Search Results
224results
Docetaxel to Androgen Receptor Pathway Inhibitors in Patients With Metastatic Castration Sensitive Prostate Cancer and Suboptimal PSA Response (TRIPLE-SWITCH)
clinicaltrials@northshore.org
MALE
18 years and over
PHASE3
NCT06592924
Inclusion Criteria:
* Histologically/cytologically confirmed adenocarcinoma of the prostate
* Metastatic disease by conventional imaging
* PSA of ≥5.0 ng/ml (5.0 ug/L) prior to commencement of ADT
* Receipt of ADT for mCSPC for at least 6 months and no greater than 12 months at time of enrollment.
* Receipt of ARPI (e.g. abiraterone acetate, enzalutamide, apalutamide, or darolutamide) for at least 4 months at time of enrollment
* Potential trial participants should have recovered from clinically significant adverse events of their most recent therapy/intervention prior to enrollment.
* Serum testosterone \<1.7 nmol/L or 50 ng/dL.
* PSA ≥ 0.2 ng/ml (0.2 ug/L) within 14 days of enrollment. If there is any rise in PSA since starting ADT and achieving castrate-level testosterone, PSA must be repeated and must not fulfill ineligibility criteria 4.2.1.
* Candidate for docetaxel chemotherapy
* ECOG Performance Status (PS) 0 to 2.
* Adequate organ and marrow function measured within 14 days prior to enrollment.
* Participant consent must be appropriately obtained in accordance with applicable local and regulatory requirements. Each participant must sign a consent form prior to enrollment in the trial to document their willingness to participate.
* Participants must be accessible for treatment and follow-up. Investigators must assure themselves the participants enrolled on this trial will be available for complete documentation of the treatment, adverse events, and follow-up.
* In accordance with CCTG policy, protocol treatment is to begin within 5 working days of participant enrollment.
* If the participant and the participant's partner are of childbearing potential, they must agree to use medically accepted methods of contraception
* HIV-infected participants on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial.
* Participant access to all protocol therapies must be confirmed prior to enrollment
Exclusion Criteria:
* Two consecutive rises in PSA since achieving castration on ADT at least 2 weeks apart with at least one PSA ≥5% above the PSA nadir and with at least one PSA having an absolute increase of ≥0.5 ng/ml above the PSA nadir.
* Evidence of radiographic progression or clinical progression since start of ADT.
* Docetaxel criteria:
* Prior treatment with taxane chemotherapy
* Grade 2 or worse peripheral neuropathy
* Severe hypersensitivity to drugs formulated with polysorbate 80
* Patients with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification. To be eligible for this trial, patients should be class II or better.
* Patients with uncontrolled intercurrent illness or any other significant condition(s) that would make this protocol unreasonably hazardous.
* Patients with a prior or concurrent malignancy whose natural history of treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial.
* Concurrent treatment with other anti-cancer systemic therapy other than ADT and ARPI.
* Live attenuated vaccination administered within 30 days prior to enrollment/randomization.
* For participants with a history of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated.
* Participants with a history of hepatitis C virus (HCV) infection must have been treated and cured. For participants with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load.
* High-grade neuroendocrine prostate cancer or small cell features. DRUG: Abiraterone, DRUG: Enzalutamide, DRUG: Apalutamide, DRUG: Darolutamide (BAY 1841788), DRUG: Docetaxel, DRUG: ADT
Prostate Cancer (Adenocarcinoma)
PR26, Castration sensitive
The PREDICT Registry:
clinicaltrials@northshore.org
FEMALE
30 years to 85 years old
NCT03448926
Inclusion criteria
• Patient must have histologically confirmed ductal carcinoma in situ (DCIS) in a single breast (presence of lobular carcinoma in situ (LCIS) or other benign breast disease in addition to DCIS is acceptable).
• Patient must have the DCISionRT test ordered during routine patient care.
• Patient must be eligible for or have recently completed breast conserving surgery.
• Patient must be eligible to receive radiation and/or systemic treatment.
• Patient must be 30 to 85 years old.
• Patient must have tumor size of less than 6 cm.
• Patient must have been diagnosed with DCIS within 120 days of consent. Exclusion criteria
• Patient tissue is insufficient to generate DCISionRT test results or required DCISionRT inputs (age, tumor size, margin status, palpability) are missing.
• Patient has evidence of invasive breast cancer, including microinvasion, lymph node involvement, or Paget's disease of the nipple or suspicious mammogram findings in the lymph nodes or contralateral breast.
• Patient has been surgically treated with an ipsilateral mastectomy for primary DCIS.
