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641 Study Matches
International REgistry of COnservative or Radical Treatment of Localized Kidney Tumors (i-RECORd)
Marco Carini, Prof. - carini@unifi.it
NCT05363657
Inclusion Criteria:
• Radiological diagnosis of renal tumor susceptible to active treatment or AS/WW.
• Age ?18 years
• Informed consent signed
Exclusion Criteria:
• Patient refuse to participate in clinical research.
• Urothelial renal carcinoma.
Procedure: Partial Nephrectomy (PN), Procedure: Radical Nephrectomy (RN), Procedure: Ablation therapy (AT), Diagnostic Test: Active Surveillance (AS)
Kidney Cancer
Kidney cancer, Partial Nephrectomy, Radical Nephrectomy, Ablation Techniques, Active Surveillance, Recurrence Free Survival, Watchful Waiting
Single-Session Intervention - Neurocognitive Functioning of Children/Adolescents - Neurofibromatosis (OPTIMAL-SSI)
Jewell, Andrea - Andrea.Jewell@vcuhealth.org
Rohan, Jennifer
NCT05377008
HM20024159
Inclusion Criteria:
• Patients are eligible if they are English-speaking children and adolescents between the ages of 6 to 16 years diagnosed with NF who are currently followed by the Pediatric NF Clinic at VCU. Patients are eligible if they currently have a diagnosis of ADHD or do not have a diagnosis of ADHD.
• At least one parent/caregiver must be actively involved in the patient's care and able to complete study-related questionnaires at baseline, 3-, and 6-months; and the exit interview at 7-months. Parents are eligible if they if they are English-speaking adults 18+ years old and self-identify as the parent or guardian of the patient.
Exclusion Criteria:
• Presence of serious, chronic comorbid condition (asthma and ADHD are not exclusionary criteria), presence of serious cognitive/learning impairment (e.g., down syndrome, moderate to severe intellectual disability or developmental disability), temporary foster care or residential care placement with no known plans to remain with foster parent for at least one year, presence of serious ongoing psychiatric disorder that prevents patient or family member from accurately completing questionnaires, and/or family anticipates moving in the next 12 months.
• No subject will be excluded on the basis of gender or ethnicity.
Behavioral: OPTIMAL-SSI
Neurocognitive Deficit, Mental Health Impairment, Neurofibromatosis 1, Neoplasms
Neurofibromatosis, Neurocognitive, Intervention
Microeconomic Intervention to Reduce HIV Transmission in Economically Disadvantaged Transgender Women
Eric Benotsch, PhD - ebenotsch@vcu.edu
Benotsch, Eric, G
NCT04275310
HM20011245
Inclusion Criteria:
• Transgender woman
• 18-45 years of age At least one of the following economic vulnerability factors: unemployment or underemployment [less than 20 hours/week], low income [less than the Medicaid poverty threshold], housing insecurity in the past year or food insecurity in the past year • Behavioral vulnerability to HIV transmission (reported at least one episode of unprotected sex in prior 6 months or at least one other behavioral HIV transmission risk factor in the past 6 months: [transactional sex, multiple sexual partners, 1-time sexual partner, sex under the influence of drugs or alcohol, sex with partner of unknown HIV status).
Exclusion Criteria:
• obvious signs of intoxication or cognitive impairment
• cannot speak English.
Behavioral: Microeconomic Intervention
Hiv, Transgenderism
Study to Evaluate Symptoms of Exocrine Pancreatic Insufficiency in Adult Participants With Cystic Fibrosis or Chronic Pancreatitis Treated With Creon
ABBVIE CALL CENTER - abbvieclinicaltrials@abbvie.com
Chaudary, Nauman
NCT05069597
HM20025086
Inclusion Criteria:
• Previous diagnosis of cystic fibrosis (CF) or chronic pancreatitis (CP).
• Previous diagnosis of exocrine pancreatic insufficiency (EPI) that is currently clinically controlled.
• Total Symptom Score (TSS) < 1.8 on Pancreatic Exocrine Insufficiency Questionnaire (PEI-Q) at Screening.
