Tato stránka byla automaticky přeložena a přesnost překladu není zaručena. Podívejte se prosím na anglická verze pro zdrojový text.

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)

8. září 2026 aktualizováno: 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.

Přehled studie

Postavení

Zatím nenabíráme

Podmínky

Intervence / Léčba

Typ studie

Intervenční

Zápis (Odhadovaný)

646

Fáze

  • Fáze 3

Kontakty a umístění

Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.

Studijní kontakt

Kritéria účasti

Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.

Kritéria způsobilosti

Věk způsobilý ke studiu

  • Dospělý
  • Starší dospělý

Přijímá zdravé dobrovolníky

Ne

Popis

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.

Studijní plán

Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.

Jak je studie koncipována?

Detaily designu

  • Primární účel: Léčba
  • Přidělení: Randomizované
  • Intervenční model: Paralelní přiřazení
  • Maskování: Singl

Zbraně a zásahy

Skupina účastníků / Arm
Intervence / Léčba
Experimentální: 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
Biologický: R-DXd
R-DXd alone or in combination with bevacizumab administered via IV infusion
Ostatní jména:
  • DS-6000a
  • MK-5909
  • raludotatug deruxtecan
Lék: Bevacizumab
Bevacizumab 10 or 15 mg/kg administered via IV infusion on day 1 q3w
Ostatní jména:
  • AVASTIN®
  • MVASI®
Aktivní komparátor: 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
Lék: Bevacizumab
Bevacizumab 10 or 15 mg/kg administered via IV infusion on day 1 q3w
Ostatní jména:
  • AVASTIN®
  • MVASI®
Lék: Carboplatin
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
Lék: Paclitaxel
Paclitaxel 175 mg/m^2 administered via IV infusion on day 1 q3w for a maximum of 8 cycles
Lék: Gemcitabine
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
Lék: Pegylated liposomal doxorubicin (PLD)
PLD 30 mg/m^2 administered via IV infusion on day 1 of each 4-week cycles for a maximum of 8 cycles

Co je měření studie?

Primární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Celkové přežití (OS)
Časové okno: Do cca 4 let
OS je definován jako doba od randomizace do smrti z jakékoli příčiny.
Do cca 4 let
Progression-free Survival (PFS)
Časové okno: 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

Sekundární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Number of Participants who Experience One or More Adverse Events (AEs)
Časové okno: 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
Časové okno: 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)
Časové okno: 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
Duration of Response (DOR)
Časové okno: 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)
Časové okno: 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
Time to First Subsequent Anticancer Treatment (TFST)
Časové okno: 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
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
Časové okno: 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
Change from Baseline in EORTC Quality of Life Questionnaire Ovarian Cancer Module 28 (QLQ-OV28) Abdominal/Gastrointestinal (GI) Scale
Časové okno: 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

Spolupracovníci a vyšetřovatelé

Zde najdete lidi a organizace zapojené do této studie.

Sponzor

Merck Sharp & Dohme LLC

Spolupracovníci

Daiichi Sankyo

Vyšetřovatelé

  • Ředitel studie: Medical Director, Merck Sharp & Dohme LLC

Publikace a užitečné odkazy

Osoba odpovědná za zadávání informací o studiu tyto publikace poskytuje dobrovolně. Mohou se týkat čehokoli, co souvisí se studiem.

Užitečné odkazy

Termíny studijních záznamů

Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.

Hlavní termíny studia

Začátek studia (Odhadovaný)

5. října 2026

Primární dokončení (Odhadovaný)

31. srpna 2031

Dokončení studie (Odhadovaný)

31. srpna 2031

Termíny zápisu do studia

První předloženo

29. července 2026

První předloženo, které splnilo kritéria kontroly kvality

29. července 2026

První zveřejněno (Aktuální)

3. srpna 2026

Aktualizace studijních záznamů

Poslední zveřejněná aktualizace (Aktuální)

11. září 2026

Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality

8. září 2026

Naposledy ověřeno

1. září 2026

Více informací

Termíny související s touto studií

Další relevantní podmínky MeSH

Další identifikační čísla studie

  • 5909-008
  • 2025 (Grant/smlouva NIH USA: Faculty of Social Sciences Scientific Grant at the University of Gdańsk)
  • ENGOT-ov107 (Jiný identifikátor: European Network of Gynaecological Oncological Trial Groups)
  • GOG-3142 (Jiný identifikátor: GOG Foundation)
  • REJOICE-Ovarian05 (RO-05) (Jiný identifikátor: Daiichi Sankyo)
  • U1111-1333-3042 (Identifikátor registru: UTN)
  • MK-5909-008 (Jiný identifikátor: MSD)
  • 2025-525130-59-00 (Identifikátor registru: EU CT)

Plán pro data jednotlivých účastníků (IPD)

Plánujete sdílet data jednotlivých účastníků (IPD)?

ANO

Popis plánu IPD

https://trialstransparency.msdclinicaltrials.com/pdf/ProcedureAccessClinicalTrialData.pdf

Informace o lécích a zařízeních, studijní dokumenty

Studuje lékový produkt regulovaný americkým FDA

Ano

Studuje produkt zařízení regulovaný americkým úřadem FDA

Ne

Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .

Předplatit