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11 Study Matches

Neoadjuvant therapy for patients with high risk stage III melanoma: a pilot clinical trial (NeoACTIVATE)

To estimate the percentage of patients with stage III BRAFm melanoma that achieves a pathologic complete response after 12 weeks of neoadjuvant vemurafenib/cobimetinib/atezolizumab. To estimate the percentage of patients with stage III BRAFwt melanoma that achieves a pathologic complete response after 12 weeks of neoadjuvant cobimetinib/atezolizumab. Adjuvant phase primary objectives: To assess recurrence-free survival (RFS) in patients with stage III BRAFm melanoma after neoadjuvant vemurafenib/cobimetinib/atezolizumab, surgery, and adjuvant atezolizumab. To assess RFS in patients with stage III BRAFwt melanoma after neoadjuvant cobimetinib/atezolizumab, surgery, and adjuvant atezolizumab.

Evidio Domingo Musibay
All
18 Years and over
Phase 2
This study is NOT accepting healthy volunteers
NCT03554083
STUDY00004666
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Inclusion Criteria:

• PRE-REGISTRATION: High-risk stage III melanoma, defined as (any of the following):
• Recurrent nodal metastasis, or
• Clinically detectable nodal metastasis, or
• Metastatic involvement of more than one nodal basin
• NOTE: For the purpose of pre-registration, high-risk stage III melanoma is defined based on clinical and imaging assessment (positron emission tomography/computed tomography [PET/CT], CT, or magnetic resonance imaging [MRI]). Histologic confirmation of nodal metastatic disease is not needed at the time of pre-registration, provided there is histologic confirmation of primary melanoma or a prior lymph node metastasis.
• PRE-REGISTRATION: Willing to submit archival tissue from a lymph node biopsy or undergo a needle biopsy (with clip placement) for BRAF testing and for research purposes.
• PRE-REGISTRATION: Willing to forego anticancer treatments or investigational agents during pre-registration period.
• PRE-REGISTRATION: The following laboratory values obtained =< 28 days prior to pre-registration:
• Only for patients receiving therapeutic anticoagulation: stable anticoagulant regimen and stable international normalized ratio (INR).
• REGISTRATION: Histologic confirmation of stage III melanoma, as defined by the American Joint Committee on Cancer, 8th revised edition.
• REGISTRATION: Documentation of BRAFV600 mutation status in melanoma tumor tissue (archival or newly obtained) through use of a Clinical Laboratory Improvement Amendments (CLIA)-approved clinical mutation test.
• REGISTRATION: Surgically resectable disease, as determined by a melanoma surgical oncologist.
• REGISTRATION: Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
• REGISTRATION: Life expectancy >= 26 weeks.
• REGISTRATION: Absolute neutrophil count (ANC) >= 1500/mm^3 obtained =< 14 days prior to registration.
• REGISTRATION: Platelet count >= 100,000/mm^3 obtained =< 14 days prior to registration.
• REGISTRATION: Hemoglobin >= 9.0 g/dL obtained =< 14 days prior to registration.
• REGISTRATION: Direct bilirubin =< institutional upper limit of normal (ULN) obtained =< 14 days prior to registration.
• REGISTRATION: Aspartate transaminase (AST) and alanine transaminase (ALT) =< 2 x ULN obtained =< 14 days prior to registration.
• REGISTRATION: Alkaline phosphatase < 2.5 x ULN obtained =< 14 days prior to registration.
• REGISTRATION: Creatinine =< 1.5 x ULN or creatinine clearance (CrCl) >= 45 mL/min on the basis of measured CrCl from a 24-hour urine collection or Cockcroft-Gault glomerular filtration rate estimation obtained =< 14 days prior to registration.
• REGISTRATION: Arms A and B only: Left ventricular ejection fraction (LVEF) >= 50% or institutional lower limit of normal (LLN) =< 6 months prior to registration.
• REGISTRATION: Arms A and B only: Average corrected QT interval (QTc) =< 450 ms on triplicate 12 lead electrocardiography (ECG) =< 28 days prior to registration.
• NOTE: QTc intervals will be corrected using Fridericia's formula.
• REGISTRATION: Negative pregnancy test done =< 7 days prior to registration, for persons of childbearing potential only.
• REGISTRATION: For persons of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use a contraceptive method with a failure rate of < 1% per year during the treatment period and for 6 months after the last dose of study treatment.
• REGISTRATION: For persons able to father a child: agreement to remain abstinent (refrain from heterosexual intercourse with a person of childbearing potential) or use contraceptive measures, and agreement to refrain from donating sperm during the treatment period and for 6 months after the last dose of study treatment.
• REGISTRATION: Provide written informed consent.
• REGISTRATION: Willing to return to enrolling institution for follow-up (during the active monitoring phase of the study).
• REGISTRATION: Willing to provide tissue, blood, and stool samples for correlative research purposes.
• REGISTRATION: Arm C Only: Negative serology for acute Epstein-Barr virus (EBV) infection (negative EBV viral capsid antigen [VCA] immunoglobulin M [IgM]).
Exclusion Criteria:

• PRE-REGISTRATION: Prior systemic anti-cancer therapy for melanoma (e.g., chemotherapy, hormonal therapy, targeted therapy, immunotherapy including anti-PD-1, anti-PDL1 agents, or other biologic therapies), with the following exceptions: adjuvant treatment with interferon, IL-2, granulocyte-macrophage colony-stimulating factor (GM-CSF) or vaccine therapies are allowed, if discontinued >= 28 days prior to pre-registration.
• PRE-REGISTRATION: Receiving any other investigational agent which would be considered as a treatment for the primary neoplasm.
• PRE-REGISTRATION: For patients with concurrent diagnosis of primary melanoma with nodal involvement, major surgical procedure other than lymph node biopsy or wide local excision of primary melanoma =< 4 weeks prior to pre-registration, or anticipation of need for a major surgical procedure for reasons other than melanoma during the course of the study.
• PRE-REGISTRATION: For patients with nodal recurrence, surgical procedure or anti-cancer therapy for this recurrence (other than lymph node biopsy) or anticipation of need for a major surgical procedure for reasons other than melanoma during the course of the study.
• PRE-REGISTRATION: Prior radiotherapy for melanoma.
• PRE-REGISTRATION: History of non-nodal melanoma metastasis or central nervous system (CNS) lesion(s) proven or clinically suspected to be metastasis.
• PRE-REGISTRATION: Active malignancy (other than melanoma) or malignancy =< 3 years prior to pre-registration.
• NOTE: Exceptions: Asymptomatic papillary thyroid cancer (not requiring treatment), resected basal cell carcinoma (BCC), resected cutaneous squamous cell carcinoma (SCC), resected carcinoma in situ of the cervix, resected carcinoma in situ of the breast, in situ prostate cancer, non-muscle-invasive bladder cancer, Stage I uterine cancer, or other curatively treated malignancies from which the patient has been disease-free for at least 3 years prior to pre registration.
• PRE-REGISTRATION: Prior allogeneic stem cell or solid organ transplantation.
• PRE-REGISTRATION: History of idiopathic pulmonary fibrosis, organizing pneumonia (e.g., bronchiolitis obliterans), drug-induced pneumonitis, or idiopathic pneumonitis, or evidence of active pneumonitis on screening chest CT scan.
• PRE-REGISTRATION: History of autoimmune disease requiring systemic immunosuppressive or immune-modulatory therapy =< 5 years prior to pre-registration.
• NOTE: Exceptions are allowed for hypothyroidism on thyroid replacement therapy; or Type 1 diabetes on insulin regimen.
• PRE-REGISTRATION: Active psoriasis requiring therapy (systemic or topical).
• PRE-REGISTRATION: Known clinically significant liver disease, including alcoholism, cirrhosis, fatty liver, and other inherited liver disease as well as active viral disease.
• PRE-REGISTRATION: Arms A and B only: History of or evidence of retinal pathology on ophthalmologic examination including but not limited to:
• Neurosensory retinal detachment
• Central serous chorioretinopathy
• Retinal vein occlusion (RVO)
• Neovascular macular degeneration
• PRE-REGISTRATION: Immunocompromised patients and patients known to be human immunodeficiency virus (HIV) positive and currently receiving antiretroviral therapy.
• NOTE: Patients known to be HIV positive, but without clinical evidence of an immunocompromised state, are eligible for this trial.
• PRE-REGISTRATION: Uncontrolled intercurrent illness including, but not limited to:
• Ongoing or active infection (including but not limited to tuberculosis)
• Clinically significant cardiac dysfunction including:
• Symptomatic congestive heart failure defined as New York Heart Association class II or higher
• Unstable angina pectoris or new-onset angina =< 3 months prior to pre-registration
• Unstable cardiac arrhythmia
• Myocardial infarction =< 3 months prior to pre-registration
• Congenital long QT syndrome
• Clinically significant stroke, reversible ischemic neurological defect, or transient ischemic attack =< 6 months prior to pre-registration
• Any grade 3 hemorrhage or bleeding event =< 4 weeks prior to pre-registration
• Uncontrolled diabetes or symptomatic hyperglycemia
• Psychiatric illness/social situations that, in the judgement of the investigator, would: a) limit compliance with study requirements, or b) make the patient inappropriate for entry into this study, or c) interfere significantly with the proper assessment of safety and toxicity of the prescribed regimens.
• PRE-REGISTRATION: Known hypersensitivity to biopharmaceutical agents produced in Chinese hamster ovary cells (example [ex]: recombinant follicle-stimulating hormone [FSH]).
• PRE-REGISTRATION: Known hypersensitivity to any components of the atezolizumab (all arms), tiragolumab (Arm C only), cobimetinib (Arms A and B only), or vemurafenib (Arms A and B only) formulations.
• PRE-REGISTRATION: History of severe allergic, anaphylactic or other hypersensitivity reactions to chimeric or humanized antibodies or fusion proteins.
• REGISTRATION: Received anticancer treatments or investigational agents during pre-registration period.
• REGISTRATION: Clinically suspected non-nodal metastatic melanoma.
• REGISTRATION: Arm A only: For BRAF-mutant patients only: anticipated use of any concomitant medication =< 7 days prior to registration that is known to cause QT prolongation (which may lead to torsade de pointes).
• REGISTRATION: Arms A and B only: History of malabsorption or other clinically significant metabolic dysfunction that may interfere with absorption of oral study treatment or inability or unwillingness to swallow oral medication.
• REGISTRATION: Signs or symptoms of infection or has received antibiotics =< 14 days prior to registration.
• NOTE: Patients receiving prophylactic antibiotics (e.g., to prevent a urinary tract infection or chronic obstructive pulmonary disease exacerbation) are eligible for the study.
• REGISTRATION: Any of the following because this study involves investigational agents whose genotoxic, mutagenic and teratogenic effects on the developing fetus and newborn are unknown:
• Pregnant persons
• Nursing persons
• Persons of childbearing potential who are unwilling to employ adequate contraception
• REGISTRATION: Treatment with a live, attenuated vaccine =< 4 weeks prior to registration, or anticipation of need for such a vaccine during the course of the study.
• REGISTRATION: Treatment with systemic immunosuppressive medication (including, but not limited to, prednisone, cyclophosphamide, azathioprine, methotrexate, thalidomide, and anti-tumor necrosis factor (TNF)-alpha agents) =< 2 weeks prior to registration, or anticipation of need for systemic immunosuppressive medication during the course of the study.
• NOTE: Patients who have received acute, low-dose systemic steroids (=< 10 mg/day oral prednisone or equivalent) prior to registration or a one-time pulse dose of systemic immunosuppressant medication (e.g., 48 hours of corticosteroids for a contrast allergy) are eligible for the study.
• NOTE: The use of inhaled corticosteroids for chronic obstructive pulmonary disease or asthma, mineralocorticoids (e.g., fludrocortisone), or low-dose corticosteroids for patients with orthostatic hypotension or adrenocortical insufficiency is allowed.
• REGISTRATION: Requirement for concomitant therapy or food that is prohibited during the study.
• REGISTRATION: Arms A and B only: Inability to abstain from alcohol during neoadjuvant phase.
• REGISTRATION: Arm C only: Known Epstein-Barr virus (EBV) infection.
• NOTE: Patients with symptoms such as splenomegaly, fever, sore throat, non-malignant cervical lymphadenopathy, and/or tonsillar exudate, should undergo an EBV polymerase chain reaction (PCR) test to screen for acute infection or suspected chronic active infection. Patients with a positive EBV PCR test are excluded.
Drug: Atezolizumab, Drug: Cobimetinib, Biological: Tiragolumab, Drug: Vemurafenib
Clinical Stage III Cutaneous Melanoma AJCC v8, Pathologic Stage III Cutaneous Melanoma AJCC v8, Pathologic Stage IIIA Cutaneous Melanoma AJCC v8, Pathologic Stage IIIB Cutaneous Melanoma AJCC v8, Pathologic Stage IIIC Cutaneous Melanoma AJCC v8, Pathologic Stage IIID Cutaneous Melanoma AJCC v8
Clinics and Surgery Center (CSC)
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An Open Label Study to Evaluate DPCP Ointment for the Treatment of Alopecia Areata

This is an open labeled study to determine the response and characteristics, safety and efficacy, of the proprietary DPCP ointment composition as a topical immunotherapeutic agent for the treatment of extensive alopecia areata.

