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A Study to Evaluate the Efficacy and Safety of Sacituzumab Tirumotecan (MK-2870) Treatment Versus Standard of Care in Participants With Platinum-sensitive Recurrent Ovarian Cancer (MK-2870-022/TroFuse-022/ENGOT-ov84/GOG-3103)

NCT ID: NCT06824467

Last Updated: 2026-01-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE3

Total Enrollment

770 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-04-09

Study Completion Date

2032-10-15

Brief Summary

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The main goals of this study are to learn about the safety of sacituzumab tirumotecan with bevacizumab and if people tolerate it; and If people who take sacituzumab tirumotecan with or without bevacizumab live longer without the cancer getting worse than those who receive standard of care treatment.

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Detailed Description

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Conditions

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Ovarian Cancer Fallopian Tube Cancer Primary Peritoneal Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Part 1: Sacituzumab tirumotecan + Bevacizumab

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

Group Type EXPERIMENTAL

Sacituzumab tirumotecan

Intervention Type BIOLOGICAL

IV Infusion

Bevacizumab

Intervention Type BIOLOGICAL

IV Infusion

H1 receptor antagonist

Intervention Type DRUG

Rescue medication taken per approved product label before sacituzumab tirumotecan

H2 receptor antagonist

Intervention Type DRUG

Rescue medication taken per approved product label before sacituzumab tirumotecan

Acetaminophen (or equivalent)

Intervention Type DRUG

Rescue medication taken per approved product label before sacituzumab tirumotecan

Dexamethasone (or equivalent)

Intervention Type DRUG

Rescue medication taken per approved product label before sacituzumab tirumotecan

Steroid mouthwash (dexamethasone or equivalent)

Intervention Type DRUG

Rescue medication taken orally 4 times daily

Part 2: Sacituzumab tirumotecan

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.

Group Type EXPERIMENTAL

Sacituzumab tirumotecan

Intervention Type BIOLOGICAL

IV Infusion

Bevacizumab

Intervention Type BIOLOGICAL

IV Infusion

H1 receptor antagonist

Intervention Type DRUG

Rescue medication taken per approved product label before sacituzumab tirumotecan

H2 receptor antagonist

Intervention Type DRUG

Rescue medication taken per approved product label before sacituzumab tirumotecan

Acetaminophen (or equivalent)

Intervention Type DRUG

Rescue medication taken per approved product label before sacituzumab tirumotecan

Dexamethasone (or equivalent)

Intervention Type DRUG

Rescue medication taken per approved product label before sacituzumab tirumotecan

Steroid mouthwash (dexamethasone or equivalent)

Intervention Type DRUG

Rescue medication taken orally 4 times daily

Part 2: Standard of care (SOC)

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.

Group Type ACTIVE_COMPARATOR

Bevacizumab

Intervention Type BIOLOGICAL

IV Infusion

Interventions

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Sacituzumab tirumotecan

IV Infusion

Intervention Type BIOLOGICAL

Bevacizumab

IV Infusion

Intervention Type BIOLOGICAL

H1 receptor antagonist

Rescue medication taken per approved product label before sacituzumab tirumotecan

Intervention Type DRUG

H2 receptor antagonist

Rescue medication taken per approved product label before sacituzumab tirumotecan

Intervention Type DRUG

Acetaminophen (or equivalent)

Rescue medication taken per approved product label before sacituzumab tirumotecan

Intervention Type DRUG

Dexamethasone (or equivalent)

Rescue medication taken per approved product label before sacituzumab tirumotecan

Intervention Type DRUG

Steroid mouthwash (dexamethasone or equivalent)

Rescue medication taken orally 4 times daily

Intervention Type DRUG

Other Intervention Names

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MK-2870 sac-TMT SKB264 Avastin Altusan MVASI

Eligibility Criteria

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Inclusion 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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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European Network of Gynaecological Oncological Trial Groups (ENGOT)

