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 comparing trastuzumab deruxtecan plus bevacizumab versus bevacizumab alone as first-line maintenance therapy for HER2-positive 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
daiichi sankyo Taiwan Ltd.
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Trial scale
Multi-Regional Multi-Center
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Update
2026/08/17
Investigators and Locations
Co-Principal Investigator
- 吳珮瑩 Division of Obstetrics & Gynecology
- Meng-Ru Shen Division of Obstetrics & Gynecology
- Cheng-Yang Chou Division of Obstetrics & Gynecology
- 林語涵 Division of Obstetrics & Gynecology
- 梁玉玲 Division of Obstetrics & Gynecology
- Keng-Fu Hsu Division of Obstetrics & Gynecology
- 黃蘭茵 Division of Obstetrics & Gynecology
- 鄭雅敏 Division of Obstetrics & Gynecology
- 戴依柔 Division of Obstetrics & Gynecology
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- 王韶靖 Division of Obstetrics & Gynecology
- 石宇翔 Division of Obstetrics & Gynecology
- 呂亭芳 Division of Obstetrics & Gynecology
- 范鈞婷 Division of Obstetrics & Gynecology
- 孫珞 Division of Obstetrics & Gynecology
- 許世典 Division of Obstetrics & Gynecology
- 陳蓉宣 Division of Radiology
- 黃曉峰 Division of Obstetrics & Gynecology
- 劉芝谷 Division of Obstetrics & Gynecology
- 簡鴻仁 Division of Ophthalmology
- 詹松儒 Division of Radiology
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- 施怡倫 Division of Radiology
- 張文君 Division of Obstetrics & Gynecology
- BOR-CHING SHEU Division of Obstetrics & Gynecology
- CHI-HAU CHEN CHI-HAU CHEN Division of Obstetrics & Gynecology
- Ta-Ching Chen Division of Ophthalmology
- 戴依柔 Division of Obstetrics & Gynecology
- 吳尚俊
- 吳晉睿 Division of Obstetrics & Gynecology
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
- 王映文 Division of Obstetrics & Gynecology
- 吳貞璇 Division of Obstetrics & Gynecology
- 李仲哲 Division of Ophthalmology
- 林浩 Division of Obstetrics & Gynecology
- 陳盈儀 Division of Obstetrics & Gynecology
- 湯禹舜 Division of Radiology
- 黃思于 Division of Obstetrics & Gynecology
- 黃偲媁 Division of Obstetrics & Gynecology
- 歐育哲 Division of Obstetrics & Gynecology
- 蔡景州 Division of Obstetrics & Gynecology
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- 沈書慧 Division of Radiology
- Mei-Ju Chen Division of Ophthalmology
- 楊思婷 Division of Obstetrics & Gynecology
The Actual Total Number of Participants Enrolled
0 Recruiting
Principal Investigator
Yun-Hsin Tang
Co-Principal Investigator
- 周宏學 Division of Obstetrics & Gynecology
- Cheng-Tao Lin Division of Obstetrics & Gynecology
- 容世明 Division of Others -
- Ting-Chang Chang Division of Obstetrics & Gynecology
- 張宸邠 Division of Obstetrics & Gynecology
- 張淑涵 Division of Obstetrics & Gynecology
- 陳怡杏 Division of Ophthalmology
- 陳威君 Division of Obstetrics & Gynecology
- Min-Yu Chen Division of Obstetrics & Gynecology
- 黃彥綾 Division of Radiology
- 黃寬仁 Division of Obstetrics & Gynecology
- Huei-Jean Huang Division of Obstetrics & Gynecology
- HSIU-JUNG TUNG Division of Obstetrics & Gynecology
- Angel Chao Division of Obstetrics & Gynecology
- Chyong-Huey Lai
The Actual Total Number of Participants Enrolled
0 Recruiting
Condition/Disease
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).
