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Here are the studies that match your search criteria. If you are interested in participating, please reach out to the contact listed for the study. If no contact is listed, contact us and we'll help you find the right person.

426 Study Matches

PEPN2111 - A Phase 1/2 Trial of CBL0137 (NSC# 825802, IND# 155843) in Patients with Relapsed or Refractory Solid Tumors including CNS Tumors and Lymphoma

A Phase I/II trial of single agent intravenous CBL0137 in pediatric patients (≥ 12 months and ≤ 30 years) with relapsed/refractory solid tumors, including CNS tumors and lymphoma.

Principal Investigator: Robin Williams
Age Group: Not specified
This study is NOT accepting healthy volunteers
IRB Number: SITE00001450
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Inclusion Criteria:

• 12 months to 30 years old
• patients with relapsed or refractory solid tumors or lymphoma, including patients with CNS tumors or known CNS metastases, or patients with progressive or recurrent DIPG (diagnosed by biopsy or imaging characteristics) and other H3 K27M-mutant diffuse midline gliomas previously treated with radiation therapy, or patients with relapsed or refractory osteosarcoma
• patients must have fully recovered from the acute toxic effects of all prior anti-cancer therapy and must meet the following minimum duration from prior anti-cancer directed therapy prior to enrollment
• patients have consented to receive a central venous catheter prior to the administration of CBL0137
• see link to clnicaltrials.gov for complete inclusion and exclusion criteria
Exclusion Criteria:

• pregnant or breast-feeding women
• patients who have an uncontrolled infection
• patients who have received a prior solid organ transplantation
Conditions: Cancer, Cancer
Keywords: Brain Cancer, Glioma, Recurrent Lymphoma
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PEPN2121 : A Phase 1/2 Study of Tiragolumab (NSC# 827799, IND# 161266) and Atezolizumab (NSC# 783608, IND# 161266) in Patients with Relapsed or Refractory SMARCB1 or SMARCA4 Deficient Tumors

This phase I/II trial studies how well tiragolumab and atezolizumab works when given to children and adults with SMARCB1 or SMARCA4 deficient tumors that that has either come back (relapsed) or does not respond to therapy (refractory). SMARCB1 or SMARCA4 deficiency means that tumor cells are missing the SMARCB1 and SMARCA4 genes, which is related to having more aggressive cancers that are harder to treat. Immunotherapy with monoclonal antibodies, such as tiragolumab and atezolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread.

Principal Investigator: Robin Williams
Age Group: Not specified
This study is NOT accepting healthy volunteers
IRB Number: SITE00001713
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Inclusion Criteria:

• patients must be >= 12 months of age at the time of study enrollment. For part A, patients must be <18 years old at enrollment. For part B, there is no upper age limit
• patients must have SMARCB1 (INI1) or SMARCA4 deficient tumors verified through institutional immunohistochemistry (IHC) or molecular confirmation of a pathologic tumor bi-allelic SMARCB1 (INI1) or SMARCA4 loss or mutation from a Clinical Laboratory Improvement Act (CLIA) certified lab
• see link to clinicaltrials.gov for complete eligibility criteria
Exclusion Criteria:

• patients who have undergone allogeneic bone marrow or stem cell transplant are not eligible
• patients with known, untreated CNS metastases will be excluded
Conditions: Cancer
Keywords: Malignant Solid Neoplasm
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A Multicenter, Randomized, Parallel-group, Double-blind, Two-arm, Phase III Study to Evaluate the Safety and Efficacy of Anifrolumab Compared with Placebo in Male and Female Participants 18 to 70 Years of Age Inclusive with Systemic Sclerosis (DAISY)

We are doing this study to learn more about anifrolumab (SAPHNELOTM) in patients with systemic sclerosis and to better understand the studied disease and associated health problems. Systemic sclerosis (scleroderma) affects the skin as well as other organs, such as blood vessels, muscles and joints, digestive tract, kidneys, lungs and heart.

Principal Investigator: Jerry Molitor
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
IRB Number: STUDY00019243
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Inclusion Criteria:

• 18 to 70 years old
• diagnosis of systemic sclerosis within 6 years from first non-Raynaud's symptoms
• skin at injections sites is without symptoms
• see link to clinicaltrials.gov for complete inclusion and exclusion criteria
Exclusion Criteria:

• severe heart or lung disease
• history of any other inflammatory diseases
• history of hematopoietic stem cell transplantation or solid organ or limb transplantation
• current or a history of cancer within past 5 years
• active current or history of reoccurring infections
Conditions: Arthritis & Rheumatic Diseases
Keywords: Clinics and Surgery Center (CSC), systemic sclerosis, Scleroderma
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Effects of tobacco and nicotine cessation on biomarkers

This study will bank biological samples (cells from mouth, urine, blood, saliva) to investigate the effects of quitting smoking or vaping on different markers in the body.

