[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT06477419":3,"trial-entities:NCT06477419":168,"trial-summary:NCT06477419":171},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":15,"conditions":17,"keywords":21,"study_type":24,"primary_purpose":25,"phases":26,"enrollment_info":28,"interventions":31,"primary_outcomes":38,"secondary_outcomes":43,"sex":44,"minimum_age":45,"maximum_age":15,"healthy_volunteers":46,"eligibility_criteria":47,"std_ages":81,"locations":84,"central_contacts":154,"overall_officials":161,"references":164,"see_also_links":165},"NCT06477419","24-081","A Study of Sacituzumab Govitecan in People With Mesothelioma","Phase 2 Study of Sacituzumab Govitecan-hziy in Patients With Previously Treated Mesothelioma","RECRUITING","2029-06-21","2026-05","2026-05-28","2024-06-21","Memorial Sloan Kettering Cancer Center","OTHER",null,"Participants will receive sacituzumab govitecan until their disease gets worse (progresses), they have severe side effects and cannot continue study treatment, or the participants or the study doctor thinks it's in your best interest to stop treatment.",[18,19,20],"Mesothelioma","Mesotheliomas Pleural","Mesothelioma; Pleura",[18,19,20,22,23,5,13],"Diffuse Pleural Mesothelioma","Sacituzumab","INTERVENTIONAL","TREATMENT",[27],"PHASE2",{"count":29,"type":30},33,"ESTIMATED",[32],{"type":33,"name":34,"description":35,"armGroupLabels":36},"DRUG","Sacituzumab govitecan-hziy","After enrollment, participants will receive SG until disease progression or intolerable toxicity.",[37],"Participants with Mesothelioma",[39],{"measure":40,"description":41,"timeFrame":42},"Overall Response Rate","Clinical efficacy of SG in participants with recurrent and\u002For unresectable\u002Fmetastatic DPM treated past the Cycle 3 tumor assessment determined by overall response rate as primarily assessed by modified (m)RECIST. Overall response rate defined as participants who achieve complete response or partial response as best overall response by modified RECIST v1.1 criteria for mesothelioma.","2 years",[],"ALL","18 Years",false,{"inclusion":48,"exclusion":64,"raw_text":80},[49,50,51,52,53,54,55,56,57,58,59,60,61,62,63],"Patient, or legally authorized representative (LAR), willing and able to provide written informed consent for the trial","Patient age ≥ 18 at time of consent","Pathologically confirmed diffuse pleural mesothelioma","Must have received at least one prior systemic therapy (platinum\u002Fpemetrexed, immunotherapy or a combination thereof)","Measurable disease as defined primarily by the modified RECIST criteria for mesothelioma (at PI discretion RECIST v1.1 may be used)","Consent to undergo a biopsy prior to Cycle 1 Day 1 and Cycle 3 Day 1 if deemed medically safe and feasible","Eastern Cooperative Oncology Group (ECOG) score 0 or Karnofsky Performance Status ≥ 70%","Adequate organ function, defined as","Absolute neutrophil count ≥ 1.5K\u002FmcL","Platelet count ≥ 100K\u002FmcL","Adequate renal function defined as creatinine clearance ≥ 30ml\u002Fmin (as calculated by Cockcroft-Gault Formula)","Hemoglobin \\> 9g\u002FdL (prior transfusion permitted if not within 7 days of enrollment)","Total bilirubin ≤1.5 x upper limit of normal (ULN) if no liver metastases or \\\u003C3 × ULN in the presence of documented Gilbert's Syndrome (unconjugated hyperbilirubinemia) or liver metastases; subjects with Gilbert's syndrome can enroll if conjugated bilirubin is within normal limits","AST, ALT ≤ 2.5 x ULN (if liver metastases are present, ≤5 × ULN)","If of childbearing potential, must be willing to use highly effective mode of contraception for at least one month prior, during, and for 2 months after the end of active therapy",[65,66,67,68,69,70,71,72,73,74,75,76,77,78,79],"Currently participating in another study and receiving another study therapy or has participated in a study of an investigational agent and received study therapy or used an investigational device within 3 weeks of the first dose of treatment","Prior hypersensitivity to irinotecan or any components of sacituzumab govitecan-hziy","Prior cytotoxic\u002Fimmunologic systemic therapy within 3 weeks prior to study Day 1 or has not recovered (i.e., CTCAE v5 ≥ Grade 1 at baseline; from clinically significant adverse events due to a previously administered agent (excluding Grade 2 neuropathy)","Known psychiatric or substance abuse disorders that would interfere with the requirements of the trial within the opinion of the investigator","Known additional malignancy that is progressing or requires active treatment. Exceptions include basal cell carcinoma of the skin, squamous cell carcinoma of the skin, early stage prostate cancer, or in situ cervical cancer after definitive treatment","Positive hepatitis B (hepatitis B virus \\[HBV\\]) surface antigen (HBsAg)","Positive hepatitis C antibody (anti-HCV)","Participant is positive for human immunodeficiency virus (HIV), with 1 or more of the following:","Receiving ART that may