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
Trastuzumab Deruxtecan (T-DXd、DS-8201a)
Active Ingredient
trastuzumab deruxtecan
Dosage Form
Frozen Crystal Injection
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: Participants must meet all of the following criteria to be eligible for inclusion/randomization in the trial:
1. Signed and dated the Organizational Pre-screening Subject Consent Form (ICF) before undergoing HER2 central testing. Signed and dated the Principal Subject Consent Form before starting any trial-specific eligibility procedures. Consented to selective PGx before any pharmacogenetic (PGx) procedures.
• For participants in the safe dose-induction phase, a safe dose-induction phase subject consent form must be signed and dated before any trial-specific eligibility procedures.
2. Adults aged ≥18 years as of the date of signing the subject consent form. If the legal age of consent for trial participation is >18 years, local regulations will apply.
3. Histologically confirmed epithelial well-differentiated ovarian cancer, fallopian tube cancer, or primary peritoneal cancer (including but not limited to serous, endometrial, clear cell, carcinosarcoma, and mucinous carcinoma).
4. Newly diagnosed FIGO stage III or IV.
5. HER2 expression via prospective central testing, according to the 2016 American Society of Clinical Oncology (ASCO)-American College of Pathology (CAP) Immunohistochemical Staining (IHC) scoring (3+/2+/1+) guidelines for gastric cancer.
• For participants in the safe-dose induction phase, HER2 expression from either local assessment (using the ASCO-CAP gastric cancer IHC scoring [IHC 3+/2+/1+] guidelines) or central assessment (if applicable) is acceptable. Participants enrolled based on local HER2 IHC results are required to submit a pathology report.
6. Sufficient tumor tissue specimens are available for central laboratory assessment of HER2. HER2 testing and retrospective loss of homologous recombination repair (HRD) status determination require tumor tissue blocks or sufficient tissue slides.
• For participants in the safe-dose induction phase enrolled based on local HER2 IHC results, it is recommended to provide tumor tissue specimens from the same specimen for central assessment.
7. Local HRD or breast cancer gene (BRCA) testing results are available. Participants with BRCA wild-type will have local HRD testing results (if applicable).
8. Have received standard care with bevacizumab and first-line platinum-based chemotherapy according to the approved indication and clinical guidelines, and are eligible to continue bevacizumab monotherapy maintenance therapy based on standard care and at the trial administrator's discretion.
9. Have not experienced disease progression (PD) after completing at least 6 and a maximum of 8 cycles of first-line carboplatin-paclitaxel (allowing intravenous or intraperitoneal or pre-adjuvant/adjuvant chemotherapy, or intraperitoneal hyperthermic chemotherapy [HIPEC]).
• Participants who have completed fewer than 6 cycles of first-line chemotherapy are eligible if they experience toxicity that prevents further chemotherapy administration. In this case, the reason for fewer than 6 cycles will be recorded in the electronic case report form (eCRF).
• No PD is defined as no evidence of disease (defined as no residual disease after initial tumor debulking surgery [PDS]), or a complete response/partial response/stable disease as assessed by the trial administrator at the end of first-line chemotherapy according to the Solid Tumor Response Assessment Criteria, version 1.1 (RECIST v1.1). There should be no clinical evidence of disease progression (physical examination, imaging, or cancer antigen [CA] 125) during the participant's first-line treatment and prior to trial randomization.
10. Trial intervention should begin 3 to 12 weeks after the last dose of first-line chemotherapy. Participants who begin bevacizumab monotherapy maintenance therapy before randomization are ineligible.
11. Participants who are not considered surgical candidates or who have completed a scheduled tumor debulking surgery (initial or interim tumor debulking surgery [IDS]) are eligible.
12. East Coast Cancer Clinical Research Consortium (ECOG) performance status of 0 or 1.
13. Left ventricular ejection fraction (LVEF) ≥50% within 28 days prior to randomization.
14. Urine protein <2+ as detected by urine test strips. If urine test strips show ≥2+, then a 24-hour urine sample must show <1 g of protein within 24 hours.
15. Normal blood pressure or adequately treated and controlled hypertension (systolic blood pressure ≤140 mmHg and/or diastolic blood pressure ≤90 mmHg).
Adequate organ/bone marrow function.
Must be within 14 days prior to inclusion/randomization.
No blood transfusions (red blood cells or platelets) or use of granulocyte colony-stimulating factor (G-CSF) are permitted within 14 days prior to screening laboratory testing.
Adequate organ/bone marrow function is defined as follows: Parameter Laboratory Values
Adequate Bone Marrow Function
Platelet Count ≥100 × 10⁹/L
Heme ≥9.0 g/dL
ANC ≥1.5 × 10⁹/L
Adequate Kidney Function
Cretinol ≥30 mL/min, calculated using the Cockcroft-Gault formula*
Adequate Liver Function
ALT and/or AST ≤3.0 × ULN (without liver metastases) or
≤5.0 × ULN (with liver metastases at baseline)
Total bilirubin ≤1.5 × ULN (without liver metastases) or
≤3.0 × ULN (if liver metastases are present at baseline or Gilbert's syndrome is recorded)
Serum Albumin ≥2.5 g/dL
Adequate Coagulation Function
PT/INR and aPTT or PTT ≤1.5 × ULN
*Cockcroft-Gault Formula
CLcr (mL/min) = "[140 – Age (years)] × Weight (kg)" / "72 × Serum creatinine (mg/dL)" {× 0.85 [for women]}
ALT = Alanine transaminase; ANC = Absolute neutrophil count; aPTT = Activated partial thromboplastin time; AST = Aspartate transaminase; INR = International Normalized Ratio; PT = Prothrombin time; PTT = Activated partial thromboplastin time; ULN = Upper limit of normal
17. Sufficient treatment washout period is required before randomization, defined as follows:
Treatment washout period
Major surgery ≥4 weeks
Radiation therapy, including palliative stereotactic radiotherapy to the chest ≥4 weeks
Patient stereotactic radiotherapy to other anatomical regions ≥2 weeks
Anticancer chemotherapy, immunotherapy (non-antibody-based therapy), retinoid therapy, hormone therapy ≥3 weeks
Targeted drugs and small molecule drugs (≥2 weeks or 5 weeks) Half-life, whichever is longer: Nitrosourea or mitomycin C (Multiple Cancer Reduction®) ≥6 weeks
Antibody-based anticancer therapy ≥4 weeks
Chloroquine/Hydroxychloroquine >14 days
Cell-free concentrated ascites reinfusion, abdominal drainage, or drainage of pleural effusion, ascites, or pericardial effusion ≥2 weeks prior to primary screening assessment
18. Participants of childbearing potential (POCBP) are eligible if they meet the following criteria:
• Confirmed not pregnant by a highly sensitive pregnancy test.
• Refrain from breastfeeding during the trial intervention and for at least 7 months after the last dose of the trial intervention.
• Participants agree to use highly effective contraception and agree not to donate oocytes (eggs, oocytes) or freeze/store oocytes during the intervention and for at least the required washout period after the last dose of the trial intervention. The required duration of continuous contraception after the last dose of each trial intervention is 7 weeks. Months. Egg preservation may be considered before the first trial intervention.
19. Willing and able to adhere to scheduled follow-up appointments, medication administration plans, laboratory tests, other trial procedures, and trial restrictions.
1. Signed and dated the Organizational Pre-screening Subject Consent Form (ICF) before undergoing HER2 central testing. Signed and dated the Principal Subject Consent Form before starting any trial-specific eligibility procedures. Consented to selective PGx before any pharmacogenetic (PGx) procedures.
• For participants in the safe dose-induction phase, a safe dose-induction phase subject consent form must be signed and dated before any trial-specific eligibility procedures.
2. Adults aged ≥18 years as of the date of signing the subject consent form. If the legal age of consent for trial participation is >18 years, local regulations will apply.
3. Histologically confirmed epithelial well-differentiated ovarian cancer, fallopian tube cancer, or primary peritoneal cancer (including but not limited to serous, endometrial, clear cell, carcinosarcoma, and mucinous carcinoma).
