[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100654817":3},{"organization":4,"outcomesModule":7,"designInfo":50,"detailedDescription":56,"studyPopulation":49,"armGroups":57,"interventions":68,"overallOfficials":77,"centralContacts":82,"locations":91,"responsibleParty":290,"collaborators":49,"id":292,"slug":293,"hasResults":294,"nctId":295,"briefTitle":296,"officialTitle":297,"acronym":298,"eligibilityCriteria":299,"healthyVolunteers":294,"sex":300,"minAge":301,"maxAge":49,"enrollmentInfo":302,"targetDuration":49,"studyType":305,"phases":306,"briefSummary":308,"conditions":309,"keywords":312,"overallStatus":314,"whyStopped":49,"lastUpdateSubmitDate":315,"lastUpdatePostDateStruct":316,"startDateStruct":319,"completionDateStruct":321,"leadSponsor":323,"locationsCount":324},{"fullName":5,"class":6},"Latin American Cooperative Oncology Group","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":49},[9],{"measure":10,"description":11,"timeFrame":12},"Objective Response Rate (ORR) by Investigator Assessment","Proportion of participants with a best overall response of complete response (CR) or partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST 1.1) as assessed by local site investigator\u002Fradiology.","Up to Week 24",[14,18,21,25,28,31,35,39,42,46],{"measure":15,"description":16,"timeFrame":17},"Objective Response Rate by Independent Central Review (ORR-ICR)","Proportion of participants achieving complete response (CR) or partial response (PR) as evaluated by Independent Central Review using RECIST v1.1 criteria.","Up to 24 weeks.",{"measure":19,"description":20,"timeFrame":17},"Disease Control Rate (DCR)","Proportion of participants achieving a best overall response of complete response (CR), partial response (PR), or stable disease (SD) according to RECIST v1.1 by investigator assessment..",{"measure":22,"description":23,"timeFrame":24},"Duration of Response (DoR)","Time from the first documented evidence of complete response (CR) or partial response (PR) until the date of first documented disease progression or death due to any cause, whichever occurs first.","Up to approximately 40 months.",{"measure":26,"description":27,"timeFrame":24},"Progression-Free Survival (PFS)","Time from the date of enrollment until the date of first documented disease progression (radiographically or clinically confirmed per RECIST 1.1) by investigator assessment, or death due to any cause, whichever occurs first.",{"measure":29,"description":30,"timeFrame":24},"Overall Survival (OS)","Time from the date of enrollment to the date of participant death due to any cause.",{"measure":32,"description":33,"timeFrame":34},"Clinical Benefit Rate (CBR)","Rate, incidence, and severity of treatment-emergent adverse events (AEs) and Grade $\\\\ge 3$ AEs evaluated according to NCI CTCAE version 5.0, including Adverse Events of Special Interest (AESIs).","From enrollment up to 30 days after the last dose of study intervention.",{"measure":36,"description":37,"timeFrame":38},"Treatment Compliance","Assessment of treatment modifications, including the proportion and reasons for dose reductions, treatment delays, or permanent discontinuations (e.g., disease progression, AEs, consent withdrawal).","Up to approximately 2 years.",{"measure":40,"description":41,"timeFrame":24},"Post-Progression Therapies","Descriptive characterization and timing of subsequent anticancer therapies administered after disease progression on sac-TMT.",{"measure":43,"description":44,"timeFrame":45},"Health-Related Quality of Life (HRQoL) - EORTC QLQ-C30","Assessment of changes from baseline in global health status, functional domains, and symptom scales evaluated using the EORTC QLQ-C30 core cancer instrument.","Baseline and every 6 weeks during treatment up to Week 24.",{"measure":47,"description":48,"timeFrame":45},"Health-Related Quality of Life (HRQoL) - EORTC QLQ-VU34","ssessment of changes from baseline in vulvar\u002Fvaginal cancer-specific symptoms evaluated using the EORTC QLQ-VU34 