Actively Recruiting
A Study of Raludotatug Deruxtecan (R-DXd) in Subjects With Platinum-resistant, High-grade Ovarian, Primary Peritoneal, or Fallopian Tube Cancer
Led by Daiichi Sankyo · Updated on 2026-05-12
860
Participants Needed
129
Research Sites
322 weeks
Total Duration
On this page
Sponsors
D
Daiichi Sankyo
Lead Sponsor
M
Merck Sharp & Dohme LLC
Collaborating Sponsor
AI-Summary
What this Trial Is About
This study will evaluate the safety and efficacy of R-DXd therapy in participants with ovarian, peritoneal, or fallopian tube cancer.
CONDITIONS
Official Title
A Study of Raludotatug Deruxtecan (R-DXd) in Subjects With Platinum-resistant, High-grade Ovarian, Primary Peritoneal, or Fallopian Tube Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Sign and date the informed consent form before any study procedures
- Age 18 years or older at consent
- Histologically or cytologically confirmed high-grade serous ovarian cancer, high-grade endometrioid ovarian cancer, primary peritoneal cancer, or fallopian tube cancer
- For Phase 2: Have at least 1 lesion suitable for biopsy and consent to provide biopsy samples (pretreatment and on-treatment); archival tumor tissue may substitute pretreatment biopsy if recent
- For Phase 2: Received 1 to 3 prior systemic anticancer therapies; For Phase 3: Received 1 to 4 prior systemic anticancer therapies
- At least 1 prior therapy line included bevacizumab unless not eligible due to precautions or intolerance
- Disease is platinum-resistant, with progression occurring within specified time frames after platinum therapy
- For participants with high-folate receptor alpha expression, prior treatment with mirvetuximab soravtansine if available and tolerated
- Have at least 1 measurable lesion by CT or MRI per RECIST v1.1
- Eastern Cooperative Oncology Group performance status 0 or 1
- Adequate organ and bone marrow function within 14 days before starting study drug
- Willing and able to follow study visits, treatments, tests, and restrictions
- For Phase 3: Eligible for investigator's choice chemotherapy arm
You will not qualify if you...
- Clear cell, mucinous, sarcomatous, mixed, or low-grade/borderline ovarian cancer histology
- Inadequate washout periods before starting study drug including recent major surgery, radiation, systemic anticancer therapy, chloroquine/hydroxychloroquine, or investigational drugs
- Active brain metastases, spinal cord compression, or leptomeningeal carcinomatosis requiring treatment; untreated asymptomatic brain metastases allowed with conditions
- Cerebrovascular events within 6 months prior to randomization
- Uncontrolled or significant cardiovascular diseases including abnormal QT interval, arrhythmias, recent myocardial infarction, heart failure, uncontrolled hypertension, or certain heart blocks
- History or current interstitial lung disease or pneumonitis requiring corticosteroids or suspected but not ruled out
- Severe pulmonary compromise from other lung diseases or autoimmune disorders with lung involvement
- Chronic steroid treatment over 10 mg/day except specific allowable uses
- History of other malignancies within 3 years except certain low-risk treated cancers
- Unresolved toxicities from prior anticancer therapy above grade 1 except stable chronic grade 2 toxicities
- Prior exposure to other CDH6-targeted agents or topoisomerase I inhibitor antibody-drug conjugates
- Hypersensitivity to study drugs or their components
- Active or uncontrolled HIV, hepatitis B, or hepatitis C infections without proper treatment and viral control
- Pregnant or breastfeeding women or those intending pregnancy during the study
- Psychological, social, familial, or geographic factors preventing follow-up
- Recent live-attenuated vaccine within 30 days before first study drug dose
- For Phase 3: Clinical symptoms or imaging evidence of intestinal obstruction
- For Phase 3: Ascites or pleural effusions requiring repeated drainage less than 4 weeks apart
