- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT07652515
A Study to Evaluate the Safety of Dostarlimab in Adult Participants in India With Primary Advanced or Recurrent Endometrial Cancer
2026년 6월 11일 업데이트: GlaxoSmithKline
Phase 4, Open Label, Single-arm, Interventional, Multicenter Study to Evaluate the Safety of Dostarlimab in Adult Patients in India With Primary Advanced or Recurrent Endometrial Cancer
This study will evaluate the safety of dostarlimab in combination with carboplatin and paclitaxel followed by monotherapy when administered as a first-line treatment in advanced or recurrent endometrial cancer (EC).
연구 개요
연구 유형
중재적
등록 (추정된)
100
단계
- 4단계
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 연락처
- 이름: US GSK Clinical Trials Call Center
- 전화번호: 877-379-3718
- 이메일: GSKClinicalSupportHD@gsk.com
연구 연락처 백업
- 이름: EU GSK Clinical Trials Call Center
- 전화번호: +44 (0) 20 89904466
- 이메일: GSKClinicalSupportHD@gsk.com
참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
아니
설명
Inclusion Criteria:
- Participant with greater than or equals to (>=) 18 years of age, at the time of signing the informed consent.
- Participant has histologically or cytologically proven EC with recurrent or advanced disease.
- Participant must have primary Stage III or Stage IV disease or first recurrent EC with a low potential for cure by radiation therapy or surgery alone or in combination based on investigator's assessment.
- Eligible for dostarlimab treatment according to the approved prescribing information and the investigator's clinical judgement.
- Woman of childbearing potential (WOCBP) agrees to use contraceptive from screening through at least 180 days after the last dose.
- Negative urine pregnancy test at most 24 hours prior to the first dose of study intervention.
- Capable of giving signed informed consent.
- Participant has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
Exclusion Criteria:
- Participant has had greater than (>) 1 recurrence of endometrial cancer.
- Participant has a concomitant malignancy, or participant has a prior non endometrial invasive malignancy who has been disease-free for less than (<) 3 years or who received any active treatment in the last 3 years for that malignancy.
- Participant has known uncontrolled central nervous system metastases, carcinomatosis meningitis, or both.
- Participant is considered a poor medical risk due to a serious, uncontrolled medical disorder, nonmalignant systemic disease, or active infection requiring systemic therapy.
- Participant has not recovered adequately from AEs or complications from any major surgery prior to starting therapy.
- Participant has not recovered (i.e., to Grade less than or equal to [<=] 1 or to Baseline) from cytotoxic therapy induced AEs or has received transfusion of blood products (including platelets or red blood cells) or administration of colony-stimulating factors (including Granulocyte colony-stimulating factor [G-CSF], Granulocyte macrophage colony-stimulating factor [GM-CSF], or recombinant erythropoietin) within 21 days prior to the first dose of study drug.
- Either the history of hypersensitivity to excipients of the study intervention or to drugs with a similar chemical structure or class of the study intervention.
- Participant has known active hepatitis B (e.g., hepatitis B surface antigen reactive) or hepatitis C (e.g., hepatitis C virus ribonucleic acid [qualitative] is detected).
Participant has received neo-adjuvant/adjuvant systemic anticancer therapy for primary Stage III or IV disease and:
- has not had a recurrence or Progressive disease (PD) prior to first dose on the study, or
- has had a recurrence or PD within 6 months of completing systemic anticancer therapy treatment prior to first dose on the study.
- Participant has received prior therapy with an anti- Programmed death protein 1 (anti-PD-1), anti- Programmed death ligand 1 (anti-PD-L1), or Programmed death ligand 2 (anti PD L2) agent.
- Participant has received prior anticancer therapy (chemotherapy, targeted therapies, radiotherapy, or immunotherapy) within 21 days or <5 times the half life of the most recent therapy prior to study Day 1, whichever is shorter.
