A Study of Raludotatug Deruxtecan (R-DXd) in Subjects With Platinum-resistant, High-grade Ovarian, Primary Peritoneal, or Fallopian Tube Cancer
A Phase 2/3, Multicenter, Randomized Study of Raludotatug Deruxtecan (R-DXd), a CDH6-directed Antibody-drug Conjugate, in Subjects With Platinum-resistant, High-grade Ovarian, Primary Peritoneal, or Fallopian Tube Cancer
5 other identifiers
interventional
860
19 countries
146
Brief Summary
This study will evaluate the safety and efficacy of R-DXd therapy in participants with ovarian, peritoneal, or fallopian tube cancer.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Feb 2024
Longer than P75 for phase_2
146 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 27, 2023
CompletedFirst Posted
Study publicly available on registry
December 7, 2023
CompletedStudy Start
First participant enrolled
February 27, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 29, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
April 30, 2030
May 22, 2026
May 1, 2026
4 years
November 27, 2023
May 20, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Objective Response Rate (ORR) Based on Blinded Independent Central Review (BICR) Assessment (Part A)
The ORR was defined as the percentage of participants with confirmed Complete Response (CR) or Partial Response (PR), by BICR assessment based on RECIST version 1.1.
From date of randomization to data cut off, up to 18 months
Progression-free Survival (PFS) Based on BICR Assessment (Part B)
PFS is defined as the time from the date of randomization to the date of disease progression, defined as the first documented radiological progression or death due to any cause, whichever comes first.
From date of randomization to data cut off, up to 26 months
Secondary Outcomes (21)
Objective Response Rate (ORR) Based on Investigator Assessment
From date of randomization to data cut off, up to 30 months
Overall Survival (OS)
From date of randomization to data cut off, up to 40 months
Duration of Response (DOR)
From date of randomization to data cut off, up to 40 months
Progression-free Survival (PFS) Based on BICR and Investigator Assessment
From date of randomization to data cut off, up to 30 months
Disease Control Rate (DCR)
From date of randomization to data cut off, up to 40 months
- +16 more secondary outcomes
Study Arms (5)
Part A: R-DXd 4.8mg/kg Q3W
EXPERIMENTALParticipants will be randomized to receive intravenous R-DXd administered at a dose of 4.8 mg/kg every 3 weeks (Q3W).
Part A: R-DXd 5.6 mg/kg Q3W
EXPERIMENTALParticipants will be randomized to receive intravenous R-DXd administered at a dose of 5.6 mg/kg every 3 weeks (Q3W).
Part A: R-DXd 6.4 mg/kg Q3W
EXPERIMENTALParticipants will be randomized to receive intravenous R-DXd administered at a dose of 6.4 mg/kg every 3 weeks (Q3W).
Part B: R-DXd RP3D Q3W
EXPERIMENTALParticipants will be randomized to receive intravenous R-DXd administered at the Recommended Phase 3 Dose (RP3D) every 3 weeks (Q3W).
Part B: Investigator's Choice
ACTIVE COMPARATORParticipants will be randomized to receive intravenous treatment with investigator's choice of paclitaxel, pegylated liposomal doxorubicin (PLD), or topotecan.
Interventions
R-DXd will be administered as an intravenously (IV) infusion
PLD will be administered as an IV infusion
Eligibility Criteria
You may qualify if:
- Sign and date the informed consent form prior to the start of any study-specific qualification procedures.
- 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).
- +2 more criteria
You may not qualify if:
- Has clear cell, mucinous, or sarcomatous histology, mixed tumors containing any histology, or low-grade/borderline OVC. (Note for Phase 3 \[Part B\]: seromucinous, low-grade serous carcinoma or ovarian sarcoma, carcinosarcoma and undifferentiated carcinoma are excluded.)
- 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.
- +37 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Daiichi Sankyolead
- Merck Sharp & Dohme LLCcollaborator
Study Sites (146)
Alaska Women's Cancer Care
Anchorage, Alaska, 99508, United States
Yale University School of Medicine
New Haven, Connecticut, 06520, United States
Sylvester Comprehensive Cancer Center at Lennar
Coral Gables, Florida, 33146, United States
Sylvester Comprehensive Cancer Center at Deerfield Beach
Deerfield Beach, Florida, 33442, United States
Florida Cancer Specialists
Lake Mary, Florida, 32746, United States
Sylvester Cancer Center
Miami, Florida, 33136, United States
Mount Sinai Comprehensive Cancer Center
Miami Beach, Florida, 33140, United States
Sylvester Comprehensive Cancer Center at Plantation
Plantation, Florida, 33324, United States
Community MD Anderson Cancer Center- East
Indianapolis, Indiana, 46219, United States
Community MD Anderson Cancer Center- South
Indianapolis, Indiana, 46227, United States
Community Health Network - MD Anderson
Indianapolis, Indiana, 46250, United States
St. Elizabeth Medical Center
Edgewood, Kentucky, 41017, United States
Baystate Medical Center
Springfield, Massachusetts, 01199-1001, United States
Washington University School of Medicine Obstetrics and Gynecology
St Louis, Missouri, 63110, United States
Valley Health System
Paramus, New Jersey, 07652, United States
Holy Name
Teaneck, New Jersey, 07666, United States
NHPP Imbert
Bay Shore, New York, 11706, United States
Northwell Health, LLC PRIME
Lake Success, New York, 11042, United States
Perlmutter Cancer Center at NYU Langone Hospital- Long Island
Mineola, New York, 11501, United States
NYU Langone Health
New York, New York, 10016, United States
NHPP LHH
New York, New York, 10065, United States
Duke Women's Cancer Care- Raleigh
Durham, North Carolina, 27607, United States
Duke Cancer Center
Durham, North Carolina, 27710, United States
Ohio State University Wexner Medical Center
Hilliard, Ohio, 43026, United States
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, 73104, United States
Oklahoma Cancer Specialists and Research Institute
Tulsa, Oklahoma, 12967, United States
Oncology Associates of Oregon, P.C.
