A Clinical Trial of Raludotatug Deruxtecan (R-DXd) With or Without Bevacizumab in Participants With Ovarian Cancer Who Have Progressed During Treatment With PARP-inhibitors Treatment on First Line Maintenance (MK-5909-008/ENGOT-ov107/GOG-3142 / REJOICE-Ovarian05)
2026년 9월 8일 업데이트: Merck Sharp & Dohme LLC
A Phase 3, Open-Label, Multicenter, Randomized Study of Raludotatug Deruxtecan (MK-5909, R-DXd) With or Without Bevacizumab Versus Standard-of-Care Platinum-Based Doublet Chemotherapy With or Without Bevacizumab in Participants With Advanced Platinum-Sensitive High-Grade Serous or High-Grade Endometrioid Epithelial Ovarian, Primary Peritoneal, or Fallopian Tube Cancer Who Have Progressed During First-Line PARPi Maintenance (ENGOT-ov107 / GOG-3142 / REJOICE-Ovarian05)
Researchers are looking for new ways to treat advanced, high-grade ovarian cancer (OC). Advanced means the cancer has spread to other parts of the body (metastatic) and may not be removed with surgery. High-grade means the cancer cells grow and spread quickly. This trial includes types of OC that started in cells that cover the ovaries, in the lining of the belly, or in the fallopian tubes.
The usual treatment for high-grade OC may include one or both of these:
- Chemotherapy, which is a treatment that uses medicine to destroy cancer cells or stop them from growing.
- Bevacizumab, which is a targeted therapy that works to control how specific types of cancer cells grow and spread and targets tumor blood vessels.
Researchers want to learn about the trial medicine, raludotatug deruxtecan (also called R-DXd or MK-5909), when given with and without bevacizumab and how participants respond to it. R-DXd is an antibody drug conjugate (ADC). An ADC is a type of medicine that attaches to a specific target on cancer cells and delivers treatment to destroy those cells.
The goals of this trial are to learn if participants who receive R-DXd, with or without bevacizumab, live longer overall and without their cancer growing or spreading compared to those who receive usual treatment.
연구 개요
상태
아직 모집하지 않음
연구 유형
중재적
등록 (추정된)
646
단계
- 3단계
연락처 및 위치
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연구 연락처
- 이름: Toll Free Number
- 전화번호: 1-888-577-8839
- 이메일: Trialsites@msd.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
The main inclusion criteria include but are not limited to the following:
- Has a histologically or cytologically documented advanced high-grade serous or high-grade endometrioid epithelial ovarian, primary peritoneal, or fallopian tube cancer.
- Has received 1 line of platinum-based therapy with a minimum of 4 cycles of platinum-doublet chemotherapy and have platinum-sensitive disease.
- Has received a poly (ADP-ribose) polymerase inhibitor (PARPi) as maintenance treatment after the first line platinum-based chemotherapy course and experienced radiographic progression during treatment or within 42 days of the last dose of PARPi.
- Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 assessed within 7 days before randomization.
- Has recovered from any AEs due to previous anticancer therapies.
The main exclusion criteria include but are not limited to the following:
- Has clear cell, mucinous, or sarcomatous histology, mixed tumors containing any histology, or low-grade/borderline ovarian cancer.
- Has a history of thrombotic disorders, hemorrhage, hemoptysis, or active GI bleeding within 6 months before randomization.
- Has uncontrolled or significant cardiovascular disease.
- Has clinically severe pulmonary compromise resulting from intercurrent pulmonary illnesses including, but not limited to, any underlying pulmonary disorder (ie, pulmonary emboli within 3 months of randomization, severe asthma, severe chronic obstructive pulmonary disease [COPD], restrictive lung disease, pleural effusion) and any autoimmune, connective tissue, or inflammatory disorders with potential pulmonary involvement (eg, rheumatoid arthritis, Sjogren's syndrome, sarcoidosis), or prior pneumonectomy.
- Has received chronic steroid treatment, with some exceptions.
- Has current, clinically relevant bowel obstruction (including subocclusive disease) including obstruction related to underlying epithelial ovarian cancer, abdominal fistula or GI perforation, intra-abdominal abscess, or evidence of rectosigmoid involvement by pelvic exam.
- Has known additional malignancy that is progressing or has required active treatment within the past 3 years.