questionnaire.",null,{"allocation":51,"interventionModel":52,"interventionModelDescription":49,"primaryPurpose":53,"observationalModel":49,"timePerspective":49,"maskingInfo":54},"NON_RANDOMIZED","PARALLEL","TREATMENT",{"masking":55,"maskingDescription":49,"whoMasked":49},"NONE","RATIONALE AND MOLECULAR TARGETING\n\nAdvanced and metastatic vulvar and vaginal squamous cell carcinomas share pathophysiological features with cervical cancer, including high rates of Human Papillomavirus (HPV) driver oncogenesis and robust expression of Trophoblast Cell Surface Antigen 2 (TROP-2). Sacituzumab tirumotecan (sac-TMT, MK-2870) is a novel TROP-2-directed antibody-drug conjugate (ADC) composed of a humanized anti-TROP2 IgG1 monoclonal antibody linked via a methyl sulfonyl moiety to a potent topoisomerase 1 inhibitor payload (KL610023). Upon binding to TROP-2 on tumor cells, sac-TMT internalizes and releases its payload, inducing cell cycle arrest and apoptosis while exerting bystander-killing and antibody-dependent cellular cytotoxicity.\n\nDREAM STUDY DESIGN AND STATISTICAL CONSIDERATIONS\n\nThis Phase II study utilizes a Simon's two-stage Minimax design for each independent cohort (Cohort A: Vagina; Cohort B: Vulva) to control the familywise alpha level at 0.05 (one-sided) with 80% power:\n\nStage 1: 12 participants per cohort will be enrolled. An interim analysis for futility will be conducted; if 0 responses are observed in Stage 1, enrollment in that cohort will be halted.\n\nStage 2: If $\\\\ge 1$ objective response is achieved in Stage 1, an additional 10 participants will be accrued (totaling 22 evaluable patients per cohort, expanded to 24 to account for a 10% dropout rate). A cohort is considered positive if $\\\\ge 4$ responses are observed among evaluable participants.\n\nTREATMENT ADMINISTRATION AND MANDATORY PROPHYLAXISSac-TMT is administered intravenously on Days 1 and 15 of 28-day cycles. Mandatory premedication administered 1.5 hours ($\\\\pm30$ minutes) prior to each infusion includes an H1 receptor antagonist (diphenhydramine or equivalent), acetaminophen, dexamethasone (8-10 mg IV), and an H2 receptor antagonist to minimize infusion-related reactions. To prevent oral mucositis, participants receive mandatory daily prophylactic steroid-containing mouthwash (dexamethasone solution) 4 times daily. Prophylactic artificial tears are also strongly recommended to mitigate ocular surface toxicities.\n\nEXPLORATORY BIOMARKER RESEARCH\n\nThe trial incorporates a longitudinal biorepository to identify predictive signatures and resistance mechanisms. Mandatory archival or freshly obtained FFPE tumor tissue blocks\u002Fslides collected at baseline will undergo TROP-2 immunohistochemistry (IHC), p16\u002FHPV16 profiling, and high-throughput next-generation sequencing (NGS). Serial blood samples (plasma\u002FPBMCs) collected at baseline and prespecified on-treatment timepoints (Weeks 6, 12, 24, and at disease progression) will evaluate circulating tumor DNA (ctDNA) dynamics and immune cell profiling to monitor treatment response and genomic resistance patterns over time.",[58,64],{"label":59,"type":60,"description":61,"interventionNames":62},"Cohort A: Vaginal Cancer","EXPERIMENTAL","Participants with advanced or metastatic vaginal squamous cell carcinoma who progressed on or after platinum-based chemotherapy. Participants will receive sacituzumab tirumotecan (sac-TMT, MK-2870) monotherapy at a dose of $4\\\\text{ mg\u002Fkg}$ via intravenous (IV) infusion on Days 1 and 15 of every 28-day cycle. Treatment continues until disease progression, unacceptable toxicity, or for a maximum exposure duration of approximately 2 years.",[63],"Drug: Sacituzumab Tirumotecan (sac-TMT)",{"label":65,"type":60,"description":66,"interventionNames":67},"Cohort B: Vulvar Cancer","Participants with advanced or metastatic vulvar squamous cell carcinoma who progressed on or after platinum-based chemotherapy. Participants will receive sacituzumab tirumotecan (sac-TMT, MK-2870) monotherapy at a dose of $4\\\\text{ mg\u002Fkg}$ via intravenous (IV) infusion on Days 1 and 15 of every 28-day cycle. Treatment continues until disease progression, unacceptable toxicity, or for a maximum exposure duration of approximately 2 years.",[63],[69],{"type":70,"name":71,"description":72,"armGroupLabels":73,"otherNames":74},"DRUG","Sacituzumab Tirumotecan (sac-TMT)","Sacituzumab tirumotecan is a TROP-2-directed antibody-drug conjugate (ADC) consisting of a humanized anti-TROP2 IgG1 monoclonal antibody linked to a topoisomerase 1 inhibitor payload (KL610023). It will be administered intravenously at a dose of $4\\\\text{ mg\u002Fkg}$ on Days 1 and 15 of every 28-day cycle until disease progression, unacceptable toxicity, or up to a maximum duration of approximately 2 years.",[59,65],[75,76],"MK-2870","SKB264",[78],{"name":79,"affiliation":80,"role":81},"Fernando Cotait Maluf","Hospital Israelita Albert Einstein","PRINCIPAL_INVESTIGATOR",[83,88],{"name":84,"role":85,"phone":86,"phoneExt":49,"email":87},"Project Manager","CONTACT","+55 (51) 3384.5334","lacog1724@lacog.group",{"name":89,"role":85,"phone":86,"phoneExt":49,"email":90},"Head of Clinical Operations","laura.voelcker@lacog.group",[92,112,129,142,159,176,193,210,226,243,260,273],{"facility":93,"status":49,"city":94,"state":95,"zip":96,"country":97,"countryCode":98,"cosmosGeoPoint":99,"geoPoint":104,"contacts":105},"Pronutrir - Suporte Nutricional e Quimioterapia","Fortaleza","Ceará","60810-180","Brazil","BR",{"type":100,"coordinates":101},"Point",[102,103],-38.54306,-3.71722,{"lat":103,"lon":102},[106,110],{"name":107,"role":85,"phone":108,"phoneExt":49,"email":109},"Antonia Felizalvina Barroso Dias","+5585992656791","branca.dias@pronutrir.com.br",{"name":111,"role":81,"phone":49,"phoneExt":49,"email":49},"Rosane Oliveira de Sant'Ana",{"facility":113,"status":49,"city":114,"state":115,"zip":116,"country":97,"countryCode":98,"cosmosGeoPoint":117,"geoPoint":121,"contacts":122},"Santa Casa de Misericórdia da Bahia - Hospital Santa Izabel (Oncoclínicas)","Salvador","Estado de Bahia","40050-410",{"type":100,"coordinates":118},[119,120],-38.49096,-12.97563,{"lat":120,"lon":119},[123,127],{"name":124,"role":85,"phone":125,"phoneExt":49,"email":126},"Nivana Borges do Sacramento","+557122038476","nivana.sacramento@santacasaba.org.br",{"name":128,"role":81,"phone":49,"phoneExt":49,"email":49},"Daniela Galvão Barros de Oliveira",{"facility":130,"status":49,"city":131,"state":130,"zip":132,"country":97,"countryCode":98,"cosmosGeoPoint":133,"geoPoint":137,"contacts":138},"HIAE - Hospital Israelita Albert Einstein","São Paulo","05653-000",{"type":100,"coordinates":134},[135,136],-46.63611,-23.5475,{"lat":136,"lon":135},[139],{"name":79,"role":85,"phone":140,"phoneExt":49,"email":141},"+5511981214499","maluffc@uol.com.br",{"facility":143,"status":49,"city":144,"state":145,"zip":146,"country":97,"countryCode":98,"cosmosGeoPoint":147,"geoPoint":151,"contacts":152},"UFMG - Universidade Federal de Minas Gerais","Belo Horizonte","Minas Gerais","30130-100",{"type":100,"coordinates":148},[149,150],-43.93778,-19.92083,{"lat":150,"lon":149},[153,157],{"name":154,"role":85,"phone":155,"phoneExt":49,"email":156},"Carla de Oliveira do Nascimento","+553133079255","carla-nascimento.cn@ebserh.gov.br",{"name":158,"role":81,"phone":49,"phoneExt":49,"email":49},"Angélica Nogueira Rodrigues",{"facility":160,"status":49,"city":161,"state":162,"zip":163,"country":97,"countryCode":98,"cosmosGeoPoint":164,"geoPoint":168,"contacts":169},"Hospital Napoleão Laureano","João Pessoa","Paraíba","58013-140",{"type":100,"coordinates":165},[166,167],-34.86306,-7.115,{"lat":167,"lon":166},[170,174],{"name":171,"role":85,"phone":172,"phoneExt":49,"email":173},"Débora Alves Rodrigues de Lima","+5583988250322","debora.enf.hnl@gmail.com",{"name":175,"role":81,"phone":49,"phoneExt":49,"email":49},"Thiago Lins da Costa Almeida",{"facility":177,"status":49,"city":178,"state":179,"zip":180,"country":97,"countryCode":98,"cosmosGeoPoint":181,"geoPoint":185,"contacts":186},"Hospital Ophir