- Systemic glucocorticoids for any purpose other than to manage symptoms of suspected irAEs. If medically deemed necessary (e.g., acute asthma or chronic obstructive pulmonary disease exacerbation, prophylaxis for intravenous (IV) contrast if indicated), Investigators are allowed to use their judgment to treat participants with systemic steroids. In such cases, systemic steroids should be stopped at least 24 hours prior to the next dose of study treatment.
- Participant has received, or is scheduled to receive, a live vaccine within 30 days before first dose of study intervention, during study treatment, and for up to 180 days after receiving the last dose of study intervention.
- Participant has a diagnosis of immunodeficiency and is receiving systemic steroid therapy (>10 milligrams [mg] daily prednisone or equivalent) within 7 days prior to the first dose of the study treatment or is receiving any other form of immunosuppressive medication.
- Participant is currently receiving study intervention, or is enrolled or has participated in any other clinical study involving an investigational intervention and received investigational treatment or used an investigational device within 4 weeks of the first dose of dostarlimab.
- Participant is pregnant or breastfeeding or is expecting to conceive children within the projected duration of the study, starting with the screening visit through 180 days after the last dose of study intervention.
- Judgment by the investigator that the participant should not participate in the study if the participant is unlikely to comply with study procedures, restrictions, and requirements.
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 해당 없음
- 중재 모델: 단일 그룹 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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실험적: Participants receiving Dostarlimab with Carboplatin + Paclitaxel followed by Dostarlimab Monotherapy
Participants will receive dose level 1 of dostarlimab in combination with carboplatin and paclitaxel followed by dose level 2 of dostarlimab monotherapy.
Dose level 1 is the lowest dose level.
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Dostarlimab이 투여됩니다.
Carboplatin이 투여됩니다.
파클리탁셀이 투여됩니다.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
기간 |
|---|---|
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Number of participants with Grade 3 or greater treatment-emergent adverse events (TEAEs) up to Week 49
기간: Up to Week 49
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Up to Week 49
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2차 결과 측정
결과 측정 |
기간 |
|---|---|
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Number of participants with Grade 3 or greater TEAEs up to Week 170
기간: Up to Week 170
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Up to Week 170
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Number of participants with TEAEs up to Week 49
기간: Up to Week 49
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Up to Week 49
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Number of participants with TEAEs up to Week 170
기간: Up to Week 170
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Up to Week 170
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Number of participants with Immune-related adverse events (irAEs) up to Week 49
기간: Up to Week 49
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Up to Week 49
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Number of participants with Immune-related adverse events (irAEs) up to Week 170
기간: Up to Week 170
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Up to Week 170
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Number of Participants with Serious Adverse Events (SAEs), treatment related Adverse Events (AEs), treatment related SAEs, fatal AEs, non-fatal SAEs up to Week 49
기간: Up to Week 49
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Up to Week 49
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Number of Participants with Serious Adverse Events (SAEs), treatment related Adverse Events (AEs), treatment related SAEs, fatal AEs, non-fatal SAEs up to Week 170
기간: Up to Week 170
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Up to Week 170
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Number of Participants with AEs leading to discontinuation of treatment, AEs leading to study withdrawal and AEs leading to dose modification up to Week 49
기간: Up to Week 49
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Up to Week 49
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Number of Participants with AEs leading to discontinuation of treatment, AEs leading to study withdrawal and AEs leading to dose modification up to Week 170
기간: Up to Week 170
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Up to Week 170
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Change from Baseline in hematology parameters: neutrophils, lymphocytes, monocytes, eosinophils, basophils and platelet count (Giga cells per Liter) up to Week 49
기간: Baseline (Day 1) and up to Week 49
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Baseline (Day 1) and up to Week 49