OTHER

Sponsor Role collaborator

GOG Foundation

NETWORK

Sponsor Role collaborator

Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Medical Director

Role: STUDY_DIRECTOR

Merck Sharp & Dohme LLC

Locations

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Sarasota Memorial Hospital ( Site 0075)

Sarasota, Florida, United States

Site Status RECRUITING

Florida Cancer Specialists East ( Site 7000)

West Palm Beach, Florida, United States

Site Status RECRUITING

St. Dominic's Hospital ( Site 0064)

Jackson, Mississippi, United States

Site Status ACTIVE_NOT_RECRUITING

Nebraska Methodist Hospital ( Site 0053)

Omaha, Nebraska, United States

Site Status RECRUITING

Rutgers Cancer Institute of New Jersey ( Site 0071)

New Brunswick, New Jersey, United States

Site Status RECRUITING

FirstHealth Cancer Center ( Site 0079)

Pinehurst, North Carolina, United States

Site Status RECRUITING

University of Cincinnati Medical Center ( Site 0090)

Cincinnati, Ohio, United States

Site Status RECRUITING

Oklahoma Cancer Specialists and Research Institute, LLC ( Site 0056)

Tulsa, Oklahoma, United States

Site Status RECRUITING

Oncology Associates of Oregon, P.C.(Willamette Valley Cancer Institute) (WVCI) ( Site 8010)

Eugene, Oregon, United States

Site Status RECRUITING

Women & Infants Hospital ( Site 0050)

Providence, Rhode Island, United States

Site Status RECRUITING

Texas Oncology - Central/South Texas ( Site 8009)

Austin, Texas, United States

Site Status RECRUITING

Texas Oncology - DFW ( Site 8001)

Fort Worth, Texas, United States

Site Status RECRUITING

Texas Oncology - San Antonio ( Site 8005)

San Antonio, Texas, United States

Site Status RECRUITING

Texas Oncology - Gulf Coast ( Site 8003)

Webster, Texas, United States

Site Status RECRUITING

Blacktown Hospital ( Site 0211)

Sydney, New South Wales, Australia

Site Status RECRUITING

Gallipoli Medical Research Ltd ( Site 0214)

Brisbane, Queensland, Australia

Site Status RECRUITING

Epworth Freemasons ( Site 0217)

East Melbourne, Victoria, Australia

Site Status RECRUITING

Frankston Hospital ( Site 0216)

Frankston, Victoria, Australia

Site Status RECRUITING

IBCC - Núcleo de Pesquisa e Ensino ( Site 0424)

São Paulo, , Brazil

Site Status RECRUITING

FUNDACION CTIC CENTRO DE TRATAMIENTO E INVESTIGACION SOBRE CANCER LUIS CARLOS SARMIENTO ANGULO ( Site 0806)

Bogotá, Bogota D.C., Colombia

Site Status RECRUITING

Instituto Nacional De Cancerologia ( Site 0807)

Bogotá, Bogota D.C., Colombia

Site Status RECRUITING

Oncologos Del Occidente ( Site 0805)

Pereira, Risaralda Department, Colombia

Site Status RECRUITING

Aalborg Universitetshospital ( Site 0901)

Aalborg, North Denmark, Denmark

Site Status RECRUITING

Kuopion Yliopistollinen Sairaala ( Site 1004)

Kuopio, Northern Savonia, Finland

Site Status RECRUITING

Tampereen yliopistollinen sairaala ( Site 1002)

Tampere, Pirkanmaa, Finland

Site Status RECRUITING

Institut Bergonié - Centre Régional de Lutte Contre Le Cancer de Bordeaux et Sud Ouest ( Site 1101)

Bordeaux, Aquitaine, France

Site Status RECRUITING

Pôle Santé Léonard de Vinci ( Site 1112)

Chambray-lès-Tours, Indre-et-Loire, France

Site Status RECRUITING

Rambam Health Care Campus ( Site 1402)

Haifa, , Israel

Site Status RECRUITING

Instituto Tumori Giovanni Paolo II ( Site 1505)