Loyola","Belém","Pará","66063-240",{"type":100,"coordinates":182},[183,184],-48.50444,-1.45583,{"lat":184,"lon":183},[187,191],{"name":188,"role":85,"phone":189,"phoneExt":49,"email":190},"Cynthia Lins Pereira","+5591981298434","cpchol@ophirloyola.pa.gov.br",{"name":192,"role":81,"phone":49,"phoneExt":49,"email":49},"Marcella Coelho Mesquita Fernandes",{"facility":194,"status":49,"city":195,"state":196,"zip":197,"country":97,"countryCode":98,"cosmosGeoPoint":198,"geoPoint":202,"contacts":203},"Centro de Pesquisa Vencer e Oncoclínica","Teresina","Piauí","60449-200",{"type":100,"coordinates":199},[200,201],-42.80194,-5.08917,{"lat":201,"lon":200},[204,208],{"name":205,"role":85,"phone":206,"phoneExt":49,"email":207},"Fernanda Bitencourt da Rocha","+5586994370620","VENCERPESQUISACLINICA@GMAIL.COM",{"name":209,"role":81,"phone":49,"phoneExt":49,"email":49},"Danilo da Fonseca Reis Silva",{"facility":211,"status":49,"city":212,"state":212,"zip":213,"country":97,"countryCode":98,"cosmosGeoPoint":214,"geoPoint":218,"contacts":219},"INCA - Instituto Nacional de Câncer","Rio de Janeiro","20230-130",{"type":100,"coordinates":215},[216,217],-43.18223,-22.90642,{"lat":217,"lon":216},[220,224],{"name":221,"role":85,"phone":222,"phoneExt":49,"email":223},"Flavia Vieira Guerra Alves","+5521981127437","falves@inca.gov.br",{"name":225,"role":81,"phone":49,"phoneExt":49,"email":49},"Andreia Cristina de Melo",{"facility":227,"status":49,"city":228,"state":229,"zip":230,"country":97,"countryCode":98,"cosmosGeoPoint":231,"geoPoint":235,"contacts":236},"Liga Norte Riograndense Contra o Câncer","Natal","Rio Grande do Norte","59062-000",{"type":100,"coordinates":232},[233,234],-35.20944,-5.795,{"lat":234,"lon":233},[237,241],{"name":238,"role":85,"phone":239,"phoneExt":49,"email":240},"Ana Paula Ferreira Costa","+558440095595","anapaula.costa@liga.org.br",{"name":242,"role":81,"phone":49,"phoneExt":49,"email":49},"Sulene Cunha Sousa Oliveira",{"facility":244,"status":49,"city":245,"state":246,"zip":247,"country":97,"countryCode":98,"cosmosGeoPoint":248,"geoPoint":252,"contacts":253},"Futtura Oncologia - Hub de Pesquisa Clínica","Porto Alegre","Rio Grande do Sul","90470-340",{"type":100,"coordinates":249},[250,251],-51.23019,-30.03283,{"lat":251,"lon":250},[254,258],{"name":255,"role":85,"phone":256,"phoneExt":49,"email":257},"Tereza Mandarino","555199905582","tereza.mandarino@futturaoncologia.com",{"name":259,"role":81,"phone":49,"phoneExt":49,"email":49},"Fernanda Cano Casarotto",{"facility":261,"status":49,"city":131,"state":131,"zip":262,"country":97,"countryCode":98,"cosmosGeoPoint":263,"geoPoint":265,"contacts":266},"ICESP - Instituto do Câncer do Estado de São Paulo","01246-000",{"type":100,"coordinates":264},[135,136],{"lat":136,"lon":135},[267,271],{"name":268,"role":85,"phone":269,"phoneExt":49,"email":270},"Marlene Salgado Fidelis","+551138932645","marlene.salgado@hc.fm.usp.br",{"name":272,"role":81,"phone":49,"phoneExt":49,"email":49},"Maria Del Pilar Estevez Diz",{"facility":274,"status":49,"city":275,"state":276,"zip":277,"country":97,"countryCode":98,"cosmosGeoPoint":278,"geoPoint":282,"contacts":283},"FUNFARME - Fundação Faculdade Regional de Medicina de São José do Rio Preto","São José do Rio Preto","São Paul","15090-000",{"type":100,"coordinates":279},[280,281],-49.37944,-20.81972,{"lat":281,"lon":280},[284,288],{"name":285,"role":85,"phone":286,"phoneExt":49,"email":287},"Kátia Nishiyama","+551732011771","katia.nishiyama@centrodepesquisacip.com.br",{"name":289,"role":81,"phone":49,"phoneExt":49,"email":49},"Camila Gardin Ferrari",{"type":291,"investigatorFullName":49,"investigatorTitle":49,"investigatorAffiliation":49,"oldNameTitle":49,"oldOrganization":49},"SPONSOR","100654817","phase-2-sac-tmt-in-vaginal-and-vulvar-cancers-100654817",false,"NCT07804966","Sac-TMT in Vaginal and Vulvar Cancers","A Single-arm Phase II Trial of Sacituzumab Tirumotecan (Sac-TMT) as Second-line Treatment for Advanced\u002FMetastatic Vaginal and Vulvar Squamous Cell Carcinoma - ARCANA Trial (LACOG 1724)","ARCANA","Inclusion Criteria:\n\n1. Has a histologically- or cytologically confirmed diagnosis of squamous cell carcinoma of vagina (cohort A) or vulvar (cohort B) origin\n2. Advanced disease, defined as presence of metastatic disease or locally advanced disease not amenable to curative therapy in the opinion of the investigator\n3. Has measurable disease per RECIST 1.1 as assessed by the local site investigator\u002Fradiology. Lesions situated in a previously-irradiated area are considered measurable if progression has been shown in such lesions.