Maria Hordinsky
All
18 Years and over
Phase 3
This study is NOT accepting healthy volunteers
NCT03651752
1407M52002
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Inclusion Criteria:

• Subject has clinical diagnosis of extensive alopecia areata (76%-99% involvement as determined by SALT score, Appendix B, Part I).
• Written informed consent and HIPAA authorization have been obtained.
• Subject is > 18 to years of age.
• Female subjects of childbearing potential have a negative pregnancy test and agree to use an acceptable, highly effective method of birth control (i.e., failure rate of less than 1% per year) to prevent pregnancy.
• Subject agrees to comply with protocol requirements and attend all required study visits and is considered to be a good study subject.
• Subject meets concomitant medication washout requirements -
Exclusion Criteria:

• Subject has <76 or greater than 99% hair loss.
• Subject is pregnant or lactating.
• Subject has current controlled or uncontrolled bacterial, viral (with the exception of herpes simplex), fungal, atypical, or opportunistic infection(s).
• Subject has a history of substance abuse within the past five years.
• Immunosuppression (history of transplantation, chemotherapy, splenectomy, HIV).
• Administration of systemic treatment (e.g., Imuran, biologics) that have an immunomodulatory mechanism of action in the preceding 3 months.
• Previous treatment with DPCP.
• Application of topical immunomodulating agent in the preceding 6 weeks.
• Application of topical or intralesional corticosteroids within the past 6 weeks.
• Systemic (oral, inhaled, or intravenous) administration of corticosteroid or other systemic treatment (i.e., prednisone) with an immunosuppressive mechanism of action within the past 3 months.
• Use of light treatments (e.g., PUVA, narrow band UVB) in the preceding 6 weeks.
• Use of Anthralin in preceding 6 weeks.
• Use of minoxidil, topical or oral, in the preceding 4 weeks.
• Subject is currently or has undergone systemic therapy for malignancy within the past five years except for adequately treated Squamous Cell Carcinoma (SCC) or Basal Cell Carcinoma (BCC) of the skin.
• Clinical evidence of secondary skin infection (i.e., folliculitis).
• Participation in other therapeutic investigational clinical trials within 4 weeks of enrollment.
• Evidence of anemia, thyroid disease, sarcoidosis or other medical condition that could be adversely affected by participating in the study.
• Subject has any medical condition that, in the judgment of the Investigator, would jeopardize the subject's safety following exposure to the administered medications. -
Drug: Diphenylcyclopropenone (DPCP) Ointment
Alopecia Areata
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Pharmacokinetics, Pharmacodynamics, and Safety Profile of Understudied Drugs Administered to Children per Standard of Care / (POPS): NICHD-2019-POP02 (including COVID-19 drugs) (POPS or POP02)

The majority of drugs administered to children are used off label, and PK studies to define appropriate dosing are lacking across pediatric age groups and special populations of children. Challenges associated with clinical trials in children limit the ability to conduct PK and dosing trials in this population. Studies capitalizing on standard-of-care procedures have proven successful in characterizing the PK of drugs used in children. The purpose of this study is to characterize the PK of understudied drugs administered to children per SOC as prescribed by their treating provider. This study will serve as a tool to better understand drug exposure in children receiving drugs per SOC. The data collected through this initiative will provide valuable PK and dosing information for drugs in different pediatric age groups as well as special populations of children, such as premature infants, critically ill children receiving ECMO or CRRT, children with Down syndrome and children with obesity, for which dosing may vary due to altered PK. In addition, the data collected in this study will serve as preliminary data to design and plan the best and most efficacious BPCA trials, proof-of-concept studies associated with biomarkers, and data to support applications for extramural funding. All of the drugs studied in this protocol are used as standard of care in children and are approved in adults. There will be multiple INDs held by the core study Principal Investigator: Danny Benjamin, MD, PhD (IND Sponsor) Kiser-Arena Distinguished Professor of Pediatrics, Duke University Faculty Associate Director, Duke Clinical Research Institute PO Box 17969 Durham NC 27715 Phone: 919-668-8295 Fax: 919-681-9457 danny.benjamin@duke.edu The Funding Sponsor is The National Institute of Child Health and Human Development (NICHD) NOTE: We will be participating in the COVID 19 arm of this study, which includes 6 drugs of interest (DOI). All other arms are on hold currently; and focus has been placed on the COVID 19 arm. However, in the future we may be interested in participating in other DOIs. The details of this arm of the study will be provided at the end of this document. (See Appendix P, pages 82-86 of main protocol)

Catherine Bendel
All
up to 20 Years old
NA
This study is NOT accepting healthy volunteers
NCT04278404
STUDY00009884
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Inclusion Criteria:

• Participant is < 21 years of age
• Parent/ Legal Guardian/ Adult Participant can understand the consent process and is willing to provide informed consent/HIPAA:
• (a) Participant is receiving one or more of the study drugs of interest at the time of enrollment or (b) Participant is NOT receiving one or more of the study drugs of interest but is SARS-COV-2 positive within 60 days prior to enrollment
Exclusion Criteria:

• Participant has a known pregnancy Below exclusion criteria apply only to participants receiving one or more of the study drugs of interest at the time of enrollment,
• Has had intermittent dialysis within previous 24 hours
• Has had a kidney transplant within previous 30 days
• Has had a liver transplant within previous 1 year
• Has had a stem cell transplant within previous 1 year
• Has had therapeutic hypothermia within previous 24 hours
• Has had plasmapheresis within the previous 24 hours
• Has a Ventricular Assist Device
• Has any condition which would make the participant, in the opinion of the investigator, unsuitable for the study
Drug: The POP02 study is collecting bodily fluid samples (i.e., whole blood, effluent samples) of children prescribed the following drugs of interest per standard of care:
Coronavirus Infection (COVID-19), Pulmonary Arterial Hypertension, Urinary Tract Infections in Children, Hypertension, Pain, Hyperphosphatemia, Primary Hyperaldosteronism, Edema, Hypokalemia, Heart Failure, Hemophilia, Menorrhagia, Insomnia, Pneumonia, Skin Infection, Arrythmia, Asthma in Children, Bronchopulmonary Dysplasia, Adrenal Insufficiency, Fibrinolysis, Hemorrhage, Attention Deficit Hyperactivity Disorder, Multisystem Inflammatory Syndrome in Children (MIS-C), Kawasaki Disease, Coagulation Disorder, Down Syndrome
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Tipifarnib for the Treatment of Advanced Solid Tumors, Lymphoma, or Histiocytic Disorders With HRAS Gene Alterations, a Pediatric MATCH Treatment Trial

The NCI-COG Pediatric MATCH (Molecular Analysis for Therapy Choice) study, referred to as Pediatric MATCH, will match targeted agents with specific molecular changes identified using genomic sequencing technologies in refractory/recurrent tumors from children and adolescents with cancer. The NCI-COG Pediatric MATCH study (APEC1621) is considered one study under one IND consisting of a Master Version Control protocol, screening protocol component and multiple subprotocol components, with each component being contained in its own separate document. Each “component” consists of the protocol document and its associated informed consent document. The Master Version Control Protocol is the overarching administrative protocol that will keep an up-to-date record of the current version of the screening protocol component and each subprotocol component of Pediatric MATCH. Since each subprotocol component operates independently from the other subprotocol components contained in Pediatric MATCH, each has its own version date. Likewise, the screening protocol component has its own version date since changes in any of the subprotocols may not require changes in the screening protocol.