Exclusion Criteria:
• Malignancy involving the digestive tract in the last 5 years, or other significant disease or medical condition that may interfere with EPI symptom assessment.
Drug: CREON
Cystic Fibrosis, Chronic Pancreatitis
Cystic Fibrosis, Chronic Pancreatitis, Exocrine Pancreatic Insufficiency, Creon, Pancrelipase
Study to Continue Treatment With Darolutamide in Patients Who Have Been Participating in Previous Darolutamide Studies Supported by Bayer
Bayer Clinical Trials Contact - clinical-trials-contact@bayer.com
Paul, Asit, K.
NCT04464226
HM20024689
Inclusion Criteria:
* Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol.
* Participants enrolled in any Bayer-sponsored darolutamide feeder study at the time of study closure or primary completion, who are currently receiving darolutamide and are experiencing clinical benefit from treatment.
* Participants who have not met any treatment discontinuation criteria in the feeder study protocol.
* Willingness to continue practicing acceptable methods of birth control during the study.
Exclusion Criteria:
* Participant is unable to comply with the requirements of the study.
* Negative benefit/ risk ratio as determined by the investigator.
* Meet any criteria for treatment discontinuation of the feeder study the participant is coming from. DRUG: Darolutamide (Nubeqa, BAY1841788)
Cancer
Roll-Over Study
Autologous LN-145 in Patients With Metastatic Non-Small-Cell Lung Cancer
Iovance Biotherapeutics Study Team lungcelltherapy.com - Clinical.Inquiries@iovance.com
Poklepovic, Andrew, S
NCT04614103
HM20023194
Inclusion Criteria:
* Patients who are over 70 years of age may be allowed to enroll after discussion with the Medical Monitor.
* Have historically or pathologically confirmed diagnosis of metastatic Stage IV NSCLC without EGFR, ALK, or ROS1 genomic alterations.
* For patients who have actionable mutations (other than EGFR, ALK, or ROS1 genomic alterations), 1 additional line of therapy with the appropriate health authority approved targeted therapy is required.
* Patients must have documented radiographic disease progression on or after the first-line therapy, including concurrent or sequential ICI and platinum-based chemotherapy ± bevacizumab. No more than 1 prior line is allowed if ICI and platinum-based chemotherapy were administered concurrently and no more than 2 prior lines are allowed for sequential administration of platinum-based chemotherapy and ICI as 2 separate lines.
* LN-145 manufacture is allowed for patients who have residual resectable disease after completion of the platinum-based chemotherapy component of the front-line ICI and platinum-based chemotherapy combination and meet all eligibility criteria except documented disease progression. These patients must intend to receive TIL therapy after disease progression
* Prior systemic therapy in the adjuvant or neoadjuvant setting, or as part of definitive chemoradiotherapy, will count as a line of therapy if the patient had disease progression during or within 12 months after the completion of such therapy.
* At least 1 resectable lesion for TIL production and at least one remaining measurable lesion, as defined by RECIST v1.1
* Have adequate organ function
* LVEF \> 45%, NYHA Class 1
* Have adequate pulmonary function
* ECOG performance status of 0 or 1
* 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
Exclusion Criteria:
* Patients who have EGFR, ALK or ROS1 driver mutations
* Patients who have symptomatic, untreated brain metastases.
* Patients who have had allogeneic organ transplant or prior cell therapy within the past 20 years
* Patients who have any form of primary immunodeficiency
* Patients who are on systemic steroid therapy ≥ 10 mg/day of prednisone or equivalent.