interfere with study treatment (consult sponsor for review of medication prior to enrollment)","CD4 count \\\u003C 350 cells\u002Fmm3 at screening","AIDS-defining opportunistic infection within 6 months of start of screening","Not agreeing to start ART and be on ART \\> 4 weeks plus having HIV viral load \\\u003C400 copies\u002FmL at end of 4-week period (to ensure ART is tolerated and HIV controlled)","Myocardial infarction, unstable angina, stroke, transient ischemic attack (TIA), or coronary\u002Fperipheral artery bypass graft, or any acute coronary syndrome within 6 months of start of study drug","Congestive heart failure defined as New York Heart Association (NYHA) Class III-IV or hospitalization for congestive heart failure (any NYHA class) within 6 months of study Day 1","Pregnant women or women who are breastfeeding or of childbearing potential and not using a highly effective method of birth control for at least one month prior to enrollment. If the risk of contraception exists, male and female subjects must use highly effective contraception throughout the study and for at least 60 days after last treatment. Highly effective contraception includes either 2 barrier methods (diaphragm, condom by the partner, copper intrauterine device, sponge, or spermicide), or 1 barrier method and 1 hormonal method (any oral, subcutaneous, intrauterine, or intramuscular registered and marketed contraceptive agent that contains an estrogen and\u002For a progesterone agent)","Inclusion Criteria:\n\n* Patient, or legally authorized representative (LAR), willing and able to provide written informed consent for the trial\n* Patient age ≥ 18 at time of consent\n* Pathologically confirmed diffuse pleural mesothelioma\n* Must have received at least one prior systemic therapy (platinum\u002Fpemetrexed, immunotherapy or a combination thereof)\n* Measurable disease as defined primarily by the modified RECIST criteria for mesothelioma (at PI discretion RECIST v1.1 may be used)\n* Consent to undergo a biopsy prior to Cycle 1 Day 1 and Cycle 3 Day 1 if deemed medically safe and feasible\n* Eastern Cooperative Oncology Group (ECOG) score 0 or Karnofsky Performance Status ≥ 70%\n* Adequate organ function, defined as\n\n  * Absolute neutrophil count ≥ 1.5K\u002FmcL\n  * Platelet count ≥ 100K\u002FmcL\n  * Adequate renal function defined as creatinine clearance ≥ 30ml\u002Fmin (as calculated by Cockcroft-Gault Formula)\n  * Hemoglobin \\> 9g\u002FdL (prior transfusion permitted if not within 7 days of enrollment)\n  * Total bilirubin ≤1.5 x upper limit of normal (ULN) if no liver metastases or \\\u003C3 × ULN in the presence of documented Gilbert's Syndrome (unconjugated hyperbilirubinemia) or liver metastases; subjects with Gilbert's syndrome can enroll if conjugated bilirubin is within normal limits\n  * AST, ALT ≤ 2.5 x ULN (if liver metastases are present, ≤5 × ULN)\n* If of childbearing potential, must be willing to use highly effective mode of contraception for at least one month prior, during, and for 2 months after the end of active therapy\n\nExclusion Criteria:\n\n* Currently participating in another study and receiving another study therapy or has participated in a study of an investigational agent and received study therapy or used an investigational device within 3 weeks of the first dose of treatment\n* Prior hypersensitivity to irinotecan or any components of sacituzumab govitecan-hziy\n* Prior cytotoxic\u002Fimmunologic systemic therapy within 3 weeks prior to study Day 1 or has not recovered (i.e., CTCAE v5 ≥ Grade 1 at baseline; from clinically significant adverse events due to a previously administered agent (excluding Grade 2 neuropathy)\n* Known psychiatric or substance abuse disorders that would interfere with the requirements of the trial within the opinion of the investigator\n* Known additional malignancy that is progressing or requires active treatment. Exceptions include basal cell carcinoma of the skin, squamous cell carcinoma of the skin, early stage prostate cancer, or in situ cervical cancer after definitive treatment\n* Positive hepatitis B (hepatitis B virus \\[HBV\\]) surface antigen (HBsAg)\n\n  o NOTE: Subjects with a prior history of HBV demonstrated by positive hepatitis B core antibody are eligible if they have at Screening 1) a negative HBsAg and 2) a HBV DNA (viral load) below the lower limit of quantification, per local testing. Patients who fit these criteria must use Hep B prophylaxis during treatment. Subjects with a positive HBsAg due to recent vaccination are eligible if HBV DNA (viral load) is below the lower limit of quantification, per local testing\n* Positive hepatitis C antibody (anti-HCV)\n\n  o NOTE: Subjects with a prior history of HCV, who have completed antiviral treatment and have subsequently documented HCV RNA below the lower limit of quantification per local testing are eligible\n* Participant is positive for human immunodeficiency virus (HIV), with 1 or more of