Bari, , Italy

Site Status RECRUITING

Ospedale Mauriziano ( Site 1509)

Torino, , Italy

Site Status RECRUITING

National Hospital Organization Shikoku Cancer Center ( Site 1631)

Matsuyama, Ehime, Japan

Site Status RECRUITING

Kurume University Hospital ( Site 1640)

Kurume, Fukuoka, Japan

Site Status RECRUITING

Gunma Prefectural Cancer Center ( Site 1630)

Ōta, Gunma, Japan

Site Status RECRUITING

Saitama Medical University International Medical Center ( Site 1632)

Hidaka, Saitama, Japan

Site Status RECRUITING

Cancer Institute Hospital of JFCR ( Site 1639)

Koto, Tokyo, Japan

Site Status RECRUITING

Keio University Hospital ( Site 1636)

Shinjyuku, Tokyo, Japan

Site Status RECRUITING

Niigata Cancer Center Hospital ( Site 1633)

Niigata, , Japan

Site Status RECRUITING

IPOR Instituto Peruano de Oncología & Radioterapia ( Site 3604)

Lima, , Peru

Site Status RECRUITING

Cabinet Medical Oncomed ( Site 2217)

Timișoara, Timiș County, Romania

Site Status RECRUITING

National Cancer Center ( Site 2305)

Goyang-si, Kyonggi-do, South Korea

Site Status RECRUITING

Severance Hospital ( Site 2302)

Seodaemun-Gu, Seoul, South Korea

Site Status RECRUITING

Asan Medical Center ( Site 2304)

Songpa-gu, Seoul, South Korea

Site Status RECRUITING

Seoul National University Hospital ( Site 2301)

Seoul, , South Korea

Site Status RECRUITING

Samsung Medical Center ( Site 2303)

Seoul, , South Korea

Site Status RECRUITING

Institut Català d'Oncologia (ICO) - Girona ( Site 2402)

Girona, Gerona, Spain

Site Status RECRUITING

Hospital General Gregorio Maranon de Madrid ( Site 2412)

Madrid, Madrid, Comunidad de, Spain

Site Status RECRUITING

Clinica Universidad de Navarra ( Site 2407)

Madrid, Madrid, Comunidad de, Spain

Site Status RECRUITING

Hosp Clinico Universitario de Valencia ( Site 2401)

Valencia, Valenciana, Comunitat, Spain

Site Status RECRUITING

Hospital Vall D Hebron ( Site 2403)

Barcelona, , Spain

Site Status RECRUITING

ICO L Hospitalet ( Site 2408)

Barcelona, , Spain

Site Status RECRUITING

Hospital Universitario Reina Sofia ( Site 2406)

Córdoba, , Spain

Site Status RECRUITING

Hospital Ramon y Cajal ( Site 2405)

Madrid, , Spain

Site Status RECRUITING

Hospital Clinico San Carlos... ( Site 2410)

Madrid, , Spain

Site Status RECRUITING

Hospital Universitario 12 de Octubre ( Site 2411)

Madrid, , Spain

Site Status RECRUITING

Taichung Veterans General Hospital ( Site 2603)

Taichung, , Taiwan

Site Status RECRUITING

National Cheng Kung University Hospital ( Site 2602)

Tainan, , Taiwan

Site Status RECRUITING

National Taiwan University Hospital ( Site 2601)

Taipei, , Taiwan

Site Status RECRUITING

Mackay Memorial Hospital ( Site 2604)

Taipei, , Taiwan

Site Status RECRUITING

Chang Gung Memorial Hospital - Linkou Branch ( Site 2605)

Taoyuan District, , Taiwan

Site Status RECRUITING

Countries

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United States Australia Brazil Colombia Denmark Finland France Israel Italy Japan Peru Romania South Korea Spain Taiwan