* Patients who have received a live or attenuated vaccination within 28 days prior to the start of treatment
* Patients who have had another primary malignancy within the previous 3 years
* Participation in another interventional clinical study within 21 days BIOLOGICAL: LN-145, BIOLOGICAL: LN-145
Metastatic Non Small Cell Lung Cancer
LN-145, Cell Therapy, Autologous Adoptive Cell Therapy, Cellular Immuno-therapy, Tumor Infiltrating Lymphocytes, TIL, IL-2, Non Small Cell Lung Cancer, NSCLC, Second line Lung Cancer, Bronchial Neoplasms, Carcinoma, Lung Disease, Metastatic Lung Cancer, Metastatic Non Small Cell Lung Cancer, Metastatic NSCLC, Lung Carcinoma, PD-L1, Stage IV Lung Cancer, Stage IV Non-Small Cell Lung Cancer, Stage IV NSCLC, Systemic Therapy, 2nd line therapy, Second line therapy, CPI, Immune checkpoint inhibitor (ICI), NSCLC Recurrent, Recurrent Lung Cancer, Recurrent Lung Carcinoma
Randomized Double Blinded Placebo-Controlled w/Semaglutide to Prevent Weight Gain After Liver Transplant
Sherry Boyett, RN - sherry.boyett@vcuhealth.org
NCT05424003
Inclusion Criteria:
* Male or female age 18-75 years who received LT for any indication (i.e. NASH, hepatitis C, alcohol-induced cirrhosis, autoimmune hepatitis, etc.)
* Liver transplant surgery within 8-24 weeks prior to randomization
* Fasting glucose \> 125 mg/dL or presence of diabetes (HbA1c≥6.5% or use of diabetes medications) or pre-diabetes (HbA1c \>5.7%)
* Ability to provide informed consent
* Discharged from the hospital following LT surgery
* Tolerating diet
* Normal graft function\* (determined by treating hepatologist/surgeon based on clinical status and hepatic panel)
* Stable immunosuppression according the VCU (Virginia Commonwealth University) post-LT protocols \*\* (i.e. calcineurin inhibitors + mycophenolate)
* Eligible female patients will be (1) non-pregnant, evidenced by a negative urine pregnancy test, (2) non-lactating, (3)surgically sterile or post-menopausal, or they will agree to continue to use an accepted method of birth control during the study
Exclusion Criteria:
* BMI≤ 27kg/m2
* GFR (Glomerular Filtration Rate) ≤ 25 ml/min/1.73m2
* Type 1 autoimmune diabetes (by anti-GAD (glutamic acid decarboxylase) or history of ketoacidosis)
* History of gastroparesis
* Familial or personal history of medullary thyroid cancer or MEN (Multiple Endocrine Neoplasia) 2
* History of pancreatitis
* History of active malignancy post- LT with the exception of non-melanoma skin cancers
* History of uncontrolled or unstable diabetic retinopathy or maculopathy
* Acute cellular rejection
* Hepatic artery thrombosis
* Medical non-compliance
* Active treatment with GLP (glucagon-like peptide)-1RA (receptor agonist) or SGLT (sodium-glucose cotransporter)-2 inhibitors at time of screening
* History of hypersensitivity to semaglutide or its excipients
* Women who are nursing, pregnant, or planning to become pregnant during the study, or are not using adequate contraceptive measures DRUG: Semaglutide Pen Injector, DRUG: Placebo
NAFLD
Liver Transplant
Transspinal Stimulation With and Without Blood Flow Restricted Exercise Via Telehealth in Persons With Tetraplegia (SCIMS Main)
Ashraf Gorgey, MPT, PhD, FACSM, FACRM - Ashraf.Gorgey@va.gov
NCT05423600
Inclusion Criteria:
• A written clearance from the study medical doctor to ensure that the participant is safely able to engage in the study.
• Participants must have a companion that will be able to help him/her throughout the study.
• Greater than 1-year post SCI, neurologic level of C8 or above.
• American Spinal Injury Association Impairment Scale (AIS) scores of B, C, or D indicating presence of an incomplete SCI.
• Visible muscle contraction response to NMES wrist extensors, bilaterally.
• Agreement to use telehealth services for delivery of research exercise training by study staff. Possesses appropriate technology to engage in telehealth including a personal web camera, computer, microphone, speakers, and high-speed broadband internet connection, valid email address (needed to obtain VA issued video conferencing software), and telephone number used to obtain login credentials for the In-Home Video Software - Cisco Jabber Video for Telepresence Software.
• Response of muscle contraction of wrist extensors bilaterally to neuromuscular electrical stimulation.