the following:\n\n  * Receiving ART that may interfere with study treatment (consult sponsor for review of medication prior to enrollment)\n  * CD4 count \\\u003C 350 cells\u002Fmm3 at screening\n  * AIDS-defining opportunistic infection within 6 months of start of screening\n  * Not agreeing to start ART and be on ART \\> 4 weeks plus having HIV viral load \\\u003C400 copies\u002FmL at end of 4-week period (to ensure ART is tolerated and HIV controlled)\n* Myocardial infarction, unstable angina, stroke, transient ischemic attack (TIA), or coronary\u002Fperipheral artery bypass graft, or any acute coronary syndrome within 6 months of start of study drug\n* Congestive heart failure defined as New York Heart Association (NYHA) Class III-IV or hospitalization for congestive heart failure (any NYHA class) within 6 months of study Day 1\n* Pregnant women or women who are breastfeeding or of childbearing potential and not using a highly effective method of birth control for at least one month prior to enrollment. If the risk of contraception exists, male and female subjects must use highly effective contraception throughout the study and for at least 60 days after last treatment. Highly effective contraception includes either 2 barrier methods (diaphragm, condom by the partner, copper intrauterine device, sponge, or spermicide), or 1 barrier method and 1 hormonal method (any oral, subcutaneous, intrauterine, or intramuscular registered and marketed contraceptive agent that contains an estrogen and\u002For a progesterone agent)",[82,83],"ADULT","OLDER_ADULT",[85,99,109,118,128,137,145],{"facility":86,"status":8,"city":87,"state":88,"zip":89,"country":90,"contacts":91,"geoPoint":96},"Memorial Sloan Kettering Basking Ridge","Basking Ridge","New Jersey","07920","United States",[92],{"name":93,"role":94,"phone":95},"Michael Offin, MD","CONTACT","646-449-1778",{"lat":97,"lon":98},40.70621,-74.54932,{"facility":100,"status":8,"city":101,"state":88,"zip":102,"country":90,"contacts":103,"geoPoint":106},"Memorial Sloan Kettering Monmouth","Middletown","07748",[104],{"name":93,"role":94,"phone":105},"646-608-3763",{"lat":107,"lon":108},40.39428,-74.11709,{"facility":110,"status":8,"city":111,"state":88,"zip":112,"country":90,"contacts":113,"geoPoint":115},"Memorial Sloan Kettering Bergen","Montvale","07645",[114],{"name":93,"role":94,"phone":105},{"lat":116,"lon":117},41.04676,-74.02292,{"facility":119,"status":8,"city":120,"state":121,"zip":122,"country":90,"contacts":123,"geoPoint":125},"Memorial Sloan Kettering Cancer Center @ Commack","Commack","New York","11725",[124],{"name":93,"role":94,"phone":105},{"lat":126,"lon":127},40.84288,-73.29289,{"facility":129,"status":8,"city":130,"state":121,"zip":131,"country":90,"contacts":132,"geoPoint":134},"Memorial Sloan Kettering Westchester","Harrison","10604",[133],{"name":93,"role":94,"phone":105},{"lat":135,"lon":136},40.96899,-73.71263,{"facility":138,"status":8,"city":121,"state":121,"zip":139,"country":90,"contacts":140,"geoPoint":142},"Memorial Sloan - Kettering Cancer Center","10021",[141],{"name":93,"role":94,"phone":105},{"lat":143,"lon":144},40.71427,-74.00597,{"facility":146,"status":8,"city":147,"state":121,"zip":148,"country":90,"contacts":149,"geoPoint":151},"Memorial Sloan Kettering Nassau","Uniondale","11553",[150],{"name":93,"role":94,"phone":105},{"lat":152,"lon":153},40.70038,-73.59291,[155,157],{"name":93,"role":94,"phone":105,"email":156},"offinm@mskcc.org",{"name":158,"role":94,"phone":159,"email":160},"Robert Daly, MD, MBA","646-608-3789","dalyr1@mskcc.org",[162],{"name":93,"affiliation":13,"role":163},"PRINCIPAL_INVESTIGATOR",[],[166],{"label":13,"url":167},"http:\u002F\u002Fwww.mskcc.org",{"nct_id":4,"conditions":169,"biomarkers":170},[22],[],{"nct_id":4,"found":172,"summary":173,"prompt_version":183},true,{"design":174,"status":175,"heading":176,"summary":177,"follow_up":178,"word_count":179,"commitments":180,"compensation":181,"drugs_mentioned":182},"This is an interventional study, meaning participants will receive a specific treatment. It plans to enroll 33 people.","completed","A Study of Sacituzumab Govitecan for Mesothelioma","This study is looking at a treatment called sacituzumab govitecan-hziy for people with mesothelioma that affects the lining of the lungs (pleural mesothelioma). You might be able to join if you are 18 or older, have been diagnosed with diffuse pleural mesothelioma, and have already received at least one other treatment like chemotherapy or immunotherapy. The main goal is to see how many people respond to the treatment over two years. The study is currently recruiting about 33 participants, but its overall status is unclear.","The main goal is measured at 2 years, suggesting follow-up for at least that long.",85,"Participants will receive sacituzumab govitecan-hziy until their disease gets worse, they have severe side effects, or they or their doctor decide to stop treatment.","Not stated in the trial record.",[34],"v2"]