Eugene, Oregon, 97401, United States
Perelman School of Medicine at the University of Pennsylvania
Philadelphia, Pennsylvania, 19104-4238, United States
Medical University of South Carolina (MUSC)
Charleston, South Carolina, 29425, United States
Sanford Cancer Center Gynecologic Oncology
Sioux Falls, South Dakota, 57104, United States
Texas Oncology-Bedford
Bedford, Texas, 76022, United States
Houston Area Locations- Woodlands
Conroe, Texas, 77384, United States
Texas Oncology-Presbyterian Cancer Center Dallas
Dallas, Texas, 75231, United States
Texas Oncology-Baylor Charles A. Sammons Cancer Center
Dallas, Texas, 75246, United States
Texas Oncology Paris
Fort Worth, Texas, 76104, United States
Houston Methodist Hospital
Houston, Texas, 77030, United States
University of Texas - MD Anderson
Houston, Texas, 77030, United States
Houston Area Locations- Sugar Land
Houston, Texas, 77079, United States
Houston Area Locations- West Houston
Houston, Texas, 77079, United States
Houston Area Locations- League City
League City, Texas, 77573, United States
University of Virginia Comprehensive Cancer Center
Charlottesville, Virginia, 22903, United States
University of Washington - Seattle Cancer Care Alliance
Seattle, Washington, 98109, United States
Froedtert and the Medical College of Wisconsin
Milwaukee, Wisconsin, 53226, United States
GenesisCare St Andrews Hospital
Adelaide, 5000, Australia
GenesisCare North Shore (Oncology)
St Leonards, Australia
Oncocentro - Belo Horizonte
Belo Horizonte, 30360680, Brazil
Hospital Ernesto Dornelles
Porto Alegre, 90.160-093, Brazil
Hospital Moinhos de Vento
Porto Alegre, 90035-001, Brazil
Instituto COI de Pesquisa
Rio de Janeiro, 22775-001, Brazil
Arthur J. E. Child Comp CC
Calgary, Alberta, T2N 5G2, Canada
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, 400030, China
Fujian Provincial Cancer Hospital
Fuzhou, 350015, China
The First Affiliated Hospital of Guangzhou Medical University
Guangzhou, China
Zhejiang Cancer Hospital
Hangzhou, 310022, China
Shandong Cancer Hospital
Jinan, 250117, China
Qilu Hospital of Shandong University
Jinan, China
Guangxi Medical University Cancer Hospital
Nanning, China
Fudan University Shanghai Cancer Center
Shanghai, 200032, China
National Cheng Kung University Hospital
Tainan, China
Tianjin Medical University Cancer Institute & Hospital
Tianjin, China
Hubei Cancer Hospital
Wuhan, 430079, China
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, China
Fakultni nemocnice Brno
Brno, 625 00, Czechia
Fakultni nemocnice Hradec Kralove
Hradec Králové, 50005, Czechia
Fakultni nemocnice v Motole
Prague, 150 06, Czechia
Fakultni nemocnice Bulovka
Prague, Czechia
Vseobecna fakultni nemocnice v Praze
Prague, Czechia
Kuopio University Hospital
Kuopio, 70210, Finland
Institut Bergonié
Bordeaux, 33076, France
Centre Francois Baclesse
Caen, 14076, France
Centre Jean Perrin - CLCC
Clermont-Ferrand, 63000, France
Centre Georges François Leclerc
Dijon, 21079, France
Centre Leon Berard
Lyon, 69008, France
Institut Paoli Calmettes
Marseille, 13273, France
Institut du Cancer de Montpellier
Montpellier, 34298, France
Hôpital Privé du Confluent
Nantes, 44277, France
Groupe Hospitalier Diaconesses - Hôpital De La Croix Saint Simon
Paris, 75571, France
CARIO - Centre Armoricain de Radiothérapie, Imagerie médicale et Oncologie
Plérin, 22190, France
Institut Curie
Saint-Cloud, 92210, France
ICL Alexis Vautrin
Vandœuvre-lès-Nancy, 54500, France
Universitaetsklinikum Carl Gustav Carus TU Dresden
Dresden, 01307, Germany
Kliniken Essen-Mitte
Essen, 45136, Germany
Universitaetsklinikum Mannheim
Mannheim, 68167, Germany
Universitaetsklinikum Ulm
Ulm, 89075, Germany
Diagnostic and Therapeutic Centre of Athens "Hygeia" S.A.