Exclusion Criteria:
• Unhealed fracture in upper or lower extremities.
• Severe scoliosis, severe upper extremity contractures, or other musculoskeletal issues that would impede participation in a BES + TS intervention or valid evaluation of outcome measures.
• High resting blood pressure greater than 140/80 mmHg.
• Taking anti-coagulants or anti-platelet agents, including aspirin if unable to be off this medication for medical reasons.
• Pregnancy (female participants). A home pregnancy test will be conducted to role out any pregnancy before the study at the McGuire VAMC. The test will be repeated every month during the course of the study.
• Implanted pacemakers and/or implanted defibrillator devices.
• Other exclusion criteria may include the presence of implanted electrical device, cancer, thrombosis, pacemaker, defibrillator, or seizures. Patients who are currently on or receive anti-platelet or anticoagulant medications will be excluded from the trial.
• Any condition that, in the judgment of the principal investigator or medical provider, precludes safe participation in the study.
• Other exclusion criteria at the discretion of the medical team may include:
• Uncontrolled autonomic dysreflexia (AD), refers to episodes of AD that do not respond to medications to ensure stable blood pressure in persons with SCI
• Concurrent severe neurological injuries other than SCI: MS, CP, severe TBI, and stroke.
• Unresolved deep vein thrombosis.
• Psychiatric or cognitive impairments that preclude adherence to the intervention.
• Known cardiac pathology that precludes safe participation.
• Metabolic conditions such as cardiovascular disease, uncontrolled type II diabetes mellitus, uncontrolled hypertension, and those on insulin.
• Presence of pressure sores stage three or greater.
• Presence of a symptomatic urinary tract infection.
• Severe spasticity as assessed by the Modified Ashworth Scale.
• Changing neurologic status due to conditions such as progressive posttraumatic syringomyelia.
PROCEDURE: BES + TS, PROCEDURE: Experimental: BES+sham TS
Tetraplegia/Tetraparesis
Spinal Cord Injury
Children's Bipolar Network Treatment Trial I (CBN)
David J Miklowitz, PhD - dmiklowitz@mednet.ucla.edu
NCT05427123
Inclusion Criteria:
* Youth 9-19 years old
* Youth diagnosed with Bipolar disorder (I, II, Other Specified) or Cyclothymic Disorder by the study team during the diagnostic interview screening
* Youth is able to read and communicate in English to the degree necessary to be able to assent and participate (with help) in their treatment and assessments appropriate for ages 9 and up
* Youth has a caregiver able to participate in ongoing basis in assessment and treatment
* The participating caregiver can reliably read and communicate in English for purposes of study consenting, assessment, and treatment, unless preferred language translation services are regularly available.
Exclusion Criteria:
* Youth has DSM-5 diagnosis of autism spectrum disorder
* Youth has DSM-5 diagnosis of substance or alcohol abuse with impairment within 3 mos.
* Youth has a medical or psychiatric disorder that is life-threatening or requires immediate hospitalization or emergency medical or therapeutic treatment
* Evidence of recent sexual or physical abuse of the youth by legally responsible caregivers
* Evidence of recent intimate partner violence between caregivers responsible for the youth's care OTHER: Medication or psychosocial treatment
Bipolar Disorder, Bipolar I Disorder, Bipolar II Disorder, Other Specified Bipolar and Related Disorder, Mood Instability, Child Mental Disorder, Adolescent - Emotional Problem
medication, psychosocial, treatment, longitudinal, naturalistic, assessment
GiST (GiST)
Vences, Karina - venceskm@vcu.edu
Goldman, Myla
NOT REQUIRED
HM20022775
Diseases of Nervous System and Sense Organs (320-389)
Uptake of NCI Research Tested Intervention Program to Increase CRC Screening in Rural Setting
Preston, Michael - prestonm2@vcu.edu
Preston, Michael
16928
HM20019703
Rectum, Colon
Community Outreach and Engagement Key Informant Interviews
Cummings, Yvonne - yvonne.cummings@vcuhealth.org
Sheppard, Vanessa, B.