Emily Greengard
All
12 Months to 21 Years old
Phase 2
This study is NOT accepting healthy volunteers
NCT04284774
STUDY00001752
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Inclusion Criteria:

• Patient must have enrolled onto APEC1621SC and must have been given a treatment assignment to MATCH to APEC1621M based on the presence of an actionable mutation as defined in APEC1621SC
• Patients must have a body surface area >= 0.29 m^2 at enrollment
• Patients must have radiographically measurable disease at the time of study enrollment. Patients with neuroblastoma who do not have measurable disease but have metaiodobenzylguanidine (MIBG) positive (+) evaluable disease are eligible. Measurable disease in patients with CNS involvement is defined as any lesion that is at minimum 10 mm in one dimension on standard magnetic resonance imaging (MRI) or computed tomography (CT)
• Note: The following do not qualify as measurable disease:
• Malignant fluid collections (e.g., ascites, pleural effusions)
• Bone marrow infiltration except that detected by MIBG scan for neuroblastoma
• Lesions only detected by nuclear medicine studies (e.g., bone, gallium or positron emission tomography [PET] scans) except as noted for neuroblastoma
• Elevated tumor markers in plasma or cerebral spinal fluid (CSF)
• Previously radiated lesions that have not demonstrated clear progression post radiation
• Leptomeningeal lesions that do not meet the measurement requirements for Response Evaluation Criteria in Solid Tumors (RECIST) 1.1
• Karnofsky >= 50 for patients > 16 years of age and Lansky >= 50 for patients =< 16 years of age. Note: Neurologic deficits in patients with CNS tumors must have been relatively stable for at least 7 days prior to study enrollment. Patients who are unable to walk because of paralysis, but who are up in a wheelchair, will be considered ambulatory for the purpose of assessing the performance score
• 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. If after the required timeframe, the numerical eligibility criteria are met, e.g. blood count criteria, the patient is considered to have recovered adequately
• Cytotoxic chemotherapy or other anti-cancer agents known to be myelosuppressive.
• >= 21 days after the last dose of cytotoxic or myelosuppressive chemotherapy (42 days if prior nitrosourea)
• Anti-cancer agents not known to be myelosuppressive (e.g. not associated with reduced platelet or absolute neutrophil count [ANC] counts): >= 7 days after the last dose of agent.
• Antibodies: >= 21 days must have elapsed from infusion of last dose of antibody, and toxicity related to prior antibody therapy must be recovered to grade =< 1
• Corticosteroids: If used to modify immune adverse events related to prior therapy, >= 14 days must have elapsed since last dose of corticosteroid
• Hematopoietic growth factors: >= 14 days after the last dose of a long-acting growth factor (e.g. pegfilgrastim) or 7 days for short-acting growth factor. For growth factors that have known adverse events occurring beyond 7 days after administration, this period must be extended beyond the time during which adverse events are known to occur. The duration of this interval must be discussed with the study chair and the study-assigned research coordinator
• Interleukins, interferons and cytokines (other than hematopoietic growth factors): >= 21 days after the completion of interleukins, interferon or cytokines (other than hematopoietic growth factors)
• Stem cell infusions (with or without total body irradiation [TBI]):
• Allogeneic (non-autologous) bone marrow or stem cell transplant, or any stem cell infusion including donor lymphocyte infusion (DLI) or boost infusion: >= 84 days after infusion and no evidence of graft versus host disease (GVHD)
• Autologous stem cell infusion including boost infusion: >= 42 days
• Cellular therapy: >= 42 days after the completion of any type of cellular therapy (e.g. modified T cells, natural killer [NK] cells, dendritic cells, etc.)
• Radiation therapy (XRT)/external beam irradiation including protons: >= 14 days after local XRT; >= 150 days after TBI, craniospinal XRT or if radiation to >= 50% of the pelvis; >= 42 days if other substantial bone marrow (BM) radiation
• Note: Radiation may not be delivered to "measurable disease" tumor site(s) being used to follow response to subprotocol treatment
• Radiopharmaceutical therapy (e.g., radiolabeled antibody, 131I-MIBG): >= 42 days after systemically administered radio-pharmaceutical therapy
• Patients must not have received prior exposure to tipifarnib
• For patients with solid tumors without known bone marrow involvement (within 7 days prior to enrollment):
• Peripheral absolute neutrophil count (ANC) >= 1000/mm^3
• For patients with solid tumors without known bone marrow involvement (within 7 days prior to enrollment):
• Platelet count >= 100,000/mm^3 (transfusion independent, defined as not receiving platelet transfusions for at least 7 days prior to enrollment)
• Patients with known bone marrow metastatic disease will be eligible for study provided they meet the blood counts (may receive transfusions provided they are not known to be refractory to red cell or platelet transfusions). These patients will not be evaluable for hematologic toxicity
• Creatinine clearance or radioisotope glomerular filtration rate (GFR) >= 70 ml/min/1.73 m^2 (within 7 days prior to enrollment) or
• A serum creatinine based on age/gender as follows (within 7 days prior to enrollment):
• Age: Maximum serum creatinine (mg/dL)
• 1 to < 2 years: male (0.6), female (0.6)
• 2 to < 6 years: male (0.8), female (0.8)
• 6 to < 10 years: male (1), female (1)
• 10 to < 13 years: male (1.2), female (1.2)
• 13 to < 16 years: male (1.5), female (1.4)
• >= 16 years: male (1.7), female (1.4)
• Bilirubin (sum of conjugated + unconjugated) =< 1.5 x upper limit of normal (ULN) for age (within 7 days prior to enrollment)
• Serum glutamate pyruvate transaminase (SGPT) (alanine aminotransferase [ALT]) =< 135 U/L. (For the purpose of this study, the ULN for SGPT is 45 U/L.) (within 7 days prior to enrollment)
• Serum albumin >= 2 g/dL (within 7 days prior to enrollment)
• Patients with seizure disorder may be enrolled if on anticonvulsants and well controlled
• Nervous system disorders (Common Terminology Criteria for Adverse Events [CTCAE] version [v] 5.0) resulting from prior therapy must be =< grade 2
• Patients must be able to swallow intact tablets or crushed tablets mixed in water, orange juice, apple juice, tomato juice, ginger ale, applesauce, yogurt, protein shake, or a dietary supplement drink (such as Ensure). Percutaneous endoscopic gastrostomy (PEG)-tube or nasogastric tube administration is permitted
• All patients and/or their parents or legally authorized representatives must sign a written informed consent. Assent, when appropriate, will be obtained according to institutional guidelines
Exclusion Criteria:

• Pregnant or breast-feeding women will not be entered on this study due to risks of fetal and teratogenic adverse events as seen in animal/human studies. Pregnancy tests must be obtained in girls who are post-menarchal. Males or females of reproductive potential may not participate unless they have agreed to use two effective contraceptive methods for the duration of study treatment. Both female subjects and male subjects with female partners of child-bearing potential must agree to use a highly effective method of contraception for 2 weeks prior to protocol therapy, during, and at least 4 weeks after last dose of tipifarnib. In addition, since tipifarnib could induce toxicity of male reproductive organs and cause impairment of fertility, sperm cryopreservation should be recommended for male subjects wishing to preserve their fertility following tipifarnib treatment
• Patients receiving corticosteroids who have not been on a stable or decreasing dose of corticosteroid for at least 7 days prior to enrollment are not eligible. If used to modify immune adverse events related to prior therapy, >= 14 days must have elapsed since last dose of corticosteroid
• Patients who are currently receiving another investigational drug are not eligible
• Patients who are currently receiving other anti-cancer agents are not eligible
• Patients who are receiving cyclosporine, tacrolimus or other agents to prevent graft-versus-host disease post bone marrow transplant are not eligible for this trial
• Patients who are currently receiving drugs that are strong inducers or inhibitors of CYP3A4/5 or UGT are not eligible. Strong inducers or inhibitors of CYP3A4/5 or UGT should be avoided from 14 days prior to the 1st dose of tipifarnib to the end of the study. In addition, patients receiving agents that are sensitive or narrow therapeutic range substrates of CYP3A4/5 are not eligible. Note: CYP3A4/5 inducing anti-epileptic drugs and dexamethasone for CNS tumors or metastases, on a stable dose, are allowed
• Patients with known hypersensitivity to tipifarnib or any components of the tablet are not eligible
• Patients with hypersensitivity to imidazoles, such as clotrimazole, ketoconazole, miconazole and others in this drug class are not eligible
• Patients who have an uncontrolled infection are not eligible
• Patients who have received a prior solid organ transplantation are not eligible
• Patients who in the opinion of the investigator may not be able to comply with the safety monitoring requirements of the study are not eligible
Drug: Tipifarnib
Malignant Solid Neoplasm, Recurrent Adrenal Gland Pheochromocytoma, Recurrent Ectomesenchymoma, Recurrent Ependymoma, Recurrent Ewing Sarcoma, Recurrent Hepatoblastoma, Recurrent Kidney Wilms Tumor, Recurrent Langerhans Cell Histiocytosis, Recurrent Malignant Germ Cell Tumor, Recurrent Malignant Glioma, Recurrent Medulloblastoma, Recurrent Melanoma, Recurrent Neuroblastoma, Recurrent Non-Hodgkin Lymphoma, Recurrent Osteosarcoma, Recurrent Peripheral Primitive Neuroectodermal Tumor, Recurrent Rhabdoid Tumor, Recurrent Rhabdoid Tumor of the Kidney, Recurrent Rhabdomyosarcoma, Recurrent Soft Tissue Sarcoma, Recurrent Thyroid Gland Carcinoma, Recurrent WHO Grade 2 Glioma, Refractory Adrenal Gland Pheochromocytoma, Refractory Ependymoma, Refractory Ewing Sarcoma, Refractory Hepatoblastoma, Refractory Langerhans Cell Histiocytosis, Refractory Malignant Germ Cell Tumor, Refractory Malignant Glioma, Refractory Medulloblastoma, Refractory Melanoma, Refractory Neuroblastoma, Refractory Non-Hodgkin Lymphoma, Refractory Osteosarcoma, Refractory Peripheral Primitive Neuroectodermal Tumor, Refractory Rhabdoid Tumor, Refractory Rhabdoid Tumor of the Kidney, Refractory Rhabdomyosarcoma, Refractory Soft Tissue Sarcoma, Refractory Thyroid Gland Carcinoma, Refractory WHO Grade 2 Glioma
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A DOUBLE-BLIND, RANDOMIZED, PLACEBO-CONTROLLED STUDY TO EVALUATE THE EFFICACY AND SAFETY OF CTP-543 IN ADULT PATIENTS&WITH MODERATE TO SEVERE ALOPECIA AREATA (THRIVE-AA1)

This is a double-blind, randomized, placebo-controlled multicenter study to evaluate the efficacy and safety of CTP-543 in adult patients with moderate to severe alopecia areata. Patients will be between 18 and 65 years of age and experiencing an episode of hair loss associated with alopecia areata lasting at least 6 months and not exceeding 10 years.

Maria Hordinsky
All
18 Years to 65 Years old
Phase 3
This study is NOT accepting healthy volunteers
NCT04518995
STUDY00010630
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Inclusion Criteria:

• Clinical presentation compatible with alopecia areata with a current episode lasting at least 6 months and not exceeding 10 years at the time of Screening. Total disease duration greater than 10 years is permitted.
• At least 50% scalp hair loss, as defined by a SALT score ≥50, at Screening and Baseline.
• Willing to comply with the study visits and requirements of the study protocol.
Exclusion Criteria:

• Treatment with other medications or agents within 1 month of Baseline or during the study that may affect hair regrowth or immune response.
• Active scalp inflammation, psoriasis, or seborrheic dermatitis requiring topical treatment to the scalp, significant trauma to the scalp, or other scalp condition that may interfere with the SALT assessment, or untreated actinic keratosis anywhere on the body at Screening and/or Baseline.
• Treatment with systemic immunosuppressive medications within 3 months of Screening or during the study, or biologics within 6 months of Screening or during the study.
• Females who are nursing, pregnant, or planning to become pregnant while in the study, and for 30 days after last dose of study drug.
• Clinically significant medical condition, psychiatric disease, or social condition, as determined by the Investigator, that may unfavorably alter the risk-benefit of study participation, adversely affect study compliance, or confound interpretation of study results.
Drug: CTP-543, 8 mg BID, Drug: CTP-543, 12 mg BID, Drug: Placebo, BID
Alopecia Areata
Alopecia, Hair loss, Hair disease, CTP-543, Clinics and Surgery Center (CSC)
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Testing Of Alternatives For Dark Hair Dyes In Patients With Proven Sensitization To Para-Phenylenediamine

Permanent hair dyes are commonly used in over-the-counter direct to consumer products and within hair salons. Allergy, also known as contact dermatitis, to hair dye is a well-known phenomenon. Herein, we seek to decrease the risks of allergy to hair dyes by testing a novel version of PPD with less allergy potential.