\n4. Has received up to 2 prior lines of systemic therapy. Disease progression to first-line or second-line platinum-based chemotherapy for locally advanced\u002Fmetastatic disease. Previous anti-PD-1\u002Fanti-PD-L1 therapy is allowed. Disease progression within 6 months of (neo) adjuvant chemotherapy completion is considered first-line of therapy. The participant may have received prior radiation with or without radio-sensitizing chemotherapy at least \\>2 weeks before the start of study treatment.\n5. At least 18 years of age at the time of providing informed consent.\n6. A participant assigned female sex at birth is eligible to participate if not pregnant or breastfeeding, and at least one of the following conditions applies:\n\n   * Is not a POCBP OR\n   * Is a POCBP and: - Uses a contraceptive method that is highly effective (with a failure rate of \\\u003C1% per year), with low user dependency, or is abstinent from penile-vaginal intercourse as their preferred and usual lifestyle (abstinent on a long-term and persistent basis), as described in Appendix 4 during the intervention period and for at least the time needed to eliminate the study intervention after the last dose of study intervention. The participant agrees not to donate eggs (ova, oocytes) to others or freeze\u002Fstore eggs during this period for the purpose of reproduction. The length of time required to continue contraception for the study intervention is 210 days. The investigator should evaluate the potential for contraceptive method failure (ie, noncompliance, recently initiated) in relationship to the first dose of study intervention. Contraceptive use by POCBPs should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies. If the contraception requirements in the local label for any of the study interventions are more stringent than the requirements above, the local label requirements are to be followed.\n\nHas a negative highly sensitive pregnancy test (urine or serum) as required by local regulations within 24 hours (for a urine test) or 72 hours (for a serum test) before the first dose of study intervention. If a urine test cannot be confirmed as negative (eg, an ambiguous result), a serum pregnancy test is required. In such cases, the participant must be excluded from participation if the serum pregnancy result is positive. Additional requirements for pregnancy testing during and after study intervention are in Section 8.4.5.\n\nAbstains from breastfeeding during the study intervention period and for at least 10 days after study intervention.\n\nMedical history, menstrual history, and recent sexual activity has been reviewed by the investigator to decrease the risk for inclusion of a POCBP with an early undetected pregnancy.\n\n8\\. Has provided an archival tumor tissue sample or most recently obtained core, incisional, or excisional biopsy of a tumor lesion from any site not previously irradiated. Sites should follow local guidelines regarding fresh tissue collection. Formalin-fixed, paraffin embedded (FFPE) tissue blocks are preferred to slide. Newly obtained biopsies are preferred to archived tissue (recommended 22-28 slides). 9. Participants who have AEs due to previous anticancer therapies must have recovered to Grade ≤1 or baseline (except for alopecia and vitiligo). Participants with endocrine-related AEs who are adequately treated with hormone replacement therapy are eligible.\n\n10\\. Adequate organ function as defined in the following table (Table 2). Specimens must be collected within 14 days before the start of study intervention.