Marousi, 15123, Greece
IASO General Clinic
Marousi, 15123, Greece
St Luke's Hospital
Thessaloniki, 55236, Greece
IRCCS Centro di Riferimento Oncologico
Aviano, Italy
Azienda Ospedaliera Universitaria Policlinico Sant'Orsola Malpighi IRCCS
Bologna, 40138, 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
Fondazione IRCCS San Gerardo dei Tintori di Monza
Monza, 20900, Italy
Istituto Nazionale Tumori Fondazione G. Pascale
Naples, Italy
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Roma, Italy
Istituto Clinico Humanitas
Rozzano, 20089, Italy
Ospedale Mauriziano Umberto I
Torino, Italy
National Cancer Center Hospital
Chūōku, 104-0045, Japan
NHO Kyushu Cancer Center
Fukuoka, 811-1395, Japan
Saitama Medical University International Medical Center
Hidaka-shi, 350-1298, Japan
National Cancer Center Hospital East
Kashiwa-shi, 277-8577, Japan
Cancer Institute Hospital of JFCR
Kōtoku, 135-8550, Japan
Jikei University Hospital
Minatoku, 105-8471, Japan
Shizuoka Cancer Center
Nagaizumi-cho, 411-8777, Japan
Aichi Cancer Center Hospital
Nagoya, 464-8681, Japan
Niigata Cancer Center Hospital
Niigata, 951-8566, Japan
Osaka International Cancer Institute
Osaka, 541-8567, Japan
Hokkaido University Hospital
Sapporo, 060-8648, Japan
Iwate Medical University Hospital
Shiwa-gun, 028-3695, Japan
Uniwersytecki Szpital Kliniczny w Bialymstoku
Bialystok, 15-276, Poland
Uniwersyteckie Centrum Kliniczne
Gdansk, Poland
Uniwersytecki Szpital Kliniczny W Poznaniu
Poznan, 60-569, Poland
Mazowiecki Szpital Wojewodzki w Siedlcach Sp z o o
Siedlce, Poland
Hospital Professor Doutor Fernando Fonseca, E.P.E.
Amadora, Portugal
Hospital da Luz
Lisbon, 1500-650, Portugal
National Cancer Center
Goyang-si, 10408, South Korea
CHA Bundang Medical Center, CHA University
Seongnam-si, South Korea
National University Hospital
Seoul, 03080, South Korea
Severance Hospital, Yonsei University Health System - Site 8201
Seoul, 03722, South Korea
Severance Hospital, Yonsei University Health System - Site 8207
Seoul, 03722, 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
ICO Badalona - Hospital Universitari Germans Trias i Pujol
Barcelona, 08916, Spain
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, 28040, 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 Universitari i Politecnic La Fe
Valencia, 46026, Spain
Hospital Clínico Universitario Valencia
Valencia, Spain
Taichung Veterans General Hospital
Taichung, 40705, Taiwan
Taipei Veterans General Hospital
Taipei, 11217, Taiwan
Koo Foundation Sun Yat-Sen Cancer Center
Taipei, Taiwan
Chang Gung Memorial Hospital,Linkou
Taoyuan City, Taiwan
Baskent University Adana Application and Research Center
Adana, 01240, Turkey (Türkiye)
I. U. Cerrahpasa Faculty of Med
Istanbul, 34153, Turkey (Türkiye)
Medipol University Medical Faculty
Istanbul, 34214, Turkey (Türkiye)
Royal United Hospital
Bath, United Kingdom
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Global Clinical Leader
Daiichi Sankyo
Central Study Contacts
Medical Director Contact for Clinical Trial Information
CONTACT
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SEQUENTIAL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 27, 2023
First Posted
December 7, 2023
Study Start
February 27, 2024
Primary Completion (Estimated)
February 29, 2028
Study Completion (Estimated)
April 30, 2030
Last Updated
May 22, 2026
Record last verified: 2026-05
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF
- Access Criteria
- Formal request from qualified scientific and medical researchers on IPD and clinical study documents from clinical trials supporting products submitted and licensed in the United States, the European Union and/or Japan from 01 January 2014 and beyond for the purpose of conducting legitimate research. This must be consistent with the principle of safeguarding study participants' privacy and consistent with provision of informed consent.
De-identified individual participant data (IPD) and applicable supporting clinical trial documents may be available upon request at https://vivli.org/. In cases where clinical trial data and supporting documents are provided pursuant to our company policies and procedures, Daiichi Sankyo will continue to protect the privacy of our clinical trial participants. Details on data sharing criteria and the procedure for requesting access can be found at this web address: https://vivli.org/ourmember/daiichi-sankyo/