Fallopian Tube CancerPhase 3NCT07791732
A Study of Raludotatug Deruxtecan (R-DXd) With or Without Bevacizumab as Maintenance Therapy in Second-Line Platinum-Sensitive Recurrent Ovarian Cancer (REJOICE-Ovarian03)
A Phase 3 study testing R-DXd and Bevacizumab in people with Fallopian Tube Cancer and Primary Peritoneal Cancer, run by Daiichi Sankyo.
Trial summary
The primary purpose of the study is to evaluate the efficacy of R-DXd with or without bevacizumab as maintenance therapy compared with standard of care (SOC) in participants with platinum-sensitive ovarian cancer (PSOC) as measured by progression-free survival (PFS) as assessed by Blinded Independent Central Review… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Fallopian Tube Cancer, Primary Peritoneal Cancer, High-Grade Serous Ovarian Cancer
- What is being tested?
- R-DXd and Bevacizumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 600 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2026to 1 Dec 2033
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult participants with assigned female sex at birth.
- Participants with histologically or cytologically documented high-grade (Grade 3) serous or endometrioid epithelial ovarian cancer (OVC), primary peritoneal cancer, or fallopian tube cancer.
- Has an homologous recombinant deficiency (HRD) or breast cancer gene (BRCA) test result using a validated or approved test as per applicable regulations available.
- Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1.
- Required baseline local laboratory data (within 7 days prior to randomization) as specified in the protocol.
- A woman of childbearing potential (WOCBP), as specified in the protocol, is eligible to participate if the protocol-specified conditions are met.
Show all 13Show fewer
- Must have received 2 prior lines of platinum-based therapy:
- For the first-line (1L) platinum-based chemotherapy (penultimate, platinum-based course prior to enrollment on the trial), must have platinum-sensitive disease after this treatment, defined as documented radiologic disease progression assessed by the investigator (evident measurable or non-measurable disease according to RECIST v1.1) >6 months following the last dose of the platinum administered.
- For the second (last) platinum-based chemotherapy course prior to enrollment on the trial, must have received a platinum-containing regimen for a minimum of 4 cycles and a maximum of 8 cycles.
- Must have achieved evidence of non-progressive radiological disease based on investigator-assessed RECIST 1.1 and CA-125 at the end of induction treatment with platinum-based doublet chemotherapy (no evidence of disease [NED], complete response [CR], partial response [PR] or stable disease [SD] for participants with measurable disease at baseline; or NED, CR, or non-CR/non-progressive disease [PD] for participants with non-measurable disease based on RECIST v1.1).
- According to investigator assessment, polymerase inhibitor (PARPi) as 2L maintenance treatment is not the preferred option for the participant.
- Must be randomized between 4 and 9 weeks after completion of their final dose of the platinum-containing regimen.
- Is willing and able to comply with scheduled visits, drug administration plan, laboratory tests, other trial procedures, and trial restrictions.
Who cannot join
- Non-serous or non-endometrioid high-grade epithelial histology, or non-epithelial tumor origin of the ovary, the fallopian tube or the peritoneum (i.e., germ cell tumors) or low-grade/borderline OVC.
- Inadequate washout period before randomization, defined as follows:
- Major surgery less than (<)28 days.
- Radiation therapy less than equal to (≤)28 days (if palliative stereotactic radiation therapy without abdominal radiation, ≤14 days).
- Systemic anticancer therapy (including but not limited to antibody-drug therapy, retinoid therapy, and hormonal therapy) <28 days or 5 half-lives, whichever is shorter, before starting trial intervention or current participation in other therapeutic investigational procedures.
- Chloroquine/hydroxychloroquine ≤14 days.
Show all 50Show fewer
- Exposure to another investigational trial intervention within 28 days prior to start of trial intervention 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. Participants with untreated and asymptomatic brain metastases or participants with previously treated brain metastases who are no longer symptomatic and who require no treatment with steroids may be included in the trial 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 trial intervention and there should be no evidence of progression or need for steroids treatment or anticonvulsants for at least 2 weeks prior to randomization.