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: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 하나의
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
실험적: R-DXd +/- Bevacizumab
Participants will receive intravenous (IV) raludotatug deruxtecan (R-DXd) with or without IV bevacizumab for up to 2 years until progressive disease (PD), unacceptable toxicity, or other protocol-specified reason for discontinuation
|
R-DXd alone or in combination with bevacizumab administered via IV infusion
다른 이름들:
Bevacizumab 10 or 15 mg/kg administered via IV infusion on day 1 q3w
다른 이름들:
|
|
활성 비교기: Standard of Care
Participants receive 6 to 8 cycles of investigator's choice of one of three options of platinum-based chemotherapy with or without IV bevacizumab.
Bevacizumab treatment if elected, will continue until PD, unacceptable toxicity, or other protocol specified reason for discontinuation
|
Bevacizumab 10 or 15 mg/kg administered via IV infusion on day 1 q3w
다른 이름들:
Carboplatin area under the curve (AUC) 5 mg/mL*min or AUC 4 mg/mL*min administered on day 1 q3w for a maximum of 8 cycles
Paclitaxel 175 mg/m^2 administered via IV infusion on day 1 q3w for a maximum of 8 cycles
Gemcitabine 1000 mg/mL administered via IV infusion on day 1 and day 8 of each 3-week cycle for a maximum of 8 cycles
PLD 30 mg/m^2 administered via IV infusion on day 1 of each 4-week cycles for a maximum of 8 cycles
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
전체 생존(OS)
기간: 최대 약 4년
|
OS는 임의의 원인으로 인한 무작위 배정에서 사망까지의 시간으로 정의됩니다.
|
최대 약 4년
|
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Progression-free Survival (PFS)
기간: Up to approximately 3 years
|
PFS is defined as the time from randomization to the first documented disease progression per Response Criteria in Solid Tumors Version 1.1 (RECIST 1.1) or death due to any cause, whichever occurs first.
Disease progression is defined as ≥20% increase in the sum of diameters of target lesions.
In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of ≥5 mm.
The appearance of one or more new lesions is also considered disease progression.
PFS as assessed by blinded independent central review (BICR) will be presented.
|
Up to approximately 3 years
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Number of Participants who Experience One or More Adverse Events (AEs)
기간: Up to approximately 3 years
|
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention. |
Up to approximately 3 years
|
|
Number of Participants who Discontinue Study Intervention Due to an AE
기간: Up to approximately 3 years
|
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention. |
Up to approximately 3 years
|
|
Objective Response Rate (ORR)
기간: Up to approximately 3 years
|
ORR is defined as the percentage of participants with Complete Response (CR: disappearance of all target lesions) or Partial Response (PR: at least a 30% decrease in the sum of diameters of target lesions) per Response Evaluation Criteria In Solid Tumors Version 1.1 (RECIST 1.1).
The percentage of participants who experience CR or PR as assessed by Blinded Independent Central Review (BICR) will be presented.
|
Up to approximately 3 years
|
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Duration of Response (DOR)
기간: Up to approximately 3 years
|
For participants who demonstrate confirmed CR or PR, duration of response is defined as the time from the first documented evidence of CR or PR until disease progression or death due to any cause, whichever occurs first.
Per RECIST 1.1, disease progression (DP) is defined as at least a 20% increase in the sum of diameters of target lesions.
In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm.
The appearance of one or more new lesions is also considered DP.
|
Up to approximately 3 years
|
|
Progression-free Survival 2 (PFS2)
기간: Up to approximately 4 years
|
PFS2 is defined as the time from randomization to the documented subsequent objective disease progression after initiation of new anticancer therapy or death due to any cause, whichever occurs first.
|
Up to approximately 4 years
|
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Time to First Subsequent Anticancer Treatment (TFST)
기간: Up to approximately 3 years
|
TFST is defined as the time from randomization to initiation of first subsequent anticancer treatment or death due to any cause, whichever occurs first.
|
Up to approximately 3 years
|
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Change from Baseline in European Organisation for Research and Treatment of Cancer (EORTC) Core Quality of Life Questionnaire 30- (QLQ-C30) Global Health Status (Item 29) and Quality of Life (Item 30) Combined Score
기간: Baseline and at designated time points up to approximately 3 years
|
EORTC QLQ-C30 is a questionnaire to assess the overall quality of life of cancer patients.