4. Newly diagnosed FIGO stage III or IV.
5. HER2 expression via prospective central testing, according to the 2016 American Society of Clinical Oncology (ASCO)-American College of Pathology (CAP) Immunohistochemical Staining (IHC) scoring (3+/2+/1+) guidelines for gastric cancer.
• For participants in the safe-dose induction phase, HER2 expression from either local assessment (using the ASCO-CAP gastric cancer IHC scoring [IHC 3+/2+/1+] guidelines) or central assessment (if applicable) is acceptable. Participants enrolled based on local HER2 IHC results are required to submit a pathology report.
6. Sufficient tumor tissue specimens are available for central laboratory assessment of HER2. HER2 testing and retrospective loss of homologous recombination repair (HRD) status determination require tumor tissue blocks or sufficient tissue slides.
• For participants in the safe-dose induction phase enrolled based on local HER2 IHC results, it is recommended to provide tumor tissue specimens from the same specimen for central assessment.
7. Local HRD or breast cancer gene (BRCA) testing results are available. Participants with BRCA wild-type will have local HRD testing results (if applicable).
8. Have received standard care with bevacizumab and first-line platinum-based chemotherapy according to the approved indication and clinical guidelines, and are eligible to continue bevacizumab monotherapy maintenance therapy based on standard care and at the trial administrator's discretion.
9. Have not experienced disease progression (PD) after completing at least 6 and a maximum of 8 cycles of first-line carboplatin-paclitaxel (allowing intravenous or intraperitoneal or pre-adjuvant/adjuvant chemotherapy, or intraperitoneal hyperthermic chemotherapy [HIPEC]).
• Participants who have completed fewer than 6 cycles of first-line chemotherapy are eligible if they experience toxicity that prevents further chemotherapy administration. In this case, the reason for fewer than 6 cycles will be recorded in the electronic case report form (eCRF).
• No PD is defined as no evidence of disease (defined as no residual disease after initial tumor debulking surgery [PDS]), or a complete response/partial response/stable disease as assessed by the trial administrator at the end of first-line chemotherapy according to the Solid Tumor Response Assessment Criteria, version 1.1 (RECIST v1.1). There should be no clinical evidence of disease progression (physical examination, imaging, or cancer antigen [CA] 125) during the participant's first-line treatment and prior to trial randomization.
10. Trial intervention should begin 3 to 12 weeks after the last dose of first-line chemotherapy. Participants who begin bevacizumab monotherapy maintenance therapy before randomization are ineligible.
11. Participants who are not considered surgical candidates or who have completed a scheduled tumor debulking surgery (initial or interim tumor debulking surgery [IDS]) are eligible.
12. East Coast Cancer Clinical Research Consortium (ECOG) performance status of 0 or 1.
13. Left ventricular ejection fraction (LVEF) ≥50% within 28 days prior to randomization.
14. Urine protein <2+ as detected by urine test strips. If urine test strips show ≥2+, then a 24-hour urine sample must show <1 g of protein within 24 hours.
15. Normal blood pressure or adequately treated and controlled hypertension (systolic blood pressure ≤140 mmHg and/or diastolic blood pressure ≤90 mmHg).
Adequate organ/bone marrow function.
Must be within 14 days prior to inclusion/randomization.
No blood transfusions (red blood cells or platelets) or use of granulocyte colony-stimulating factor (G-CSF) are permitted within 14 days prior to screening laboratory testing.