- Any of the following within the past 6 months prior to randomization: cerebrovascular accident, transient ischemic attack, other arterial thromboembolic event (e.g., intestinal ischemia).
- Uncontrolled or significant cardiovascular disease:
- QTcF interval >470 milliseconds (ms).
- Diagnosed or suspected long QT syndrome.
- History of clinically relevant ventricular arrhythmias, such as ventricular tachycardia, ventricular fibrillation, or Torsade de Pointes.
- Participant has clinically relevant bradycardia of less than 50 beats per minute (bpm), unless the participant 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 (NYHA) Class 3 or 4 congestive heart failure (CHF).
- Left ventricular ejection fraction <50% or institutional lower limit of normal as measured by echocardiography or multigated acquisition scan (MUGA) scan.
- Coronary/peripheral artery bypass graft within 6 months prior to screening.
- Prior history of hypertensive crisis (common terminology criteria for adverse events [CTCAE] Grade 4) or hypertensive encephalopathy or uncontrolled hypertension CTCAE Grade greater than equal to (≥)3 hypertension as per National Cancer Institute (NCI) CTCAE version 6.0.
- Complete left or right bundle branch block.
- Has any history of interstitial lung disease (ILD)/pneumonitis irrespective of steroid use, or current ILD, or suspected ILD, or ILD that cannot be ruled out by imaging at screening. Participants may be eligible if they had history of radiation pneumonitis that did not require steroids. Examples of suspected ILD/pneumonitis by imaging include the presence of lung parenchymal fibrosis, such as combined pulmonary fibrosis and emphysema (CPFE), and any radiographic features consistent with ILA, including but not limited to extensive ground glass opacities, reticular opacities, traction bronchiectasis, and honeycombing.
- Clinically severe pulmonary compromise resulting from intercurrent pulmonary illnesses including, but not limited to, any underlying pulmonary disorder (i.e., pulmonary emboli within 3 months of the trial enrollment, severe asthma, severe COPD, restrictive lung disease, pleural effusion, etc.) and any autoimmune, connective tissue, or inflammatory disorders with potential pulmonary involvement (e.g., rheumatoid arthritis, Sjogren's syndrome, sarcoidosis, etc.), or prior pneumonectomy.
- Chronic steroid treatment (>10 mg/day prednisone [or equivalent] per day), with the exception of the following:
- Inhaled steroids for asthma or chronic obstructive pulmonary disease (COPD).
- Mineralocorticoids (e.g., fludrocortisone) for participants 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 randomization, with the exception of those with a negligible risk of metastasis or death (e.g., 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 6.0, Grade ≤1 or baseline.
- Has current, clinically relevant bowel obstruction (including subocclusive disease) including obstruction related to underlying epithelial OVC, abdominal fistula or gastrointestinal perforation, intra-abdominal abscess.
- History of severe hypersensitivity (≥ Grade 3) or any known contraindication to R-DXd or any excipients in R-DXd.
- Has 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 participant to participate in the trial or which would jeopardize compliance with the protocol. Screening for chronic conditions is not required;
- Has active or uncontrolled HBV infection. Hepatitis B screening testing is required.
- Has active or uncontrolled hepatitis C virus (HCV) infection. Hepatitis C screening testing is required.
- Female who is pregnant or breastfeeding or intends to become pregnant during the trial.
- Psychological, social, familial, or geographical factors that would prevent regular follow-up (FU).
- Has a history of receiving live-attenuated vaccine (messenger ribonucleic acid [mRNA] and replication-deficient adenoviral vaccines are not considered attenuated live vaccines) within 30 days prior to the first exposure to trial intervention.
- Participants are ineligible if they have a history of any contraindication included in the approved local label for the control group treatment.
- Additional Exclusion Criteria for Bevacizumab Participants:
- Has a history of arterial thromboembolic events, hemorrhage, hemoptysis, active gastrointestinal bleeding that occurred within 6 months before randomization.