• Patient has had any prior ipsilateral or contralateral breast DCIS or invasive breast cancer.
• Patient has a prior history of in-field radiation in the ipsilateral breast.
• Patient has had prior systemic endocrine or chemotherapy prior to testing.
• Patient is pregnant.
• Patient must have histologically confirmed ductal carcinoma in situ (DCIS) in a single breast (presence of lobular carcinoma in situ (LCIS) or other benign breast disease in addition to DCIS is acceptable).
• Patient must have the DCISionRT test ordered during routine patient care.
• Patient must be eligible for or have recently completed breast conserving surgery.
• Patient must be eligible to receive radiation and/or systemic treatment.
• Patient must be 30 to 85 years old.
• Patient must have tumor size of less than 6 cm.
• Patient must have been diagnosed with DCIS within 120 days of consent. Exclusion criteria
• Patient tissue is insufficient to generate DCISionRT test results or required DCISionRT inputs (age, tumor size, margin status, palpability) are missing.
• Patient has evidence of invasive breast cancer, including microinvasion, lymph node involvement, or Paget's disease of the nipple or suspicious mammogram findings in the lymph nodes or contralateral breast.
• Patient has been surgically treated with an ipsilateral mastectomy for primary DCIS.
• Patient has had any prior ipsilateral or contralateral breast DCIS or invasive breast cancer.
• Patient has a prior history of in-field radiation in the ipsilateral breast.
• Patient has had prior systemic endocrine or chemotherapy prior to testing.
• Patient is pregnant.
OTHER: Treatment recommendation surveys, DEVICE: 7-gene biosignature
DCIS, Stage 0 Breast Cancer, Ductal Breast Carcinoma In Situ
DCIS, molecular testing, risk of recurrence, treatment decision, decision impact, predictive
Evaluating the Impact of Maridebart Cafraglutide on Cardiovascular Outcomes in Participants With Atherosclerotic Cardiovascular Disease and Overweight or Obesity (MARITIME-CV)
clinicaltrials@northshore.org
ALL
45 years to 99 years old
PHASE3
NCT07037433
Inclusion Criteria
* Age ≥ 45 years at screening.
* BMI of ≥ 27.0 kg/m\^2 at screening.
* History of Atherosclerotic Cardiovascular Disease (ASCVD) with a documented history of at least one of the following:
* Prior MI (presumed atherothrombotic event due to plaque rupture/erosion).
* Prior ischemic stroke (presumed due to atherosclerosis; may include ischemic stroke with hemorrhagic transformation).
* Symptomatic peripheral arterial disease (PAD), as evidenced by intermittent claudication with ankle-brachial index (ABI) \< 0.9 (at rest), or peripheral arterial revascularization procedure, or amputation due to atherosclerotic disease.
Exclusion Criteria
* History of any of the following within 60 days before screening or between screening and randomization: MI, hospitalization for unstable angina, arterial revascularization (eg, coronary, cerebrovascular or peripheral) major cardiovascular surgery, stroke, or transient ischemic attack (TIA).
* New York Heart Association (NYHA) class IV HF during screening or hospitalization for HF within 60 days before screening or between screening and randomization.
* Type 1 DM, or any other type of diabetes with the exception of T2DM or prior gestational diabetes. Participants with a history of gestational diabetes should be stratified according to their current diabetes classification.
* For participants with T2DM (including those without a prior history of T2DM but with a HbA1c ≥ 6.5% during screening):
* HbA1c \> 10.0% (86 mmol/mol) at screening.
* History of diabetic ketoacidosis or hyperosmolar state/coma within 12 months before randomization.
* One or more episodes of severe hypoglycemia within 6 months before randomization and/or history of hypoglycemia unawareness.
* History of proliferative diabetic retinopathy, diabetic maculopathy, severe non-proliferative diabetic retinopathy, or currently receiving or planning to receive treatment for diabetic retinopathy and/or diabetic macular edema.
* Use of any glucagon-like peptide-1 receptor agonist (GLP-1 RA), glucose-dependent insulinotropic polypeptide (GIP) agonists or antagonists, or amylin analogs within 90 days before randomization or planned use during the conduct of the trial.
* History of chronic pancreatitis or history of acute pancreatitis in the 180 days before screening or between screening and randomization.
* Family (first-degree relative\[s\]), or personal history of medullary thyroid carcinoma (MTC), or multiple endocrine neoplasia syndrome type 2 (MEN-2).
* Calcitonin ≥ 50 ng/L (pg/mL) at screening.
