A Study of Raludotatug Deruxtecan (R-DXd) in Subjects With Platinum-resistant, High-grade Ovarian, Primary Peritoneal, or Fallopian Tube Cancer
NCT ID: NCT06161025
Last Updated: 2026-01-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2/PHASE3
860 participants
INTERVENTIONAL
2024-02-27
2030-04-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
SEQUENTIAL
TREATMENT
NONE
Study Groups
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Part A: R-DXd 4.8mg/kg Q3W
Participants will be randomized to receive intravenous R-DXd administered at a dose of 4.8 mg/kg every 3 weeks (Q3W).
R-DXd
R-DXd will be administered as an intravenously (IV) infusion
Part A: R-DXd 5.6 mg/kg Q3W
Participants will be randomized to receive intravenous R-DXd administered at a dose of 5.6 mg/kg every 3 weeks (Q3W).
R-DXd
R-DXd will be administered as an intravenously (IV) infusion
Part A: R-DXd 6.4 mg/kg Q3W
Participants will be randomized to receive intravenous R-DXd administered at a dose of 6.4 mg/kg every 3 weeks (Q3W).
R-DXd
R-DXd will be administered as an intravenously (IV) infusion
Part B: R-DXd RP3D Q3W
Participants will be randomized to receive intravenous R-DXd administered at the Recommended Phase 3 Dose (RP3D) every 3 weeks (Q3W).
R-DXd
R-DXd will be administered as an intravenously (IV) infusion
Part B: Investigator's Choice
Participants will be randomized to receive intravenous treatment with investigator's choice of paclitaxel, pegylated liposomal doxorubicin (PLD), or topotecan.
Paclitaxel
Paclitaxel will be administered as an IV infusion
Topotecan
Topotecan will be administered as an IV infusion
PLD
PLD will be administered as an IV infusion
Interventions
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R-DXd
R-DXd will be administered as an intravenously (IV) infusion
Paclitaxel
Paclitaxel will be administered as an IV infusion
Topotecan
Topotecan will be administered as an IV infusion
PLD
PLD will be administered as an IV infusion
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Age ≥18 years or the minimum legal adult age (whichever is greater) at the time the informed consent form is signed.
* Participants with histologically or cytologically documented high-grade serous ovarian cancer (OVC), high-grade endometrioid OVC, primary peritoneal cancer, or fallopian tube cancer.
* For Phase 2 (Part A) Participants must have at least 1 lesion, not previously irradiated, amenable to biopsy, and must consent to provide a pretreatment biopsy and on-treatment biopsy tissue sample (on-treatment biopsy sample not required for the Phase 3 part of the study). Fresh pretreatment biopsy may be waived for subjects who consent to provide an archival tumor tissue sample from a lesion not previously irradiated, performed within 6 months of consent and performed after treatment with their most recent cancer therapy regimen.
* For Phase 2 (Part A): Has received at least 1 but no more than 3 prior systemic lines of anticancer therapy. For Phase 3 (Part B): Has received at least 1 but no more than 4 prior systemic lines of anticancer therapy:
* Neoadjuvant +/-adjuvant considered 1 line of therapy.
* Maintenance therapy (eg, bevacizumab, poly-ADP ribose polymerase \[PARP\] inhibitors) will be considered part of the preceding line of therapy.
* Therapy changed due to toxicity in the absence of progression will be considered part of the same line.
* Hormonal therapy will be counted as a separate line of therapy, unless it was given as maintenance.
* At least 1 line of therapy containing bevacizumab, unless the subject is not eligible for treatment with bevacizumab due to precautions/intolerance. Note: Subjects must have progressed radiologically on or after their most recent line of systemic therapy. Biochemical progression will not be considered progression for this study.
* Has platinum-resistant disease. If a subject had only 1 line of platinum therapy, must have received at least 4 cycles of platinum, must have had a best response of not PD, and then progressed between \>90 and ≤180 days after the date of the last dose of platinum If a subject had 2 or 4 lines of platinum therapy, must have received at least 2 cycles of platinum and have progressed on or within 180 days after the date of the last dose of platinum.
* If mirvetuximab soravtansine (MIRV) is locally available: Has had prior treatment with MIRV for participants with documented high-folate receptor alpha expression, unless the participant is not eligible for treatment with mirvetuximab soravtansine due to precautions/intolerance, or if the treatment is not approved or available locally.