15900
HM20018062
A Cognitive Task Analysis of Pediatric Hematology/Oncology Faculty
DiazGranados, Deborah - diazgranados@vcu.edu
Helou, Marieka, Ann
15801
HM20017417
CASTOR-2: Identifying Subclinical Cardiotoxicity Following RT for Locally Advanced Lung Cancer (CASTOR-2)
Kontos, Emily - kontosej@vcu.edu
Thomas, Georgia
15564
HM20017432
Lung
Killer Immunoglobulin-Like Receptor Interactions to Optimize Natural Killer Cell Function in SCT
Roberts, Catherine, H. - croberts2@vcu.edu
Toor, Amir, A
15122
HM20016672
Other Hematopoietic
Biomarkers of Malignant and Non-Malignant Pleural Effusion
Narron, Kyle, A - Kyle.Narron@vcuhealth.org
Shojaee, Samira
15081
HM20012669
Any Site
Acceptability and Efficacy of Enterade in Children at Risk for Environmental Enteric Dysfunction
Minter, Sabrina - sabrina.minter@vcuhealth.org
Donowitz, Jeffrey
NCT05291559
HM20023567
Infectious and Parasitic Diseases (001-139)
HEALEY ALS Platform Trial - REGIMEN E
Smith, LaVon - lavon.smith@vcuhealth.org
Gwathmey, Kelly
NCT05136885
HM20022250E
drug: Trehalose
Diseases of Nervous System and Sense Organs (320-389)
OL Clinical Efficacy of Different Dosing Regimens of Efgartigimod IV Generalized MG (ADAPT NXT) (ADAPT NXT)
Wilkins, Bridget - bridget.wilkins@vcuhealth.org
Gwathmey, Kelly
NCT04980495
HM20023221
drug: Argx-113
Diseases of Nervous System and Sense Organs (320-389)
ASCEND - Post-Market Follow-Up - Patients Treated with On-X Ascending Aortic Prosthesis
Han, Jinfeng - jinfeng.han@vcuhealth.org
Quader, Mohammed
NCT05082454
HM20023997
Modality: No vcuhs billing
Diseases of Circulatory System (390-459)
A Study of Efruxifermin in Subjects With Compensated Cirrhosis Due to NASH (Symmetry)
Lester Scholtes, Rebecca - Rebecca.Lester@vcuhealth.org
Asgharpour, Amon
NCT05039450
HM20023488
drug: Efruxifermin
Diseases of Digestive System (520-579)
Study of Pembrolizumab (MK-3475) Versus Chemotherapy in Mismatch Repair Deficient (dMMR) Advanced or Recurrent Endometrial Carcinoma (MK-3475-C93/KEYNOTE-C93/GOG-3064/ENGOT-en15) (MK3475-C93)
Toll Free Number - Trialsites@merck.com
Miller, Devin, T
NCT05173987
HM20023914
The main inclusion and exclusion criteria include but are not limited to the following:
• Has a histologically confirmed diagnosis of inoperable, Stage III or IV or recurrent Endometrial Carcinoma (EC) or carcinosarcoma (mixed Mullerian tumor) that is centrally confirmed as dMMR
• Has received no prior systemic therapy for EC except for the following:
• May have received prior radiation with or without radiosensitizing chemotherapy if >2 weeks before the start of study intervention. Participants must have recovered from all radiation-related toxicities, not require corticosteroids, and not have had radiation pneumonitis. A 1-week washout is permitted for palliative radiation (≤2 weeks of radiotherapy) to non-central nervous system (CNS) disease
• May have received prior hormonal therapy for treatment of EC, provided that it was discontinued ≥1 week prior to randomization
• Has Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 within 7 days before randomization.