* Acute or chronic hepatitis; signs and symptoms of any liver disease other than metabolic dysfunction-associated steatotic liver disease, or alanine aminotransferase (ALT) \> 3.0 x the upper limit of normal (ULN) during screening, or total bilirubin (TBL) \> 1.8 x ULN during screening (for participants with a known diagnosis of Gilbert syndrome, direct bilirubin should be used instead of TBL).
* History of malignancy within the last 5 years before screening or between screening and randomization (except for the following treated with curative intent: non-melanoma skin cancer, breast ductal carcinoma in situ, cervical carcinoma in situ, or prostate cancer in situ).
* Participants of childbearing potential planning to become pregnant while on study or unwilling to use protocol-specified methods of contraception during treatment.
DRUG: Maridebart Cafraglutide, DRUG: Placebo
Atherosclerotic Cardiovascular Disease, Overweight, Obesity
Atherosclerotic Cardiovascular Disease, Overweight, Obesity, Maridebart cafraglutide, AMG 133, MariTide
REGN7508 Versus Acetylsalicylic Acid (ASA) for Venous Thromboprophylaxis After Total Knee Arthroplasty in Adult Participants (ROXI-ASPEN)
clinicaltrials@northshore.org
ALL
18 years and over
PHASE3
NCT07213778
Key
• Is undergoing a primary elective unilateral TKA
• Is in good health based on laboratory safety testing as described in the protocol Key
• Any condition that, as assessed by the investigator, may confound the results of the study or pose an additional risk to the participant by study participation
• History of bleeding in the 6 months prior to randomization requiring hospitalization or transfusion; history of intracranial or intraocular bleeding, excessive operative or post-operative bleeding, and traumatic spinal or epidural anesthesia; history of bleeding diathesis (eg, hemophilia A or B, von Willebrand's Factor deficiency)
• History of thromboembolic disease or thrombophilia
• History of platelet dysfunction
• Has received or plans to receive preoperative enoxaparin on the day prior to TKA surgery Note: Other protocol-defined Inclusion/ Exclusion criteria apply
Inclusion Criteria:
• Is undergoing a primary elective unilateral TKA
• Is in good health based on laboratory safety testing as described in the protocol Key
Exclusion Criteria:
• Any condition that, as assessed by the investigator, may confound the results of the study or pose an additional risk to the participant by study participation
• History of bleeding in the 6 months prior to randomization requiring hospitalization or transfusion; history of intracranial or intraocular bleeding, excessive operative or post-operative bleeding, and traumatic spinal or epidural anesthesia; history of bleeding diathesis (eg, hemophilia A or B, von Willebrand's Factor deficiency)
• History of thromboembolic disease or thrombophilia
• History of platelet dysfunction
• Has received or plans to receive preoperative enoxaparin on the day prior to TKA surgery Note: Other protocol-defined Inclusion/ Exclusion criteria apply
DRUG: REGN7508, DRUG: Acetylsalicylic Acid (ASA), DRUG: Placebo
Symptomatic Venous Thromboembolism (VTE)
Total Knee Arthroplasty (TKA), Elective Unilateral TKA, Deep Vein Thrombosis (DVT), Pulmonary Embolism (PE)
A 16-Week Study to Learn About the Study Medicine Called Ritlecitinib in Adults With Long Lasting Painful Red Skin Lumps, Known by the Medical Term, Hidradenitis Suppurativa, or HS.
clinicaltrials@northshore.org
ALL
18 years to 75 years old
PHASE2
NCT07228390
Key Eligibility Criteria:
• Male or female participants ≥18 to ≤75 years of age.
• Participants with a diagnosis (based on clinical history and physical examination) of moderate to severe HS for at least 6 months prior to Screening Visit and inadequate response to at least 4-week (28 days) treatment with oral antibiotics for the treatment of HS.
• Presence of ≥20 draining fistulae at Screening or BL visit
• Evidence of other active skin disease or condition at screening
• Have a known immunodeficiency disorder
• Having a history of systemic infection requiring hospitalization or parenteral therapy, including history of infection with Mycobacterium TB
• Specific Viral Infection History (incl. history of herpes zoster, HBV or HCV Infection
• Current or recent history of clinically significant severe, progressive, or uncontrolled other medical conditions
• Any medical or psychiatric condition including any active suicidal ideation in the past year or suicidal behavior in the past 5 years
Inclusion Criteria:
• Male or female participants ≥18 to ≤75 years of age.
• Participants with a diagnosis (based on clinical history and physical examination) of moderate to severe HS for at least 6 months prior to Screening Visit and inadequate response to at least 4-week (28 days) treatment with oral antibiotics for the treatment of HS.