* Has at least 1 measurable lesion evaluated by computed tomography or magnetic resonance imaging according to Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) per investigator assessment.
* Eastern Cooperative Oncology Group performance status of 0 or 1.
* Has adequate organ and bone marrow function as assessed by local laboratory (within 14 days before start of study drug administration).
* Is willing and able to comply with scheduled visits, drug administration plan, laboratory tests, other study procedures and study restrictions.
* For Phase 3 (Part B) only: Subjects must be eligible for one of the treatments included in the investigator's choice of chemotherapy arm.
Exclusion Criteria
* Inadequate washout period before Cycle 1 Day 1, defined as follows:
* Major surgery \<28 days
* Radiation therapy \<28 days (if palliative stereotactic radiation therapy without abdominal radiation, ≤14 days)
* Systemic anticancer therapy (including antibody-drug therapy, retinoid therapy, and hormonal therapy) \<28 days or 5 half-lives, whichever is shorter, before starting study drug
* Chloroquine/hydroxychloroquine \<14 days
* Exposure to another investigational drug within 28 days prior to start of study treatment or current participation in other therapeutic investigational procedures
* Clinically active brain metastases, spinal cord compression, or leptomeningeal carcinomatosis, defined as untreated or symptomatic, or requiring therapy with steroids or anticonvulsants to control associated symptoms. Subjects with untreated and asymptomatic brain metastases or subjects with treated brain metastases who are no longer symptomatic and who require no treatment with steroids may be included in the study if they have recovered from the acute toxic effect of radiotherapy, at the investigator's discretion A minimum of 2 weeks must have elapsed between the end of radiotherapy and randomization and there should be no evidence of progression or need for steroid treatment or anticonvulsants for at least 2 weeks prior to randomization. Note: If there is a history or suspicion of central nervous system. Note: If there is a history or suspicion of central nervous system metastasis, a CT scan of the head or MRI of the brain must be performed at baseline.
* Any of the following within the past 6 months prior to randomization: cerebrovascular accident, transient ischemic attack, or other arterial thromboembolic event.
* Uncontrolled or significant cardiovascular disease, including the following:
* QT interval corrected with Fridericia's formula interval \>470 ms.
* Diagnosed or suspected long QT syndrome.
* History of clinically relevant ventricular arrhythmias, such as ventricular tachycardia, ventricular fibrillation, or Torsade de Pointes.
* The participant has bradycardia of less than 50 bpm, unless the subject has a pacemaker.
* History of second- or third-degree heart block. Candidates with a history of heart block may be eligible if they currently have pacemakers and have no history of fainting or clinically relevant arrhythmia with pacemakers.
* Myocardial infarction within 6 months prior to screening.
* Uncontrolled angina pectoris within 6 months prior to screening.
* New York Heart Association Class 3 or 4 congestive heart failure.
* Left ventricular ejection fraction \<50% or institutional lower limit of normal as measured by echocardiography or multigated acquisition (MUGA) scan.
* Coronary/peripheral artery bypass graft within 6 months prior to screening
* Uncontrolled hypertension (HgCTCAE Grade ≥3 hypertension as per NCI-CTCAE version 5.0).
* Complete left or right bundle branch block.
* Has a history of (noninfectious) ILD/pneumonitis that required corticosteroids, has current ILD/pneumonitis, or where suspected ILD/pneumonitis cannot be ruled out by imaging at screening.
* 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 the study enrollment, severe asthma, severe chronic obstructive pulmonary disease (COPD), restrictive lung disease, pleural effusion, etc) and any autoimmune, connective tissue, or inflammatory disorders with potential pulmonary involvement (eg, rheumatoid arthritis, Sjogren's syndrome, sarcoidosis, etc), or prior pneumonectomy.