- Participants with history of serious, non-healing wound, active ulcer or untreated bone fracture.
- History of vascular endothelial growth factor (VEGF) therapy related abdominal fistula or gastrointestinal perforation.
- Participants who discontinued bevacizumab during the second (last) platinum-based chemotherapy due to any AE related to bevacizumab are not eligible to receive bevacizumab.
- Severe hypersensitivity (≥Grade 3) to bevacizumab and/or any of its excipients. Participants with known sensitivity to Chinese Hamster Ovary cell products or other recombinant human or humanized antibodies are prohibited from receiving bevacizumab during the trial.
- Participants who have had a major surgical procedure, open biopsy, dental extractions or other dental surgery/procedure that results in an open wound, or significant traumatic injury (e.g., long-bone fracture requiring surgery) as per investigator judgment within 28 days prior to the first date of treatment on this trial, or anticipation of need for major surgical procedure during the course of the trial; participants with placement of vascular access device or core biopsy within 7 days prior to the first date of treatment in the trial.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Phase 3, Multicenter, Randomized, Open-Label Trial of Raludotatug Deruxtecan With or Without Bevacizumab as Maintenance Therapy Versus Standard of Care in Participants With First Recurrence Platinum-Sensitive, High-Grade Serous or Endometrioid Epithelial Ovarian, Primary Peritoneal, or Fallopian Tube Cancer (REJOICE-Ovarian03)
The primary purpose of the study is to evaluate the efficacy of R-DXd with or without bevacizumab as maintenance therapy compared with standard of care (SOC) in participants with platinum-sensitive ovarian cancer (PSOC) as measured by progression-free survival (PFS) as assessed by Blinded Independent Central Review (BICR).
- Conditions
- Fallopian Tube Cancer, Primary Peritoneal Cancer, High-Grade Serous Ovarian Cancer, Endometrioid Epithelial Ovarian
- Being tested
- R-DXd, Bevacizumab
- Keywords
- Primary Peritoneal Cancer, Ovarian Cancer, Fallopian Tube Cancer, Raludotatug Deruxtecan (R-DXd), Cadherin 6 (CDH6)
- Medical subject headings
- Fallopian Tube Neoplasms, Ovarian Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
R-DXdDrug
Also called DS-6000a
R-DXd will be administered as an intravenous (IV) infusion.
BevacizumabDrug
Also called AVASTIN®, MVASI
Bevacizumab will be administered as an IV infusion.
| Study group | Role | What they receive |
|---|---|---|
| Arm 1: R-DXd Alone or R-DXd Combined with Bevacizumab | Experimental | Participants will be randomized to receive either R-DXd, intravenously (IV), every 3 weeks (Q3W) alone, or R-DXd IV along with bevacizumab 15mg/kg, IV, Q3W, on Day 1 of each 21-day cycle, until radiological disease progression according to RECIST v1.1 as assessed by BICR, unacceptable toxicity or other protocol-specified discontinuation criteria are met. Receives: Drug: R-DXd; Drug: Bevacizumab |
| Arm 2: Bevacizumab Alone or Observation | Active comparator | Participants will be randomized to receive either bevacizumab 15 mg/kg, IV, Q3W, or Investigator's choice of observation until radiological disease progression as assessed by BICR or unacceptable toxicity or until other protocol-specified discontinuation criteria are met. Receives: Drug: Bevacizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression Free Survival (PFS) as Assessed by Blinded Independent Central Review (BICR) per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1)
PFS is defined as the time (month) from the date of randomization to the earlier date of the first objective documentation of radiographic disease progression as assessed by BICR per RECIST v1.1 or death due to any cause.
Measured: Up to approximately 6 years
Secondary outcomes (16)
Overall Survival (OS)
OS is defined as the time (month) from the date of randomization to the date of death due to any cause.