Exclusion Criteria:
• Presence of ≥20 draining fistulae at Screening or BL visit
• Evidence of other active skin disease or condition at screening
• Have a known immunodeficiency disorder
• Having a history of systemic infection requiring hospitalization or parenteral therapy, including history of infection with Mycobacterium TB
• Specific Viral Infection History (incl. history of herpes zoster, HBV or HCV Infection
• Current or recent history of clinically significant severe, progressive, or uncontrolled other medical conditions
• Any medical or psychiatric condition including any active suicidal ideation in the past year or suicidal behavior in the past 5 years
DRUG: Ritlecitinib, DRUG: Placebo
Hidradenitis Suppurativa
Ritlecitinib
Patient Quality of Recovery After TAVR With Different Sedation Regimens
clinicaltrials@northshore.org
ALL
18 years to 90 years old
PHASE4
NCT07556523
Inclusion Criteria:
* 18-90 years old, inclusive
* Undergoing transfemoral TAVR under Monitored Anesthesia Care (MAC)
* Speaks English or Spanish
* Consents to participate
Exclusion Criteria:
* Preoperative heart rate \< 50 bpm or arrhythmias (e.g., AFib with RVR)
* Conduction abnormalities (e.g., 2nd/3rd degree AV block without pacer)
* Allergy or contraindication to study drugs
* Pulmonary artery pressure \> 70mmHg
* Morbid obesity BMI \> 50
* Pregnancy
* Unable to consent in English or Spanish DRUG: Propofol, DRUG: Dexmedetomidine, DRUG: Midazolam, DRUG: Fentanyl
Transcatheter Aortic Valve Replacement (TAVR), Aortic Valve Stenosis
Transcatheter aortic valve replacement, TAVR, Sedation strategy, Anesthesia
A Research Study to Look at How Two Different Doses of CagriSema and One Dose of Semaglutide Help People Living With Obesity With or Without Type 2 Diabetes Lose Weight
clinicaltrials@northshore.org
ALL
18 years and over
PHASE3
NCT07564414
Inclusion Criteria :
* Male or female (sex assigned at birth, inclusive of all gender identities).
* Age 18 years or above at the time of signing the informed consent.
* BMI≥ 35.0 kg/m\^2.
* Participants without T2D: No history of T2D and HbA1c \< 6.5% (48 millimoles per mole (mmol/mol)) Participants with T2D: A history of T2D and HbA1c \< 10% (\< 86 mmol/mol). If a participant without a history of diabetes during the screening period receives an HbA1c result of 6.5% (48 mmol/mol) or higher, the investigator or the participant's healthcare provider must confirm the diagnosis of type 2 diabetes before the participant is randomised.
Exclusion Criteria:
* A self-reported change in body weight \> 5% within 90 days before screening, irrespective of medical records.
* Use of any glucagon-like-peptide-1 receptor agonist (GLP-1 RA), including medication with GLP-1 RA activity, or amylin analogues, including medication with amylin activity, within 6 months before screening. DRUG: Cagrisema, DRUG: Semaglutide
Obesity, Type 2 Diabetes
Vivistim Registry for Paired VNS Therapy (GRASP) (GRASP)
clinicaltrials@northshore.org
ALL
22 years and over
NCT05301140
Inclusion Criteria:
* Patients implanted with the Vivistim System for upper limb deficits associated with an ischemic stroke
Exclusion Criteria:
* Not eligible for surgery DEVICE: Vivistim System
Upper Extremity Problem
Ischemic Stroke, Paired Vagus Nerve Stimulation
Study of AGN-151607-DP to Assess Adverse Events and Change in Disease Activity in Adult Participants Undergoing Open Abdominal Ventral Hernia Repair
clinicaltrials@northshore.org
ALL
18 years to 80 years old
PHASE2
NCT07226791
Inclusion Criteria:
\- Midline ventral hernia requiring open surgical repair.
Exclusion Criteria:
* Medical condition that may put the participant at increased risk with exposure to AGN-151607-DP, including diagnosed muscular dystrophy (e.g., Duchenne's muscular dystrophy), myasthenia gravis, Eaton-Lambert syndrome, amyotrophic lateral sclerosis, mitochondrial disease, or any other significant disease which might interfere with neuromuscular function.
* History of abdominal or hernia repair surgery requiring hospitalization within 6 months prior to screening. DRUG: AGN-151607-DP, DRUG: Placebo for AGN-151607-DP
Ventral Hernia
Ventral Hernia, AGN-151607-DP, Primary fascial closure, Open Abdominal Ventral Hernia Repair
A Phase 2b Study of the Effects of Camoteskimab in Adults With Moderate-to-Severe Atopic Dermatitis
clinicaltrials@northshore.org
ALL
18 years to 65 years old
PHASE2
NCT07599813
Inclusion Criteria:
• Age 18-65 inclusive, at the time of signing the informed consent.
• Chronic AD for at least 1 year based on clinically confirmed diagnosis of active AD, according to Hanfin and Rajka criteria.
• Participants with moderate-to-severe AD defined by:
• Investigator global assessment (IGA) score of ≥ 3 (on a scale of 0 to 4, in which three is moderate and four is severe) at Screening and Baseline.
• AD involvement of ≥ 10% body surface area (BSA) at Screening and Baseline.
• EASI score of ≥ 16 at Screening and at Baseline.
• Peak pruritus numerical rating scale (PP-NRS) ≥ 4 at Baseline. Note: The PP-NRS will be calculated from the 7 consecutive days immediately preceding Baseline. A minimum of 4 daily scores out of the 7 days is needed.
• Participants who are candidates for systemic therapy, defined as history of inadequate response to topical AD treatments applied for at least 28 days, or for the maximum duration recommended by the product prescribing information, or for treatment with topical AD treatments is medically inadvisable due to important side effects or safety risks.
• Contraceptive use should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
• Participant provides signed informed consent
Exclusion Criteria:
• History or other evidence of severe illness or any other conditions such as psychiatric illness, severe depression or previous history of suicidal attempt in past 10 years that would render the participant, in the opinion of the Investigator, unsuitable for the study.
• Active, chronic or acute infection requiring systemic antibiotics, antivirals, antiparasitics, antiprotozoals, or antifungals within 2 weeks before the Baseline.
• Participant has a current diagnosis of other active skin disease (e.g., psoriasis or lupus erythematosus) or skin infection (bacterial, fungal, or viral) that may affect the evaluation of AD or would interfere with the study assessments based on the Investigator's judgement.
• Participant has history of significant flares of AD within 4 weeks prior to screening, in the opinion of the investigator.
• Participant has a severe comorbidity that may require systemic steroids therapy or other interventions or requires active frequent monitoring (e.g., unstable chronic asthma) based on investigator judgement.
• Any clinically significant abnormalities in rhythm, conduction or morphology of the resting electrocardiogram (ECG) and any clinically significant abnormalities in the 12-lead ECG as considered by the Investigator that may interfere with the interpretation of QTc interval changes.
• Participant has severe and uncontrolled seasonal or allergic rhinitis, severe and uncontrolled asthma or any other severe and uncontrolled atopic disease as judged by the Investigator.
• Treatment of AD with medicated moisturizers available only by prescription within 2 weeks prior to the Baseline visit.
• Active human immunodeficiency virus (HIV): confirmed positive anti-HIV antibody (HIV Ab) test.
• Active hepatitis B virus (HBV): hepatitis B surface antigen (HBs Ag) positive (+) or hepatitis B core antibody (HBc Ab) positive (+) confirmed by HBV PCR positive (+).
• Active hepatitis C virus (HCV): If hepatitis C antibody positive (+), confirmed by HCV RNA test. Note: a participant with documented proof of cure from HCV may be enrolled.
• Evidence of active or latent tuberculosis.
• Receipt of live or attenuated live vaccine within 6 weeks prior to screening.
• Participant had a major surgery within 8 weeks prior to Baseline or has a major surgery planned during the study.
• Participant is known to have immune deficiency or is immunocompromised
• Diagnosed with a malignancy within 5 years of enrollment (suspected malignancy should be ruled out by blood or tissue biopsy, as applicable) with the exception of: * Completely resected basal cell or squamous cell carcinoma of the skin. * Carcinoma in situ of the cervix.
• Has had previous exposure to anti-IL-18 therapy.
• Known allergy/sensitivity to any component of IMP.
• History of use of any of these medications as follows:
• Dupilumab, tralokinumab, lebrikizumab, nemolizumab within 8 weeks prior to Baseline.
• Systemic JAKi within 4 weeks prior to Baseline.
• Any topical medicated treatment that could affect AD within 2 weeks prior to Baseline, including, but not limited to, topical corticosteroids, topical phosphodiesterase (PDE4) inhibitors, topical calcineurin inhibitors, topical JAKi, tars, antimicrobials, medical devices, and bleach baths.