* Chronic steroid treatment (\>10 mg/day), with the exception of the following:
* Inhaled steroids for asthma or COPD
* Mineralocorticoids (eg, fludrocortisone) for subjects with orthostatic hypotension
* Topical steroids for mild skin conditions
* Low-dose supplemental corticosteroids for adrenocortical insufficiency
* Premedication for treatment groups and/or premedication in case of any hypersensitivity
* Intra-articular steroid injections
* History of malignancy other than epithelial OVC, primary peritoneal cancer, or fallopian tube cancer within 3 years prior to enrollment, with the exception of those with a negligible risk of metastasis or death (eg, 5-year OS rate \>90%) and treated with expected curative outcome (such as adequately treated carcinoma in situ of the cervix, nonmelanoma skin carcinoma, ductal carcinoma in situ, or Stage 1 uterine cancer).
* Unresolved toxicities from previous anticancer therapy, defined as toxicities (other than alopecia) not yet resolved to NCI-CTCAE Version 5.0, Grade ≤1 or baseline. Note: Subjects may be enrolled with chronic, stable Grade 2 toxicities (defined as no worsening to Grade \>2 for 3 months prior to randomization and managed with SOC treatment) that the investigator deems related to previous anticancer therapy, following discussion with the Sponsor, such as the following:
* Chemotherapy-induced neuropathy
* Fatigue
* Endocrinopathies, which may include hypothyroidism, hyperthyroidism, Type 1 diabetes, hyperglycemia, and adrenal insufficiency
* Skin pigmentation (vitiligo)
* For Phase 2 (Part A): Prior exposure to other CDH6-targeted agents or an ADC that consists of an exatecan derivative that is a topoisomerase I inhibitor (eg, trastuzumab deruxtecan or datopotamab deruxtecan). For Phase 3 (Part B): Prior exposure to other CDH6-targeted agents or an antibody-drug conjugate containing a topoisomerase I inhibitor.
* History of hypersensitivity to any excipients in the R-DXd or any known contraindication to treatment with, including hypersensitivity to, the study drug(s).
* Has an active or uncontrolled human immunodeficiency virus (HIV) infection.
* Has any evidence of severe or uncontrolled systemic diseases (including active bleeding diatheses or active infection, substance abuse) or other factors that, in the investigator's opinion, makes it undesirable for the subject to participate in the study or which would jeopardize compliance with the protocol. Screening for chronic conditions is not required.
* Has an active or uncontrolled hepatitis B virus (HBV) or hepatitis C virus (HCV) infection. Hepatitis B and Hepatitis C Screening tests are required.
Subjects are eligible if:
1. Hepatitis B virus surface antigen (HBsAg) positive are eligible if they have received HBV antiviral therapy for at least 4 weeks and have undetectable HBV viral load prior to randomization.
2. History of hepatitis C infection: eligible if the HCV viral load is below the level of detection in the absence of antiviral therapy during the previous 4 weeks.
3. Have normal transaminase values, or, if liver metastases are present, abnormal transaminases with a result of AST/ALT \<3 × ULN, which are not attributable to HCV infection.
* Female who is pregnant or breastfeeding or intends to become pregnant during the study.
* Psychological, social, familial, or geographical factors that would prevent regular follow-up.
* Prior or ongoing clinically relevant illness, medical condition, surgical history, physical finding, or laboratory abnormality that, in the investigator's opinion, could affect the safety of the subject; alter the absorption, distribution, metabolism, or excretion of the study drug; or confound the assessment of study results.
* Has a history of receiving live-attenuated vaccine (messenger RNA \[mRNA\] and replication-deficient adenoviral vaccines are not considered attenuated live vaccines) within 30 days prior to the first exposure to study intervention.
* For Phase 3 (Part B) only: Has clinical symptoms or radiographic evidence of intestinal obstruction.
* For Phase 3 (Part B) only: Has ascites or pleural effusions that require repeated drainage (less than 4 weeks between drainages).
