Clinical Trials List
Protocol NumberDS8201-772
NCT Number(ClinicalTrials.gov Identfier)NCT06819007
Active
2025-03-01 - 2032-01-31
Phase III
Recruiting7
ICD-10C56.1
Malignant neoplasm of right ovary
ICD-10C56.2
Malignant neoplasm of left ovary
ICD-10C56.9
Malignant neoplasm of unspecified ovary
ICD-10Z51.12
Encounter for antineoplastic immunotherapy
ICD-9183.0
Malignant neoplasm of ovary
A Phase 3, Open-label, Multicenter, Randomized Trial of Trastuzumab Deruxtecan With Bevacizumab Versus Bevacizumab Monotherapy as First-line Maintenance Therapy in HER2-Expressing Ovarian Cancer (DESTINY-Ovarian01/ENGOT-ov89/GEICO144- O/GOG-3112/APGOT-OV13)
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Trial Applicant
Daiichi Sankyo Taiwan Ltd.
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Sponsor
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Trial scale
Multi-Regional Multi-Center
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Update
2026/04/10
Investigators and Locations
Co-Principal Investigator
- 石宇翔 Division of Obstetrics & Gynecology
- 孫珞 Division of Obstetrics & Gynecology
- 劉芝谷 Division of Obstetrics & Gynecology
- 呂亭芳 Division of Obstetrics & Gynecology
- 許世典 Division of Obstetrics & Gynecology
- 簡鴻仁 Division of Ophthalmology
- 王韶靖 Division of Obstetrics & Gynecology
- 范鈞婷 Division of Obstetrics & Gynecology
- 黃曉峰 Division of Obstetrics & Gynecology
- 陳蓉宣 Division of Radiology
- 詹松儒 Division of Radiology
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- Cheng-Tao Lin Division of Obstetrics & Gynecology
- 張淑涵 Division of Obstetrics & Gynecology
- HSIU-JUNG TUNG Division of Obstetrics & Gynecology
- 容世明 Division of Others -
- 陳怡杏 Division of Ophthalmology
- 黃彥綾 Division of Radiology
- Angel Chao Division of Obstetrics & Gynecology
- 周宏學 Division of Obstetrics & Gynecology
- 張宸邠 Division of Obstetrics & Gynecology
- Min-Yu Chen Division of Obstetrics & Gynecology
- Huei-Jean Huang Division of Obstetrics & Gynecology
- Ting-Chang Chang Division of Obstetrics & Gynecology
- 陳威君 Division of Obstetrics & Gynecology
- 黃寬仁 Division of Obstetrics & Gynecology
- Chyong-Huey Lai Division of Obstetrics & Gynecology
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- 張文君 Division of Obstetrics & Gynecology
- 戴依柔 Division of Obstetrics & Gynecology
- BOR-CHING SHEU Division of Obstetrics & Gynecology
- 施怡倫 Division of Radiology
- Ta-Ching Chen Division of Ophthalmology
- 吳晉睿 Division of Obstetrics & Gynecology
- CHI-HAU CHEN CHI-HAU CHEN Division of Obstetrics & Gynecology
- 吳尚俊 Division of General Internal Medicine
The Actual Total Number of Participants Enrolled
0 Recruiting
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- 王劭琪 Division of Obstetrics & Gynecology
- 林浩 Division of Obstetrics & Gynecology
- 黃思于 Division of Obstetrics & Gynecology
- 王映文 Division of Obstetrics & Gynecology
- 陳盈儀 Division of Obstetrics & Gynecology
- 黃偲媁 Division of Obstetrics & Gynecology
- 李仲哲 Division of Ophthalmology
- 湯禹舜 Division of Radiology
- 蔡景州 Division of Obstetrics & Gynecology
- 吳貞璇 Division of Obstetrics & Gynecology
- 歐育哲 Division of Obstetrics & Gynecology
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- 沈書慧 Division of Radiology
- 楊思婷 Division of Obstetrics & Gynecology
- Mei-Ju Chen Division of Ophthalmology
The Actual Total Number of Participants Enrolled
0 Recruiting
Principal Investigator
Yu-Fang Huang
Co-Principal Investigator
- 林語涵 Division of Obstetrics & Gynecology
- 鄭雅敏 Division of Obstetrics & Gynecology
- 吳珮瑩 Division of Obstetrics & Gynecology
- 梁玉玲 Division of Obstetrics & Gynecology
- 戴依柔 Division of Obstetrics & Gynecology
- Cheng-Yang Chou Division of Obstetrics & Gynecology
- 黃蘭茵 Division of Obstetrics & Gynecology
- Meng-Ru Shen Division of Obstetrics & Gynecology
- Keng-Fu Hsu Division of Obstetrics & Gynecology
The Actual Total Number of Participants Enrolled
0 Recruiting
Condition/Disease
Ovarian Cancer
Objectives
This clinical trial aimed to evaluate the efficacy and safety of T-DXd combined with bevacizumab compared to bevacizumab alone as first-line maintenance therapy in participants with advanced well-differentiated epithelial ovarian cancer exhibiting type II human epidermal growth factor receptor (HER2) expression (immunohistochemistry, IHC) 3+/2+/1+.