Participant responses to the questions "How would you rate your overall health during the past week?"
and "How would you rate your overall quality of life during the past week?"
are scored on a 7-point scale (1= Very poor to 7=Excellent).
Using linear transformation, raw scores are standardized, so that scores range from 0 to 100.
A higher score indicates a better overall health status.
The change from baseline in EORTC QLQ-C30 Items 29 and 30 combined score will be presented.
|
Baseline and at designated time points up to approximately 3 years
|
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Change from Baseline in EORTC Quality of Life Questionnaire Ovarian Cancer Module 28 (QLQ-OV28) Abdominal/Gastrointestinal (GI) Scale
기간: Baseline and at designated time points up to approximately 3 years
|
EORTC QLQ-OV28 is an ovarian cancer-specific module to supplement the EORTC QLQ-C30.
Participant responses to the 6 abdominal/GI symptoms scale questions are scored on a 4-point scale (1=not at all, 4=very much).
The combined score is computed by averaging the raw scores of the 6 items and then applying a linear transformation to standardize the average score, so that the combined score ranges from 0 to 100.
The change from baseline in abdominal and gastrointestinal symptoms (EORTC QLQ-OC28 Items 31-36) score will be presented.
A lower score indicates a better outcome.
|
Baseline and at designated time points up to approximately 3 years
|
공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
협력자
수사관
- 연구 책임자: Medical Director, Merck Sharp & Dohme LLC
간행물 및 유용한 링크
연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.
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 10월 5일
기본 완료 (추정된)
2031년 8월 31일
연구 완료 (추정된)
2031년 8월 31일
연구 등록 날짜
최초 제출
2026년 7월 29일
QC 기준을 충족하는 최초 제출
2026년 7월 29일
처음 게시됨 (실제)
2026년 8월 3일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2026년 9월 11일
QC 기준을 충족하는 마지막 업데이트 제출
2026년 9월 8일
마지막으로 확인됨
2026년 9월 1일
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
- 비뇨생식기 질환
- 생식기 질환
- 내분비계 질환
- 비뇨생식기 신생물
- 부위별 신생물
- 신생물
- 여성 비뇨 생식기 질환
- 여성 비뇨 생식기 질환 및 임신 합병증
- 생식기 질환, 여성
- 내분비샘 신생물
- 난소 질환
- 부속기 질환
- 생식기 신생물, 여성
- 생식선 장애
- 나팔관 질환
- 난소 신생물
- 나팔관 신생물
- 아미노산, 펩티드 및 단백질
- 단백질
- 유기 화학 물질
- 이종 사이 클릭 화합물, 1- 링
- 이종 사이 클릭 화합물
- 탄화수소
- 사이클로 파라핀
- 탄화수소, alicyclic
- 탄화수소, 순환
- 테르펜
- 항체, 모노클로 날, 인간화
- 항체, 모노클로 날
- 항체
- 면역 글로불린
- 면역 단백질
- 혈액 단백질
- 혈청 글로불린
- 글로불린
- 조정 복합체
- 박습니다
- 사이클로 데카네
- Diterpenes
- 데 옥시 시티 딘
- 시티 딘
- 피리 미딘 뉴 클레오 시드
- 피리 미딘
- 베바시주맙
- 젬시타빈
- 카르보플라틴
- 파클리탁셀
- 리포좀 독소루비신
기타 연구 ID 번호
- 5909-008
- 2025 (미국 NIH 보조금/계약: Faculty of Social Sciences Scientific Grant at the University of Gdańsk)
- ENGOT-ov107 (기타 식별자: European Network of Gynaecological Oncological Trial Groups)
- GOG-3142 (기타 식별자: GOG Foundation)
- REJOICE-Ovarian05 (RO-05) (기타 식별자: Daiichi Sankyo)
- U1111-1333-3042 (레지스트리 식별자: UTN)
- MK-5909-008 (기타 식별자: MSD)
- 2025-525130-59-00 (레지스트리 식별자: EU CT)
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
예
IPD 계획 설명
https://trialstransparency.msdclinicaltrials.com/pdf/ProcedureAccessClinicalTrialData.pdf
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
예
미국 FDA 규제 기기 제품 연구
아니
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. .