Principal Investigator: Stephen Hecht, PhD
Age Group: Up to 18 years old
This study is NOT accepting healthy volunteers
IRB Number: STUDY00020438
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Inclusion Criteria:

• 21 years of age or older
• in good health
• smokes cigarettes daily
• willing to abstain from smoking for 15 days
Exclusion Criteria:

• marijuana use
Conditions: Prevention & Wellness
Keywords: cigarettes, lozenges, nicotine, patches, smoking, smoking cessation, tobacco
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A Multicenter Observational Study of GammaTile Surgically Targeted Radiation Therapy (STaRT) in Intracranial Brain Neoplasms

We are studying the effectiveness of GammaTiles TM that are placed during surgery done to remove brain tumors. GammaTiles TM are used to deliver radiation to the surgical area in the brain. We are collecting information about the effectiveness and side effects and will compare to people who receive the usual treatment.

Principal Investigator: Lindsey Sloan
Age Group: Not specified
This study is NOT accepting healthy volunteers
IRB Number: SITE00000958
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Inclusion Criteria:

• undergo maximum safe resection of intracranial neoplasm(s) AND implantation of GammaTiles.
Exclusion Criteria:

• unable to have pre-operative and post-operative imaging for disease and implant assessment
• major medical or psychiatric illness (study staff will review)
• unable to speak and read English
Conditions: Brain & Nervous System, Cancer
Keywords: Brain Tumor
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CATALINA-2: A Phase 2 Study Evaluating the Efficacy and Safety of TORL-1-23 in Women with Advanced Platinum-Resistant Epithelial Ovarian Cancer (Including Primary Peritoneal and Fallopian Tube Cancers) Expressing Claudin 6

This study is being conducted to determine the safest and most effective dose of TORL-1-23 in treating advanced platinum-resistant ovarian cancer.

Principal Investigator: Boris Winterhoff
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
IRB Number: STUDY00024234
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Inclusion Criteria:

• diagnosis of advanced (unresectable) or metastatic (has spread) high grade serous ovarian, primary peritoneal (i.e, of primary origin), or fallopian tube cancer
• positive for CLDN6 expression
• have platinum-resistant disease
• may not be able to do strenuous activity but able to walk and carry out work of a light or sedentary nature, e.g., light house work, office work
• must agree to use a highly effective birth control method from the time of the first study drug treatment through 7 months after the last study drug treatment
• must agree to not breastfeed from the first dose of study treatment through 90 days after the last dose of study treatment
• see link to clinicaltrials.gov for complete inclusion criteria
Exclusion Criteria:

• have not recovered from serious side effects of previous treatment
• progressive or symptomatic brain metastases
• history of significant heart disease
• history of another cancer within 3 years (exception of basal or squamous cell carcinoma of the skin)
• see link to clinicaltrials.gov for complete exclusion criteria
Conditions: Cancer
Keywords: Clinics and Surgery Center (CSC), Fallopian Tube Cancer, Ovarian Cancer, Primary Peritoneal Cancer

A Phase 2 Randomized Trial of Neoadjuvant Enoblituzumab versus Standard of Care in Men with High-Risk Localized Prostate Cancer: The Help Elucidate & Attack Longitudinally (HEAT) Prostate Cancer Randomized Study (HEAT)

This study aims to improve prostate cancer treatment by testing a drug, enoblituzumab, which targets a protein called B7-H3. Previous research suggests it might boost the immune system to fight cancer. The objective is to see if it delays cancer return compared to standard treatment and identify who responds best.

Principal Investigator: Christopher Warlick, MD
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
IRB Number: STUDY00022418
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Inclusion Criteria:

• confirmed adenocarcinoma of the prostate
• an initial prostate biopsy within 3 months of enrollment is available for review, showing at least 3 positive cores, including one with ≥50% involvement and Gleason ≥8
• radical prostatectomy has been scheduled
• see link to clinicaltrials.gov for complete inclusion & exclusion criteria
Exclusion Criteria:

• known lymph node involvement on CT or distant metastases on CT or bone scan; non-adenocarcinoma prostate cancers
• previous or concurrent use of radiation, hormonal, biologic, chemotherapy, immunotherapy, experimental agents, 5α-reductase inhibitors, or systemic corticosteroids
• autoimmune diseases requiring systemic immunosuppression; malignancy within the last 3 years; uncontrolled major infections or illnesses
Conditions: Cancer
Keywords: Clinics and Surgery Center (CSC), Prostate Cancer
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Single-Arm Phase II Study of Carboplatin and Mirvetuximab Soravtansine in First-Line Treatment of Patients receiving Neoadjuvant Chemotherapy with Advanced-Stage Ovarian, Fallopian Tube or Primary Peritoneal Cancer who are Folate Receptor positive

The purpose of the study is to document the feasibility of undergoing surgery for cancer after receiving 3 cycles of neoadjuvant chemotherapy carboplatin and mirvetuximab soravtansine as first-line treatment in patients with advanced-stage ovarian cancer that are Folate Receptor alpha positive.

