A Study to Evaluate the Efficacy and Safety of Sacituzuma... | NCT06824467

NCT06824467

ID	Type	Description
MK-2870-022	Other Identifier	MSD
TroFuse-022	Other Identifier	MSD
2023-508015-23-00	Registry Identifier	EU CT
U1111-1297-4489	Registry Identifier	UTN
GOG-3103	Other Identifier	Gynecologic Oncology Group
ENGOT-ov84	Other Identifier	European Network of Gynaecological Oncological Trial Groups (ENGOT)
jRCT2031240722	Registry Identifier	Japan Registry of Clinical Trials (jRCT)

Status Module

Name	Class
European Network of Gynaecological Oncological Trial Groups (ENGOT)	OTHER
GOG Foundation	NETWORK

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Part 1: Sacituzumab tirumotecan + Bevacizumab	Experimental	Participants receive 4 mg/kg of sacituzumab tirumotecan once every 2 weeks (Q2W) plus 15 mg/kg of bevacizumab once every 3 weeks (Q3W) via intravenous (IV) infusion over 6 weeks	Biological: Sacituzumab tirumotecan Biological: Bevacizumab Drug: H1 receptor antagonist Drug: H2 receptor antagonist Drug: Acetaminophen (or equivalent) Drug: Dexamethasone (or equivalent) Drug: Steroid mouthwash (dexamethasone or equivalent)
Part 2: Sacituzumab tirumotecan	Experimental	Participants receive 4 mg/kg of sacituzumab tirumotecan Q2W via IV infusion until progressive disease or discontinuation. At the physician's discretion, participants receive 15 mg/kg of bevacizumab Q3W via IV infusion until progressive disease or discontinuation.	Biological: Sacituzumab tirumotecan Biological: Bevacizumab Drug: H1 receptor antagonist Drug: H2 receptor antagonist Drug: Acetaminophen (or equivalent) Drug: Dexamethasone (or equivalent) Drug: Steroid mouthwash (dexamethasone or equivalent)
Part 2: Standard of care (SOC)	Active Comparator	Participants receive local standard of care until progressive disease or discontinuation. At the physician's discretion, participants receive 15 mg/kg of bevacizumab Q3W via IV infusion until progressive disease or discontinuation.	Biological: Bevacizumab

Name	Type	Description	Arm Group Labels	Other Names
Sacituzumab tirumotecan	Biological	IV Infusion	Part 1: Sacituzumab tirumotecan + Bevacizumab Part 2: Sacituzumab tirumotecan

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Part 1: Number of participants with one or more adverse events (AEs)	An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention.	Up to 6 weeks
Part 1: Number of participants who discontinue study intervention due to an AE	An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention.	Up to 6 weeks
Part 2: Progression-free Survival (PFS)	PFS is defined as the time from randomization to the first documented progressive disease (PD) or death from any cause, whichever occurs first. Per RECIST 1.1, PD is defined as at least a 20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions is also considered PD. PFS as assessed by blinded independent central review (BICR) will be presented.	Up to approximately 4 years

Secondary Outcomes

Measure	Description	Time Frame
Part 2: Overall Survival (OS)	OS is defined as the time from randomization to death due to any cause	Up to approximately 4 years
Part 2: Number of participants with one or more AEs	An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention.

Eligibility Module

Eligibility 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)

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

Name	Role	Phone	Extension	Email
Toll Free Number	Contact	1-888-577-8839		Trialsites@msd.com

Name	Affiliation	Role
Medical Director	Merck Sharp & Dohme LLC	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
University of Alabama at Birmingham ( Site 0006)	Recruiting	Birmingham	Alabama	35249	United States

Label	URL
Merck Clinical Trials Information	View source
Plain Language Summary	View source

Ancestor Terms

ID	Term
D061067	Antibodies, Monoclonal, Humanized
D000911	Antibodies, Monoclonal
D000906	Antibodies
D007136	Immunoglobulins
D007162	Immunoproteins
D001798	Blood Proteins
D011506	Proteins
D000602	Amino Acids, Peptides, and Proteins
D012712	Serum Globulins
D005916	Globulins
D018494	Histamine Agents
D018377	Neurotransmitter Agents
D045504	Molecular Mechanisms of Pharmacological Action
D020228	Pharmacologic Actions
D020164	Chemical Actions and Uses
D045505	Physiological Effects of Drugs
D000083	Acetanilides
D000813	Anilides
D000577	Amides
D009930	Organic Chemicals
D000814	Aniline Compounds
D000588	Amines
D011246	Pregnadienetriols
D011245	Pregnadienes
D011278	Pregnanes
D013256	Steroids
D000072473	Fused-Ring Compounds
D011083	Polycyclic Compounds
D013259	Steroids, Fluorinated

ID	Term
D010051	Ovarian Neoplasms
D005185	Fallopian Tube Neoplasms

ID	Term
D004701	Endocrine Gland Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms
D010049	Ovarian Diseases
D000291	Adnexal Diseases
D005831	Genital Diseases, Female
D052776	Female Urogenital Diseases
D005261	Female Urogenital Diseases and Pregnancy Complications
D000091642	Urogenital Diseases
D005833	Genital Neoplasms, Female
D014565	Urogenital Neoplasms
D000091662	Genital Diseases
D004700	Endocrine System Diseases
D006058	Gonadal Disorders
D005184	Fallopian Tube Diseases

ID	Term
D000068258	Bevacizumab
D006633	Histamine Antagonists
D006635	Histamine H2 Antagonists
D000082	Acetaminophen
D003907	Dexamethasone