Paul Bigliardi
All
18 Years and over
Pilot
This study is NOT accepting healthy volunteers
NCT04772482
STUDY00012094
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Inclusion Criteria:
Diagnosis of PPD to hair dye
Exclusion Criteria:
Used oral immunosuppressive or chemotherapy medications within 1 month of patch testing
Diagnostic Test: Sensitivity Patch Testing
Dermatology (Skin, Hair & Nails), Contact Dermatitis, Allergy, Dermatitis, Dermatitis
Clinics and Surgery Center (CSC), Allergy
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A STUDY TO EVALUATE MAINTENANCE OF HAIR REGROWTH FOLLOWING DOSE REDUCTION OF CTP-543 IN ADULT PATIENTS WITH MODERATE TOSEVERE ALOPECIA AREATA

You are being asked to take part in a research study of an investigational study drug called CTP-543. Investigational means that the study drug is currently being tested. It is not approved by the U.S. Food and Drug Administration (FDA). This is a two part research study that will evaluate the regrowth of hair of research subjects with alopecia areata (sudden hair loss) when treated with CTP-543 at two different doses twice daily for 24 weeks. The first part of the study will also evaluate what happens to hair re-growth when the dose of CTP-543 is reduced or changed to placebo (looks identical to the study drug but contains an inactive substance) after the initial 24 weeks of treatment. In the second part of the study, subjects who experienced significant hair loss following dose reduction or being changed to placebo will be re-treated with the original CTP-543 dose that they received for an additional 24 weeks to further evaluate the effects of the dose reduction or drug discontinuation (being changed to placebo) on hair re-growth. Other purposes of the study are to determine how you and the Study Doctor feel about your alopecia areata during the study. CTP-543 is a modified version of another drug called Jakafi, which is approved by the FDA for other uses, but not for alopecia areata. This study will involve approximately 300 subjects at about 25 different study sites in the United States. The study will take place for up to a maximum of 80 weeks. You will have a maximum of 16 visits to the study site in Part A, and a maximum of 9 visits to the study site in Part B. You were selected as a possible subject in this study because you have at least 50% hair loss on your head due to alopecia areata, and are between the ages of 18 and 65. You will not be able to participate if you are currently undergoing treatment with another drug or with other treatments that might affect your hair regrowth or if you are taking medications that weaken the immune system; these medications may not allow your body to protect against infection and foreign substances like bacteria and viruses. The Study Doctor can explain this to you and will make the necessary assessments and tell you if you are eligible to participate.

Maria Hordinsky
All
18 Years to 65 Years old
Phase 2
This study is NOT accepting healthy volunteers
NCT04784533
STUDY00012359
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Inclusion Criteria:

• Definitive diagnosis of alopecia areata with a current episode of scalp hair loss lasting at least 6 months and not exceeding 10 years at the time of Screening. Total disease duration greater than 10 years is permitted.
• At least 50% scalp hair loss, as defined by a SALT score ≥50, at Screening and Baseline.
• Willing to comply with the study visits and requirements of the study protocol.
Exclusion Criteria:

• Treatment with other medications or agents within 1 month of Baseline or during the study that may affect hair regrowth or immune response.
• Active scalp inflammation, psoriasis, or seborrheic dermatitis requiring topical treatment to the scalp, significant trauma to the scalp, or other scalp condition that may interfere with the SALT assessment, or untreated actinic keratosis anywhere on the body at Screening and/or Baseline.
• Treatment with systemic immunosuppressive medications within 3 months of Screening or during the study, or biologics within 6 months of Screening or during the study.
• Females who are nursing, pregnant, or planning to become pregnant while in the study, and for 30 days after last dose of study drug.
• Clinically significant medical condition, psychiatric disease, or social condition, as determined by the Investigator, that may unfavorably alter the risk-benefit of study participation, adversely affect study compliance, or confound interpretation of study results.
Drug: CTP-543, Drug: Placebo
Alopecia Areata
CTP-543
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PEPN2011 - A Phase 1/2 Study of Tegavivint (IND#156033, NSC#826393) in Children, Adolescents, and Young Adults with Recurrent or Refractory Solid Tumors, Including Lymphomas and Desmoid Tumors

This phase I/II trial evaluates the highest safe dose, side effects, and possible benefits of tegavivint in treating children, adolescents, and young adults with recurrent or refractory solid tumors, including lymphomas and desmoid tumors.

Emily Greengard
All
12 Months to 30 Years old
Phase 1/Phase 2
This study is NOT accepting healthy volunteers
NCT04851119
STUDY00014319
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Inclusion Criteria:

• PART A: Patients must be >= 12 months and =< 21 years of age at the time of study enrollment
• PART B: Patients must be >= 12 months and =< 30 years of age at the time of study enrollment
• Patients with recurrent or refractory solid tumors including non-Hodgkin lymphoma and desmoid tumors are eligible. Patients must have had histologic verification of malignancy at original diagnosis or relapse
• PART A: Patients with relapsed or refractory solid tumors, including patients with non-Hodgkin lymphoma and desmoid tumors
• PART B: Patients with recurrent or refractory Ewing sarcoma, desmoid tumors, osteosarcoma, liver tumors (HCC and hepatoblastoma), Wilms tumor, and tumors with Wnt pathway aberrations. For the Wnt pathway aberrations cohort we will include the most common CTNNB1 mutations (S37F, S45F, T41A, S45P, S33C, S37C, D32Y, S33F, T41I, G34R, G34V, D32N, S33P, G34E, D32G) as well as any loss of function mutations in the APC, Axin2FBXW7, TCF7L2, and RNF43 genes or any gain-of-function mutations in the GSK3B, LRP6, and LGR5 genes. For patients without prior sequencing, immunohistochemistry (IHC), is required. IHC showing strong nuclear beta-catenin staining will be accepted for the following tumor types: colorectal carcinoma, melanoma, endometrial cancer, ovarian cancer, neuroblastoma, non-Hodgkin lymphoma, pancreatic ductal adenocarcinoma, and solid pseudopapillary tumor of the pancreas
• PART A: Patients must have either measurable or evaluable disease. For desmoid tumors, the patient must have disease that the investigator deems unresectable or sufficiently morbid or potentially life-threatening that there is favorable risk/benefit to the patient to participate in the trial
• PART B: Patients must have measurable disease. For desmoid tumors, the patient must have measurable disease that the investigator deems unresectable or sufficiently morbid or potentially life-threatening that there is favorable risk/benefit to the patient to participate in the trial
• Patients must have a performance status corresponding to Eastern Cooperative Oncology Group (ECOG) scores of 0, 1 or 2. Use Karnofsky for patients > 16 years of age and Lansky for patients =< 16 years of age
• 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. If after the required timeframe, the numerical eligibility criteria are met, e.g., blood count criteria, the patient is considered to have recovered adequately.
• Cytotoxic chemotherapy or other anti-cancer agents known to be myelosuppressive
• Solid tumor patients: >= 21 days after the last dose of myelosuppressive chemotherapy (42 days if prior nitrosourea)
• Non-Hodgkin lymphoma patients
• A waiting period prior to enrollment is not required for patients receiving standard maintenance chemotherapy (i.e., corticosteroid, vincristine, thioguanine [6MP], and/or methotrexate)
• >= 14 days must have elapsed after the completion of other cytotoxic therapy, with the exception of hydroxyurea, for patients not receiving standard maintenance therapy
• NOTE: Cytoreduction with hydroxyurea must be discontinued >= 24 hours prior to the start of protocol therapy
• Anti-cancer agents not known to be myelosuppressive (e.g., not associated with reduced platelet or absolute neutrophil counts [ANC]): >= 7 days after the last dose of agent
• Antibodies: >= 21 days must have elapsed from infusion of last dose of antibody, and toxicity related to prior antibody therapy must be recovered to grade =< 1
• Corticosteroids: If used to modify immune adverse events related to prior therapy, >= 14 days must have elapsed since last dose of corticosteroid
• Hematopoietic growth factors: >= 14 days after the last dose of a long-acting growth factor (e.g., pegfilgrastim) or 7 days for short acting growth factor. For agents that have known adverse events occurring beyond 7 days after administration, this period must be extended beyond the time during which adverse events are known to occur
• Interleukins, interferons and cytokines (other than hematopoietic growth factors): >= 21 days after the completion of interleukins, interferon or cytokines (other than hematopoietic growth factors)
• Stem cell Infusions (with or without total-body irradiation [TBI]):
• Allogeneic (non-autologous) bone marrow or stem cell transplant, or any stem cell infusion including donor lymphocyte infusion (DLI) or boost infusion: >= 84 days after infusion and no evidence of graft versus host disease (GVHD)
• Autologous stem cell infusion including boost infusion: >= 42 days.
• Cellular therapy: >= 42 days after the completion of any type of cellular therapy (e.g., modified T cells, natural killer [NK] cells, dendritic cells, etc.).
• External beam radiation therapy (XRT)/external beam irradiation including protons: >= 14 days after local XRT; >= 150 days after TBI, craniospinal XRT or if radiation to >= 50% of the pelvis; >= 42 days if other substantial bone marrow (BM) radiation
• Radiopharmaceutical therapy (e.g., radiolabeled antibody, iobenguane I-131 [131I MIBG]): >= 42 days after systemically administered radiopharmaceutical therapy
• Patients must not have received prior exposure to tegavivint
• PATIENTS WITH SOLID TUMORS WITHOUT KNOWN BONE MARROW INVOLVEMENT: Peripheral absolute neutrophil count (ANC) >= 1000/uL (within 7 days prior to enrollment)
• PATIENTS WITH SOLID TUMORS WITHOUT KNOWN BONE MARROW INVOLVEMENT: Platelet count >= 100,000/uL(transfusion independent, defined as not receiving platelet transfusions for at least 7 days prior to enrollment) (within 7 days prior to enrollment)
• PATIENTS WITH SOLID TUMORS WITHOUT KNOWN BONE MARROW INVOLVEMENT: Hemoglobin >= 8.0 g/dL at baseline (may receive red blood cell [RBC] transfusions) (within 7 days prior to enrollment)
• Patients with known bone marrow metastatic disease will be eligible for study provided they meet blood counts (may receive transfusions provided they are not known to be refractory to red cell or platelet transfusions). These patients will not be evaluable for hematologic toxicity. At least 5 of every cohort of 6 patients must be evaluable for hematologic toxicity for the dose-escalation part of the study. If dose-limiting hematologic toxicity is observed, all subsequent patients enrolled on Part A must be evaluable for hematologic toxicity
• Creatinine clearance or radioisotope glomerular filtration rate (GFR) >= 70 mL/min/1.73 m^2 or a creatinine based on age/gender as follows:
• Age; maximum serum creatinine
• Age 1 to < 2 years; 0.6 mg/dL (male); 0.6 mg/dL (female)
• Age 2 to < 6 years; 0.8 mg/dL (male); 0.8 mg/dL (female)
• Age 6 to < 10 years; 1 mg/dL (male); 1 mg/dL (female)
• Age 10 to < 13 years; 1.2 mg/dL (male); 1.2 mg/dL (female)
• Age 13 to < 16 years; 1.5 mg/dL (male); 1.4 mg/dL (female)
• Age >= 16 years; 1.7 mg/dL (male); 1.4 mg/dL (female)
• PATIENTS WITH SOLID TUMORS: Bilirubin (sum of conjugated + unconjugated or total) =<
• 5 x upper limit of normal (ULN) for age
• PATIENTS WITH SOLID TUMORS: Serum glutamic pyruvic transaminase (SGPT) (alanine aminotransferase [ALT]) =< 135 U/L. For the purpose of this study, the ULN for SGPT is 45 U/L
• PATIENTS WITH SOLID TUMORS: Albumin >= 2 g/dL
Exclusion Criteria:

• Pregnant or breast-feeding women will not be entered on this study because there is yet no available information regarding human fetal or teratogenic toxicities. Pregnancy tests must be obtained in girls who are post-menarchal. Males or females of reproductive potential may not participate unless they have agreed to use two effective methods of birth control, including a medically accepted barrier or contraceptive method (e.g., male or female condom) for the duration of the study. Abstinence is an acceptable method of birth control
• Patients receiving corticosteroids who have not been on a stable or decreasing dose of corticosteroid for at least 7 days prior to enrollment are not eligible. If used to modify immune adverse events related to prior therapy, >= 14 days must have elapsed since last dose of corticosteroid
• Patients who are currently receiving another investigational drug are not eligible
• Patients who are currently receiving other anti-cancer agents are not eligible
• Patients who are receiving cyclosporine, tacrolimus or other agents to prevent graft-versus-host disease post bone marrow transplant are not eligible for this trial
• Patients who are currently receiving drugs that are strong inducers or inhibitors of CYP3A4 are not eligible. Strong inducers or inhibitors of CYP3A4 should be avoided from 14 days prior to the 1st dose of tegavivint to the end of the study
• Patients who have received bisphosphonates within 4 weeks prior to study enrollment will be excluded
• Patients who have received denosumab within 180 days prior to study enrollment will be excluded
• Patients with primary brain tumors are ineligible
• Patients with known central nervous system (CNS) metastasis will be excluded
• Patients with a known metabolic bone disease (ex: hyperparathyroidism, Paget's disease, osteomalacia) are not eligible
• Patients with a disorder associated with abnormal bone metabolism will be excluded
• Patients with grade >= 2 hypocalcemia that is not corrected with oral calcium supplementation will be excluded
• Patients with vitamin D < 20 ng/mL will require supplementation, or will otherwise be excluded. Patients must agree to take vitamin D +/- calcium supplements (if necessary) according to institutional or published guidelines. Additional calcium supplementation is not required if adequate dietary intake can be ascertained
• Patients with pre-existing grade 3 osteoporosis are excluded
• Patients who have an uncontrolled infection are not eligible
• Patients who have received a prior solid organ transplantation are not eligible
• Patients who in the opinion of the investigator may not be able to comply with the safety monitoring requirements of the study are not eligible
Drug: Tegavivint
Colorectal Carcinoma, Endometrial Carcinoma, Melanoma, Neuroblastoma, Ovarian Carcinoma, Pancreatic Ductal Adenocarcinoma, Recurrent Desmoid Fibromatosis, Recurrent Ewing Sarcoma, Recurrent Hepatoblastoma, Recurrent Hepatocellular Carcinoma, Recurrent Malignant Solid Neoplasm, Recurrent Non-Hodgkin Lymphoma, Recurrent Osteosarcoma, Refractory Desmoid Fibromatosis, Refractory Ewing Sarcoma, Refractory Hepatoblastoma, Refractory Hepatocellular Carcinoma, Refractory Malignant Solid Neoplasm, Refractory Non-Hodgkin Lymphoma, Refractory Osteosarcoma, Solid Pseudopapillary Neoplasm of the Pancreas, Wilms Tumor
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A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Rosnilimab (ANB030) in the Treatment of Subjects with Alopecia Areata

This research is studying a new treatment, rosnilimab, in a small number of people to learn about the safety, potential effect on alopecia areata, and how it interacts with the body. Researchers want to understand if rosnilimab may cause hair regrowth in people with alopecia areata and how it may work.