Test Drug
Frozen Crystal Injection
Active Ingredient
trastuzumab deruxtecan
Dosage Form
243
Dosage
100MG/vial
Endpoints
Compare the efficacy of T-DXd plus bevacizumab (Group A) versus bevacizumab monotherapy (Group B) in the HER2 IHC 3+/2+ population, as assessed by BICR for progression-free survival (PFS).
Inclution Criteria
Key Inclusion Criteria:
Sign and date the tissue prescreening ICF, prior to HER2 central testing. Sign and date the Main ICF, prior to the start of any trial- specific qualification procedures. Consent to optional PGx prior to any PGx procedures.
*For participants in the safety run-in phase, a safety run-in ICF needs to be signed and dated prior to the start of any trial-specific qualification procedures.
Adults ≥18 years of age on the day of signing the ICF. Follow local regulatory requirements if the legal age of consent for trial participation is >18 years old.
Has histologically confirmed diagnosis of epithelial high-grade ovarian, fallopian tube or primary peritoneal carcinoma per local assessment (including but not limiting to serous, endometrioid, clear cell, carcinosarcoma, mucinous).
Is newly diagnosed FIGO Stage III or IV.
Has HER2 expression per 2016 ASCO-CAP gastric cancer IHC scoring (3+/2+/1+) guidelines1 by prospective central testing.
*For participants in the safety run-in phase, HER2 expression assessed by either local (require using ASCO-CAP gastric cancer IHC scoring [IHC 3+/2+/1+] guidelines) or central assessment (if available) is acceptable. Submission of the pathology report is required for participants enrolled based on local HER2 IHC results.
Has adequate tumor tissue sample available for assessment of HER2 by central laboratory. Tumor tissue block or sufficient tissue slides are required for HER2 testing and retrospective HRD status determination.
*Participants in the safety run-in phase who are enrolled based on local HER2 IHC results are recommended to provide tumor tissue sample from the same specimen for central assessment.
Has a local HRD or BRCA test result available. Participants with BRCA-wildtype will have a local HRD test results, as applicable.
Has received up to 6 cycles of standard of care bevacizumab in combination with frontline platinum- based chemotherapy as per approved indication and clinical guidelines and is eligible to continue single agent bevacizumab maintenance per standard of care and investigator discretion.
Sign and date the tissue prescreening ICF, prior to HER2 central testing. Sign and date the Main ICF, prior to the start of any trial- specific qualification procedures. Consent to optional PGx prior to any PGx procedures.
*For participants in the safety run-in phase, a safety run-in ICF needs to be signed and dated prior to the start of any trial-specific qualification procedures.
Adults ≥18 years of age on the day of signing the ICF. Follow local regulatory requirements if the legal age of consent for trial participation is >18 years old.
Has histologically confirmed diagnosis of epithelial high-grade ovarian, fallopian tube or primary peritoneal carcinoma per local assessment (including but not limiting to serous, endometrioid, clear cell, carcinosarcoma, mucinous).
Is newly diagnosed FIGO Stage III or IV.
Has HER2 expression per 2016 ASCO-CAP gastric cancer IHC scoring (3+/2+/1+) guidelines1 by prospective central testing.
*For participants in the safety run-in phase, HER2 expression assessed by either local (require using ASCO-CAP gastric cancer IHC scoring [IHC 3+/2+/1+] guidelines) or central assessment (if available) is acceptable. Submission of the pathology report is required for participants enrolled based on local HER2 IHC results.
Has adequate tumor tissue sample available for assessment of HER2 by central laboratory. Tumor tissue block or sufficient tissue slides are required for HER2 testing and retrospective HRD status determination.