Measured: Up to approximately 6 years
PFS as Assessed by Investigator per RECIST v1.1
PFS is defined as the time (month) from the date of randomization to the earlier date of the first objective documentation of radiological disease progression as assessed by the investigator per RECIST v1.1 or death due to any cause.
Measured: Up to approximately 6 years
Progression Free Survival 2 (PFS2)
PFS2 is defined as the time (in months) from the date of randomization to the earlier date of the second disease progression, or death due to any cause.
Measured: Up to approximately 6 years
Number of Participants With at Least One Treatment-emergent Adverse Event (TEAE)
TEAEs are defined as those adverse events (AEs) with a start or worsening date during the on-treatment period (from the first dose date to 70 days after the last dose date of study treatment).
Measured: Up to approximately 6 years
Plasma Concentrations of R-DXd (Conjugated Antibody)
Measured: Pre-dose and post-dose at multiple timepoints during each cycle, up to approximately 6 years (Cycle length=21 days)
Plasma Concentrations of Total Anti-Cadherin-6 (CDH6) Antibody
Measured: Pre-dose and post-dose at multiple timepoints during each cycle, up to approximately 6 years (Cycle length=21 days)
Plasma Concentrations of DXd Payload
Measured: Pre-dose and post-dose at multiple timepoints during each cycle, up to approximately 6 years (Cycle length=21 days)
Percentage of Participants Having Treatment-Emergent Antidrug Antibody (ADA)
Measured: Pre-dose and post-dose at multiple timepoints during each cycle, up to approximately 6 years (Cycle length=21 days)
CDH6 Protein Expression in Tumor Tissue as Determined by Immunochemistry Assay (Immunohistochemistry [IHC]) and Correlation with PFS and OS
Measured: Up to approximately 6 years
Change From Baseline in Global Health Status/Quality of Life (QoL) Assessed by European Organisation for Research and Treatment of Cancer Core Quality of Life Questionnaire Version 3.0 (EORTC QLQ-C30 v3.0)
The EORTC QLQ-C30 assesses 5 functional scales, 3 symptom scales, a global health/QoL scale, and 6 single items. Change in QOLwill be assessed using 2 global health/QoL items scored on a 7-point scale ranging from 1 ("very poor") to 7 ("excellent"). Scores are linearly transformed on a scale 0 to 100. A high scale score represents a better QoL.
Measured: Baseline up to approximately 6 years
Change From Baseline in Functional Sub-scales Scores Assessed by EORTC QLQ-C30 v3.0
The EORTC QLQ-C30 assesses 5 functional scales, 3 symptom scales, a global health/QoL scale, and 6 single items. The functional items are scored on a 4-point scale ranging from 1 ("not at all") to 4 ("very much"). Scores are linearly transformed on a scale 0 to 100. A high scale score represents a better functioning.
Measured: Baseline up to approximately 6 years
Change From Baseline in Symptom Sub-scales Score Assessed by EORTC QLQ-C30 v3.0
The EORTC QLQ-C30 assesses 5 functional scales, 3 symptom scales, a global health/QoL scale, and 6 single items. The symptom items are scored on a 4-point scale ranging from 1 ("not at all") to 4 ("very much"). Scores are linearly transformed on a scale 0 to 100. A high scale score represents worst symptoms.
Measured: Baseline up to approximately 6 years
Time to Deterioration (TTD) in Global Health Scale/QoL, Functioning and Symptoms as Measured by EORTC QLQ-C30 v3.0
The EORTC QLQ-C30 assesses 5 functional scales, 3 symptom scales, a global health/QoL scale, and 6 single items. The functional, symptom and single items are scored on a 4-point scale ranging from 1 ("not at all") to 4 ("very much"). The final 2 global health/QoL items are scored on a 7-point scale ranging from 1 ("very poor") to 7 ("excellent"). All of the scales and single-item measures scores are linearly transformed on a scale 0 to 100. A high scale score represents a higher response level and worst symptoms for the symptom scales.
Measured: Up to approximately 6 years
Change From Baseline in Abdominal/Gastrointestinal (GI) Symptoms Assessed by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire - Ovarian Cancer Module (EORTC QLQ-OV28)
The EORTC QLQ-OV28 consists of 28 items assessing abdominal/GI symptoms (6 items), peripheral neuropathy (2 items), other chemotherapy side effects (5 items), hormonal symptoms (2 items), body image (2 items), attitudes to disease/treatment (3 items), sexuality (4 items), indigestion/heartburn (1 item), hair loss (2 items), and change in taste (1 item). All scores range from 0 to 100, with a higher score indicating a worse outcome, except for the sexuality domain, where this is reversed.
Measured: Baseline up to approximately 6 years
Change From Baseline in Attitude to Disease/Treatment Assessed by EORTC QLQ-OV28
The EORTC QLQ-OV28 consists of 28 items assessing abdominal/GI symptoms (6 items), peripheral neuropathy (2 items), other chemotherapy side effects (5 items), hormonal symptoms (2 items), body image (2 items), attitudes to disease/treatment (3 items), sexuality (4 items), indigestion/heartburn (1 item), hair loss (2 items), and change in taste (1 item). All scores range from 0 to 100, with a higher score indicating a worse outcome, except for the sexuality domain, where this is reversed.
Measured: Baseline up to approximately 6 years
TTD in Abdominal/GI Symptoms and Attitude to Disease/Treatment as Measured by EORTC QLQ-OV28
The EORTC QLQ-OV28 consists of 28 items assessing abdominal/GI symptoms (6 items), peripheral neuropathy (2 items), other chemotherapy side effects (5 items), hormonal symptoms (2 items), body image (2 items), attitudes to disease/treatment (3 items), sexuality (4 items), indigestion/heartburn (1 item), hair loss (2 items), and change in taste (1 item). All scores range from 0 to 100, with a higher score indicating a worse outcome, except for the sexuality domain, where this is reversed.
Measured: Up to approximately 6 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2026
- Study start1 Oct 2026 (estimated)
- Primary completion1 Jul 2029 (estimated)
- Study completion1 Dec 2033 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fallopian Tube CancerStudies of the same condition, open and under way.
- More trials run by Daiichi SankyoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Daiichi Sankyo
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Merck Sharp & Dohme LLC
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07791732
- Sponsor's protocol ID
- DS6000-169
- Other IDs
- 2025-522715-41-00, GOG-3138, 192-O, ENGOT-ov104, jRCT2031260346, 2025
- Status last verified
- Aug 2026
- First submitted
- 3 Aug 2026
- Last updated
- 1 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data (IPD) on completed studies 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/
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 3, Multicenter, Randomized, Open-Label Trial of Raludotatug Deruxtecan With or Without Bevacizumab as Maintenance Therapy Versus Standard of Care in Participants With First Recurrence Platinum-Sensitive, High-Grade Serous or Endometrioid Epithelial Ovarian, Primary Peritoneal, or Fallopian Tube Cancer (REJOICE-Ovarian03)
- ClinicalTrials.gov ID
- NCT07791732
- Acronym / sponsor ID
- DS6000-169
- Conditions
- Fallopian Tube Cancer, Primary Peritoneal Cancer, High-Grade Serous Ovarian Cancer, Endometrioid Epithelial Ovarian
- Keywords
- Primary Peritoneal Cancer, Ovarian Cancer, Fallopian Tube Cancer, Raludotatug Deruxtecan (R-DXd), Cadherin 6 (CDH6)
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- Daiichi SankyoIndustry (pharma, biotech, devices)
- Collaborators
- Merck Sharp & Dohme LLC
- Study start
- 1 Oct 2026 (estimated)
- Primary completion
- 1 Jul 2029 (estimated)
- Study completion
- 1 Dec 2033 (estimated)
- First posted
- 28 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary purpose of the study is to evaluate the efficacy of R-DXd with or without bevacizumab as maintenance therapy compared with standard of care (SOC) in participants with platinum-sensitive ovarian cancer (PSOC) as measured by progression-free survival (PFS) as assessed by Blinded Independent Central Review (BICR).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm 1: R-DXd Alone or R-DXd Combined with Bevacizumab | Experimental | Drug: R-DXd, Drug: BevacizumabParticipants will be randomized to receive either R-DXd, intravenously (IV), every 3 weeks (Q3W) alone, or R-DXd IV along with bevacizumab 15mg/kg, IV, Q3W, on Day 1 of each 21-day cycle, until radiological disease progression according to RECIST v1.1 as assessed by BICR, unacceptable toxicity or other protocol-specified discontinuation criteria are met. |
| Arm 2: Bevacizumab Alone or Observation | Active comparator | Drug: BevacizumabParticipants will be randomized to receive either bevacizumab 15 mg/kg, IV, Q3W, or Investigator's choice of observation until radiological disease progression as assessed by BICR or unacceptable toxicity or until other protocol-specified discontinuation criteria are met. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Adult participants with assigned female sex at birth.
- Participants with histologically or cytologically documented high-grade (Grade 3) serous or endometrioid epithelial ovarian cancer (OVC), primary peritoneal cancer, or fallopian tube cancer.
- Has an homologous recombinant deficiency (HRD) or breast cancer gene (BRCA) test result using a validated or approved test as per applicable regulations available.
- Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1.
- Required baseline local laboratory data (within 7 days prior to randomization) as specified in the protocol.
Key exclusion criteria (50 listed)
- Non-serous or non-endometrioid high-grade epithelial histology, or non-epithelial tumor origin of the ovary, the fallopian tube or the peritoneum (i.e., germ cell tumors) or low-grade/borderline OVC.
- Inadequate washout period before randomization, defined as follows:
- 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. Participants with untreated and asymptomatic brain metastases or participants with previously treated brain metastases who are no longer symptomatic and who require no treatment with steroids may be included in the trial 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 trial intervention and there should be no evidence of progression or need for steroids treatment or anticonvulsants for at least 2 weeks prior to randomization.
- Any of the following within the past 6 months prior to randomization: cerebrovascular accident, transient ischemic attack, other arterial thromboembolic event (e.g., intestinal ischemia).
- Uncontrolled or significant cardiovascular disease:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| R-DXdAlso: DS-6000aR-DXd will be administered as an intravenous (IV) infusion. | Drug | Arm 1: R-DXd Alone or R-DXd Combined with Bevacizumab |
| BevacizumabAlso: AVASTIN®, MVASIBevacizumab will be administered as an IV infusion. | Drug | Arm 1: R-DXd Alone or R-DXd Combined with Bevacizumab, Arm 2: Bevacizumab Alone or Observation |
Primary outcome
Progression Free Survival (PFS) as Assessed by Blinded Independent Central Review (BICR) per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1)
Time frame: Up to approximately 6 years
PFS is defined as the time (month) from the date of randomization to the earlier date of the first objective documentation of radiographic disease progression as assessed by BICR per RECIST v1.1 or death due to any cause.
16 secondary outcomes
Overall Survival (OS)
Time frame: Up to approximately 6 years
PFS as Assessed by Investigator per RECIST v1.1
Time frame: Up to approximately 6 years
Progression Free Survival 2 (PFS2)
Time frame: Up to approximately 6 years
Number of Participants With at Least One Treatment-emergent Adverse Event (TEAE)
Time frame: Up to approximately 6 years
Plasma Concentrations of R-DXd (Conjugated Antibody)
Time frame: Pre-dose and post-dose at multiple timepoints during each cycle, up to approximately 6 years (Cycle length=21 days)
Plasma Concentrations of Total Anti-Cadherin-6 (CDH6) Antibody
Time frame: Pre-dose and post-dose at multiple timepoints during each cycle, up to approximately 6 years (Cycle length=21 days)
Plasma Concentrations of DXd Payload
Time frame: Pre-dose and post-dose at multiple timepoints during each cycle, up to approximately 6 years (Cycle length=21 days)
Percentage of Participants Having Treatment-Emergent Antidrug Antibody (ADA)
Time frame: Pre-dose and post-dose at multiple timepoints during each cycle, up to approximately 6 years (Cycle length=21 days)
CDH6 Protein Expression in Tumor Tissue as Determined by Immunochemistry Assay (Immunohistochemistry [IHC]) and Correlation with PFS and OS
Time frame: Up to approximately 6 years
Change From Baseline in Global Health Status/Quality of Life (QoL) Assessed by European Organisation for Research and Treatment of Cancer Core Quality of Life Questionnaire Version 3.0 (EORTC QLQ-C30 v3.0)
Time frame: Baseline up to approximately 6 years
Change From Baseline in Functional Sub-scales Scores Assessed by EORTC QLQ-C30 v3.0
Time frame: Baseline up to approximately 6 years
Change From Baseline in Symptom Sub-scales Score Assessed by EORTC QLQ-C30 v3.0
Time frame: Baseline up to approximately 6 years
Time to Deterioration (TTD) in Global Health Scale/QoL, Functioning and Symptoms as Measured by EORTC QLQ-C30 v3.0
Time frame: Up to approximately 6 years
Change From Baseline in Abdominal/Gastrointestinal (GI) Symptoms Assessed by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire - Ovarian Cancer Module (EORTC QLQ-OV28)
Time frame: Baseline up to approximately 6 years
Change From Baseline in Attitude to Disease/Treatment Assessed by EORTC QLQ-OV28
Time frame: Baseline up to approximately 6 years
TTD in Abdominal/GI Symptoms and Attitude to Disease/Treatment as Measured by EORTC QLQ-OV28
Time frame: Up to approximately 6 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Sep 2026.
- Individual participant dataSharing planned: Yes. De-identified individual participant data (IPD) on completed studies 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/
Related trials for Fallopian Tube Cancer
RecruitingPhase 2
Investigation of Ubamatamab Combination Therapy in Adult Participants With Platinum-Resistant Ovarian Cancer
Ovarian Cancer, Fallopian Tube Cancer
RecruitingPhase 3
Torvutatug Samrotecan Plus Bevacizumab as First-line Maintenance in Non-Homologous Recombination Deficiency (Non-HRD) Positive Advanced Epithelial Ovarian Cancer
Epithelial Ovarian Cancer
RecruitingPhase 2
At-Home Cancer Directed Therapy Versus in Clinic for the Treatment of Patients With Advanced Cancer
Advanced Anal Carcinoma, Advanced Biliary Tract Carcinoma
RecruitingObservational study
Clonal Hematopoiesis and Therapy-Emergent Myeloid Neoplasms in Patients With Cancers, CHANCES Study
Recurrent Fallopian Tube Carcinoma, Recurrent Ovarian Carcinoma
RecruitingPhase 2
Sacituzumab Govitecan With Bevacizumab Compared to Usual Chemotherapy (Carboplatin, Pegylated Liposomal Doxorubicin and Bevacizumab) for Treating Recurrent Platinum-Sensitive Ovarian Cancer After PARP Inhibitor Maintenance Therapy
Recurrent Platinum-Sensitive Fallopian Tube Endometrioid Adenocarcinoma, Recurrent Platinum-Sensitive Fallopian Tube High Grade Serous Adenocarcinoma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing R-DXd and Bevacizumab in people with Fallopian Tube Cancer and Primary Peritoneal Cancer, run by Daiichi Sankyo.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 50 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 1 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Daiichi Sankyo Contact for Clinical Trial Information (9089926400, CTRinfo_us@daiichisankyo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression Free Survival (PFS) as Assessed by Blinded Independent Central Review (BICR) per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) (time frame: Up to approximately 6 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Sep 2026.