Principal Investigator: Britt Erickson
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
IRB Number: STUDY00021464
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Inclusion Criteria:

• confirmed high grade serous epithelial ovarian cancer
• stage III or IV disease and be appropriate to receive neoadjuvant chemotherapy (before surgery)
• strenuous activity may be restricted but able to walk and carry out work of a light or sedentary nature, e.g., light house work, office work
• women of childbearing potential (WCBP) must agree to use highly effective contraceptive method(s) while on MIRV and for at least 4 months after the last dose
• see link to clinicaltrials.gov for complete inclusion and exclusion criteria
Exclusion Criteria:

• previously treated with a systemic anti-cancer therapy
• low-grade serous, endometrioid, clear cell, or mucinous cancer
• women who have active or chronic corneal (eye) disorders, history of corneal transplantation, or active ocular conditions requiring ongoing treatment/monitoring, such as uncontrolled glaucoma, wet age-related macular degeneration requiring intravitreal injections, active diabetic retinopathy with macular edema, macular degeneration, presence of papilledema, and /or monocular vision
• history of hepatitis B or C infection or human immunodeficiency virus (HIV) infection
• women who are pregnant or breastfeeding
• history of other cancer within 3 years prior
• significant heart, lung, liver disease
Conditions: Cancer
Keywords: Clinics and Surgery Center (CSC), Fallopian Tube, Ovarian Cancer, Primary Peritoneal Cancer
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Home-based Pulmonary Rehabilitation with Health Coaching in Patients with Fibrotic Interstitial Lung Disease: A Prospective Pragmatic Randomized Waitlist-Controlled Trial

This research study is for people who have a diagnosis of lung fibrosis and are experiencing increased shortness of breath from it. Participation involves being randomly (by chance) selected to participate in either the home-based rehab program right away or an observation only group. If randomly selected to participate in the observation group first, participants will be transitioned to the home-based rehab program after the observation period. Both programs last 12 weeks. The home-based rehab program involves the use of an electronic tablet containing video exercises that to complete daily for a total of 24 minutes of exercise each day. There is also a mindful breathing meditation that lasts about 3 minutes which you will do after completing the video exercises.

Principal Investigator: Hyun Kim
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
IRB Number: STUDY00024433
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Inclusion Criteria:

• fibrotic interstitial lung diseases (F-ILD) diagnosis, any disease subtype, active or prior medical treatment
• translators available for non- English speaking participants
Exclusion Criteria:

• unable to walk
• cognitive impairment or unable understand and follow instructions
• completed traditional center-based pulmonary rehabilitation within past 3 months
Conditions: Rare Diseases, Respiratory System
Keywords: f-ILD, Lung Fibrosis, Lung Interstitial Disease, pulmonary rehabilitation
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COG AGCT1531 - A Phase 3 Study of Active Surveillance for Low Risk and a Randomized Trial of Carboplatin vs. Cisplatin for Standard Risk Pediatric and Adult Patients with Germ Cell Tumors

This partially randomized phase III trial studies how well active surveillance, bleomycin, carboplatin, etoposide, or cisplatin work in treating pediatric and adult patients with germ cell tumors. Active surveillance may help doctors to monitor subjects with low risk germ cell tumors after their tumor is removed. Drugs used in chemotherapy, such as bleomycin, carboplatin, etoposide, 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.

Principal Investigator: Robin Williams
Age Group: Not specified
This study is NOT accepting healthy volunteers
IRB Number: SITE00000295
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Inclusion Criteria:

• newly diagnosed with a Stage I germ cell tumor or metastatic germ cell tumor
• see link to clinicaltrials.gov for detailed inclusion criteria
Exclusion Criteria:

• patients must have had no prior systemic therapy for the current cancer diagnosis
• patients must have had no prior radiation therapy (exception of CNS irradiation of brain metastases for standard risk 1 patients)
• female patients who are pregnant since fetal toxicities and teratogenic effects have been noted for several of the study drugs
• lactating females who plan to breastfeed their infants
• there are additional exclusion criteria (study staff will review)
Conditions: Cancer
Keywords: Germ Cell Tumor, Malignant Germ Cell Tumor
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Oxidative Stress Markers in Heart Failure II

This research is being done to better understand why people develop a type of heart failure where the heart contracts normally but does not relax well. By comparing levels of chemicals in the blood that are secreted by the body in subjects with normal hearts and in subjects with abnormal relaxation, we hope to gain a better understanding of why heart failure occurs.

Principal Investigator: Samuel Dudley
Age Group: 18 years and over
This study is also accepting healthy volunteers
IRB Number: STUDY00017627
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Inclusion Criteria:

• Looking for both healthy and diastolic dysfunction participants who have had an echo in the past 6 months
• Age greater than or equal to 18 years
• Transthoracic echocardiogram within 1 year prior to enrollment containing tissue Doppler, mitral inflow velocities, left ventricular ejection fraction and left ventricular end‐diastolic volume index data
• Able to provide written consent
• Healthy patients with an E/e’ ratio < 15
• Patients with asymptomatic diastolic dysfunction with an E/e’ ratio > 15
• Able to give a blood sample
• EF greater than or equal to 50%
Exclusion Criteria:

• EF<50%
• Any regional wall motion defects, any valvular heart disease with greater than a mild stenosis or regurgitation, any congenital or other significant structural heart disease,
• Patients undergoing cancer treatment
• Patients with an anticipated life expectancy less than 18 months.
• Age < 75 years
• Previous hospital admission for acute heart failure
• History of NYHA Class II, III or IV functional status
• The need for loop diuretics specifically for heart failure at any time.
• History of congestive heart failure.
• History of coronary artery disease.
• History of myocardial infarction.
• Significant structural heart disease
• Evidence of infiltrative cardiac disease
• Atrial fibrillation (AF) within 6 weeks
• Rhythm other than sinus at enrollment
• Patient with a pacemaker
• Cardiogenic shock
• History of heart transplant or left ventricular assist device
• Hemodialysis or peritoneal dialysis
• Active infection including bacteremia
• Major trauma or surgery within 6 weeks
• Collagen vascular disease if on active treatment including steroids and other immunomodulating drugs
• Systemic steroid use within 6 week.
Conditions: Heart & Vascular
Keywords: Clinics and Surgery Center (CSC), cMyBP-C, Heart failure, HFpEF, cardiac diastolic dysfunction (DD)
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A Phase 3, Multicenter, Randomized, Double-Blind Study of the Efficacy and Safety of Rezafungin for Injection Versus the Standard Antimicrobial Regimen to Prevent Invasive Fungal Diseases in Adults Undergoing Allogeneic Blood and Marrow Transplantation (The ReSPECT Study) (ReSPECT)

One type of infection that is possible after bone marrow transplant is called an invasive fungal disease (IFD), a type of fungal infection that has the ability to spread throughout the body. In this study, rezafungin will be compared with the currently approved drugs for the prevention of IFD. The currently approved drugs are referred to as the standard antimicrobial regimen (SAR) which is posaconazole or fluconazole. We want to learn if rezafungin is safe and tolerable, if it is effective in preventing IFD compared to the standard treatment and to find out how much rezafungin is in blood over time after study drug has been given.

Principal Investigator: Jo-Anne Young, MD
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
IRB Number: STUDY00021347
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Inclusion Criteria:

• receiving a human leukocyte antigen (HLA) matched or unmatched peripheral bone marrow transplant (BMT)
• diagnosis of one of the following underlying diseases: acute myeloid leukemia (AML), acute lymphoblastic leukemia, acute undifferentiated leukemia, acute biphenotypic leukemia, or chronic myelogenous leukemia
• women and men must agree to use birth control for 120 days after last dose of study drug
• see link to clinicaltrials.gov for completed inclusion and exclusion criteria
Exclusion Criteria:

• diagnosis of AML not in remission
• significant heart or lung disease
• previous allogeneic BMT
• ataxia, neuropathy or tremors; or a diagnosis of multiple sclerosis or a movement disorder (including Parkinson's disease or Huntington's disease)
Conditions: Infectious Diseases
Keywords: BMT, Bone Marrow Transplant, Candidemia, Fungal Infection, Infection, Infectious Disease, Mycoses
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A PHASE III TRIAL OF ONE VS. TWO YEARS OF MAINTENANCE OLAPARIB, WITH OR WITHOUT BEVACIZUMAB, IN PATIENTS WITH BRCA1/2 MUTATED OR HOMOLOGOUS RECOMBINATION DEFICIENT (HRD+) OVARIAN CANCER FOLLOWING RESPONSE TO FIRST LINE PLATINUM-BASED CHEMOTHERAPY

The usual approach for patients who are not in a study is treatment of ovarian cancer with surgery, radiation, or U.S. Food and Drug Administration (FDA)-approved drugs. Sometimes, combinations of these treatments are used. We are doing this study because we want to find out if the use of Olaparib for one year is as good or worse than the usual approach for ovarian tumor.

Principal Investigator: Jordan N Mattson
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
IRB Number: STUDY00024824
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Inclusion Criteria:

• newly diagnosed, confirmed stage III or IV ovarian cancer of the following types: high grade serous or endometrioid, or other epithelial ovarian cancer with BRCA1/2 alteration
• ovarian cancer includes ovarian, fallopian, or primary peritoneal cancer
• must have had cytoreductive surgery
• must have completed first line platinum-based therapy before starting the study (no more than 12 weeks prior)
• not pregnant or breastfeeding
• see link to clinicaltrials.gov for complete inclusion criteria
Conditions: Cancer
Keywords: Fallopian Tube Cancer, Ovarian Cancer, Clinics and Surgery Center (CSC)
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HM2017-24 : Phase I/II Study of Nivolumab in Combination with Ruxolitinib in Relapsed or Refractory Classical Hodgkin Lymphoma: BTCRC-HEM-027

Participants who take part in this study will receive a study drug called ruxolitinib with a standard drug called nivolumab. The study is being done to measure the percentage of tumor (lymphoma) that shrinks after receiving ruxolitinib in combination with nivolumab. This study will also measure the length of time the lymphoma is inactive and how safe the combination is to administer to participants. Ruxolitinib is a pill that is taken twice every day. Nivolumab is given as an infusion in the clinic once every 4 weeks.

Principal Investigator: Veronika Bachanova, MD
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
IRB Number: STUDY00001341
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Inclusion Criteria:

• age 18 or older
• able to walk and do all selfcare but unable to carry out any work activities; up and about more than 50% of waking hours
• confirmed diagnosis of classical Hodgkin lymphoma that has reoccurred or not responded to treatment
• women and men who are of child bearing age must use required birth control
• there are additional criteria for prior treatment and laboratory results (study staff will review)
Exclusion Criteria:

• inability to swallow oral medication or any condition that affects absorption of oral medications
• women who are pregnant or breast feeding
• additional criteria about current medical history (study staff will review)
Conditions: Cancer
Keywords: Clinics and Surgery Center (CSC), Hodgkin Lymphoma
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Observational Study of Pediatric Rheumatic Diseases: The CARRA Registry

The primary objective for this observational study is to collect general and medical data from children, adolescents, and young adults who had pediatric onset rheumatic disease. This data will be used to evaluate the long-term safety and efficacy of therapeutic agents used to treat these diseases. This information will allow investigators to accurately report and follow changes in current medication use patterns and compare these to proposed standards and current treatment recommendations. The use of a single registry will allow for more analysis of the different therapeutic agents by allowing them to be compared to each other.