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Change from Baseline in hematology parameters: neutrophils, lymphocytes, monocytes, eosinophils, basophils and platelet count (Giga cells per Liter) up to Week 170
기간: Baseline (Day 1) and up to Week 170
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Baseline (Day 1) and up to Week 170
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Change from Baseline in hematology parameter: Red Blood Cell (RBC) count (Trillion cells per Liter) up to Week 49
기간: Baseline (Day 1) and up to Week 49
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Baseline (Day 1) and up to Week 49
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Change from Baseline in hematology parameter: Red Blood Cell (RBC) count (Trillion cells per Liter) up to Week 170
기간: Baseline (Day 1) and up to Week 170
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Baseline (Day 1) and up to Week 170
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Change from Baseline in hematology parameter: Hemoglobin (Hb) (Grams per Liter) up to Week 49
기간: Baseline (Day 1) and up to 49
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Baseline (Day 1) and up to 49
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Change from Baseline in hematology parameter: Hemoglobin (Hb) (Grams per Liter) up to Week 170
기간: Baseline (Day 1) and up to Week 170
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Baseline (Day 1) and up to Week 170
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Change from Baseline in hematology parameter: Reticulocytes (Percentage of reticulocytes) up to Week 49
기간: Baseline (Day 1) and up to Week 49
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Baseline (Day 1) and up to Week 49
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Change from Baseline in hematology parameter: Reticulocytes (Percentage of reticulocytes) up to Week 170
기간: Baseline (Day 1) and up to Week 170
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Baseline (Day 1) and up to Week 170
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Change from Baseline in hematology parameter: Mean Corpuscular Volume (MCV) (Femtoliters) up to Week 49
기간: Baseline (Day 1) and up to Week 49
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Baseline (Day 1) and up to Week 49
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Change from Baseline in hematology parameter: Mean Corpuscular Volume (MCV) (Femtoliters) to up to Week 170
기간: Baseline (Day 1) and up to Week 170
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Baseline (Day 1) and up to Week 170
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Change from Baseline in hematology parameter: Mean Corpuscular Hemoglobin (MCH) (Picograms) up to Week 49
기간: Baseline (Day 1) and up to Week 49
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Baseline (Day 1) and up to Week 49
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Change from Baseline in hematology parameter: Mean Corpuscular Hemoglobin (MCH) (Picograms) up to Week 170
기간: Baseline (Day 1) and up to Week 170
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Baseline (Day 1) and up to Week 170
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Change from Baseline in clinical chemistry parameters: Blood urea nitrogen (BUN), glucose, calcium, sodium, and potassium levels (Millimoles per Liter) up to Week 49
기간: Baseline (Day 1) and up to Week 49
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Baseline (Day 1) and up to Week 49
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Change from Baseline in clinical chemistry parameters: Blood urea nitrogen (BUN), glucose, calcium, sodium, and potassium levels (Millimoles per Liter) up to Week 170
기간: Baseline (Day 1) and up to Week 170
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Baseline (Day 1) and up to Week 170
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Change from Baseline in clinical chemistry parameters: Total bilirubin, direct bilirubin and creatinine levels (Micromoles per Liter) up to Week 49
기간: Baseline (Day 1) and up to Week 49
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Baseline (Day 1) and up to Week 49
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Change from Baseline in clinical chemistry parameters: Total bilirubin, direct bilirubin and creatinine levels (Micromoles per Liter) up to Week 170
기간: Baseline (Day 1) and up to Week 170
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Baseline (Day 1) and up to Week 170
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Change from Baseline in clinical chemistry parameters: Total protein levels (Gram per liter) up to Week 49
기간: Baseline (Day 1) and up to Week 49
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Baseline (Day 1) and up to Week 49
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Change from Baseline in clinical chemistry parameters: Total protein levels (Gram per liter) up to Week 170
기간: Baseline (Day 1) and up to Week 170
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Baseline (Day 1) and up to Week 170
