Sac-TMT in Salivary Gland Cancers (Saint-Tropez)
Phase 2 Study of Sacituzumab Tirumotecan (Sac-TMT) in Salivary Gland Cancers - Saint-Tropez (LACOG 1824) Trial
This is a Phase 2, open-label, non-randomized, parallel, two-cohort study evaluating the efficacy and safety of Sacituzumab Tirumotecan (Sac-TMT, MK-2870) monotherapy in patients with advanced, recurrent, or metastatic salivary gland carcinomas who have received no more than 3 prior non-curative systemic treatment regimens. The study evaluates the activity of Sac-TMT separately in two independent cohorts based on tumor histology: Cohort 1 for Adenoid Cystic Carcinoma (ACC) and Cohort 2 for Non-Adenoid Cystic Carcinoma (non-ACC).
연구 개요
상태
상태
정황
정황
개입 / 치료
개입 / 치료
상세 설명
Malignant salivary gland neoplasms are rare and heterogeneous malignancies with limited systemic treatment options and no widely established standard-of-care in advanced settings. Trophoblast cell surface antigen 2 (TROP-2) is broadly expressed in epithelial salivary gland carcinomas, making it a promising therapeutic target. Sacituzumab tirumotecan (Sac-TMT / MK-2870) is an antibody-drug conjugate (ADC) targeting TROP-2 coupled with a topoisomerase 1 inhibitor payload (KL610023).
This study aims to evaluate the clinical activity, safety, and patient-reported outcomes of Sac-TMT in two parallel, non-comparative cohorts:
Cohort 1: Patients with advanced/metastatic Adenoid Cystic Carcinoma (ACC). Cohort 2: Patients with advanced/metastatic Non-Adenoid Cystic Carcinoma (non-ACC).
Participants receive Sac-TMT at a dose of 4 mg/kg via intravenous (IV) infusion on Days 1 and 15 of each 28-day cycle for up to 12 cycles (approximately 1 year), or until disease progression, unacceptable toxicity, or withdrawal of consent. The primary objective is to evaluate the Objective Response Rate (ORR) according to RECIST 1.1 in each cohort. Secondary objectives include assessment of ORR by Independent Central Review (ORR-ICR), Disease Control Rate (DCR), Duration of Response (DoR), Progression-Free Survival (PFS), 6- and 12-month PFS, Overall Survival (OS), safety and tolerability, compliance, post-progression therapies, and Patient-Reported Outcomes (EORTC QLQ-C30 and EORTC QLQ-H&N43). Exploratory research will assess ctDNA dynamics and potential predictive/resistance biomarkers in baseline and serial blood and tissue samples.
연구 유형
연구 유형
등록 (추정된)
등록
단계
단계
- 2 단계
연락처 및 위치
연구 연락처
연구 연락처
- 이름: Head of Clinical Operations
- 전화번호: +55 (51) 3384.5334
- 이메일: laura.voelcker@lacog.group
연구 연락처 백업
- 이름: Project Manager
- 전화번호: +55 (51) 3384.5334
- 이메일: lacog1824@lacog.group
연구 장소
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Ceará
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Fortaleza, Ceará, 브라질, 60335-480
- CRIO - Centro Regional Integrado de Oncologia
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연락하다:
- Amanda Lima Sena
- 이메일: tarcilo.crio@gmail.com
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수석 연구원:
- Iane Pinto Figueiredo Lima
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Estado de Bahia
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Salvador, Estado de Bahia, 브라질, 40050-410
- Santa Casa de Misericórdia da Bahia - Hospital Santa Izabel (Oncoclínicas)
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수석 연구원:
- Daniel Brito
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연락하다:
- Nivana Borges do Sacramento
- 전화번호: +557122038476
- 이메일: nivana.sacramento@santacasaba.org.br
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Federal District
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Brasília, Federal District, 브라질, 70710-904
- CETTRO - Centro de Câncer de Brasília (Onco Vida - Oncoclínicas)
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연락하다:
- Jade Tayline Boscolo de Aragao
- 전화번호: +556130276200
- 이메일: jade.aragao@oncoclinicas.com
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수석 연구원:
- Janice Rodrigues Farias
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INCA - Instituto Nacional de Câncer
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Rio de Janeiro, INCA - Instituto Nacional de Câncer, 브라질, 20230-130
- INCA - Instituto Nacional de Câncer
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연락하다:
- Luana Aguiar Mesquita Cerva
- 전화번호: +552132076569
- 이메일: luana.cerva@inca.gov.br
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수석 연구원:
- Daniel Gonçalves Kischinhevsky
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Minas Gerais
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Belo Horizonte, Minas Gerais, 브라질, 30360-680
- Oncocentro de Minas Gerais (Oncoclínicas)
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연락하다:
- Thayara Christi Soares
- 전화번호: +5531998266045
- 이메일: thayara.soares@oncoclinicas.com
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수석 연구원:
- Aline Lauda Freitas Chaves
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Paraná
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Londrina, Paraná, 브라질, 86015-520
- HCL - Hospital do Câncer de Londrina
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연락하다:
- Elaine Lins
- 전화번호: +5543991069442
- 이메일: pesquisa.elainecbc@hcl.org.br
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수석 연구원:
- Mariana Lopes Zanatta
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Rio Grande do Norte
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Natal, Rio Grande do Norte, 브라질, 59062-000
- Liga Norte Riograndense Contra o Câncer
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연락하다:
- Ana Paula Ferreira Costa
- 전화번호: +558440095595
- 이메일: anapaula.costa@liga.org.br
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수석 연구원:
- Andrea Juliana Pereira de Santana Gomes
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Rio Grande do Sul
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Porto Alegre, Rio Grande do Sul, 브라질, 90050-170
- ISCMPA - Santa Casa de Porto Alegre
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연락하다:
- Igor Cesar Santos de Miranda
- 이메일: igor.miranda@santacasa.org.br
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수석 연구원:
- Jamille Rizzardi Lava
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Rio de Janeiro
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Rio de Janeiro, Rio de Janeiro, 브라질, 22250-905
- CTTB - Centro de Tratamento de Tumores Botafogo (Oncoclínicas)
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연락하다:
- Thamires Cristine de Souza Castro Almeida
- 전화번호: +5521974680316
- 이메일: thamires.almeida@oncoclinicas.com
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수석 연구원:
- Marina Xavier Reis
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Santa Catarina
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Lages, Santa Catarina, 브라질, 88501-001
- ANIMI - Unidade de Tratamento Oncológico
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연락하다:
- Mariane Cabral
- 이메일: mariane.animi@gmail.com
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수석 연구원:
- Maitê de Liz Vassen Schurmann
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São Paulo
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Barretos, São Paulo, 브라질, 14784-400
- Hospital de Amor de Barretos
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연락하다:
- Pedro Gabriel França Santos
- 전화번호: +551733216637
- 이메일: pedro.santos@hospitaldeamor.com.br
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수석 연구원:
- Flávio Augusto Ferreira da Silva
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Campinas, São Paulo, 브라질, 13083-881
- Universidade Estadual de Campinas (UNICAMP)
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연락하다:
- Elcio dos Santos
- 전화번호: +5519998171210
- 이메일: elcioss@unicamp.br
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수석 연구원:
- Lígia Traldi Macedo
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São Paulo, São Paulo, 브라질, 01509-001
- A.C. Camargo Cancer Center
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연락하다:
- Arianni Di Petta
- 전화번호: +5511979985081
- 이메일: arianni.petta@accamargo.org.br
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수석 연구원:
- Thiago Bueno de Oliveira
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São Paulo, São Paulo, 브라질, 01246-000
- ICESP - Instituto do Câncer do Estado de São Paulo
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수석 연구원:
- Milena Perez Mak
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연락하다:
- Erika Assis Rodrigues
- 전화번호: +551138933555
- 이메일: erika.arodrigues@hc.fm.usp.br
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São Paulo, São Paulo, 브라질, 04538-135
- CPO - Centro Paulista de Oncologia (Oncoclínicas)
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연락하다:
- Maraisa Cristina da Costa
- 전화번호: +11971445373
- 이메일: maraisa.costa@oncoclinicas.com
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수석 연구원:
- Nathalia Gimenes
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참여기준
자격 기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
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Provided written informed consent for the study (or prescreening phase, as applicable).
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Histologically- or cytologically confirmed diagnosis of malignant salivary gland neoplasm (assessed by central pathology):
- Cohort 1: Adenoid cystic carcinoma (ACC) of the salivary gland.
- Cohort 2: Non-adenoid cystic carcinoma (non-ACC) of the salivary gland.
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Advanced disease, defined as locally advanced or recurrent disease not amenable to curative treatment, and/or metastatic disease.
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Documented disease progression within 6 months prior to enrollment.
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Received no more than 3 prior lines of non-curative intent systemic treatment regimens. Note: Patients with salivary duct carcinoma must have been tested for HER2 status; if HER2 positive (IHC 3+ or gene amplified), prior HER2-targeted therapy is required.
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Measurable disease as defined by RECIST v1.1.
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Aged 18 years or older at the time of signing informed consent.