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 129 locations
1
Alaska Women's Cancer Care
Anchorage, Alaska, United States, 99508
Active, Not Recruiting
2
Yale University School of Medicine
New Haven, Connecticut, United States, 06520
Actively Recruiting
3
Sylvester Comprehensive Cancer Center at Lennar
Coral Gables, Florida, United States, 33146
Active, Not Recruiting
4
Sylvester Comprehensive Cancer Center at Deerfield Beach
Deerfield Beach, Florida, United States, 33442
Active, Not Recruiting
5
Florida Cancer Specialists
Lake Mary, Florida, United States, 32746
Active, Not Recruiting
6
Sylvester Cancer Center
Miami, Florida, United States, 33136
Active, Not Recruiting
7
Mount Sinai Comprehensive Cancer Center
Miami Beach, Florida, United States, 33140
Active, Not Recruiting
8
Sylvester Comprehensive Cancer Center at Plantation
Plantation, Florida, United States, 33324
Active, Not Recruiting
9
Community MD Anderson Cancer Center- East
Indianapolis, Indiana, United States, 46219
Active, Not Recruiting
10
Community MD Anderson Cancer Center- South
Indianapolis, Indiana, United States, 46227
Active, Not Recruiting
11
Community Health Network - MD Anderson
Indianapolis, Indiana, United States, 46250
Actively Recruiting
12
St. Elizabeth Medical Center
Edgewood, Kentucky, United States, 41017
Actively Recruiting
13
Washington University School of Medicine Obstetrics and Gynecology
St Louis, Missouri, United States, 63110
Actively Recruiting
14
Valley Health System
Paramus, New Jersey, United States, 07652
Active, Not Recruiting
15
Holy Name
Teaneck, New Jersey, United States, 07666
Active, Not Recruiting
16
NHPP Imbert
Bay Shore, New York, United States, 11706
Active, Not Recruiting
17
Northwell Health, LLC PRIME
Lake Success, New York, United States, 11042
Active, Not Recruiting
18
Perlmutter Cancer Center at NYU Langone Hospital- Long Island
Mineola, New York, United States, 11501
Active, Not Recruiting
19
NYU Langone Health
New York, New York, United States, 10016
Active, Not Recruiting
20
NHPP LHH
New York, New York, United States, 10065
Active, Not Recruiting
21
Duke Women's Cancer Care- Raleigh
Durham, North Carolina, United States, 27607
Active, Not Recruiting
22
Duke Cancer Center
Durham, North Carolina, United States, 27710
Active, Not Recruiting
23
Ohio State University Wexner Medical Center
Hilliard, Ohio, United States, 43026
Active, Not Recruiting
24
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, United States, 73104
Actively Recruiting
25
Oklahoma Cancer Specialists and Research Institute
Tulsa, Oklahoma, United States, 12967
Actively Recruiting
26
Oncology Associates of Oregon, P.C.
Eugene, Oregon, United States, 97401
Actively Recruiting
27
Perelman School of Medicine at the University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104-4238
Active, Not Recruiting
28
Medical University of South Carolina (MUSC)
Charleston, South Carolina, United States, 29425
Actively Recruiting
29
Sanford Cancer Center Gynecologic Oncology
Sioux Falls, South Dakota, United States, 57104
Active, Not Recruiting
30
Texas Oncology-Bedford
Bedford, Texas, United States, 76022
Active, Not Recruiting
31
Houston Area Locations- Woodlands
Conroe, Texas, United States, 77384
Active, Not Recruiting
32
Texas Oncology-Presbyterian Cancer Center Dallas
Dallas, Texas, United States, 75231
Active, Not Recruiting
33
Texas Oncology-Baylor Charles A. Sammons Cancer Center
Dallas, Texas, United States, 75246
Active, Not Recruiting
34
Texas Oncology Paris
Fort Worth, Texas, United States, 76104
Active, Not Recruiting
35
Houston Methodist Hospital
Houston, Texas, United States, 77030
Actively Recruiting
36
University of Texas - MD Anderson
Houston, Texas, United States, 77030
Active, Not Recruiting
37
Houston Area Locations- Sugar Land
Houston, Texas, United States, 77079
Active, Not Recruiting
38
Houston Area Locations- West Houston
Houston, Texas, United States, 77079
Active, Not Recruiting
39
Houston Area Locations- League City
League City, Texas, United States, 77573
Active, Not Recruiting
40
University of Virginia Comprehensive Cancer Center
Charlottesville, Virginia, United States, 22903
Actively Recruiting
41
University of Washington - Seattle Cancer Care Alliance
Seattle, Washington, United States, 98109
Actively Recruiting
42
Froedtert and the Medical College of Wisconsin
Milwaukee, Wisconsin, United States, 53226
Actively Recruiting
43
GenesisCare St Andrews Hospital
Adelaide, Australia, 5000
Actively Recruiting
44
GenesisCare North Shore (Oncology)
St Leonards, Australia
Actively Recruiting
45
Arthur J. E. Child Comp CC
Calgary, Alberta, Canada, T2N 5G2
Actively Recruiting
46
McGill University Health Centre/Glen Site / Royal Victoria Hospital
Montreal, Canada
Actively Recruiting
47
University Health Network - Princess Margaret Cancer Centre
Toronto, Canada
Active, Not Recruiting
48
Beijing Cancer Hospital
Beijing, China
Active, Not Recruiting
49
Chongqing Cancer Hospital
Chongqing, China, 400030
Active, Not Recruiting
50
Fujian Provincial Cancer Hospital
Fuzhou, China, 350015
Active, Not Recruiting
51
The First Affiliated Hospital of Guangzhou Medical University
Guangzhou, China
Active, Not Recruiting
52
Zhejiang Cancer Hospital
Hangzhou, China, 310022
Active, Not Recruiting
53
Shandong Cancer Hospital
Jinan, China, 250117
Active, Not Recruiting
54
Qilu Hospital of Shandong University
Jinan, China
Active, Not Recruiting
55
Guangxi Medical University Cancer Hospital
Nanning, China
Active, Not Recruiting
56
Fudan University Shanghai Cancer Center
Shanghai, China, 200032
Active, Not Recruiting
57
National Cheng Kung University Hospital
Tainan, China
Active, Not Recruiting
58
Tianjin Medical University Cancer Institute & Hospital
Tianjin, China
Active, Not Recruiting
59
Hubei Cancer Hospital
Wuhan, China, 430079
Active, Not Recruiting
60
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, China
Active, Not Recruiting
61
Fakultni nemocnice Hradec Kralove
Hradec Králové, Czechia, 50005
Active, Not Recruiting
62
Fakultni nemocnice v Motole
Prague, Czechia, 150 06
Actively Recruiting
63
Fakultni nemocnice Bulovka
Prague, Czechia
Active, Not Recruiting
64
Vseobecna fakultni nemocnice v Praze
Prague, Czechia
Active, Not Recruiting
65
Institut Bergonié
Bordeaux, France, 33076
Active, Not Recruiting
66
Centre Francois Baclesse
Caen, France, 14076
Active, Not Recruiting
67
Centre Jean Perrin - CLCC
Clermont-Ferrand, France, 63000
Active, Not Recruiting
68
Centre Georges François Leclerc
Dijon, France, 21079
Active, Not Recruiting
69
Centre Leon Berard
Lyon, France, 69008
Active, Not Recruiting
70
Institut Paoli Calmettes
Marseille, France, 13273
Active, Not Recruiting
71
Institut du Cancer de Montpellier
Montpellier, France, 34298
Active, Not Recruiting
72
Hôpital Privé du Confluent
Nantes, France, 44277
Actively Recruiting
73
Groupe Hospitalier Diaconesses - Hôpital De La Croix Saint Simon
Paris, France, 75571
Active, Not Recruiting
74
CARIO - Centre Armoricain de Radiothérapie, Imagerie médicale et Oncologie
Plérin, France, 22190
Active, Not Recruiting
75
Institut Curie
Saint-Cloud, France, 92210
Active, Not Recruiting
76
ICL Alexis Vautrin
Vandœuvre-lès-Nancy, France, 54500
Active, Not Recruiting
77
Kliniken Essen-Mitte
Essen, Germany, 45136
Active, Not Recruiting
78
Universitaetsklinikum Mannheim
Mannheim, Germany, 68167
Active, Not Recruiting
79
Universitaetsklinikum Ulm
Ulm, Germany, 89075
Actively Recruiting
80
IRCCS Centro di Riferimento Oncologico
Aviano, Italy
Active, Not Recruiting
81
Azienda Ospedaliera Per Lemergenza Cannizzaro
Catania, Italy
Active, Not Recruiting
82
Azienda Ospedaliera Universitaria Careggi
Florence, Italy
Active, Not Recruiting
83
Humanitas San Pio X
Milan, Italy
Active, Not Recruiting
84
IEO Istituto Europeo di Oncologia
Milan, Italy
Active, Not Recruiting
85