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Change from Baseline in clinical chemistry parameters: Aspartate aminotransferase (AST), alanine aminotransferase (ALT) and alkaline phosphatase (ALP) levels (International units per liter) up to Week 49
기간: Baseline (Day 1) and up to Week 49
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Baseline (Day 1) and up to Week 49
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Change from Baseline in clinical chemistry parameters: Aspartate aminotransferase (AST), alanine aminotransferase (ALT) and alkaline phosphatase (ALP) levels (International units per liter) up to Week 170
기간: Baseline (Day 1) and up to Week 170
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Baseline (Day 1) and up to Week 170
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Change from Baseline in Vital signs: systolic blood pressure (SBP) and diastolic blood pressure (DBP) (Millimeters of mercury [mmHg]) up to Week 49
기간: Baseline (Day 1) and up to Week 49
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Baseline (Day 1) and up to Week 49
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Change from Baseline in Vital signs: systolic blood pressure (SBP) and diastolic blood pressure (DBP) (Millimeters of mercury [mmHg]) up to Week 170
기간: Baseline (Day 1) and up to Week 170
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Baseline (Day 1) and up to Week 170
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Change from Baseline in Vital signs: pulse rate (Beats per minute) up to Week 49
기간: Baseline (Day 1) and up to Week 49
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Baseline (Day 1) and up to Week 49
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Change from Baseline in Vital signs: pulse rate (Beats per minute) up to Week 170
기간: Baseline (Day 1) and up to Week 170
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Baseline (Day 1) and up to Week 170
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Change from Baseline in Vital signs: body temperature (Degrees Celsius) up to Week 49
기간: Baseline (Day 1) and up to Week 49
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Baseline (Day 1) and up to Week 49
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Change from Baseline in Vital signs: body temperature (Degrees Celsius) up to Week 170
기간: Baseline (Day 1) and up to Week 170
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Baseline (Day 1) and up to Week 170
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Change from Baseline in Vital signs: respiratory rate (breaths per minute) up to Week 49
기간: Baseline (Day 1) and up to Week 49
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Baseline (Day 1) and up to Week 49
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Change from Baseline in Vital signs: respiratory rate (breaths per minute) up to Week 170
기간: Baseline (Day 1) and up to Week 170
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Baseline (Day 1) and up to Week 170
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Change from Baseline in electrocardiogram (ECG) values: Heart rate (Beats per minute) up to Week 49
기간: Baseline (Day 1) and up to Week 49
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Baseline (Day 1) and up to Week 49
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Change from Baseline in electrocardiogram (ECG) values: Heart rate (Beats per minute) up to Week 170
기간: Baseline (Day 1) and up to Week 170
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Baseline (Day 1) and up to Week 170
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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
스폰서
수사관
- 연구 책임자: GSK Clinical Trials, GlaxoSmithKline
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작 (추정된)
2026년 8월 17일
기본 완료 (추정된)
2030년 8월 30일
연구 완료 (추정된)
2030년 8월 30일
연구 등록 날짜
최초 제출
2026년 6월 11일
QC 기준을 충족하는 최초 제출
2026년 6월 11일
처음 게시됨 (실제)
2026년 6월 17일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2026년 6월 17일
QC 기준을 충족하는 마지막 업데이트 제출
2026년 6월 11일
마지막으로 확인됨
2026년 6월 1일
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- 309169
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
예
IPD 계획 설명
Study Sponsor will assess requests from qualified researchers for anonymized individual patient-level data and related study documents.
Data sharing is subject to certain criteria, conditions, and exceptions.
For further information, refer to https://www.gsk-studyregister.com/gsk-patient-level-data-sharing-july2025.pdf
IPD 공유 기간
Anonymized IPD will be made available within 6 months of publication of primary, key secondary and safety results for studies in product with approved indication(s) or terminated asset(s) across all indications.
IPD 공유 액세스 기준
Anonymized IPD is shared with researchers whose proposals are approved by an Independent Review Panel and after a Data Sharing Agreement is in place.
Access is provided for an initial period of 12 months but an extension may be granted, when justified, for up to 6 months.
IPD 공유 지원 정보 유형
- 연구_프로토콜
- 수액
- ICF
- CSR
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
예
미국 FDA 규제 기기 제품 연구
아니
미국에서 제조되어 미국에서 수출되는 제품
예
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .