A Study to Compare Sacituzumab Tirumotecan (MK-2870) Mono... | NCT06459180

NCT06459180

Secondary IDs

ID	Type	Description
MK-2870-020	Other Identifier	MSD
TroFuse-020	Other Identifier	MSD
2023-508323-12-00	Registry Identifier	EU CT
U1111-1298-0563	Registry Identifier	UTN
GOG-3101	Other Identifier	Gynecologic Oncology Group
ENGOT-cx20	Other Identifier	European Network of Gynaecological Oncological Trial Groups (ENGOT)
jRCT2031240201	Registry Identifier	Japan Registry of Clinical Trials (jRCT)

Status Module

Sponsor/Collaborators Module

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

Oversight Module

Description Module

Conditions Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Sacituzumab Tirumotecan	Experimental	Participants will receive 4 mg/kg of sacituzumab tirumotecan once every 2 weeks (Q2W) via intravenous (IV) infusion until progressive disease or discontinuation.	Biological: Sacituzumab Tirumotecan
Treatment of Physician's Choice (TPC)	Active Comparator	At the physician's discretion, participants will receive 500 mg/m^2 of pemetrexed on day 1 of every 3-week cycle via IV infusion OR 2 mg/kg of tisotumab vedotin on day 1 of every 3-week cycle via IV infusion OR 1 mg/m^2 (or 1.25 mg/m^2 if tolerating well) topotecan on days 1, 2, 3, 4, and 5 of every 3-week cycle via IV infusion OR 30 mg/m^2 of vinorelbine on days 1 and 8 of every 3-week cycle via IV infusion OR 1000 mg/m^2 of gemcitabine on day 1 and 8 of every 3-week cycle via IV infusion OR 100 mg/m^2 (or 125 mg/m^2 if tolerating well) of irinotecan on days 1, 8, 15, and 22 of every 6 week cycle via IV infusion, until progressive disease or discontinuation.	Drug: Pemetrexed Biological: Tisotumab Vedotin Drug: Topotecan Drug: Vinorelbine Drug: Gemcitabine Drug: Irinotecan

Name	Type	Description	Arm Group Labels	Other Names
Sacituzumab Tirumotecan	Biological	IV infusion	Sacituzumab Tirumotecan

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Objective Response Rate (ORR) in Sacituzumab Tirumotecan Run-in	ORR is defined as the percentage of participants with Complete Response (CR: disappearance of all target lesions) or Partial Response (PR: at least a 30% decrease in the sum of diameters of target lesions) per Response Evaluation Criteria In Solid Tumors Version 1.1 (RECIST 1.1). The percentage of participants who experience CR or PR as assessed by Blinded Independent Central Review (BICR) will be presented.	Up to approximately 46 months
Number of Participants Experiencing One or More Adverse Events (AEs) in Sacituzumab Tirumotecan Run-in	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 approximately 46 months
Number of Participants Discontinuing Study Treatment Due to an AE in Sacituzumab Tirumotecan Run-in	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 approximately 46 months
Overall Survival (OS) in Phase 3 Portion	OS is defined as the time from randomization to death due to any cause.	Up to approximately 35 months

Secondary Outcomes

Measure	Description	Time Frame
Progression-free Survival (PFS) in Phase 3 Portion	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 BICR will be presented.

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Has histologically-confirmed diagnosis of squamous cell carcinoma, adenosquamous carcinoma, or adenocarcinoma of the cervix
Must have recurrent or metastatic cervical cancer that has progressed on or after treatment with 1 prior line of systemic platinum doublet chemotherapy (with or without bevacizumab) AND must have received anti-PD-1/anti-PD-L1 therapy as part of prior cervical cancer regimens
Has measurable disease per Response Evaluation Criteria In Solid Tumors (RECIST) 1.1, as assessed by the investigator. Lesions situated in a previously irradiated area are considered measurable if progression has been shown in such lesions
Is assigned female sex at birth, at least 18 years of age at the time of providing the informed consent
Has ECOG performance status of 0 or 1 within 7 days before allocation for the Sacituzumab Tirumotecan Run-in or within 7 days before randomization for the Phase 3 portion
Has provided tumor tissue (most recent sample is preferred) from a core or excisional biopsy of a tumor lesion not previously irradiated
HIV-infected participants must have well controlled human immunodeficiency virus (HIV) on antiretroviral therapy (ART)
Participants who are hepatitis B surface antigen (HBsAg) 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 (Sacituzumab Tirumotecan Run-in) or randomization (Phase 3 portion)
Participants with history of hepatitis C virus (HCV) infection are eligible if HCV viral load is undetectable at screening
Has adequate organ function

