is to establish a national pediatric obesity registry known as POWER (Pediatric Obesity Weight Evaluation Registry). This registry will contain clinical data from individual comprehensive pediatric weight management programs around the United States for overweight and obese youth.

Principle Investigator: Dr. Katie Queen

Contact: For more information, contact Micah Klumpp, PhD at (225) 765-7650 or research@fmolhs.org

Open for Enrollment

Clinical Trials in the Baton Rouge area:

Title: MK-7625A-034. MK-7625A Versus Meropenem in Pediatric Participants With Complicated Urinary Tract Infection (cUTI)

Purpose: This study aims to evaluate the safety and tolerability of MK-7625A (ceftolozane/tazobactam) compared with that of meropenem in pediatric participants with cUTI, including pyelonephritis.

Principal Investigator: Dr. Michael Bolton

Contact: For more information, contact Katie Vance, Ph.D. at (225) 765-4365

Open to enrollment

Title: A Pharmacokinetics Study of MK-7655A in Pediatric Participants With Gram-negative Infections

Purpose: The purpose of this research study is to determine how the body handles a single intravenous dose of imipenem (IMI), cilastatin (CIL), and relebactam (REL) in patients ranging in age from birth up to 17 years old.

Principal Investigator: Dr. Michael Bolton

Contact: For more information, contact Katie Vance, Ph.D. at (225) 765-4365

Open to Enrollment

Title: A Phase 1, Single-Administration Pharmacokinetic and Safety Study of Oral and IV Tedizolid Phosphate in Hospitalized Subjects 2 to <12 Years Old

Purpose: The purpose of this research study is to test a single intravenous or oral dose of tedizolid phosphate for tolerability and safety in patients ages 2 to <12 years old.

Principal Investigator: Dr. Michael Bolton

Contact: For more information, contact Katie Vance, Ph.D. at (225) 765-4365

Past Clinical Trials in the Baton Rouge Area:

• Passive Immunity Trial for Our Nation to Treat COVID-19 in Hospitalized Adults (PassItOn)
• Study of Efficacy and Safety of MAS825 in Patients With COVID-19 (MAS-COVID)
• Dociparstat for the Treatment of Sever COVID-19in Adults at High Risk of Respiratory Failure

Past Clinical Trials in the Baton Rouge area:

• Natural History of the Development of Type 1 Diabetes

Past Clinical Trials in the Baton Rouge area:

• CONVERGE, Convergence of Epicardial and Endocardial RF Ablation for the Treatment of Symptomatic Persistent AF
• GREAT, Global Registry for Endovascular Aortic Treatment Outcomes Evaluation
• LEOPARD, Looking at Endovascular Abdominal Aortic Aneurysm Repair (EVAR) Outcomes by Primary Analysis of Randomized Data
• PARADISE-MI, Prospective ARNI vs ACE Inhibitor Trial to Determine Superiority in Reducing Heart Failure Events After MI

Past Clinical Trials in the Baton Rouge area:

• A Phase 1, Open-Label, Two-Part Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of a Single Dose of Intravenous Lefamulin In Hospitalized Pediatric Subjects Receiving Standard of Care Antibiotic Therapy for Confirmed or Suspected Infection

Past Clinical Trials in the Baton Rouge area:

• Post Market Study of Parietene™ DS Composite Mesh in Ventral Hernia Repair
• A Prospective, Multicenter Post-Market Study to Evaluate and Compare the Clinical Outcomes, Pain and Patient Quality of Life After Open, Laparoscopic or Robotic Assisted Hernia (Incisional and Inguinal) Repair

Past Clinical Trials in the Baton Rouge area:

Breast

• Prospective Evaluation of Carvedilol in Prevention of Cardiac Toxicity in Patients with Metastatic HER-2+ Breast Cancer, Phase III
• A Study of Trastuzumab Deruxtecan (T-DXd) Versus Trastuzumab Emtansine (T-DM1) in High-risk HER2-positive Participants With Residual Invasive Breast Cancer Following Neoadjuvant Therapy (DESTINY-Breast05)

Pancreas

• Comparing the Clinical Impact of Pancreatic Cyst Surveillance Programs