Central Contacts

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Toll Free Number

Role: CONTACT

[email protected]
1-888-577-8839

Facility Contacts

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Study Coordinator

Role: primary

941-917-2225

Study Coordinator

Role: primary

561-366-4100

Study Coordinator

Role: primary

402-354-8534

Study Coordinator

Role: primary

732-235-7258

Study Coordinator

Role: primary

910-715-8684

Study Coordinator

Role: primary

513-584-1958

Study Coordinator

Role: primary

918-505-3200

Study Coordinator

Role: primary

541-683-5001

Study Coordinator

Role: primary

401-274-1100

Study Coordinator

Role: primary

512-873-8900

Study Coordinator

Role: primary

817-413-1500

Study Coordinator

Role: primary

210-595-5300

Study Coordinator

Role: primary

281-332-7505

Study Coordinator

Role: primary

+61286705071

Study Coordinator

Role: primary

+61733947284

Study Coordinator

Role: primary

+61385595000

Study Coordinator

Role: primary

+61409848084

Study Coordinator

Role: primary

+551134744264

Study Coordinator

Role: primary

+576015948650

Study Coordinator

Role: primary

+573154208007

Study Coordinator

Role: primary

+57 3187715522

Study Coordinator

Role: primary

97661400

Study Coordinator

Role: primary

+358447174617

Study Coordinator

Role: primary

+358407274241

Study Coordinator

Role: primary

+33556333333

Study Coordinator

Role: primary

+33247602060

Study Coordinator

Role: primary

+97247772688

Study Coordinator

Role: primary

+390805555355

Study Coordinator

Role: primary

+39 0115082277

Study Coordinator

Role: primary

+81-89-999-1111

Study Coordinator

Role: primary

+81-942-35-3311

Study Coordinator

Role: primary

+81-276-38-0771

Study Coordinator

Role: primary

+81-42-984-4111

Study Coordinator

Role: primary

+81-3-3520-0111

Study Coordinator

Role: primary

+81-3-3353-1211

Study Coordinator

Role: primary

+81-25-266-5111

Study Coordinator

Role: primary

+51 951 881 870

Study Coordinator

Role: primary

+40256495403

Study Coordinator

Role: primary

82-31-920-1760

Study Coordinator

Role: primary

82-2-2227-7969

Study Coordinator

Role: primary

+82-2-3010-3640

Study Coordinator

Role: primary

82-2-2072-3511

Study Coordinator

Role: primary

82-2-3410-0866

Study Coordinator

Role: primary

+34972225828

Study Coordinator

Role: primary

+34915860860

Study Coordinator

Role: primary

+34913531920

Study Coordinator

Role: primary

34 961973500

Study Coordinator

Role: primary

+34932746085

Study Coordinator

Role: primary

+34932607744

Study Coordinator

Role: primary

+34957011464

Study Coordinator

Role: primary

+3491336 82 63

Study Coordinator

Role: primary

34 913303000 x484811

Study Coordinator

Role: primary

+34913908626

Study Coordinator

Role: primary

886423592525x5822

Study Coordinator

Role: primary

+88662353535x5222

Study Coordinator

Role: primary

886-223123456x271563

Study Coordinator

Role: primary

+886225433535x3941

Study Coordinator

Role: primary

+886-33281200x8258

Related Links

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https://www.merckclinicaltrials.com/

Merck Clinical Trials Information

Other Identifiers

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MK-2870-022

Identifier Type: OTHER

Identifier Source: secondary_id

TroFuse-022

Identifier Type: OTHER

Identifier Source: secondary_id

2023-508015-23-00

Identifier Type: REGISTRY

Identifier Source: secondary_id

U1111-1297-4489

Identifier Type: REGISTRY

Identifier Source: secondary_id

GOG-3103

Identifier Type: OTHER

Identifier Source: secondary_id

ENGOT-ov84

Identifier Type: OTHER

Identifier Source: secondary_id

jRCT2031240722

Identifier Type: REGISTRY

Identifier Source: secondary_id

2870-022

Identifier Type: -

Identifier Source: org_study_id

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