Exclusion Criteria:

Has Grade ≥2 peripheral neuropathy
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 (eg, Crohn's disease, ulcerative colitis, or chronic diarrhea)
Has uncontrolled, significant cardiovascular disease or cerebrovascular disease.
Received prior systemic anticancer therapy
Received prior radiotherapy within 2 weeks of start of study intervention, or has radiation-related toxicities, requiring corticosteroids
Received a live or live-attenuated vaccine within 30 days before the first dose of study intervention. Administration of killed vaccines is allowed
Has other histological subtypes of cervical cancer apart from squamous cell carcinoma, adenocarcinoma, or adenosquamous carcinoma (eg, carcinosarcoma), or has a diagnosis of nonepithelial cancer (eg, sarcoma, neuroendocrine tumors) of the cervix.
Known additional malignancy that is progressing or has required active treatment within the past 3 years
Known active central nervous system (CNS) metastases and/or carcinomatous meningitis
Active infection requiring systemic therapy
HIV-infected participants with a history of Kaposi's sarcoma and/or Multicentric Castleman's Disease
Concurrent active Hepatitis B and active Hepatitis C virus infection
Severe hypersensitivity (≥Grade 3) to sacituzumab tirumotecan or treatment of physician's choice (TPC) and/or any of their excipients, or other biologic therapy
Participants who have not adequately recovered from major surgery or have ongoing surgical complications
Has a history of (noninfectious) pneumonitis/ILD that required steroids or has current pneumonitis/ILD

Contacts/Locations Module

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

Facility	Status	City	State	ZIP	Country	Contacts
USA Mitchell Cancer Institute-Clinical Trials ( Site 4126)		Mobile	Alabama	36604	United States
Providence Alaska Medical Center ( Site 4137)

References Module

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

IPD Sharing Statement Module

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

Intervention Browse Module

Masking Info

ID	Term
D002583	Uterine Cervical Neoplasms

Ancestor Terms

ID	Term
D014594	Uterine Neoplasms
D005833	Genital Neoplasms, Female
D014565	Urogenital Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms
D002577	Uterine Cervical Diseases
D014591	Uterine Diseases
D005831	Genital Diseases, Female
D052776	Female Urogenital Diseases
D005261	Female Urogenital Diseases and Pregnancy Complications
D000091642	Urogenital Diseases
D000091662	Genital Diseases

ID	Term
D000068437	Pemetrexed
C000707142	tisotumab vedotin
D019772	Topotecan
D000077235	Vinorelbine
D000093542	Gemcitabine
D000077146	Irinotecan

Ancestor Terms

ID	Term
D006147	Guanine
D007042	Hypoxanthines
D011688	Purinones
D011687	Purines
D006574	Heterocyclic Compounds, 2-Ring
D000072471	Heterocyclic Compounds, Fused-Ring
D006571	Heterocyclic Compounds
D005971	Glutamates
D024342	Amino Acids, Acidic
D000596	Amino Acids
D000602	Amino Acids, Peptides, and Proteins
D000600	Amino Acids, Dicarboxylic
D002166	Camptothecin
D000470	Alkaloids
D014748	Vinca Alkaloids
D046948	Secologanin Tryptamine Alkaloids
D026121	Indole Alkaloids
D007211	Indoles
D054836	Indolizidines
D007212	Indolizines
D003841	Deoxycytidine
D003562	Cytidine
D011741	Pyrimidine Nucleosides
D011743	Pyrimidines
D006573	Heterocyclic Compounds, 1-Ring