*Participants in the safety run-in phase who are enrolled based on local HER2 IHC results are recommended to provide tumor tissue sample from the same specimen for central assessment.
Has a local HRD or BRCA test result available. Participants with BRCA-wildtype will have a local HRD test results, as applicable.
Has received up to 6 cycles of standard of care bevacizumab in combination with frontline platinum- based chemotherapy as per approved indication and clinical guidelines and is eligible to continue single agent bevacizumab maintenance per standard of care and investigator discretion.
Exclusion Criteria
Key Exclusion Criteria:
Has ovarian, fallopian tube, or peritoneal cancer of non-epithelial origin.
Has a known or suspected deleterious BRCA alteration as per local test that makes the patient eligible for PARP inhibitor.
Participant to receive PARP inhibitor as maintenance per standard of care and investigator discretion. Reasons for which the participant is not eligible for PARP inhibitor will be recorded in the eCRF as follows:
HRD negative
HRD positive with SD as best response after platinum
HRD positive non-serous histology Note: For participants enrolled from the Republic of Korea
HRD tested, but inconclusive
HRD positive but safety concern (safety concern to be specified).
Has a history of severe hypersensitivity reactions to either the drug substances or inactive ingredients in the drug products and other monoclonal antibodies.
Previous Cerebral-Vascular Accident, Transient Ischemic Attack or Sub- Arachnoids Hemorrhage within 6 months prior to randomization.
*Note: For participants enrolled from the Republic of Korea,
Has evidence of bleeding diathesis or significant coagulopathy (in the absence of anticoagulation therapy).
Has a history of hemorrhagic disorders, abdominal fistula, gastrointestinal perforation, or active gastrointestinal bleeding within 6 months before randomization.
Evidence of active or ongoing bowel obstruction.
Has a medical history of myocardial infarction within 6 months before randomization, symptomatic congestive heart failure (New York Heart Association Class II to IV).
Participants with troponin levels above the upper limit of normal at Screening (as defined by the manufacturer), and without any myocardial infarction related symptoms should have a cardiologic consultation during the Screening Period to rule out myocardial infarction.
Has a corrected QT interval prolongation to >480 msec based on average of the Screening triplicate 12-lead ECG.
Has a history of (non-infectious) ILD/pneumonitis that required steroids, has current ILD/pneumonitis, or where suspected ILD/pneumonitis cannot be ruled out by imaging at Screening.
Has ovarian, fallopian tube, or peritoneal cancer of non-epithelial origin.
Has a known or suspected deleterious BRCA alteration as per local test that makes the patient eligible for PARP inhibitor.
Participant to receive PARP inhibitor as maintenance per standard of care and investigator discretion. Reasons for which the participant is not eligible for PARP inhibitor will be recorded in the eCRF as follows:
HRD negative
HRD positive with SD as best response after platinum
HRD positive non-serous histology Note: For participants enrolled from the Republic of Korea
HRD tested, but inconclusive
HRD positive but safety concern (safety concern to be specified).
Has a history of severe hypersensitivity reactions to either the drug substances or inactive ingredients in the drug products and other monoclonal antibodies.
Previous Cerebral-Vascular Accident, Transient Ischemic Attack or Sub- Arachnoids Hemorrhage within 6 months prior to randomization.
*Note: For participants enrolled from the Republic of Korea,
Has evidence of bleeding diathesis or significant coagulopathy (in the absence of anticoagulation therapy).
Has a history of hemorrhagic disorders, abdominal fistula, gastrointestinal perforation, or active gastrointestinal bleeding within 6 months before randomization.
Evidence of active or ongoing bowel obstruction.
Has a medical history of myocardial infarction within 6 months before randomization, symptomatic congestive heart failure (New York Heart Association Class II to IV).
Participants with troponin levels above the upper limit of normal at Screening (as defined by the manufacturer), and without any myocardial infarction related symptoms should have a cardiologic consultation during the Screening Period to rule out myocardial infarction.
Has a corrected QT interval prolongation to >480 msec based on average of the Screening triplicate 12-lead ECG.
Has a history of (non-infectious) ILD/pneumonitis that required steroids, has current ILD/pneumonitis, or where suspected ILD/pneumonitis cannot be ruled out by imaging at Screening.
The Estimated Number of Participants
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Taiwan
34 participants
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Global
582 participants