• Systemic therapies (other than biologics) that could affect AD not noted above, within 4 weeks prior to Baseline, including but not limited to, retinoids, calcineurin inhibitors, methotrexate, hydroxycarbamide (hydroxyurea), azathioprine, oral/injectable corticosteroids. Note: Intranasal corticosteroids and inhaled corticosteroids are allowed. Eye and ear drops containing corticosteroids are also allowed.
• Treatment with any investigational biologic agent or biologic agent approved after publication of this protocol, within 12 weeks (or 5 half-lives, whichever is greater) of screening.
• Treatment with any investigational nonbiologic agent, or any investigational device or procedure, within 4 weeks (or 5 half-lives, whichever is greater) of screening.
• UV-B phototherapy (including tanning beds) or excimer laser use within 4 weeks prior to Baseline or during the study.
• PUVA treatment within 4 weeks prior to Baseline
• Sedating antihistamines, including but not limited to doxepin, hydroxyzine or diphenhydramine within 1 week prior to Baseline
• Topical products containing urea within 1 week prior to Baseline
• Systemic antibiotics within 2 weeks or topical antibiotics within 1 week prior to Baseline
• Intravenous immunoglobulin (IVIg) therapy within 12 weeks prior to Baseline.
• Female participant who is pregnant or breastfeeding or trying to conceive.
• Participant considered unlikely to adhere to treatment and/or follow the protocol in the opinion of the Investigator.
DRUG: Camoteskimab, DRUG: Placebo
Atopic Dermatitis, Atopic, Dermatitis, Dermatitis, Atopic, Dermatologic Disease, Eczema, Eczema Atopic Dermatitis, Eczema, Atopic
Study of Trastuzumab Deruxtecan With Bevacizumab Versus Bevacizumab Monotherapy for First-line Maintenance in HER2-Expressing Ovarian Cancer (DESTINY-Ovarian01) (DO-01)
clinicaltrials@northshore.org
FEMALE
18 years and over
PHASE3
NCT06819007
Key
• Sign and date the tissue prescreening ICF, prior to HER2 central testing. Sign and date the Main ICF, prior to the start of any trial- specific qualification procedures. Consent to optional PGx prior to any PGx procedures. \*For participants in the safety run-in phase, a safety run-in ICF needs to be signed and dated prior to the start of any trial-specific qualification procedures.
• Adults ≥18 years of age on the day of signing the ICF. Follow local regulatory requirements if the legal age of consent for trial participation is \>18 years old.
• Has histologically confirmed diagnosis of epithelial high-grade ovarian, fallopian tube or primary peritoneal carcinoma per local assessment (including but not limiting to serous, endometrioid, clear cell, carcinosarcoma, mucinous).
• Is newly diagnosed FIGO Stage III or IV.
• Has HER2 expression per 2016 ASCO-CAP gastric cancer IHC scoring (3+/2+/1+) guidelines1 by prospective central testing. \*For participants in the safety run-in phase, HER2 expression assessed by either local (require using ASCO-CAP gastric cancer IHC scoring \[IHC 3+/2+/1+\] guidelines) or central assessment (if available) is acceptable. Submission of the pathology report is required for participants enrolled based on local HER2 IHC results.
• Has adequate tumor tissue sample available for assessment of HER2 by central laboratory. Tumor tissue block or sufficient tissue slides are required for HER2 testing and retrospective HRD status determination. \*Participants in the safety run-in phase who are enrolled based on local HER2 IHC results are recommended to provide tumor tissue sample from the same specimen for central assessment.
• Has a local HRD or BRCA test result available. Participants with BRCA-wildtype will have a local HRD test results, as applicable.
• Has received up to 6 cycles of standard of care bevacizumab in combination with frontline platinum- based chemotherapy as per approved indication and clinical guidelines and is eligible to continue single agent bevacizumab maintenance per standard of care and investigator discretion. Key
• Has ovarian, fallopian tube, or peritoneal cancer of non-epithelial origin.
• Has a known or suspected deleterious BRCA alteration as per local test that makes the patient eligible for PARP inhibitor.
• Participant to receive PARP inhibitor as maintenance per standard of care and investigator discretion. Reasons for which the participant is not eligible for PARP inhibitor will be recorded in the eCRF as follows: * HRD negative * HRD positive with SD as best response after platinum * HRD positive non-serous histology Note: For participants enrolled from the Republic of Korea * HRD tested, but inconclusive * HRD positive but safety concern (safety concern to be specified).
• Has a history of severe hypersensitivity reactions to either the drug substances or inactive ingredients in the drug products and other monoclonal antibodies.
