Clinical Trials List
2025-02-01 - 2033-12-31
Phase III
Recruiting5
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, Randomized, Open-label, Multicenter Study to Evaluate the Efficacy and Safety of Sacituzumab Tirumotecan Maintenance Treatment With or Without Bevacizumab Versus Standard of Care After Second-line Platinum-based Doublet Chemotherapy in Participants With Platinum-sensitive Recurrent Ovarian Cancer (TroFuse-022/ENGOT-ov84/GOG-3103)
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Trial Applicant
Merck Sharp & Dohme (I.A.) LLC
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Sponsor
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Trial scale
Multi-Regional Multi-Center
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Update
2026/02/01
Investigators and Locations
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- YING-CHENG CHIANG 無
- BOR-CHING SHEU 無
- 戴依柔 無
- 張文君 無
- 施怡倫 無
- 陳宇立 無
- 吳佳穎 無
- 郭千慈 Division of Others
- - - 無
The Actual Total Number of Participants Enrolled
0 Recruiting
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- 容世明 無
- 陳威君 無
- 黃意婷 無
- Angel Chao 無
- Cheng-Tao Lin Division of Obstetrics & Gynecology
- 張淑涵 無
- 黃彥綾 無
- Gigin Lin Division of Radiology
- 張宸邠 無
- Yun-Hsin Tang 無
- Huei-Jean Huang 無
- 周宏學 無
- Ting-Chang Chang 無
- Min-Yu Chen 無
- 黃寬仁 無
- Chyong-Huey Lai 無
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
The Actual Total Number of Participants Enrolled
0 Recruiting
Condition/Disease
Objectives
Test Drug
Active Ingredient
Dosage Form
Dosage
Endpoints
(1) Adverse events (AEs)
(2) Discontinuation of trial treatment due to AEs
Part 2:
(1) PFS: Time from randomization to the first recorded disease progression or death from any cause, whichever occurs first.
Inclution Criteria
Has histologically confirmed epithelial ovarian, fallopian tube, or primary peritoneal carcinoma.
Has received 4 or more cycles of platinum-based doublet chemotherapy in first-line and a total of 6 cycles of carboplatin-based doublet chemotherapy in second-line setting for ovarian cancer (OC).
Has platinum-sensitive epithelial OC,
Has provided tissue of a tumor lesion that was not previously irradiated
Human immunodeficiency virus (HIV)-infected participants must have well controlled HIV on antiretroviral therapy
Participants who are hepatitis B surface antigen positive are eligible if they have received hepatitis B virus (HBV) antiviral therapy for at least 4 weeks, and have undetectable HBV viral load prior to allocation (Part 1) or randomization (Part 2)
Participants with a history of hepatitis C virus (HCV) infection are eligible if HCV viral load is undetectable at screening
Has an ECOG performance status of 0 to 1 assessed within 7 days before allocation (Part 1) or randomization (Part 2)
Exclusion Criteria
Has nonepithelial cancers (germ cell tumors and sex cord-stromal tumors), borderline tumors (low malignant potential), mucinous, seromucinous that is predominantly mucinous, malignant Brenner's tumor and undifferentiated carcinoma
Has platinum-resistant OC or platinum-refractory OC
Has history of documented severe dry eye syndrome, severe Meibomian gland disease and/or blepharitis, or severe corneal disease that prevents/delays corneal healing.
Has active inflammatory bowel disease requiring immunosuppressive medication or previous history of inflammatory bowel disease (e.g. Crohn's disease, ulcerative colitis, or chronic diarrhea)
Has uncontrolled, significant cardiovascular disease or cerebrovascular disease.
Has a history of (noninfectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease.
HIV-infected participants with a history of Kaposi's sarcoma and/or Multicentric Castleman's Disease
Has received more than 2 prior lines of systemic therapy for OC.
Has received prior systemic anticancer therapy within 3 weeks or 5 half-lives (whichever is shorter) before allocation (Part 1) or randomization (Part 2)
Has received prior radiotherapy within 2 weeks of allocation (Part 1) or randomization (Part 2), or has radiation related toxicities, requiring corticosteroids
Has an additional malignancy that is progressing or has required active treatment within the past 3 years
Has active central nervous system (CNS) metastases and/or carcinomatous meningitis
Has an active infection requiring systemic therapy
The Estimated Number of Participants
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Taiwan
23 participants
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Global
770 participants