Adequate organ/bone marrow function is defined as follows: Parameter Laboratory Values
Adequate Bone Marrow Function
Platelet Count ≥100 × 10⁹/L
Heme ≥9.0 g/dL
ANC ≥1.5 × 10⁹/L
Adequate Kidney Function
Cretinol ≥30 mL/min, calculated using the Cockcroft-Gault formula*
Adequate Liver Function
ALT and/or AST ≤3.0 × ULN (without liver metastases) or
≤5.0 × ULN (with liver metastases at baseline)
Total bilirubin ≤1.5 × ULN (without liver metastases) or
≤3.0 × ULN (if liver metastases are present at baseline or Gilbert's syndrome is recorded)
Serum Albumin ≥2.5 g/dL
Adequate Coagulation Function
PT/INR and aPTT or PTT ≤1.5 × ULN
*Cockcroft-Gault Formula
CLcr (mL/min) = "[140 – Age (years)] × Weight (kg)" / "72 × Serum creatinine (mg/dL)" {× 0.85 [for women]}
ALT = Alanine transaminase; ANC = Absolute neutrophil count; aPTT = Activated partial thromboplastin time; AST = Aspartate transaminase; INR = International Normalized Ratio; PT = Prothrombin time; PTT = Activated partial thromboplastin time; ULN = Upper limit of normal
17. Sufficient treatment washout period is required before randomization, defined as follows:
Treatment washout period
Major surgery ≥4 weeks
Radiation therapy, including palliative stereotactic radiotherapy to the chest ≥4 weeks
Patient stereotactic radiotherapy to other anatomical regions ≥2 weeks
Anticancer chemotherapy, immunotherapy (non-antibody-based therapy), retinoid therapy, hormone therapy ≥3 weeks
Targeted drugs and small molecule drugs (≥2 weeks or 5 weeks) Half-life, whichever is longer: Nitrosourea or mitomycin C (Multiple Cancer Reduction®) ≥6 weeks
Antibody-based anticancer therapy ≥4 weeks
Chloroquine/Hydroxychloroquine >14 days
Cell-free concentrated ascites reinfusion, abdominal drainage, or drainage of pleural effusion, ascites, or pericardial effusion ≥2 weeks prior to primary screening assessment
18. Participants of childbearing potential (POCBP) are eligible if they meet the following criteria:
• Confirmed not pregnant by a highly sensitive pregnancy test.
• Refrain from breastfeeding during the trial intervention and for at least 7 months after the last dose of the trial intervention.
• Participants agree to use highly effective contraception and agree not to donate oocytes (eggs, oocytes) or freeze/store oocytes during the intervention and for at least the required washout period after the last dose of the trial intervention. The required duration of continuous contraception after the last dose of each trial intervention is 7 weeks. Months. Egg preservation may be considered before the first trial intervention.
19. Willing and able to adhere to scheduled follow-up appointments, medication administration plans, laboratory tests, other trial procedures, and trial restrictions.
Exclusion Criteria
Key Exclusion Criteria: Participants meeting any of the following criteria will be ineligible for the trial:
1. Ovarian, fallopian tube, or peritoneal cancer of non-epithelial origin.
2. BRCA mutation as determined by local testing.
3. Participants receiving a polyadenylate-ribose (ADP-ribose) polymerase (PARP) inhibitor as maintenance therapy under standard care and at the trial administrator's discretion. Reasons for ineligibility for PARP inhibitor therapy will be recorded in the electronic case report form as follows:
• HRD negative
• HRD positive, best response to platinum-based therapy was stable disease (SD)
• HRD positive, non-serous histology
• HRD testing performed, but results were inconclusive
• HRD positive, but safety concerns exist (safety concerns to be specified).
4. History of severe allergic reactions to any drug component, inactive ingredient, or other monoclonal antibody.
5. History of cerebrovascular accident, transient ischemic attack, or subarachnoid hemorrhage within 6 months prior to randomization.
6. Evidence of bleeding disorder or major coagulation abnormalities (without anticoagulation therapy).
7. History of bleeding disorders, abdominal fistulas, gastrointestinal perforation, or active gastrointestinal bleeding within 6 months prior to randomization.
8. Evidence of active or persistent bowel obstruction.
9. History of myocardial infarction or symptomatic congestive heart failure (New York Heart Association Class II to IV) within 6 months prior to randomization. Participants with troponin levels above the upper limit of normal (as defined by the manufacturer) and no myocardial infarction-related symptoms at screening should be consulted with a cardiologist during screening to rule out myocardial infarction.
10. Corrected QT interval prolongation to >480 msec based on the average of three consecutive 12-lead electrocardiograms (ECGs) at screening.