• Previous Cerebral-Vascular Accident, Transient Ischemic Attack or Sub- Arachnoids Hemorrhage within 6 months prior to randomization. \*Note: For participants enrolled from the Republic of Korea,
• Has evidence of bleeding diathesis or significant coagulopathy (in the absence of anticoagulation therapy).
• Has a history of hemorrhagic disorders, abdominal fistula, gastrointestinal perforation, or active gastrointestinal bleeding within 6 months before randomization.
• Evidence of active or ongoing bowel obstruction.
• Has a medical history of myocardial infarction within 6 months before randomization, symptomatic congestive heart failure (New York Heart Association Class II to IV). Participants with troponin levels above the upper limit of normal at Screening (as defined by the manufacturer), and without any myocardial infarction related symptoms should have a cardiologic consultation during the Screening Period to rule out myocardial infarction.
• Has a corrected QT interval prolongation to \>480 msec based on average of the Screening triplicate 12-lead ECG.
• Has a history of (non-infectious) ILD/pneumonitis that required steroids, has current ILD/pneumonitis, or where suspected ILD/pneumonitis cannot be ruled out by imaging at Screening.
Inclusion Criteria:
• Sign and date the tissue prescreening ICF, prior to HER2 central testing. Sign and date the Main ICF, prior to the start of any trial- specific qualification procedures. Consent to optional PGx prior to any PGx procedures. \*For participants in the safety run-in phase, a safety run-in ICF needs to be signed and dated prior to the start of any trial-specific qualification procedures.
• Adults ≥18 years of age on the day of signing the ICF. Follow local regulatory requirements if the legal age of consent for trial participation is \>18 years old.
• Has histologically confirmed diagnosis of epithelial high-grade ovarian, fallopian tube or primary peritoneal carcinoma per local assessment (including but not limiting to serous, endometrioid, clear cell, carcinosarcoma, mucinous).
• Is newly diagnosed FIGO Stage III or IV.
• Has HER2 expression per 2016 ASCO-CAP gastric cancer IHC scoring (3+/2+/1+) guidelines1 by prospective central testing. \*For participants in the safety run-in phase, HER2 expression assessed by either local (require using ASCO-CAP gastric cancer IHC scoring \[IHC 3+/2+/1+\] guidelines) or central assessment (if available) is acceptable. Submission of the pathology report is required for participants enrolled based on local HER2 IHC results.
• Has adequate tumor tissue sample available for assessment of HER2 by central laboratory. Tumor tissue block or sufficient tissue slides are required for HER2 testing and retrospective HRD status determination. \*Participants in the safety run-in phase who are enrolled based on local HER2 IHC results are recommended to provide tumor tissue sample from the same specimen for central assessment.
• Has a local HRD or BRCA test result available. Participants with BRCA-wildtype will have a local HRD test results, as applicable.
• Has received up to 6 cycles of standard of care bevacizumab in combination with frontline platinum- based chemotherapy as per approved indication and clinical guidelines and is eligible to continue single agent bevacizumab maintenance per standard of care and investigator discretion. Key
Exclusion Criteria:
• Has ovarian, fallopian tube, or peritoneal cancer of non-epithelial origin.
• Has a known or suspected deleterious BRCA alteration as per local test that makes the patient eligible for PARP inhibitor.
• Participant to receive PARP inhibitor as maintenance per standard of care and investigator discretion. Reasons for which the participant is not eligible for PARP inhibitor will be recorded in the eCRF as follows: * HRD negative * HRD positive with SD as best response after platinum * HRD positive non-serous histology Note: For participants enrolled from the Republic of Korea * HRD tested, but inconclusive * HRD positive but safety concern (safety concern to be specified).
• Has a history of severe hypersensitivity reactions to either the drug substances or inactive ingredients in the drug products and other monoclonal antibodies.
• Previous Cerebral-Vascular Accident, Transient Ischemic Attack or Sub- Arachnoids Hemorrhage within 6 months prior to randomization. \*Note: For participants enrolled from the Republic of Korea,
• Has evidence of bleeding diathesis or significant coagulopathy (in the absence of anticoagulation therapy).
• Has a history of hemorrhagic disorders, abdominal fistula, gastrointestinal perforation, or active gastrointestinal bleeding within 6 months before randomization.
• Evidence of active or ongoing bowel obstruction.
• Has a medical history of myocardial infarction within 6 months before randomization, symptomatic congestive heart failure (New York Heart Association Class II to IV). Participants with troponin levels above the upper limit of normal at Screening (as defined by the manufacturer), and without any myocardial infarction related symptoms should have a cardiologic consultation during the Screening Period to rule out myocardial infarction.