Principal Investigator: Colleen Correll
Age Group: Not specified
This study is NOT accepting healthy volunteers
IRB Number: 1506M74443
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Inclusion Criteria:

• diagnosed with rheumatic disease prior to age 16 years for juvenile idiopathic arthritis (JIA)
• onset prior to age 19 years for all other rheumatic diseases
• younger than 21 years
Conditions: Arthritis & Rheumatic Diseases, Cancer
Keywords: juvenile idiopathic arthritis (JIA), pediatric rheumatic disease
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MT2023-51 A Phase 2 Multicenter Study of Autologous Tumor Infiltrating Lymphocytes (LN-145) in Patients with Metastatic Non-Small-Cell Lung Cancer

This study is being done to learn more about the efficacy and safety of LN-145 in participants with metastatic stage IV non-small cell lung cancer.

Principal Investigator: Benjamin Manning
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
IRB Number: STUDY00022060
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Inclusion Criteria:

• confirmed diagnosis of metastatic Stage IV NSCLC without specific genomic alterations
• if the tumor has a treatable mutation(s) (other than EGFR, ALK, or ROS1 genomic alterations), 1 additional line of therapy with the appropriate targeted therapy is required
• may be restricted from strenuous activity but walking and able to carry out work of a light or sedentary nature, e.g., light house work, office work
• patients of childbearing potential or those with partners of childbearing potential must be willing to practice an approved method of highly effective birth control during treatment and up to 12 months after all protocol-related therapy
• see link to clinicaltrials.gov for complete Inclusion and Exclusion criteria
Exclusion Criteria:

• on systemic steroid therapy ≥ 10 mg/day of prednisone or equivalent
• have any form of primary immunodeficiency
• had another primary cancer within the previous 3 years
Conditions: Cancer
Keywords: Clinics and Surgery Center (CSC), Metastatic Non Small Cell Lung Cancer, NSCLC
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A Phase 1, First in Human, Dose-Escalation Study of TORL-1-23 in Participants with Advanced Cancer (TRIO049)

This first-in-human study will evaluate the safety, tolerability, pharmacokinetics, and antitumor activity of TORL-1-23 in patients with advanced cancer.

Principal Investigator: Boris Winterhoff
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
IRB Number: STUDY00014893
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Inclusion Criteria:

• advanced solid tumor
• restricted strenuous physical activity but can walk and able to carry light work e.g., light house work, office work
Exclusion Criteria:

• progressive or symptomatic brain metastases
• serious, uncontrolled medical disorder or active, uncontrolled infection
• history of significant hear disease
• history of another cancer within 3 years
• women who are pregnant or breast feeding
• contact study staff for additional exclusion criteria
Conditions: Cancer
Keywords: Clinics and Surgery Center (CSC), Advanced Solid Tumor, Endometrial Cancer, NSCLC, Ovarian Cancer
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An International, Phase 3, Randomized, Multicenter, Open label Study of Ripretinib vs Sunitinib in Patients with Advanced Gastrointestinal Stromal Tumor (GIST) with KIT Exon 11 and Co occurring KIT Exons 17 and/or 18 Mutations Who Were Previously Treated with Imatinib (INSIGHT) (INSIGHT)

This study is being done to learn how well ripretinib works against cancer as compared to sunitinib in patients with a specific GIST-gene mutation who have received imatinib. We will also learn more about the safety of ripretinib and look at how ripretinib may affect your body. The choice of whether you will be given ripretinib or sunitinib will be assigned by a computer, by chance, like the flip of a coin. You will have a 2 out of 3 chances of receiving ripretinib. You will know if you are receiving ripretinib or sunitinib.

Principal Investigator: Keith Skubitz, MD
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
IRB Number: SITE00001953
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Inclusion Criteria:

• diagnosis of GIST with co-occurring KIT exons 11+17/18 mutations confirmed by ctDNA sample
• disease progression on imatinib treatment, confirmed by scan
• ambulatory and capable of all selfcare but unable to carry out any work activities; up and about more than 50% of waking hours
• participants of reproductive potential must agree to follow contraception requirements
• contact study staff for additional inclusion criteria
Exclusion Criteria:

• known active central nervous system metastases
• heart disease, myocardial infarction within 6 months of starting the study, active ischemia or any other uncontrolled cardiac condition such as angina, significant cardiac arrhythmia requiring therapy, uncontrolled hypertension, or congestive heart failure
• Gastrointestinal abnormalities such as inability to take oral medication, malabsorption syndromes, requirement for intravenous alimentation
• additional exclusions apply malabsorption syndromes requirement for intravenous alimentation
Conditions: Rare Diseases, Cancer
Keywords: Clinics and Surgery Center (CSC), Advanced Gastrointestinal Stromal Tumor, GIST, Stomach Cancer
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A PHASE 2 STUDY OF ALISERTIB IN COMBINATION WITH ENDOCRINE THERAPY IN PATIENTS WITH HR+, HER2-NEGATIVE RECURRENT OR METASTATIC BREAST CANCER (ALISCA-Breast1)

The purpose of this study is to see if the study drug, called alisertib, in combination with an ‘endocrine therapy’ such as anastrozole, letrozole, exemestane, tamoxifen or fulvestrant can help people with HR+, HER2-negative recurrent or metastatic breast cancer. The study will also look at how well people tolerate treatment with alisertib in combination with one of the endocrine therapies that are commonly used in clinical practice.

Principal Investigator: Heather Beckwith
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
IRB Number: STUDY00023538
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Inclusion Criteria:

• diagnosis of adenocarcinoma of the breast that has reoccurred of spread to other areas of the body (metastatic)
• treatment with at least two prior lines of endocrine therapy in the recurrent or metastatic setting
• see link to clinicaltrials.gov for complete inclusion criteria
Exclusion Criteria:

• treatment with chemotherapy in the recurrent or metastatic setting
• see link to clinicaltrials.gov for complete exclusion criteria
Conditions: Cancer
Keywords: Clinics and Surgery Center (CSC), Breast Cancer, Hormone Receptor Positive HER-2 Negative Breast Cancer, Metastatic Breast Cancer
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A randomized, double-blind, placebo-controlled Phase 3 study of darolutamide plus androgen deprivation therapy (ADT) compared with placebo plus ADT in patients with high-risk biochemical recurrence (BCR) of prostate cancer (ARASTEP)

ADT is a systemic therapy called hormone therapy which reduces the androgen hormone (testosterone) levels to prevent prostate cancer cells from growing. This study is being done to learn more about a new drug called darolutamide given in combination with ADT for prostate cancer.

Principal Investigator: Emmanuel Antonarakis
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
IRB Number: SITE00001890
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Inclusion Criteria:

• diagnosis of adenocarcinoma of prostate
• treated with surgery and/or radiation therapy
• Serum testosterone 150 ng/dL or more
• see link to clinicaltrials.gov for complete inclusion and exclusion criteria
Exclusion Criteria:

• small cell, ductal or 50% or more component of neuroendocrine carcinoma of the prostate
• brain metastasis
• any other type of cancer (other than adequately treated basal cell or squamous cell skin cancer, superficial bladder cancer, or any other cancer in situ currently in complete remission) within 5 years
• study staff will review
Conditions: Cancer
Keywords: Prostate Cancer, Recurrent Prostate Cancer, Clinics and Surgery Center (CSC)
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The effects of cigarette smoking and alcohol on DNA damage in the oral cavity

The purpose of this study to examine the effects of cigarette smoking and drinking alcohol on the formation of DNA damage in the mouth. The overall goal is to identify DNA damage that may be important to the development of head and neck cancers.

Principal Investigator: Stephen Hecht, PhD
Age Group: 18 years and over
This study is also accepting healthy volunteers
IRB Number: STUDY00021212
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Inclusion Criteria:

• 21 years of age or older
• Smoke cigarettes daily
• Drink alcohol regularly
Exclusion Criteria:

• Use other tobacco/nicotine products
Conditions: Prevention & Wellness, Cancer
Keywords: alcohol, cigarettes, drinking, Smoking, tobacco
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NEPTUNE: The Nephrotic Syndrome Study Network - RDCRN Protocol 6801 (NEPTUNE)

Nephrotic syndrome is a condition which affects the kidneys causing them to leak protein from the blood into the urine. Nephrotic syndrome is a disease that can improve (remission) and worsen (relapse) at different times throughout childhood. By collecting health information and laboratory samples, our goal is to learn more about these kidney diseases and find better ways to prevent and treat people with nephrotic syndrome. New knowledge will be shared with researchers and the public.

Principal Investigator: Patrick Nachman
Age Group: Not specified
This study is NOT accepting healthy volunteers
IRB Number: SITE00000599
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Inclusion Criteria:

• Group A: up to 80 years of age with clinical diagnosis for FSGS/MCD or MN or pediatric participants who have protein in the urine and are scheduled for a kidney biopsy
• Group B: are less than 19 years old, have started immunosuppression drugs less than 30 days ago and have abnormal kidney lab values
Exclusion Criteria:

• prior solid organ transplant
• clinical diagnosis of glomerulopathy without diagnostic renal biopsy
• systemic lupus erythematosus (SLE)
• clinical evidence of other renal diseases
Conditions: Kidney, Prostate & Urinary
Keywords: Clinics and Surgery Center (CSC), Focal Segmental, Focal Segmental, Glomerulosclerosis, Glomerulosclerosis, Minimal Change Disease (MC
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MT2019-06: A Phase 3 Study Evaluating Gene Therapy by Transplantation of Autologous CD34+ Stem Cells Transduced Ex Vivo with the LentiGlobin BB305 Lentiviral Vector in Subjects with Sickle Cell Disease.

The purpose of this study is to evaluate the safety and ability of a transplant with your own gene modified stem cells (autologous stem cell transplant) to treat sickle cell disease. The goal is to determine if a sufficient amount of hemoglobin that prevents red blood sickling can be produced after the gene modified stem cells are returned to your body. This study may provide information on the potential usefulness of bb1111 for treatment of sickle cell disease

Principal Investigator: Ashish Gupta
Age Group: Not specified
This study is NOT accepting healthy volunteers
IRB Number: STUDY00006923
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Inclusion Criteria:

• must be 2 to 50 years old
• diagnosis of Sickle Cell Disease
• weigh a minimum of 6 kg (13.2 pounds)
• treated and followed for at least the past 24 months
• experienced at least 4 protocol-defined VOEs in the past 24 months
• experienced HU failure at any point in the past or must have intolerance to HU
• female and male subjects of childbearing potential agree to use 1 method of highly effective contraception from starting the study to at least 6 months after drug product infusion.
Exclusion Criteria:

• if allogeneic hematopoietic stem cell transplantation (allo-HSCT) is medically appropriate and a willing, human leukocyte antigen (HLA)-matched related hematopoietic stem cell donor is available
• unable to receive a transfusion
• prior allogeneic transplant or gene therapy
• prior or current malignancy or immunodeficiency disorder, except cured tumors such as squamous cell carcinoma of the skin
• women who are pregnant or breast feeding
• additional exclusion criteria (study staff will review)
Conditions: Blood Disorders
Keywords: SCD, Sickle Cell Disease
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Studies of Complex Auditory Perception

This study involves testing auditory and speech perception using behavioral and non-invasive physiological measures in humans.

Principal Investigator: Andrew Oxenham
Age Group: 18 years and over
This study is also accepting healthy volunteers
IRB Number: 1306S37081
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Inclusion Criteria:

• Native English speaker as all test materials are in English
Exclusion Criteria:

• Any neurological disorder diagnosis
Conditions: Ear, Nose & Throat
Keywords: Hearing, listening effort, speech understanding
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A Phase 3, Open-label, Multicenter, Randomized Study of Xaluritamig vs Cabazitaxel or Second Androgen Receptor-Directed Therapy in Subjects With Metastatic Castration- Resistant Prostate Cancer Previously Treated With Chemotherapy

This is a research study designed to test how well a new medication (xaluritamig) works compared to other treatments for people with metastatic castration-resistant prostate cancer. These patients have already been treated with a certain chemotherapy. Participants will be randomly assigned to one of two groups: xaluritamig or either cabazitaxel (existing cancer treatment) or another treatment chosen by the doctor. The goal of the study is to find out which treatment is more effective and safer for patients.

Principal Investigator: Nicholas Zorko
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
IRB Number: STUDY00023844
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Inclusion Criteria:

• diagnosis of adenocarcinoma of the prostate
• evidence of progressive disease
• completed requirements for previous treatment
• may not be able to do strenuous activity but able to walk and able to carry out work of a light or sedentary nature, e.g., light house work, office work
• see link to clinicaltrials.gov for complete inclusion criteria
Exclusion Criteria:

• history of central nervous system (CNS) metastasis
• significant side effects from previous treatment that haven't resolved
• see link to clinicaltrials.gov for complete exclusion criteria
Conditions: Cancer
Keywords: Clinics and Surgery Center (CSC), Metastatic Castration-resistant Prostate Cancer, Prostate
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A Randomized, Open-label, Phase 3 Study of Adjuvant Sacituzumab Govitecan and Pembrolizumab Versus Treatment of Physician s Choice in Patients With Triple Negative Breast Cancer Who Have Residual Invasive Disease After Surgery and Neoadjuvant Therapy (ASCENT-05)

The purpose of this study is to see if sacituzumab govitecan in combination with pembrolizumab can improve outcomes and delay the return of disease in participants with high-risk early Triple Negative Breast Cancer (TNBC) when compared to pembrolizumab alone or pembrolizumab in combination with capecitabine. Participants with low tumor expression of the estrogen and/or progesterone receptors (1 to 10%) will also be included in this study. The study treatment will be chosen by chance—like flipping a coin. There is a 1 out of 2 chances to receive Sacituzumab govitecan in combination with Pembrolizumab and 1 out of 2 chances to receive a study treatment of study doctor’s choice of either pembrolizumab alone or pembrolizumab in combination with capecitabine. Participants and their study doctor will know what study drug is being taken.

Principal Investigator: Anne Blaes, MD
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
IRB Number: STUDY00021239
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Inclusion Criteria:

• invasive triple negative breast cancer (TNBC) still remains in the breast or lymph nodes after therapy and surgery
• unable to do physically strenuous activity but able to walk and carry out work of a light or sedentary nature, e.g., light house work, office work
• see link to clinicaltrials.gov for complete inclusion and exclusion criteria
Exclusion Criteria:

• Stage IV (metastatic) breast cancer or previous cancer in the same or other breast
• evidence that the cancer has reoccurred after preoperative therapy and surgery
• presence of germline breast cancer gene (BRCA) mutations
Conditions: Cancer
Keywords: TNBC, Triple Negative Breast Cancer, Clinics and Surgery Center (CSC)
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COG AALL1732: A Phase 3 Randomized Trial of Inotuzumab Ozogamicin (IND#:133494, NSC#: 772518) for Newly Diagnosed High-Risk B-ALL; Risk-Adapted Post-Induction Therapy for High-Risk B-ALL, Mixed Phenotype Acute Leukemia, and Disseminated B-LLy

Principal Investigator: Peter Gordon
Age Group: Not specified
This study is NOT accepting healthy volunteers
IRB Number: SITE00000723
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Inclusion Criteria:

• patients must be > 365 days and < 25 years of age
• participant has newly diagnosed B-ALL or MPAL with ≥25% blasts on a bone marrow (BM) aspirate or newly diagnosed B-LLy
• see link to clinicaltrials.gov for complete inclusion criteria
Exclusion Criteria:

• patients with Down syndrome are not eligible
• patients with acute undifferentiated leukemia (AUL) are not eligible
• female patients who are pregnant, since fetal toxicities and teratogenic effects have been noted for several of the study drugs. A pregnancy test is required for female patients of childbearing potential
• lactating women who plan to breastfeed their infants while on study and for 2 months after the last dose of inotuzumab ozogamicin.
• see link to clinicaltrials.gov for complete exclusion criteria
Conditions: Cancer
Keywords: B Acute Lymphoblastic Leukemia, B Lymphoblastic Lymphoma, Leukemia, Testicular Leukemia
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Intraperitoneal FT536 in Recurrent Ovarian, Fallopian Tube, and Primary Peritoneal Cancer

FT536 is a type of cell product made up of “natural killer” or NK cells. NK cells are a type of immune blood cell that are known to attack cancer cells. FT536 is produced by growing cells that come from a healthy human donor. The primary purpose of this study is to identify a safe dose of FT536 cells when given alone (monotherapy).

Principal Investigator: Melissa Geller, MD
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
IRB Number: STUDY00021809
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Inclusion Criteria:

• epithelial ovarian cancer, fallopian tube, or primary peritoneal cancer that has recurred after treatment (no limit to the maximum number of prior treatments)
• must have received prior bevacizumab
• if there is a BRCA mutation, must have received a prior PARP inhibitor
• agree to the have an intraperitoneal catheter placed before the 1st dose of study drug
• see link to clinicaltrials.gov for complete inclusion & exclusion criteria
Exclusion Criteria:

• women who are pregnant, breastfeeding or planning to become pregnant in the next 6 months
• active autoimmune disease requiring systemic immunosuppressive therapy
• history of severe asthma and currently on chronic medications (more than inhalers)
• received enoblituzumab
• CNS disease such as stroke, epilepsy, CNS vasculitis, or neurodegenerative disease or needing medications for these conditions in the past 2 years
Conditions: Cancer, Women's Health
Keywords: Clinics and Surgery Center (CSC), Fallopian Tube Cancer, Gynecologic Cancer, Ovarian Cancer, Primary Peritoneal Cavity Cancer
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A Phase 2, Open-Label, Single-Arm, Cohort Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of Sparsentan Treatment in Pediatric Subjects with Selected Proteinuric Glomerular Diseases (EPPIK) (EPPIK)

Currently, there are no approved treatment options for pediatric subjects with proteinuric kidney conditions. The study will look at the safety, efficacy, and pharmacokinetic (PK) trial in children ≥1 to <18 years treated for up to 108 weeks with the drug sparsentan.

Principal Investigator: Michelle Rheault
Age Group: Up to 18 years old
This study is NOT accepting healthy volunteers
IRB Number: SITE00001245
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Inclusion Criteria:

• Child 1 to 18 years old
• Diagnosed by biopsy with specific types of glomerular disease & protein in the urine
• Blood pressure is within normal range for age
• Maintained on a stable dose of immunosuppressive medications
Exclusion Criteria:

• Weight less than 7.3 kg 16 pounds) at screening.
• Disease due to to viral infections, drug toxicities, or cancer.
• Kidney function is below the minimum required
Conditions: Children's Health, Kidney, Prostate & Urinary, Rare Diseases
Keywords: Alport Syndrome, Glomerulosclerosis, IgA Vasculitis, Immunoglobulin A Nephropathy
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ALTE22C1, Chronic Health Conditions in Down Syndrome-Associated Acute Leukemia: The Down Syndrome Phenotyping Acute Leukemia Study in Survivors (DS-PALS Survivors)

To determine the prevalence, type, and severity of chronic health conditions (CHC) in survivors of Down syndrome-associated acute leukemia (DS-AL), and to compare CHC with frequency-matched DS individuals that have no cancer history.

Principal Investigator: Karim Sadak
Age Group: Not specified
This study is NOT accepting healthy volunteers
IRB Number: STUDY00024697
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Inclusion Criteria:

• Age: Patients age >= 6 and < 40 years at the time of enrollment.
• A diagnosis of Down Syndrome is required; all patients must be DS-AL survivors and have been treated for ALL or AML.
• All cancer treatment must have been completed at least 36 calendar months prior to enrollment.
Exclusion Criteria:

• Patients with history of Hematopoietic Stem Cell Transplant (HSCT) are excluded.
• Patients with a history of cancer prior to their ALL or AML diagnosis are excluded. Patients that developed a subsequent malignant neoplasm following their ALL or AML diagnosis are also excluded.
• Patients whose parents or guardians are unable to complete the required forms are excluded.
Conditions: Blood Disorders, Cancer
Keywords: ALL, AML, Clinics and Surgery Center (CSC), Down Syndrome, DS-AL survivors, leukemia
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