• Is not pregnant or breastfeeding and agrees to not donate eggs and use a highly effective contraceptive method for 120 days after the last dose of pembrolizumab or 180 days after the last dose of chemotherapy if a woman of childbearing potential (WOCBP)
• Has a negative highly sensitive pregnancy test (urine or serum) within 24 hours for urine or 72 hours for serum before the first dose of study intervention if a WOCBP
• Provides an archival tumor tissue sample or newly obtained (core, incisional, or excisional) biopsy of a tumor lesion not previously irradiated for verification of dMMR status and histology
• Is Hepatitis B surface antigen (HBsAg) positive but has received Hepatitis B virus (HBV) antiviral therapy for at least 4 weeks and has undetectable HBV viral load prior to randomization
• Has a history of Hepatitis C virus (HCV) infection but has undetectable HCV viral load at screening.
• Has uterine mesenchymal tumor such as an endometrial stromal sarcoma, leiomyosarcoma, or other types of pure sarcomas. Adenosarcomas and neuroendocrine tumors are not allowed
• Has EC of any histology that is proficient mismatch repair (pMMR)
• Is a candidate for curative-intent surgery or curative-intent radiotherapy
• Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent or with an agent directed to another stimulatory or coinhibitory T-cell receptor (e.g. cytotoxic T-lymphocyte-associated protein 4 [CTLA-4], Tumor necrosis factor receptor superfamily, member 4 [OX 40], tumor necrosis factor receptor superfamily member 9 [CD137])
• Has received prior systemic anticancer therapy including investigational agents for EC. This includes any chemotherapy given for EC other than as a radiosensitizer
• Has had a major operation and has not recovered adequately from the procedure and/or any complications from the operation before starting study intervention
• Has received a live or live-attenuated vaccine within 30 days before the first dose of study intervention. Administration of killed vaccines are allowed
• Is currently participating in or has participated in a study of an investigational agent for EC, has participated in a study of an investigational agent for non-EC within 4 weeks before the first dose of study intervention, or has used an investigational device within 4 weeks before the first dose of study intervention
• Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of study intervention
• Has a known additional malignancy that is progressing or has required active treatment within the past 3 years with the exception of basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or carcinoma in situ (excluding carcinoma in situ of the bladder) that have undergone potentially curative therapy are not excluded
• Has known active CNS metastases and/or carcinomatous meningitis
• Has a known intolerance to any study intervention and/or any of its excipients
• Has an active autoimmune disease that has required systemic treatment in past 2 years
• Has a history of (noninfectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease
• Has an active infection, requiring systemic therapy
• Has a known history of human immunodeficiency virus (HIV) infection
• Has had an allogenic tissue/solid organ transplant
Inclusion Criteria:
• Has a histologically confirmed diagnosis of inoperable, Stage III or IV or recurrent Endometrial Carcinoma (EC) or carcinosarcoma (mixed Mullerian tumor) that is centrally confirmed as dMMR
• Has received no prior systemic therapy for EC except for the following:
• May have received prior radiation with or without radiosensitizing chemotherapy if >2 weeks before the start of study intervention. Participants must have recovered from all radiation-related toxicities, not require corticosteroids, and not have had radiation pneumonitis. A 1-week washout is permitted for palliative radiation (≤2 weeks of radiotherapy) to non-central nervous system (CNS) disease
• May have received prior hormonal therapy for treatment of EC, provided that it was discontinued ≥1 week prior to randomization
• Has Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 within 7 days before randomization.
• Is not pregnant or breastfeeding and agrees to not donate eggs and use a highly effective contraceptive method for 120 days after the last dose of pembrolizumab or 180 days after the last dose of chemotherapy if a woman of childbearing potential (WOCBP)
• Has a negative highly sensitive pregnancy test (urine or serum) within 24 hours for urine or 72 hours for serum before the first dose of study intervention if a WOCBP
• Provides an archival tumor tissue sample or newly obtained (core, incisional, or excisional) biopsy of a tumor lesion not previously irradiated for verification of dMMR status and histology
• Is Hepatitis B surface antigen (HBsAg) positive but has received Hepatitis B virus (HBV) antiviral therapy for at least 4 weeks and has undetectable HBV viral load prior to randomization
• Has a history of Hepatitis C virus (HCV) infection but has undetectable HCV viral load at screening.
Exclusion Criteria:
• Has uterine mesenchymal tumor such as an endometrial stromal sarcoma, leiomyosarcoma, or other types of pure sarcomas. Adenosarcomas and neuroendocrine tumors are not allowed
• Has EC of any histology that is proficient mismatch repair (pMMR)
• Is a candidate for curative-intent surgery or curative-intent radiotherapy
• Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent or with an agent directed to another stimulatory or coinhibitory T-cell receptor (e.g. cytotoxic T-lymphocyte-associated protein 4 [CTLA-4], Tumor necrosis factor receptor superfamily, member 4 [OX 40], tumor necrosis factor receptor superfamily member 9 [CD137])
• Has received prior systemic anticancer therapy including investigational agents for EC. This includes any chemotherapy given for EC other than as a radiosensitizer
• Has had a major operation and has not recovered adequately from the procedure and/or any complications from the operation before starting study intervention
• Has received a live or live-attenuated vaccine within 30 days before the first dose of study intervention. Administration of killed vaccines are allowed
• Is currently participating in or has participated in a study of an investigational agent for EC, has participated in a study of an investigational agent for non-EC within 4 weeks before the first dose of study intervention, or has used an investigational device within 4 weeks before the first dose of study intervention
• Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of study intervention
• Has a known additional malignancy that is progressing or has required active treatment within the past 3 years with the exception of basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or carcinoma in situ (excluding carcinoma in situ of the bladder) that have undergone potentially curative therapy are not excluded
• Has known active CNS metastases and/or carcinomatous meningitis
• Has a known intolerance to any study intervention and/or any of its excipients
• Has an active autoimmune disease that has required systemic treatment in past 2 years
• Has a history of (noninfectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease
• Has an active infection, requiring systemic therapy
• Has a known history of human immunodeficiency virus (HIV) infection
• Has had an allogenic tissue/solid organ transplant
Biological: pembrolizumab, Drug: carboplatin, Drug: paclitaxel, Drug: docetaxel, Drug: cisplatin
Endometrial Neoplasms
Programmed Cell Death-1 (PD1, PD-1), Programmed Cell Death 1 Ligand 1 (PDL1, PD-L1), Programmed Cell Death 1 Ligand 2 (PDL2, PD-L2)
Study to Evaluate Viralym-M (ALVR105) for the Treatment of Virus-Associated Hemorrhagic Cystitis (HC)
Kyle Herbert - ClinicalTrials@allovir.com
McCarty, John, M.
NCT04390113
HM20023279
Key Inclusion Criteria
Participants must meet all of the following criteria in order to be eligible to participate
in the study:
• Male or female ≥1 year of age.
• Had an allogeneic hematopoietic cell transplant (HCT) performed ≥21 days and ≤1 year prior to randomization.
• Myeloid engraftment confirmed, defined as an absolute neutrophil count ≥500/mm³ for 3 consecutive laboratory values obtained on different days, and platelet count >10,000/mm³ at the time of randomization.
• Diagnosed with HC based on the following criteria (all 3 criteria must be met):
• Clinical signs and/or symptoms of cystitis.
• Grade ≥3 hematuria, defined as macroscopic hematuria with visible clots.
• Viruria with ≥1 target virus (ie, BKV, JCV, AdV, CMV, EBV, and/or HHV-6).
• At least 1 identified, suitably matched posoleucel (ALVR105) cell line for infusion is available. Key Exclusion Criteria Participants who meet any of the following criteria will be excluded from participation in the study:
• Ongoing therapy with high-dose systemic corticosteroids (ie, prednisone dose >0.5 mg/kg/day or equivalent).
• Therapy with antithymocyte globulin, alemtuzumab (Campath-1H), or other immunosuppressive T cell-targeted monoclonal antibodies ≤28 days before randomization.
• Evidence of active Grade >2 acute graft versus host disease (GVHD).
• Uncontrolled or progressive bacterial or fungal infections.
• Uncontrolled or progressive viral infections not targeted by posoleucel (ALVR105).
• Uncontrolled or progressive EBV-associated post-transplant lymphoproliferative disorder.