11. History of (non-infectious) interstitial lung disease (ILD)/pneumonia requiring steroid treatment, current ILD/pneumonia, or suspected ILD/pneumonia that cannot be ruled out by contrast imaging at screening.
12. Clinically significant pulmonary comorbidities, including but not limited to any underlying lung disease (e.g., pulmonary embolism, severe asthma, severe chronic obstructive pulmonary disease, restrictive lung disease, pleural effusion, pneumonectomy, etc., occurring within 3 months of randomization).
13. Any autoimmune disease, connective tissue disease, or inflammatory disease with documented or suspected lung involvement at screening (e.g., rheumatoid arthritis, Sjogren's disease, sarcomatoid disease, etc.). Complete and detailed information on the diseases of participants included in the trial should be recorded in the electronic case report form.
14. Clinically severe lung damage caused by concurrent lung disease, including but not limited to any underlying lung disease (i.e., pulmonary embolism, severe asthma, severe chronic obstructive pulmonary disease [COPD], focal lung disease, pleural effusion, etc. occurring within three months of enrollment), and any autoimmune, connective tissue, or inflammatory disease with underlying lung involvement (i.e., rheumatoid arthritis, Shugrange's disease, sarcomatoid disease, etc.), or a previous total pneumonectomy.
15. Spinal cord compression or clinically active central nervous system metastases, defined as untreated and symptomatic, or requiring corticosteroids or antiepileptic drugs to control related symptoms. Participants with clinically inactive brain metastases may be enrolled. Participants with treated and symptom-free brain metastases who do not require corticosteroids or antiepileptic drugs and have recovered from the acute toxicity of radiotherapy may be enrolled. There must be at least a 2-week interval between the completion of whole-brain radiotherapy and randomization.
16. History of multiple primary malignancies within the past 3 years, excluding fully excised non-melanoma skin cancer or in situ diseases that have received curative treatment.
17. History of severe allergic reactions to other monoclonal antibodies.
18. Uncontrolled infection requiring intravenous (IV) antibiotics, antiviral drugs, or antifungal medications.
19. Substance abuse or any other medical condition, such as clinically significant cardiac or psychological conditions, that, as determined by the trial administrator, may interfere with participant participation in the clinical trial or the assessment of clinical trial outcomes.
20. Active or uncontrolled hepatitis B virus infection. Participants are eligible if they meet the following criteria:
a. They are hepatitis B surface antigen (HBsAg) positive and have chronic hepatitis B virus (HBV) infection (lasting 6 months or longer), and meet the following criteria:
HBV deoxyribonucleic acid (DNA) viral load <2000 IU/mL
Antiviral therapy has been initiated or maintained if the trial administrator deems it clinically necessary.
b. They have normal transaminase levels, or if liver metastases are present, they have transaminase abnormalities not caused by HBV infection, with an AST/ALT <3 x ULN result.
21. They have active or uncontrolled hepatitis C virus infection. Participants are eligible if they meet the following criteria:
a. They have a history of hepatitis C infection and are eligible if they have not received antiviral therapy in the past 4 weeks and their hepatitis C virus (HCV) viral load is below the detectable level.
b. Normal transaminase levels, or, if liver metastases are present, transaminase abnormalities not caused by HCV infection, with an AST/ALT <3 x ULN result.
22. Active or uncontrolled human immunodeficiency virus (HIV) infection. HIV viral load testing must be performed on subjects during screening if permitted by local regulations or by IRBs/Independent Ethics Committees (IECs). Participants are eligible if they meet the following criteria:
a. CD4+ T cell count ≥350 cells/mm3 at screening
b. Virological suppression is defined as a confirmed HIV RNA concentration below 50 or the lower limit of quantitation (LLOQ) (below the detection limit) within at least 12 weeks prior to screening.
c. No opportunistic infection or illness defined as acquired immunodeficiency syndrome (AIDS) within the past 12 months.
d. Received a stable antiretroviral therapy (ART) regimen for at least 4 weeks prior to entering the trial (Day 1), without changes to medication or dose adjustments, and agreed to continue ART throughout the trial.