\n\n11\\. Has ECOG performance status of 0 or 1. 12. Be willing and able to comply with study procedures, laboratory tests, and other requirements of the study.\n\n13\\. HIV testing at screening is not required unless there is a known history of HIV infection. HIV-infected participants must have well-controlled HIV on ART, defined as:\n\n1. Having a CD4+ T-cell count ≥350 cells\u002Fmm3 at the time of screening\n2. Having achieved and maintained virologic suppression, defined as confirmed HIV RNA level below 50 or the LLOQ using the locally available assay, at the time of screening and for at least 12 weeks before screening\n3. Absence of any AIDS-defining opportunistic infections within the past 12 months\n4. Being on a stable regimen, without changes in drugs or dose modification, for at least 4 weeks before enrollment and agreeing to continue ART throughout the study Note: The ART regimen must not contain any antiretroviral medications that are strong CYP3A4 inducers\u002Finhibitors\u002Fsubstrates. Refer to https:\u002F\u002Fwww.fda.gov\u002Fdrugs\u002Fdrug-interactions-labeling\u002Fdrug-development-and-drug-interactions-table-substrates-inhibitors-and-inducers. Please note that this list is not exhaustive and that investigators should review the locally-approved label for all concomitant therapy to ensure it is not a strong inducer\u002Finhibitor\u002Fsubstrate of CYP3A4.\n\n   14\\. Hepatitis B testing at screening is not required unless there is a known history of HBV infection. Participants who are HBsAg positive are eligible if they have received HBV antiviral therapy for at least 4 weeks, and have undetectable HBV viral load before enrollment.\n\n   Note: Participants should remain on antiviral therapy throughout study intervention and follow local guidelines for HBV antiviral therapy post completion of study intervention.\n\n   15\\. Hepatitis C testing at screening is not required unless there is a known history of HCV infection. Participants with a history of HCV infection are eligible if HCV viral load is undetectable at screening.\n\n   Note: Participants must have completed curative antiviral therapy at least 4 weeks before enrollment.\n\n   Exclusion Criteria:\n   1. Has a history of documented severe dry eye syndrome, severe Meibomian gland disease and\u002For blepharitis, or severe corneal disease that prevents\u002Fdelays corneal healing.\n   2. Has uncontrolled, significant cardiovascular disease or cerebrovascular disease, including New York Heart Association Class III or IV congestive heart failure, unstable angina, myocardial infarction, uncontrolled symptomatic arrhythmia, prolongation of QTcF interval to \\>480 ms, and\u002For other serious cardiovascular and cerebrovascular diseases within 6 months before the first dose of study intervention. Prior\u002FConcomitant Therapy\n   3. Received prior treatment with a TROP2-targeted ADC.\n   4. Received prior treatment with a topoisomerase 1 inhibitor-containing ADC.\n   5. Received prior systemic anticancer therapy within 2 weeks before the first dose of study intervention.\n   6. Received prior radiotherapy within 2 weeks before the first dose of study intervention, has radiation-related toxicities, requiring corticosteroids, and\u002For has had radiation pneumonitis.\n\n      Note: Two weeks or fewer of palliative radiotherapy for non-CNS disease is permitted. The last radiotherapy treatment must have been performed at least 7 days before the first dose of study intervention.\n   7. Received a live or live-attenuated vaccine within 30 days before the first dose of study intervention. Administration of killed vaccines are allowed.\n\n      Refer to Section 6.2 for information on COVID-19 vaccines.\n   8. Is currently receiving a strong inducer\u002Finhibitor of CYP3A4 that cannot be discontinued for the duration of treatment with study intervention. The required washout period before starting study intervention is 2 weeks.