• Known or presumed pneumonia secondary to any organism that is not considered to be well-controlled by antimicrobial therapy.
• Pregnant or lactating or planning to become pregnant. Note: Other protocol defined Inclusion/Exclusion criteria may apply.
• Male or female ≥1 year of age.
• Had an allogeneic hematopoietic cell transplant (HCT) performed ≥21 days and ≤1 year prior to randomization.
• Myeloid engraftment confirmed, defined as an absolute neutrophil count ≥500/mm³ for 3 consecutive laboratory values obtained on different days, and platelet count >10,000/mm³ at the time of randomization.
• Diagnosed with HC based on the following criteria (all 3 criteria must be met):
• Clinical signs and/or symptoms of cystitis.
• Grade ≥3 hematuria, defined as macroscopic hematuria with visible clots.
• Viruria with ≥1 target virus (ie, BKV, JCV, AdV, CMV, EBV, and/or HHV-6).
• At least 1 identified, suitably matched posoleucel (ALVR105) cell line for infusion is available. Key Exclusion Criteria Participants who meet any of the following criteria will be excluded from participation in the study:
• Ongoing therapy with high-dose systemic corticosteroids (ie, prednisone dose >0.5 mg/kg/day or equivalent).
• Therapy with antithymocyte globulin, alemtuzumab (Campath-1H), or other immunosuppressive T cell-targeted monoclonal antibodies ≤28 days before randomization.
• Evidence of active Grade >2 acute graft versus host disease (GVHD).
• Uncontrolled or progressive bacterial or fungal infections.
• Uncontrolled or progressive viral infections not targeted by posoleucel (ALVR105).
• Uncontrolled or progressive EBV-associated post-transplant lymphoproliferative disorder.
• Known or presumed pneumonia secondary to any organism that is not considered to be well-controlled by antimicrobial therapy.
• Pregnant or lactating or planning to become pregnant. Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Biological: Posoleucel (ALVR105), Biological: Placebo
BK Virus Infection, Hemorrhagic Cystitis
Allogeneic Hematopoietic Cell Transplant, ALVR105, Posoleucel
A Study of XL092 as Single-Agent and Combination Therapy in Subjects With Solid Tumors (STELLAR-001
Gwaltney, Lindsey - lbgwaltney@vcu.edu
Poklepovic, Andrew, S
NCT03845166
HM20023654
drug: Avelumab,
drug: Atezolizumab
Colon, Breast, Prostate, Rectum, Other Male Genital, Urinary Bladder, Other Urinary, Kidney
A Study of ZN-c3 in Combination With Gemcitabine in Subjects With Osteosarcoma
Stevens, Sarah - sstevens23@vcu.edu
Poklepovic, Andrew, S
NCT04833582
HM20023239
drug: Zn-c3,
drug: Gemcitabine
Bones and Joints
Unpacking Multilevel Drivers of Cardiotoxicity Disparities in Breast Cancer Survivors
Sutton, Arnethea - abrahamal@vcu.edu
Sheppard, Vanessa, B.
16953
HM20019941
Breast
Cognitive Support Technology for Postsecondary Students with Traumatic Brain Injuries
Getzel, Elizabeth, E - lgetzel@vcu.edu
Getzel, Elizabeth, E
17135
HM20019040
External Causes of Injury and Poisoning (800-999)
Prognostic Gene Expression Profiling and Adjuv Therapy in Stage IIB-C & IIIA-B Cutaneous Melanoma
Gnanasigamani Manogaram, Merlin Margaret - gnanasigamam@vcu.edu
Poklepovic, Andrew, S
17390
HM20021149
Melanoma, skin
Feasibility, Acceptability, and Preliminary Effectiveness of the ICAN QUIT Tobacco Program at VCUH
Hunley, Rachel - rachel.hunley@vcuhealth.org
Hayes, Rashelle
17440
HM20020118
Any Site
Assessing Electronic Cigarette Nicotine Flux (Project 2 Flux Study)
ctrrecruit@vcu.edu
Breland, Alison
19170
HM20018580
Any Site