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ECOG Performance Status of 0 or 1.
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Adequate organ function within 14 days prior to treatment initiation:
- Absolute Neutrophil Count (ANC) >= 1,500/uL;
- Platelets >= 100,000/uL;
- Hemoglobin >= 9.0 g/dL (without transfusion or growth factor support within 2 weeks);
- Measured or calculated creatinine clearance >= 30 mL/min;
- Total bilirubin <= 1.5 x ULN (or direct bilirubin < ULN for total bilirubin > 1.5 x ULN);
- AST and ALT <= 2.5 x ULN (<= 5 x ULN if liver metastases present);
- Serum albumin >= 3.0 g/dL (without albumin transfusion within 72 hours);
- INR/PT/aPTT <= 1.5 x ULN (unless receiving therapeutic anticoagulation).
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Provision of archival FFPE tumor tissue sample or fresh biopsy.
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Recovery from adverse events due to prior anticancer therapies to Grade <= 1 or baseline.
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Participants with treated HIV, HBV, or HCV are eligible if meeting protocol-specified antiviral stability and disease control parameters.
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Adherence to protocol-specified contraceptive requirements for male participants and participants of childbearing potential.
Exclusion Criteria:
- History of documented severe dry eye syndrome, severe Meibomian gland disease and/or blepharitis, or severe corneal disease that prevents/delays corneal healing.
- Uncontrolled or significant cardiovascular or cerebrovascular disease within 6 months prior to first dose (e.g., NYHA Class III/IV heart failure, unstable angina, myocardial infarction, uncontrolled symptomatic arrhythmia, QTcF > 480 ms).
- Prior treatment with a TROP2-targeted ADC or a topoisomerase 1 inhibitor-containing ADC.
- Systemic anticancer therapy within 2 weeks before the first dose of study intervention.
- Radiotherapy within 7 days before the first dose (except <= 10 fractions of palliative radiotherapy for non-CNS disease).
- Administration of a live or live-attenuated vaccine within 30 days before the first dose.
- Current use of strong CYP3A4 inducers or inhibitors requiring a 2-week washout prior to enrollment.
- Concurrent enrollment in another therapeutic clinical trial.
- Receipt of an investigational agent or device within 4 weeks before the first dose.
- History of additional active malignancy within the past 3 years (except adequately treated non-melanoma skin cancer, carcinoma in situ, or low-risk prostate cancer).
- Active, untreated, or unstable CNS metastases and/or carcinomatous meningitis.
- Active infection requiring systemic therapy.
- Severe hypersensitivity (Grade >= 3) to study intervention or its excipients.
- Major surgery or significant traumatic injury within 4 weeks before the first dose.
- History of noninfectious pneumonitis/ILD requiring steroids or current clinically meaningful pneumonitis/ILD.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위화되지 않음
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
팔의 수
무기와 개입
참가자 그룹 / 팔참가자 그룹 / 팔 |
개입 / 치료개입 / 치료 |
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실험적: Cohort 1: Adenoid Cystic Carcinoma (ACC)
Participants with advanced, recurrent, or metastatic adenoid cystic carcinoma (ACC) of the salivary gland who have received no more than three prior non-curative systemic treatment regimens. Participants receive Sacituzumab Tirumotecan (Sac-TMT) monotherapy at 4 mg/kg via intravenous (IV) infusion on Days 1 and 15 of each 28-day cycle for up to 12 cycles, or until disease progression, unacceptable toxicity, or withdrawal of consent. |
Sacituzumab tirumotecan (Sac-TMT / MK-2870) is an antibody-drug conjugate (ADC) targeting TROP-2. Administered via intravenous (IV) infusion at a dose of 4 mg/kg on Days 1 and 15 of each 28-day cycle for up to 12 cycles.
다른 이름들:
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실험적: Cohort 2: Non-Adenoid Cystic Carcinoma (Non-ACC)
rticipants with advanced, recurrent, or metastatic non-adenoid cystic carcinoma (non-ACC) of the salivary gland who have received no more than three prior non-curative systemic treatment regimens. Participants receive Sacituzumab Tirumotecan (Sac-TMT) monotherapy at 4 mg/kg via intravenous (IV) infusion on Days 1 and 15 of each 28-day cycle for up to 12 cycles, or until disease progression, unacceptable toxicity, or withdrawal of consent. |
Sacituzumab tirumotecan (Sac-TMT / MK-2870) is an antibody-drug conjugate (ADC) targeting TROP-2. Administered via intravenous (IV) infusion at a dose of 4 mg/kg on Days 1 and 15 of each 28-day cycle for up to 12 cycles.
다른 이름들:
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연구는 무엇을 측정합니까?
주요 결과 측정
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Objective Response Rate (ORR) in Cohort 1 (ACC)
기간: Up to 12 cycles (approximately 12 months).
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Proportion of participants with a best overall response of complete response (CR) or partial response (PR) as determined by RECIST 1.1 in the Adenoid Cystic Carcinoma cohort. |
Up to 12 cycles (approximately 12 months).
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Objective Response Rate (ORR) in Cohort 2 (Non-ACC)
기간: Up to 12 cycles (approximately 12 months).
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Proportion of participants with a best overall response of complete response (CR) or partial response (PR) as determined by RECIST 1.1 in the Non-Adenoid Cystic Carcinoma cohort. |
Up to 12 cycles (approximately 12 months).
|
2차 결과 측정
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Objective Response Rate by Independent Central Review (ORR-ICR)
기간: From enrollment through disease progression or end of treatment, assessed up to 12 cycles (approximately 12 months).
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Percentage of participants with a confirmed best overall response of complete response (CR) or partial response (PR) as determined by an Independent Central Review (ICR) according to Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1). |
From enrollment through disease progression or end of treatment, assessed up to 12 cycles (approximately 12 months).
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Disease Control Rate (DCR)
기간: From enrollment through disease progression or end of treatment, assessed up to 12 cycles (approximately 12 months).
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Percentage of participants with a best overall response of complete response (CR), partial response (PR), or stable disease (SD) according to Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1). |
From enrollment through disease progression or end of treatment, assessed up to 12 cycles (approximately 12 months).
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Duration of Response (DoR)
기간: From first documented response until disease progression or death, assessed up to 40 months.
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Time from the first documented objective response (complete response [CR] or partial response [PR]) to the date of first documented disease progression according to RECIST v1.1 or death due to any cause, evaluated in responders only. |
From first documented response until disease progression or death, assessed up to 40 months.
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Progression-Free Survival (PFS)
기간: From treatment initiation until disease progression or death, assessed up to 40 months.
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Time from treatment initiation to first documented disease progression according to RECIST v1.1 (as evaluated by investigator assessment) or death due to any cause, whichever occurs first. |
From treatment initiation until disease progression or death, assessed up to 40 months.
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6-Month Progression-Free Survival (6-Month PFS)
기간: At 6 months.
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Percentage of participants alive and progression-free at 6 months after enrollment according to RECIST v1.1, estimated using the Kaplan-Meier method. |
At 6 months.
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12-Month Progression-Free Survival (12-Month PFS)
기간: At 12 months.
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Percentage of participants alive and progression-free at 12 months after enrollment according to RECIST v1.1, estimated using the Kaplan-Meier method. |
At 12 months.
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Overall Survival (OS)
기간: From treatment initiation until death, assessed up to 40 months.
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Time from treatment initiation to death from any cause. |
From treatment initiation until death, assessed up to 40 months.
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Incidence of Treatment-Emergent Adverse Events (TEAEs)
기간: From baseline through 30 days after the last dose of study treatment (approximately 13 months).
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Number of participants with treatment-emergent adverse events (TEAEs) of any grade and Grade 3 or higher, characterized and graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0 (NCI CTCAE v5.0). |
From baseline through 30 days after the last dose of study treatment (approximately 13 months).
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Change From Baseline in Health-Related Quality of Life Using EORTC QLQ-C30
기간: Baseline, every 6 weeks up to 24 weeks.
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Assessed using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30). The questionnaire includes functional scales, symptom scales, and a global health status/QoL scale. All domain and item scores are linearly transformed to a 0 to 100 scale. For functional scales and global health status, higher scores represent better quality of life and higher level of functioning. For symptom scales, higher scores represent greater symptom burden/severity. |
Baseline, every 6 weeks up to 24 weeks.
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공동 작업자 및 조사자
수사관
수사관
- 수석 연구원: William Nassib William Junior, CPO - Centro Paulista de Oncologia (Oncoclínicas)
- 수석 연구원: Aline Lauda Freitas Chaves, Oncocentro de Minas Gerais (Oncoclínicas)
연구 기록 날짜
연구 주요 날짜
연구 시작 (추정된)
연구 시작
기본 완료 (추정된)
기본 완료
연구 완료 (추정된)
연구 완료
연구 등록 날짜
최초 제출
최초 제출
QC 기준을 충족하는 최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
처음 게시됨
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
마지막 업데이트 게시됨
QC 기준을 충족하는 마지막 업데이트 제출
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
기타 연구 ID 번호
기타 연구 ID 번호
- LACOG 1824
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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