Fondazione IRCCS San Gerardo dei Tintori di Monza
Monza, Italy, 20900
Actively Recruiting
86
Istituto Nazionale Tumori Fondazione G. Pascale
Naples, Italy
Active, Not Recruiting
87
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Roma, Italy
Active, Not Recruiting
88
Istituto Clinico Humanitas
Rozzano, Italy, 20089
Active, Not Recruiting
89
Ospedale Mauriziano Umberto I
Torino, Italy
Actively Recruiting
90
National Cancer Center Hospital
Chūōku, Japan, 104-0045
Active, Not Recruiting
91
NHO Kyushu Cancer Center
Fukuoka, Japan, 811-1395
Active, Not Recruiting
92
Saitama Medical University International Medical Center
Hidaka-shi, Japan, 350-1298
Active, Not Recruiting
93
National Cancer Center Hospital East
Kashiwa-shi, Japan, 277-8577
Actively Recruiting
94
Cancer Institute Hospital of JFCR
Kōtoku, Japan, 135-8550
Active, Not Recruiting
95
Jikei University Hospital
Minatoku, Japan, 105-8471
Active, Not Recruiting
96
Shizuoka Cancer Center
Nagaizumi-cho, Japan, 411-8777
Active, Not Recruiting
97
Aichi Cancer Center Hospital
Nagoya, Japan, 464-8681
Active, Not Recruiting
98
Niigata Cancer Center Hospital
Niigata, Japan, 951-8566
Active, Not Recruiting
99
Osaka International Cancer Institute
Osaka, Japan, 541-8567
Active, Not Recruiting
100
Hokkaido University Hospital
Sapporo, Japan, 060-8648
Active, Not Recruiting
101
Iwate Medical University Hospital
Shiwa-gun, Japan, 028-3695
Active, Not Recruiting
102
Uniwersyteckie Centrum Kliniczne
Gdansk, Poland
Active, Not Recruiting
103
Uniwersytecki Szpital Kliniczny W Poznaniu
Poznan, Poland, 60-569
Actively Recruiting
104
Mazowiecki Szpital Wojewodzki w Siedlcach Sp z o o
Siedlce, Poland
Active, Not Recruiting
105
Hospital Professor Doutor Fernando Fonseca, E.P.E.
Amadora, Portugal
Active, Not Recruiting
106
National Cancer Center
Goyang-si, South Korea, 10408
Active, Not Recruiting
107
CHA Bundang Medical Center, CHA University
Seongnam-si, South Korea
Active, Not Recruiting
108
National University Hospital
Seoul, South Korea, 03080
Active, Not Recruiting
109
Severance Hospital, Yonsei University Health System
Seoul, South Korea, 03722
Active, Not Recruiting
110
Asan Medical Center
Seoul, South Korea
Active, Not Recruiting
111
Samsung Medical Center
Seoul, South Korea
Active, Not Recruiting
112
The Catholic University of Korea, Seoul St. Mary's Hospital
Seoul, South Korea
Active, Not Recruiting
113
ICO Badalona - Hospital Universitari Germans Trias i Pujol
Barcelona, Spain, 08916
Actively Recruiting
114
Hospital Clinic de Barcelona
Barcelona, Spain
Active, Not Recruiting
115
Hospital Universitari Vall d'Hebron
Barcelona, Spain
Active, Not Recruiting
116
Hospital Universitario Ciudad de Jaen
Jaén, Spain
Active, Not Recruiting
117
Hospital Universitario Clinico San Carlos
Madrid, Spain, 28040
Active, Not Recruiting
118
Hospital Universitario 12 de Octubre
Madrid, Spain
Active, Not Recruiting
119
Hospital Universitario La Paz
Madrid, Spain
Active, Not Recruiting
120
Clinica Universidad de Navarra (MAD)
Pamplona, Spain
Active, Not Recruiting
121
Clinica Universidad de Navarra
Pamplona, Spain
Active, Not Recruiting
122
Hospital Universitari i Politecnic La Fe
Valencia, Spain, 46026
Actively Recruiting
123
Hospital Clínico Universitario Valencia
Valencia, Spain
Active, Not Recruiting
124
Taichung Veterans General Hospital
Taichung, Taiwan, 40705
Active, Not Recruiting
125
Taipei Veterans General Hospital
Taipei, Taiwan, 11217
Active, Not Recruiting
126
Koo Foundation Sun Yat-Sen Cancer Center
Taipei, Taiwan
Active, Not Recruiting
127
Chang Gung Memorial Hospital,Linkou
Taoyuan City, Taiwan
Active, Not Recruiting
128
I. U. Cerrahpasa Faculty of Med
Istanbul, Turkey (Türkiye), 34153
Actively Recruiting
129
Royal United Hospital
Bath, United Kingdom
Active, Not Recruiting
Research Team
M
Medical Director Contact for Clinical Trial Information
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
5
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