• Has a corrected QT interval prolongation to \>480 msec based on average of the Screening triplicate 12-lead ECG.
• Has a history of (non-infectious) ILD/pneumonitis that required steroids, has current ILD/pneumonitis, or where suspected ILD/pneumonitis cannot be ruled out by imaging at Screening.
DRUG: Trastuzumab Deruxtecan, DRUG: Bevacizumab
Ovarian Cancer
Ovarian cancer, epithelial ovarian cancer, HER2, Trastuzumab Deruxtecan, Bevacizumab
PULSED AF Post-Approval Study
clinicaltrials@northshore.org
ALL
18 years and over
NCT06578104
Inclusion Criteria
* A diagnosis of recurrent symptomatic paroxysmal AF or persistent AF
* Refractory to at least one Class I or III antiarrhythmic drug (i.e., not effective, not tolerated, or not desired)
* Patient is ≥ 18 years of age
* Planned pulmonary vein isolation procedure with the commercially available PulseSelect™ PFA System
* Willing and able to comply with study requirements and give informed consent (defined as legally effective, documented confirmation of a subject's voluntary agreement to participate in this clinical study) or authorization per institution and geographical requirements
Exclusion Criteria
* Long-standing persistent AF (continuous AF sustained \>12 months)
* Prior left atrial catheter or surgical ablation
* Patient with life expectancy \< 36 months
* Presence of a permanent pacemaker, biventricular pacemaker, loop recorder/insertable cardiac monitor (ICM), or any type of implantable cardiac defibrillator (with or without biventricular pacing function)
* Current or anticipated participation in any other clinical trial of a drug, device, or biologic not approved by the global study manager
DEVICE: PulseSelect™ PFA system
Atrial Fibrillation
Efficacy, Safety, and Tolerability Study of Lunsekimig Compared With Placebo in Adult Participants With Inadequately Controlled Chronic Obstructive Pulmonary Disease (COPD) Characterized by an Eosinophilic Phenotype (PERSEPHONE)
clinicaltrials@northshore.org
ALL
40 years to 80 years old
PHASE3
NCT07190209
Inclusion Criteria:
* Between 40 to 80 years of age
* Physician diagnosed chronic obstructive pulmonary disease (COPD) ≥1 year
* Post-bronchodilator forced expiratory volume in 1 second (post-BD FEV1) ≥ 20% and ≤ 70% of predicted value and FEV1/FVC (forced expiratory volume in 1 second /forced vital capacity) \<0.70
* Former or current smokers ≥10 pack-years
* Chronic Airways Assessment Test (CAAT) ≥10
* ≥2 moderate or ≥1 severe COPD exacerbations in the prior year
* Triple (ICS+LABA+LAMA) COPD therapy ≥12 consecutive weeks
* EOS (blood eosinophil count) ≥ 150 cells/μL
* 18.0 ≤ Body Mass Index ≤ 40.0 kg/m2
Exclusion Criteria:
Participants are excluded from the study if any of the following criteria apply:
* Asthma, including pediatric asthma, or asthma-COPD overlap syndrome (ACOS)
* Significant pulmonary disease other than COPD
* Long-term oxygen therapy \>4.0 L/min or requirement of \>2.0 L/min to maintain oxygen saturation \>88% at rest
* Unstable disorder that can impact participants safety or study outcomes
* Active or incompletely treated tuberculosis
* Current or past malignancies
* Concomitant therapies:
* long-term macrolides or phosphodiesterase Type 3 (PDE-3) or PDE-4 inhibitors unless on stable therapy for \>6 months
* any biologic therapy or systemic immunosuppressant within 4 months or 5 half-lives prior to Screening
The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial DRUG: Lunsekimig, DRUG: Placebo
Chronic Obstructive Pulmonary Disease
Registry on NeVa VS for CerebraL VAsospasm ManagemenT in Post SAH PatiEnts (DILATE)
clinicaltrials@northshore.org
ALL
22 years and over
NCT06893588
Inclusion Criteria:
• Age ≥22
• Symptomatic cerebral vasospasm secondary to aneurysmal subarachnoid hemorrhage (aSAH) in the internal carotid artery (ICA), middle cerebral artery (MCA), anterior cerebral artery (ACA), posterior cerebral artery (PCA), or basilar artery (BA)
• Vessel dilation procedure was performed with the NeVa VS
• Subject or legal representative is able and willing to give informed consent within 3 days (72 hours) post-index procedure
Exclusion Criteria:
* None DEVICE: NEVA VS
Cerebral Vasospasm, Aneurysmal Subarachnoid Hemorrhage (aSAH)
vasospasm