Clinical Trials List
Protocol NumberMK-2870-022
NCT Number(ClinicalTrials.gov Identfier)NCT06824467
Active
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
美商默沙東藥廠股份有限公司台灣分公司
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Trial scale
Multi-Regional Multi-Center
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Update
2026/04/10
Investigators and Locations
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- 施怡倫 無
- 陳宇立 無
- YING-CHENG CHIANG 無
- BOR-CHING SHEU 無
- 戴依柔 無
- 張文君 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
- Gigin Lin Division of Radiology
- 張宸邠 無
- Yun-Hsin Tang 無
- Huei-Jean Huang 無
- 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
- 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
Principal Investigator
Yu-Fang Huang
Co-Principal Investigator
- 林語涵 Division of Obstetrics & Gynecology
- 鄭雅敏 Division of Obstetrics & Gynecology
- Meng-Ru Shen Division of Obstetrics & Gynecology
- Keng-Fu Hsu Division of Obstetrics & Gynecology
- 吳珮瑩 Division of Obstetrics & Gynecology
- 梁玉玲 Division of Obstetrics & Gynecology
- Cheng-Yang Chou Division of Obstetrics & Gynecology
- 黃蘭茵 Division of Obstetrics & Gynecology
The Actual Total Number of Participants Enrolled
0 Recruiting
Condition/Disease
Ovarian Cancer、Fallopian Tube Cancer、Primary Peritoneal Cancer
Objectives
Primary Objectives
Part 1: To evaluate the safety and tolerability of sacituzumab tirumotecan maintenance therapy combined with bevacizumab
Part 2: To compare the progression-free survival (PFS) of sacituzumab tirumotecan maintenance therapy with or without bevacizumab versus SoC (with or without bevacizumab) as assessed by a blinded independent central review (BICR) according to the Responsive Criteria for Solid Tumor Response (RECIST) 1.1.
Secondary Objectives
Part 2: To compare the overall survival (OS) of sacituzumab tirumotecan maintenance therapy with or without bevacizumab versus SoC
Part 2: To evaluate the safety and tolerability of sacituzumab tirumotecan maintenance therapy with or without bevacizumab
Part 2: To evaluate sacituzumab Tirumotecan maintenance therapy with or without bevacizumab compared to SoC, using the mean change since baseline in the overall health status/quality of life (QoL) score of the European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Core 30 (QLQ-C30), and abdominal/GI symptoms using the EORTC Quality of Life Questionnaire Ovarian Cancer Module 28 (QLQ-OV28) Abdominal/Gastrointestinal (GI) Symptom Scale.
Test Drug
Injectables
Active Ingredient
MK-2870
BEVACIZUMAB
BEVACIZUMAB
Dosage Form
270
270
270
Dosage
200mg
100 mg, 400 mg
100 mg, 400 mg
Endpoints
Part 1:
(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.
(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
Inclusion Criteria:
Has histologically confirmed Federation of Gynecology and Obstetrics (FIGO) Stage III or IV epithelial ovarian, primary peritoneal, or fallopian tube carcinoma of certain histologies
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 or 1 assessed within 7 days before allocation (Part 1) or randomization (Part 2)
Has histologically confirmed Federation of Gynecology and Obstetrics (FIGO) Stage III or IV epithelial ovarian, primary peritoneal, or fallopian tube carcinoma of certain histologies
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 or 1 assessed within 7 days before allocation (Part 1) or randomization (Part 2)
Exclusion Criteria
Exclusion Criteria:
Has nonepithelial cancers (germ cell tumors and sex cord-stromal tumors), low-grade serous tumors, low-grade endometrioid 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 (ILD) that required steroids or has current pneumonitis/ILD
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
Has active or ongoing stomatitis
Has nonepithelial cancers (germ cell tumors and sex cord-stromal tumors), low-grade serous tumors, low-grade endometrioid 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 (ILD) that required steroids or has current pneumonitis/ILD
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
Has active or ongoing stomatitis
The Estimated Number of Participants
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Taiwan
23 participants
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Global
770 participants