23. History of vaccination with an active attenuated vaccine (messenger RNA [mRNA] and replication-defective adenovirus vaccines are not considered live attenuated virus vaccines) within 30 days prior to the first dose of the trial.
24. Unresolved toxicities from previous anticancer therapy, defined as toxicities that have not been resolved to ≤ Grade 1 or baseline (excluding hair loss).
Note: Participants with chronic, stable Grade 2 toxicities (defined as those that have not worsened to > Grade 2 in at least 3 months prior to randomization and are controlled with standard care) and identified by the trial administrator as related to previous anticancer therapy may be included, including the following:
• Chemotherapy-induced neuropathy
• Fatigue
• Residual toxicities from previous immuno-oncology (IO) therapy: Grade 1 or 2 endocrine disorders, which may include:
a) Hypothyroidism/Hyperthyroidism
b) Type 1 diabetes
c) Hyperglycemia
d) Adrenal insufficiency
e) Adrenitis
f) Hypopigmentation (leukoplakia)
25. Pregnancy, breastfeeding, or planning to become pregnant.
1. Ovarian, fallopian tube, or peritoneal cancer of non-epithelial origin.
2. BRCA mutation as determined by local testing.
3. Participants receiving a polyadenylate-ribose (ADP-ribose) polymerase (PARP) inhibitor as maintenance therapy under standard care and at the trial administrator's discretion. Reasons for ineligibility for PARP inhibitor therapy will be recorded in the electronic case report form as follows:
• HRD negative
• HRD positive, best response to platinum-based therapy was stable disease (SD)
• HRD positive, non-serous histology
• HRD testing performed, but results were inconclusive
• HRD positive, but safety concerns exist (safety concerns to be specified).
4. History of severe allergic reactions to any drug component, inactive ingredient, or other monoclonal antibody.
5. History of cerebrovascular accident, transient ischemic attack, or subarachnoid hemorrhage within 6 months prior to randomization.
6. Evidence of bleeding disorder or major coagulation abnormalities (without anticoagulation therapy).
7. History of bleeding disorders, abdominal fistulas, gastrointestinal perforation, or active gastrointestinal bleeding within 6 months prior to randomization.
8. Evidence of active or persistent bowel obstruction.
9. History of myocardial infarction or symptomatic congestive heart failure (New York Heart Association Class II to IV) within 6 months prior to randomization. Participants with troponin levels above the upper limit of normal (as defined by the manufacturer) and no myocardial infarction-related symptoms at screening should be consulted with a cardiologist during screening to rule out myocardial infarction.
10. Corrected QT interval prolongation to >480 msec based on the average of three consecutive 12-lead electrocardiograms (ECGs) at screening.
11. History of (non-infectious) interstitial lung disease (ILD)/pneumonia requiring steroid treatment, current ILD/pneumonia, or suspected ILD/pneumonia that cannot be ruled out by contrast imaging at screening.
12. Clinically significant pulmonary comorbidities, including but not limited to any underlying lung disease (e.g., pulmonary embolism, severe asthma, severe chronic obstructive pulmonary disease, restrictive lung disease, pleural effusion, pneumonectomy, etc., occurring within 3 months of randomization).
13. Any autoimmune disease, connective tissue disease, or inflammatory disease with documented or suspected lung involvement at screening (e.g., rheumatoid arthritis, Sjogren's disease, sarcomatoid disease, etc.). Complete and detailed information on the diseases of participants included in the trial should be recorded in the electronic case report form.
14. Clinically severe lung damage caused by concurrent lung disease, including but not limited to any underlying lung disease (i.e., pulmonary embolism, severe asthma, severe chronic obstructive pulmonary disease [COPD], focal lung disease, pleural effusion, etc. occurring within three months of enrollment), and any autoimmune, connective tissue, or inflammatory disease with underlying lung involvement (i.e., rheumatoid arthritis, Shugrange's disease, sarcomatoid disease, etc.), or a previous total pneumonectomy.