\n\n      Note: A list of strong inducers\u002Finhibitors of CYP3A4 can be found at the following website: https:\u002F\u002Fwww.fda.gov\u002Fdrugs\u002Fdrug-interactions-labeling\u002Fdrug-development-and-drug-interactions-table-substrates-inhibitors-and-inducers. Please note that this list is not exhaustive and that investigators should review the locally-approved label for all concomitant therapy to ensure it is not a strong inducer\u002Finhibitor of CYP3A4. Prior\u002FConcurrent Clinical Study Experience\n   9. Is currently enrolled on another therapeutic clinical trial. Concurrent enrollment on another therapeutic clinical trial or any trial designed to impact the efficacy of anti-cancer therapy is prohibited.\n   10. Has received an investigational agent or has used an investigational device within 4 weeks before the first dose of study intervention. Diagnostic Assessments\n   11. Has a known additional malignancy that is progressing or has required active treatment within the past 3 years. Note: Participants with basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or carcinoma in situ (excluding carcinoma in situ of the bladder) who have undergone potentially curative resection are not excluded.\n   12. History of CNS metastases and\u002For carcinomatous meningitis.\n   13. Has an active infection requiring systemic therapy within 4 weeks prior to the first dose of study treatment except those permitted as outlined in Section 5.1.\n   14. Has a history or current evidence of any condition, therapy, laboratory abnormality, or other circumstance that might confound the results of the study, interfere with the individual's ability to cooperate with the requirements of the study, or interfere with the individual's participation for the full duration of the study, such that it is not in the best interest of the individual to participate, in the opinion of the treating investigator.\n\n       Other Exclusions\n   15. Severe hypersensitivity (Grades ≥3) to study intervention, any of their excipients, and\u002For to another biologic therapy.\n   16. Has had major surgery or significant traumatic injury within 4 weeks before the first dose of study intervention. Anticipation of the need for major surgery during the course of treatment with study intervention is also exclusionary.\n\n       Note: Participants who underwent major surgery must have adequately recovered from toxicity and\u002For complications from the surgery before starting study intervention.\n   17. Has a history of (noninfectious) pneumonitis\u002Finterstitial lung disease that required steroids or has current pneumonitis\u002Finterstitial lung disease.\n   18. History or current evidence of any condition, therapy, laboratory abnormality, or other circumstance that might confound the results of the study or interfere with the participant's ability to cooperate with the requirements of the study, such that it is not in the best interest of the participant to participate, in the opinion of the treating investigator.","FEMALE","18 Years",{"count":303,"type":304},48,"ESTIMATED","INTERVENTIONAL",[307],"PHASE2","The ARCANA trial (LACOG 1724) is a single-arm, non-randomized, multi-center, parallel, two-cohort Phase II clinical study designed to evaluate the efficacy and safety of sacituzumab tirumotecan (sac-TMT, MK-2870) as a second-line or subsequent treatment in patients with advanced or metastatic vaginal and vulvar squamous cell carcinomas. Given the rarity of these cancers and the lack of standard second-line therapies, this study explores sac-TMT, a novel TROP-2-directed antibody-drug conjugate (ADC). TROP-2 is highly expressed in both vulvar and vaginal squamous cell carcinomas, making it a promising therapeutic target.",[310,311],"Vaginal Squamous Cell Carcinoma","Vulvar Squamous Cell Carcinoma",[313],"Sacituzumab Tirumotecan","NOT_YET_RECRUITING","2026-09-01",{"date":317,"type":318},"2026-09-04","ACTUAL",{"date":320,"type":304},"2027-01",{"date":322,"type":304},"2032-01",{"name":5,"class":6},12]