Maria Hordinsky
18 Years and over
Phase II
This study is NOT accepting healthy volunteers
NCT05205070
STUDY00014901
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Inclusion Criteria:
Men and women, adults 18- 65 years of age who are in good health Diagnosed with severe or very severe Alopecia Areata and have greater than or equal to 50% scalp hair loss Must be willing to stop using other types of medications to treat Alopecia Areata throughout the study Attend 10 visits over 28 weeks Other requirements, which the study team will review with you
Exclusion Criteria:
Subjects cannot participate in this study if they have another cause of hair loss in addition to alopecia areata. Subjects also cannot participate if they have had surgery in the last 4 weeks, if immune system is compromised, if are allergic to anything in rosnilimab, if recently used a prescription treatment for alopecia areata, if have tuberculosis, if person is pregnant or breastfeeding, or if person intends to become pregnant while part of this study. Subjects cannot participate in this study if they are currently part of another study that is using an experimental drug or device (medical tool).
Alopecia Areata, Dermatology (Skin, Hair & Nails), Immune Diseases
hair loss, Alopecia areata, PD-1 receptor, Rosnilimab
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A Phase 1/2 non-randomized, open-label, multi-cohort,multi-center study assessing the clinical benefit of SAR444245 (THOR- 707) combined with cemiplimab for the treatment of participants with advanced unresectable or metastatic skin cancers

SAR444245, with its site-specific pegylation, was designed to substantially reduce association with the interleukin (IL)-2 α receptor, while retaining stimulatory activity for cells expressing the moderate affinity IL-2 βγ receptor. Preclinical studies demonstrated that treatment with SAR444245 leads to polyclonal expansion of CD8+ T cells in murine and non-human primate (NHP) models while anti-PD1 antibody prevents T cell suppression through the programmed cell death-1/programmed cell death-ligand 1 (PD1/PD-L1) pathway. The combination of anti-PD1 treatment with SAR444245 was tested in the syngeneic murine colon cancer Ct-26 model and induced enhanced anti-tumor activity demonstrated as an increased number of complete responses (CR) and tumor-free surviving animals compared to each agent given in monotherapy. These data support evaluation of SAR444245 in combination with an anti-PD1 antibody. The proposed study aims to establish proof-of-concept that combining the anti-PD1 monoclonal antibody cemiplimab with the not-alpha IL-2 SAR444245 will result in a significant increase in the percentage of immune checkpoint inhibitors (ICI)-naïve patients with melanoma and cutaneous squamous cell carcinoma (CSCC) experiencing an objective response rate (ORR)

Evidio Domingo Musibay
Phase I/II
This study is NOT accepting healthy volunteers
NCT04913220
STUDY00014167
Malignant Melanoma, Squamous Cell Carcinoma of Skin
Clinics and Surgery Center (CSC)
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A Study of SEA-CD40 Given With Other Drugs in Cancers

This is a phase 2, global, open-label, multicenter trial designed to assess the activity, safety, and tolerability of SEA-CD40 in combination with standard-of-care therapies in adults with selected solid tumors. The study will include multiple indication-specific cohorts. Up to approximately 200 subjects may be enrolled in this study.

Evidio Domingo Musibay
All
18 Years and over
Phase 2
This study is NOT accepting healthy volunteers
NCT04993677
STUDY00014590
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Inclusion Criteria:

• Histologically or cytologically confirmed unresectable malignancy defined as one of the following:
• Cohort 1: Relapsed and/or refractory metastatic melanoma
• Uveal/ocular melanoma is excluded
• Must have progressed on treatment with an anti-PD-(L)1 mAb. PD-(L)1 treatment progression is defined as meeting all of the following criteria:
• Has received at least 2 doses of an approved anti-PD-(L)1 mAb
• Has demonstrated disease progression after PD-(L)1 as defined by RECIST v1.1.
• Progressive disease has been documented within 12 weeks from the last dose of anti- PD-(L)1 mAb
• Last dose of anti-PD-(L)1 must have been within 90 days prior to enrollment
• Participants with a targetable BRAF mutation must have been treated with, been intolerant of, or declined treatment with BRAF/MEK targeted therapy prior to study entry
• Cohort 2: Metastatic uveal melanoma
• Must not have received prior treatment for advanced or metastatic disease except for prior adjuvant/neoadjuvant immunotherapy
• No prior liver-directed therapy
• Cohort 3: Metastatic PD-(L)1-naive melanoma
• Uveal/ocular melanoma is excluded
• Must not have received prior treatment for advanced or metastatic disease except for prior adjuvant/neoadjuvant immunotherapy.
• For participants with a targetable BRAF mutation, prior BRAF/MEK targeted therapy is allowed if completed 4 weeks prior to first dose of study treatment.
• Cohorts 4 and 5: Non-squamous NSCLC
• Participants must have stage IV disease per AJCC 8th edition
• No known driver mutations/alterations mutation for which targeted therapy is available
• Must have non-squamous histology.
• No prior therapy for metastatic disease
• No prior treatment with anti-PD-(L)1 or PD-L2 agent or an antibody targeting other immuno-regulatory receptors or mechanisms
• Able to provide archival tumor tissue from locations not radiated prior to biopsy. If archival tumor sample is not available a fresh baseline biopsy is required.
• Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0 or 1
• Measurable disease per RECIST v1.1 at baseline
Exclusion Criteria:

• History of another malignancy within 3 years of first dose of study drug
• Active central nervous system (CNS) metastases and/or carcinomatous meningitis.
• Previous exposure to CD40-targeted therapy
• Currently on chronic systemic steroids in excess of physiologic replacement
• Has had an allogeneic tissue/solid organ transplant.
• History of autoimmune disease that has required systemic treatment in the past 2 years
Drug: SEA-CD40, Drug: pembrolizumab, Drug: pemetrexed, Drug: carboplatin
Melanoma, Carcinoma, Non-Small- Cell Lung
Relapsed melanoma, Refractory melanoma, Metastatic uveal melanoma, Metastatic PD-(L)1-naïve melanoma, Non-squamous NSCLC, NSCLC, Non-small cell lung cancer, Seattle Genetics, Clinics and Surgery Center (CSC), Phase I Clinic
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