15. Spinal cord compression or clinically active central nervous system metastases, defined as untreated and symptomatic, or requiring corticosteroids or antiepileptic drugs to control related symptoms. Participants with clinically inactive brain metastases may be enrolled. Participants with treated and symptom-free brain metastases who do not require corticosteroids or antiepileptic drugs and have recovered from the acute toxicity of radiotherapy may be enrolled. There must be at least a 2-week interval between the completion of whole-brain radiotherapy and randomization.
16. History of multiple primary malignancies within the past 3 years, excluding fully excised non-melanoma skin cancer or in situ diseases that have received curative treatment.
17. History of severe allergic reactions to other monoclonal antibodies.
18. Uncontrolled infection requiring intravenous (IV) antibiotics, antiviral drugs, or antifungal medications.
19. Substance abuse or any other medical condition, such as clinically significant cardiac or psychological conditions, that, as determined by the trial administrator, may interfere with participant participation in the clinical trial or the assessment of clinical trial outcomes.
20. Active or uncontrolled hepatitis B virus infection. Participants are eligible if they meet the following criteria:
a. They are hepatitis B surface antigen (HBsAg) positive and have chronic hepatitis B virus (HBV) infection (lasting 6 months or longer), and meet the following criteria:
HBV deoxyribonucleic acid (DNA) viral load <2000 IU/mL
Antiviral therapy has been initiated or maintained if the trial administrator deems it clinically necessary.
b. They have normal transaminase levels, or if liver metastases are present, they have transaminase abnormalities not caused by HBV infection, with an AST/ALT <3 x ULN result.
21. They have active or uncontrolled hepatitis C virus infection. Participants are eligible if they meet the following criteria:
a. They have a history of hepatitis C infection and are eligible if they have not received antiviral therapy in the past 4 weeks and their hepatitis C virus (HCV) viral load is below the detectable level.
b. Normal transaminase levels, or, if liver metastases are present, transaminase abnormalities not caused by HCV infection, with an AST/ALT <3 x ULN result.
22. Active or uncontrolled human immunodeficiency virus (HIV) infection. HIV viral load testing must be performed on subjects during screening if permitted by local regulations or by IRBs/Independent Ethics Committees (IECs). Participants are eligible if they meet the following criteria:
a. CD4+ T cell count ≥350 cells/mm3 at screening
b. Virological suppression is defined as a confirmed HIV RNA concentration below 50 or the lower limit of quantitation (LLOQ) (below the detection limit) within at least 12 weeks prior to screening.
c. No opportunistic infection or illness defined as acquired immunodeficiency syndrome (AIDS) within the past 12 months.
d. Received a stable antiretroviral therapy (ART) regimen for at least 4 weeks prior to entering the trial (Day 1), without changes to medication or dose adjustments, and agreed to continue ART throughout the trial.
23. History of vaccination with an active attenuated vaccine (messenger RNA [mRNA] and replication-defective adenovirus vaccines are not considered live attenuated virus vaccines) within 30 days prior to the first dose of the trial.
24. Unresolved toxicities from previous anticancer therapy, defined as toxicities that have not been resolved to ≤ Grade 1 or baseline (excluding hair loss).
Note: Participants with chronic, stable Grade 2 toxicities (defined as those that have not worsened to > Grade 2 in at least 3 months prior to randomization and are controlled with standard care) and identified by the trial administrator as related to previous anticancer therapy may be included, including the following:
• Chemotherapy-induced neuropathy
• Fatigue
• Residual toxicities from previous immuno-oncology (IO) therapy: Grade 1 or 2 endocrine disorders, which may include:
a) Hypothyroidism/Hyperthyroidism
b) Type 1 diabetes
c) Hyperglycemia
d) Adrenal insufficiency
e) Adrenitis
f) Hypopigmentation (leukoplakia)
25. Pregnancy, breastfeeding, or planning to become pregnant.
The Estimated Number of Participants
-
Taiwan
34 participants
-
Global
582 participants