18 Years
ALL
No
Sponsors
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Merck Sharp & Dohme LLC
INDUSTRY
Daiichi Sankyo
INDUSTRY
Responsible Party
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Principal Investigators
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Global Clinical Leader
Role: STUDY_DIRECTOR
Daiichi Sankyo
Locations
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Alaska Women's Cancer Care
Anchorage, Alaska, United States
Yale University School of Medicine
New Haven, Connecticut, United States
Sylvester Comprehensive Cancer Center at Lennar
Coral Gables, Florida, United States
Sylvester Comprehensive Cancer Center at Deerfield Beach
Deerfield Beach, Florida, United States
Florida Cancer Specialists
Lake Mary, Florida, United States
Sylvester Cancer Center
Miami, Florida, United States
Mount Sinai Comprehensive Cancer Center
Miami Beach, Florida, United States
Sylvester Comprehensive Cancer Center at Plantation
Plantation, Florida, United States
Community MD Anderson Cancer Center- East
Indianapolis, Indiana, United States
Community MD Anderson Cancer Center- South
Indianapolis, Indiana, United States
Community Health Network - MD Anderson
Indianapolis, Indiana, United States
St. Elizabeth Medical Center
Edgewood, Kentucky, United States
Washington University School of Medicine Obstetrics and Gynecology
St Louis, Missouri, United States
Valley Health System
Paramus, New Jersey, United States
Holy Name
Teaneck, New Jersey, United States
NHPP Imbert
Bay Shore, New York, United States
Northwell Health, LLC PRIME
Lake Success, New York, United States
Perlmutter Cancer Center at NYU Langone Hospital- Long Island
Mineola, New York, United States
NYU Langone Health
New York, New York, United States
NHPP LHH
New York, New York, United States
Duke Women's Cancer Care- Raleigh
Durham, North Carolina, United States
Duke Cancer Center
Durham, North Carolina, United States
Ohio State University Wexner Medical Center
Hilliard, Ohio, United States
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, United States
Oklahoma Cancer Specialists and Research Institute
Tulsa, Oklahoma, United States
Perelman School of Medicine at the University of Pennsylvania
Philadelphia, Pennsylvania, United States
Medical University of South Carolina (MUSC)
Charleston, South Carolina, United States
Sanford Cancer Center Gynecologic Oncology
Sioux Falls, South Dakota, United States
Texas Oncology-Bedford
Bedford, Texas, United States
Houston Area Locations- Woodlands
Conroe, Texas, United States
Texas Oncology-Presbyterian Cancer Center Dallas
Dallas, Texas, United States
Texas Oncology-Baylor Charles A. Sammons Cancer Center
Dallas, Texas, United States
Texas Oncology Paris
Fort Worth, Texas, United States
Houston Methodist Hospital
Houston, Texas, United States
University of Texas - MD Anderson
Houston, Texas, United States
Houston Area Locations- Sugar Land
Houston, Texas, United States
Houston Area Locations- West Houston
Houston, Texas, United States
Houston Area Locations- League City
League City, Texas, United States
University of Washington - Seattle Cancer Care Alliance
Seattle, Washington, United States
GenesisCare St Andrews Hospital
Adelaide, , Australia
GenesisCare North Shore (Oncology)
St Leonards, , Australia
McGill University Health Centre/Glen Site / Royal Victoria Hospital
Montreal, , Canada
University Health Network - Princess Margaret Cancer Centre
Toronto, , Canada
Beijing Cancer Hospital
Beijing, , China
Chongqing Cancer Hospital
Chongqing, , China
Fujian Provincial Cancer Hospital
Fuzhou, , China
The First Affiliated Hospital of Guangzhou Medical University
Guangzhou, , China
Zhejiang Cancer Hospital
Hangzhou, , China
Shandong Cancer Hospital
Jinan, , China
Qilu Hospital of Shandong University
Jinan, , China
Guangxi Medical University Cancer Hospital
Nanning, , China
Fudan University Shanghai Cancer Center
Shanghai, , China
National Cheng Kung University Hospital
Tainan, , China
Tianjin Medical University Cancer Institute & Hospital
Tianjin, , China
Hubei Cancer Hospital
Wuhan, , China
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, , China
Fakultni nemocnice Hradec Kralove
Hradec Králové, , Czechia
Fakultni nemocnice v Motole
Prague, , Czechia
Fakultni nemocnice Bulovka
Prague, , Czechia
Vseobecna fakultni nemocnice v Praze
Prague, , Czechia
Institut Bergonié
Bordeaux, , France
Centre Francois Baclesse
Caen, , France
Centre Jean Perrin - CLCC
Clermont-Ferrand, , France
Centre Georges François Leclerc
Dijon, , France
Centre Leon Berard
Lyon, , France
Institut Paoli Calmettes
Marseille, , France
Institut du Cancer de Montpellier
Montpellier, , France
Hôpital Privé du Confluent
Nantes, , France
Groupe Hospitalier Diaconesses - Hôpital De La Croix Saint Simon
Paris, , France
CARIO - Centre Armoricain de Radiothérapie, Imagerie médicale et Oncologie
Plérin, , France
Institut Curie
Saint-Cloud, , France
ICL Alexis Vautrin
Vandœuvre-lès-Nancy, , France
Kliniken Essen-Mitte
Essen, , Germany
Universitaetsklinikum Mannheim
Mannheim, , Germany
Universitaetsklinikum Ulm
Ulm, , Germany
IRCCS Centro di Riferimento Oncologico
Aviano, , Italy
Azienda Ospedaliera Per Lemergenza Cannizzaro
Catania, , Italy
Azienda Ospedaliera Universitaria Careggi
Florence, , Italy
Humanitas San Pio X
Milan, , Italy
IEO Istituto Europeo di Oncologia
Milan, , Italy
Istituto Nazionale Tumori Fondazione G. Pascale
Napoli, , Italy
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Roma, , Italy
Istituto Clinico Humanitas
Rozzano, , Italy
Ospedale Mauriziano Umberto I
Torino, , Italy
National Cancer Center Hospital
Chūōku, , Japan
NHO Kyushu Cancer Center
Fukuoka, , Japan
Saitama Medical University International Medical Center
Hidaka-shi, , Japan
National Cancer Center Hospital East
Kashiwa-shi, , Japan
Cancer Institute Hospital of JFCR
Kōtoku, , Japan
Jikei University Hospital
Minatoku, , Japan
Shizuoka Cancer Center
Nagaizumi-cho, , Japan
Aichi Cancer Center Hospital
Nagoya, , Japan
Niigata Cancer Center Hospital
Niigata, , Japan
Osaka International Cancer Institute
Osaka, , Japan
Hokkaido University Hospital
Sapporo, , Japan
Iwate Medical University Hospital
Shiwa-gun, , Japan
Uniwersyteckie Centrum Kliniczne
Gdansk, , Poland
Mazowiecki Szpital Wojewodzki w Siedlcach Sp z o o
Siedlce, , Poland
Hospital Professor Doutor Fernando Fonseca, E.P.E.
Amadora, , Portugal
National Cancer Center
Goyang-si, , South Korea
CHA Bundang Medical Center, CHA University
Seongnam-si, , South Korea
National University Hospital
Seoul, , South Korea
Severance Hospital, Yonsei University Health System
Seoul, , South Korea
Asan Medical Center
Seoul, , South Korea
Samsung Medical Center
Seoul, , South Korea
The Catholic University of Korea, Seoul St. Mary's Hospital
Seoul, , South Korea
Hospital Clinic de Barcelona
Barcelona, , Spain
Hospital Universitari Vall d'Hebron
Barcelona, , Spain
Hospital Universitario Ciudad de Jaen
Jaén, , Spain
Hospital Universitario Clinico San Carlos
Madrid, , Spain
Hospital Universitario 12 de Octubre
Madrid, , Spain
Hospital Universitario La Paz
Madrid, , Spain
Clinica Universidad de Navarra (MAD)
Pamplona, , Spain
Clinica Universidad de Navarra
Pamplona, , Spain
Hospital Clínico Universitario Valencia
Valencia, , Spain
Taichung Veterans General Hospital
Taichung, , Taiwan
Taipei Veterans General Hospital
Taipei, , Taiwan
Koo Foundation Sun Yat-Sen Cancer Center
Taipei, , Taiwan
Chang Gung Memorial Hospital,Linkou
Taoyuan, , Taiwan
Royal United Hospital
Bath, , United Kingdom
Countries
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Central Contacts
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Medical Director Contact for Clinical Trial Information
Role: CONTACT
Other Identifiers
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REJOICE-Ovarian01
Identifier Type: OTHER
Identifier Source: secondary_id
ENGOT-ov77
Identifier Type: OTHER
Identifier Source: secondary_id
GOG-3096
Identifier Type: OTHER
Identifier Source: secondary_id
jRCT2031230556
Identifier Type: OTHER
Identifier Source: secondary_id
DS6000-109
Identifier Type: -
Identifier Source: org_study_id
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