A Clinical Trial of Sac-TMT in People With Non-HRD Positive Advanced Ovarian Cancer (MK-2870-021) (TroFuse-021)

May 27, 2026 updated by: Merck Sharp & Dohme LLC

A Phase 3, Randomized, Open-label, Multicenter Study of Sacituzumab Tirumotecan (Sac-TMT, MK-2870) Maintenance Treatment With or Without Bevacizumab Versus Standard of Care in Participants With Newly Diagnosed Advanced Non-HRD Positive Ovarian Cancer Following First-line Platinum-based Chemotherapy (TroFuse-021/ENGOTov85/GOG-3102)

Researchers are looking for new ways to treat ovarian cancer (OC). Current treatment for OC may start with surgery to remove as much of the cancer as possible. After surgery, people may receive chemotherapy. After chemotherapy, standard care options may include:

  • Maintenance treatment, which is used after another therapy to keep the cancer from growing, spreading, or coming back. Bevacizumab is a targeted therapy used as standard maintenance treatment. Targeted therapy works to control how specific types of cancer cells grow and spread.
  • Observation, which is watching to see if cancer grows or worsens

The study medicine, sacituzumab tirumotecan (also called sac-TMT), is a targeted therapy. The goal of this study is to learn if people who receive sac-TMT maintenance treatment with or without bevacizumab live longer without the cancer getting worse than people who receive standard care.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

900

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Argentina
      • CABA, Argentina, C1280AEB
        • Recruiting
        • Hospital Britanico de Buenos Aires ( Site 2905)
        • Contact:
          • Study Coordinator
          • Phone Number: +5411 4309 4469
      • La Rioja, Argentina, F5300COE
        • Recruiting
        • Fundación CORI para la Investigación y Prevención del Cáncer ( Site 2907)
        • Contact:
          • Study Coordinator
          • Phone Number: +54 380 4336443
    • Buenos Aires
      • Ciudad Autónoma de Buenos Aires, Buenos Aires, Argentina, C1426ANZ
        • Recruiting
        • Instituto Alexander Fleming ( Site 2902)
        • Contact:
          • Study Coordinator
          • Phone Number: 5411 3221 8900
      • Mar del Plata, Buenos Aires, Argentina, B7600FZO
        • Recruiting
        • Instituto de Investigaciones Clinicas Mar del Plata ( Site 2901)
        • Contact:
          • Study Coordinator
          • Phone Number: +54 223 496 3224
    • Buenos Aires F.D.
      • Buenos Aires, Buenos Aires F.D., Argentina, C1426AAL
        • Recruiting
        • Fundación Respirar ( Site 2912)
        • Contact:
          • Study Coordinator
          • Phone Number: +541147815331
    • Santa Fe Province
      • Rosario, Santa Fe Province, Argentina, S2000DVC
        • Recruiting
        • Sanatorio Parque - Oncología ( Site 2911)
        • Contact:
          • Study Coordinator
          • Phone Number: +543412987413
      • Rosario, Santa Fe Province, Argentina, S2000KZE
        • Recruiting
        • Instituto de Oncologia de Rosario ( Site 2909)
        • Contact:
          • Study Coordinator
          • Phone Number: +543414218909
  • Australia
    • Queensland
      • Brisbane, Queensland, Australia, 4120
        • Recruiting
        • Gallipoli Medical Research Ltd ( Site 0204)
        • Contact:
          • Study Coordinator
          • Phone Number: +61 73394 7296
    • Victoria
      • East Melbourne, Victoria, Australia, 3002
        • Recruiting
        • Epworth Freemasons ( Site 0207)
        • Contact:
          • Study Coordinator
          • Phone Number: +61385595000
  • Austria
    • State of Vienna
      • Vienna, State of Vienna, Austria, 1090
        • Recruiting
        • Medizinische Universitat Wien ( Site 0102)
        • Contact:
          • Study Coordinator
          • Phone Number: +43 1 4040061030
  • Belgium
    • Hainaut
      • Charleroi, Hainaut, Belgium, 6000
        • Recruiting
        • Grand Hopital de Charleroi ( Site 0303)
        • Contact:
          • Study Coordinator
          • Phone Number: +3260 11 06 04
    • Oost-Vlaanderen
      • Ghent, Oost-Vlaanderen, Belgium, 9000
        • Recruiting
        • AZ Maria Middelares ( Site 0302)
        • Contact:
          • Study Coordinator
          • Phone Number: +32 9 246 95 19
    • Vlaams-Brabant
      • Leuven, Vlaams-Brabant, Belgium, 3000
        • Recruiting
        • UZ Leuven ( Site 0301)
        • Contact:
          • Study Coordinator
          • Phone Number: +32 16 34 74 19
  • Brazil
    • São Paulo
      • São José do Rio Preto, São Paulo, Brazil, 15090-000
        • Recruiting
        • Fundação Faculdade Regional de Medicina de São José do Rio Preto ( Site 0414)
        • Contact:
          • Study Coordinator
          • Phone Number: 55 17 32015054
  • Czechia
      • Prague, Czechia, 128 08
        • Recruiting
        • Vseobecna fakultni nemocnice v Praze ( Site 3305)
        • Contact:
          • Study Coordinator
          • Phone Number: +420224967451
      • Prague, Czechia, 150 06
        • Recruiting
        • Fakultni nemocnice motol ( Site 3302)
        • Contact:
          • Study Coordinator
          • Phone Number: +420224431111
    • Ostrava Mesto
      • Ostrava-Poruba, Ostrava Mesto, Czechia, 708 52
        • Recruiting
        • Fakultni nemocnice Ostrava-Gynekologicko-porodnicka klinika ( Site 3303)
        • Contact:
          • Study Coordinator
          • Phone Number: +420597371804
  • Denmark
    • Capital Region
      • Herlev, Capital Region, Denmark, 2730
        • Recruiting
        • Herlev Hospital ( Site 0902)
        • Contact:
          • Study Coordinator
          • Phone Number: +4538689255
    • North Denmark
      • Aalborg, North Denmark, Denmark, 9000
        • Recruiting
        • Aalborg Universitetshospital ( Site 0901)
        • Contact:
          • Study Coordinator
          • Phone Number: +4597660000
      • Aarhus, North Denmark, Denmark, 8200
        • Recruiting
        • Aarhus Universitetshospital, Skejby ( Site 0903)
        • Contact:
          • Study Coordinator
          • Phone Number: +4578450000
  • Finland
    • North Ostrobothnia
      • Oulu, North Ostrobothnia, Finland, 90220
        • Recruiting
        • Oulun yliopistollinen sairaala ( Site 1003)
        • Contact:
          • Study Coordinator
          • Phone Number: +358 8 3153108
    • Northern Savonia
      • Kuopio, Northern Savonia, Finland, 70200
        • Recruiting
        • Kuopion Yliopistollinen Sairaala ( Site 1004)
        • Contact:
          • Study Coordinator
          • Phone Number: +35844 7176780
    • Pirkanmaa
      • Tampere, Pirkanmaa, Finland, 33520
        • Recruiting
        • Tampereen yliopistollinen sairaala ( Site 1002)
        • Contact:
          • Study Coordinator
          • Phone Number: +358331166203
    • Southwest Finland
      • Turku, Southwest Finland, Finland, 20520
        • Recruiting
        • Turku University Hospital-Department of Obstetrics and Gynecology ( Site 1001)
        • Contact:
          • Study Coordinator
          • Phone Number: +358 2 313 0000
  • France
    • Auvergne-Rhône-Alpes
      • Lyon, Auvergne-Rhône-Alpes, France, 69008
        • Recruiting
        • CENTRE LEON BERARD ( Site 1101)
        • Contact:
          • Study Coordinator
          • Phone Number: +33478782888
    • Cotes-d Armor
      • Plérin, Cotes-d Armor, France, 22190
        • Recruiting
        • Hôpital Privé Des Côtes d'Armor ( Site 1102)
        • Contact:
          • Study Coordinator
          • Phone Number: +33296752216
    • Puy-de-Dome
      • Clermont-Ferrand, Puy-de-Dome, France, 63003
        • Recruiting
        • Centre Jean Perrin - Centre Régional de Lutte contre le Cancer d'Auvergne ( Site 1113)
        • Contact:
          • Study Coordinator
          • Phone Number: +33473278080
  • Hungary
      • Budapest, Hungary, 1122
        • Recruiting
        • Országos Onkológiai Intézet-Ngyógyászat ( Site 3913)
        • Contact:
          • Study Coordinator
          • Phone Number: +3612248600
      • Debrecen, Hungary, 4032
        • Recruiting
        • Debreceni Egyetem Klinikai Kozpont-Szülészeti és Nőgyógyászati Klinika ( Site 3912)
        • Contact:
          • Study Coordinator
          • Phone Number: 0652255705
    • Bács-Kiskun county
      • Kecskemét, Bács-Kiskun county, Hungary, 6000
        • Recruiting
        • Bacs-Kiskun Varmegyei Oktatokorhaz-Onkoradiologiai Kozpont ( Site 3910)
        • Contact:
          • Study Coordinator
          • Phone Number: +3676516719
  • Israel
      • Haifa, Israel, 3109601
        • Recruiting
        • Rambam Health Care Campus ( Site 1422)
        • Contact:
          • Study Coordinator
          • Phone Number: +97247772688
      • Holon, Israel, 5810001
        • Recruiting
        • Edith Wolfson Medical Center ( Site 1423)
        • Contact:
          • Study Coordinator
          • Phone Number: +97235028211
  • Japan
      • Kagoshima, Japan, 890-8760
        • Recruiting
        • Kagoshima City Hospital ( Site 1613)
        • Contact:
          • Study Coordinator
          • Phone Number: +81-99-230-7000
      • Niigata, Japan, 951-8566
        • Recruiting
        • Niigata Cancer Center Hospital ( Site 1608)
        • Contact:
          • Study Coordinator
          • Phone Number: +81-25-266-5111
      • Osaka, Japan, 541-8567
        • Recruiting
        • Osaka Prefectural Hospital Organization Osaka International Cancer Institute ( Site 1604)
        • Contact:
          • Study Coordinator
          • Phone Number: +81-6-6945-1181
    • Gunma
      • Ōta, Gunma, Japan, 373-8550
        • Recruiting
        • Gunma Prefectural Cancer Center ( Site 1605)
        • Contact:
          • Study Coordinator
          • Phone Number: +81-276-38-0771
    • Hokkaido
      • Sapporo, Hokkaido, Japan, 060-8648
        • Recruiting
        • Hokkaido University Hospital ( Site 1609)
        • Contact:
          • Study Coordinator
          • Phone Number: +81-11-716-1161
    • Hyōgo
      • Akashi, Hyōgo, Japan, 673-8558
        • Recruiting
        • Hyogo Cancer Center ( Site 1620)
        • Contact:
          • Study Coordinator
          • Phone Number: +81-78-929-1151
    • Iwate
      • Shiwa-gun, Iwate, Japan, 028-3695
        • Recruiting
        • Iwate Medical University Hospital ( Site 1610)
        • Contact:
          • Study Coordinator
          • Phone Number: +81-19-613-7111
    • Saitama
      • Hidaka, Saitama, Japan, 350-1298
        • Recruiting
        • Saitama Medical University International Medical Center ( Site 1607)
        • Contact:
          • Study Coordinator
          • Phone Number: +81-42-984-4111
    • Tokyo
      • Koto, Tokyo, Japan, 135-8550
        • Recruiting
        • Cancer Institute Hospital of JFCR ( Site 1614)
        • Contact:
          • Study Coordinator
          • Phone Number: +81-3-3520-0111
  • Norway
      • Oslo, Norway, 0424
        • Recruiting
        • Oslo University Hospital ( Site 2001)
        • Contact:
          • Study Coordinator
          • Phone Number: +47-48512384
    • Rogaland
      • Stavanger, Rogaland, Norway, 4068
        • Recruiting
        • Stavanger Universitetssjukehus ( Site 2002)
        • Contact:
          • Study Coordinator
          • Phone Number: 4751518000
    • Vest-Agder
      • Kristiansand, Vest-Agder, Norway, 4615
        • Recruiting
        • Sorlandet Sykehus Kristiansand ( Site 2003)
        • Contact:
          • Study Coordinator
          • Phone Number: +4738073070
  • Poland
    • Greater Poland Voivodeship
      • Poznan, Greater Poland Voivodeship, Poland, 61-866
        • Recruiting
        • Wielkopolskie Centrum Onkologii im. Marii Skłodowskiej-Curie ( Site 2105)
        • Contact:
          • Study Coordinator
          • Phone Number: +48 61 8850 557
      • Poznan, Greater Poland Voivodeship, Poland, 60-569
        • Recruiting
        • Uniwersytecki Szpital Kliniczny w Poznaniu-Oddzial Ginekologii Onkologicznej ( Site 2106)
        • Contact:
          • Study Coordinator
          • Phone Number: +48618549014
    • Masovian Voivodeship
      • Siedlce, Masovian Voivodeship, Poland, 08-110
        • Recruiting
        • Mazowiecki Szpital Wojewódzki w Siedlcach-Siedleckie Centrum Onkologii ( Site 2102)
        • Contact:
          • Study Coordinator
          • Phone Number: +48256403485
    • Podlaskie Voivodeship
      • Bialystok, Podlaskie Voivodeship, Poland, 15-027
        • Recruiting
        • Bialostockie Centrum Onkologii ( Site 2104)
        • Contact:
          • Study Coordinator
          • Phone Number: +48856646732
  • South Korea
      • Seoul, South Korea, 03080
        • Recruiting
        • Seoul National University Hospital ( Site 2301)
        • Contact:
          • Study Coordinator
          • Phone Number: +82260724984
      • Seoul, South Korea, 06351
        • Recruiting
        • Samsung Medical Center ( Site 2303)
        • Contact:
          • Study Coordinator
          • Phone Number: +82234101382
      • Seoul, South Korea, 05505
        • Recruiting
        • Asan Medical Center ( Site 2305)
        • Contact:
          • Study Coordinator
          • Phone Number: +82230103640
    • Seoul
      • Seodaemun-Gu, Seoul, South Korea, 03722
        • Recruiting
        • Severance Hospital ( Site 2302)
        • Contact:
          • Study Coordinator
          • Phone Number: +82222277969
    • Taegu-Kwangyokshi
      • Daegu, Taegu-Kwangyokshi, South Korea, 42601
        • Recruiting
        • Keimyung University Dongsan Hospital ( Site 2304)
        • Contact:
          • Study Coordinator
          • Phone Number: +82532586671
  • Spain
      • Barcelona, Spain, 08907
        • Recruiting
        • ICO L Hospitalet ( Site 2408)
        • Contact:
          • Study Coordinator
          • Phone Number: +34932607744
      • Barcelona, Spain, 08036
        • Recruiting
        • Hospital Clinic I Provincial de Barcelona ( Site 2409)
        • Contact:
          • Study Coordinator
          • Phone Number: +34932275402
      • Madrid, Spain, 28040
        • Recruiting
        • Hospital Clinico San Carlos... ( Site 2410)
        • Contact:
          • Study Coordinator
          • Phone Number: 34913303000 x484811
    • Gerona
      • Girona, Gerona, Spain, 17007
        • Recruiting
        • Institut Català d'Oncologia (ICO) - Girona ( Site 2402)
        • Contact:
          • Study Coordinator
          • Phone Number: +34972225834
    • La Coruna
      • A Coruña, La Coruna, Spain, 15006
        • Recruiting
        • Complejo Hospitalario Universitario A Coruna ( Site 2412)
        • Contact:
          • Study Coordinator
          • Phone Number: 34981178353
    • Madrid, Comunidad de
      • Madrid, Madrid, Comunidad de, Spain, 28027
        • Recruiting
        • Clinica Universidad de Navarra ( Site 2407)
        • Contact:
          • Study Coordinator
          • Phone Number: +34913531920/ 7513
    • Valenciana, Comunitat
      • Valencia, Valenciana, Comunitat, Spain, 46009
        • Recruiting
        • Instituto Valenciano de Oncologia - IVO ( Site 2411)
        • Contact:
          • Study Coordinator
          • Phone Number: +34961114229
  • Sweden
    • Stockholm County
      • Stockholm, Stockholm County, Sweden, 171 76
        • Recruiting
        • Karolinska Universitetssjukhuset Solna ( Site 2502)
        • Contact:
          • Study Coordinator
          • Phone Number: +460812370000
  • Switzerland
      • Geneva, Switzerland, 1205
        • Recruiting
        • Hôpitaux Universitaires de Genève (HUG) ( Site 3502)
        • Contact:
          • Study Coordinator
          • Phone Number: +41795534976
    • Canton Ticino
      • Bellinzona, Canton Ticino, Switzerland, 6500
        • Recruiting
        • Ospedale Regionale Bellinzona e Valli ( Site 3501)
        • Contact:
          • Study Coordinator
          • Phone Number: 41918118194
    • Canton of Bern
      • Bern, Canton of Bern, Switzerland, 3010
        • Recruiting
        • Inselspital Bern ( Site 3504)
        • Contact:
          • Study Coordinator
          • Phone Number: 41316326416
    • Kanton Graubünden
      • Chur, Kanton Graubünden, Switzerland, 7000
        • Recruiting
        • Kantonsspital Graubünden ( Site 3503)
        • Contact:
          • Study Coordinator
          • Phone Number: +41 81 256 6646
  • Taiwan
      • Taichung, Taiwan, 40705
        • Recruiting
        • Taichung Veterans General Hospital ( Site 2603)
        • Contact:
          • Study Coordinator
          • Phone Number: 886-4-23592525x5822
      • Tainan, Taiwan, 704302
        • Recruiting
        • National Cheng Kung University Hospital ( Site 2602)
        • Contact:
          • Study Coordinator
          • Phone Number: +8862353535
      • Taipei, Taiwan, 104
        • Recruiting
        • Mackay Memorial Hospital ( Site 2604)
        • Contact:
          • Study Coordinator
          • Phone Number: +886225433535
      • Taipei, Taiwan, 10002
        • Recruiting
        • National Taiwan University Hospital ( Site 2601)
        • Contact:
          • Study Coordinator
          • Phone Number: 886-223123456x271563
      • Taoyuan, Taiwan, 333
        • Recruiting
        • Linkou Chang Gung Memorial Hospital ( Site 2605)
        • Contact:
          • Study Coordinator
          • Phone Number: 886-33281200x8258
  • Thailand
    • Changwat Khon Kaen
      • Muang, Changwat Khon Kaen, Thailand, 40002
        • Recruiting
        • Faculty of Medicine - Khon Kaen University ( Site 3403)
        • Contact:
          • Study Coordinator
          • Phone Number: +6643348382
  • United States
    • Florida
      • Miami Beach, Florida, United States, 33140
        • Recruiting
        • Mount Sinai Cancer Center ( Site 0029)
        • Contact:
          • Study Coordinator
          • Phone Number: 305-674-2625
    • Indiana
      • Fort Wayne, Indiana, United States, 46845
        • Recruiting
        • Parkview Research Center at Parkview Regional Medical Center ( Site 0055)
        • Contact:
          • Study Coordinator
          • Phone Number: 206-266-7701
    • Louisiana
      • Covington, Louisiana, United States, 70433
        • Recruiting
        • Women's Cancer Care ( Site 0018)
        • Contact:
          • Study Coordinator
          • Phone Number: 985-892-2252
    • Nebraska
      • Omaha, Nebraska, United States, 68114
        • Recruiting
        • Nebraska Methodist Hospital ( Site 0004)
        • Contact:
          • Study Coordinator
          • Phone Number: 402-354-7939
    • Oklahoma
      • Tulsa, Oklahoma, United States, 74146
        • Recruiting
        • Oklahoma Cancer Specialists and Research Institute, LLC ( Site 0007)
        • Contact:
          • Study Coordinator
          • Phone Number: 918-505-3200
    • Tennessee
      • Germantown, Tennessee, United States, 38138
        • Recruiting
        • West Cancer Center and Research Institute ( Site 0013)
        • Contact:
          • Study Coordinator
          • Phone Number: 901-683-0055

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

The main inclusion criteria include but are not limited to the following:

  • Has histologically confirmed epithelial ovarian, primary peritoneal, or fallopian tube carcinoma of certain histologies.
  • Has completed primary debulking surgery or interval debulking surgery.
  • Has completed first-line (1L) platinum-based chemotherapy, with a response of stable disease, partial response, complete response or no evidence of disease per protocol.
  • Has provided tumor tissue that is not previously irradiated.
  • If human immunodeficiency virus (HIV) infected, has well-controlled HIV on antiretroviral therapy.
  • Has undetectable hepatitis B virus (HBV) viral load and received HBV antiviral therapy if hepatitis B surface antigen (HBsAg)-positive.
  • Has undetectable hepatitis C virus (HCV) viral load if has a history of HCV infection.

The main exclusion criteria include but are not limited to the following:

  • Has nonepithelial cancers, low-grade serous tumors, low-grade endometrioid tumors, borderline tumors. mucinous, seromucinous that is predominantly mucinous, malignant Brenner's tumor, and undifferentiated carcinoma.
  • Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis.
  • Has a history of severe eye disease.
  • Has active inflammatory bowel disease requiring immunosuppressive medication or a previous history of inflammatory bowel disease.
  • Has uncontrolled, significant cardiovascular disease or cerebrovascular disease.
  • Has a history of (noninfectious) pneumonitis/interstitial lung disease (ILD), which required steroids, or has current pneumonitis/ILD.
  • Received prior systemic anticancer therapy, with the exception of the first-line platinum-based chemotherapy required by the inclusion criteria.
  • Had a live or live-attenuated vaccine within 30 days of randomization.
  • Has a known additional malignancy that is progressing or required active treatment within the past 3 years.
  • Has active infection requiring systemic therapy.
  • Has concurrent and active HBV and HCV infections.
  • Has HIV infection and a history of Kaposi's sarcoma and/or multicentric Castleman's disease.
  • Has not recovered from major surgery or has ongoing surgical complications.
  • Has a homologous recombination deficiency (HRD)-positive, unknown, or inconclusive tumor status as determined by the central laboratory.
  • Has active or ongoing stomatitis of any grade.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Sac-TMT +/- Bevacizumab
Participants will receive sac-TMT on days 1, 15, and 29 (q2W) of every 6-week cycle, until disease progression, prohibitive toxicity, or other protocol-defined reason for discontinuation. Participants receive optional bevacizumab at investigator's discretion on Days 1 and 22 (q3w) of every 6-week cycle, for up to 22 courses.
Drug: Sacituzumab tirumotecan
Administered via intravenous (IV) infusion at a dose of 4mg/kg
Other Names:
  • SKB264
  • MK-2870
  • sac-TMT
Drug: Bevacizumab
Administered via IV infusion at a dose of 15mg/kg
Other Names:
  • Avastin
  • MVASI
  • Altuzan
Drug: Rescue Medications
Participants must receive prophylactic steroid mouthwash (dexamethasone or equivalent). It is recommended that participants receive the following rescue medications prior to sac-TMT infusion, per approved product label: histamine-1 receptor antagonist, histamine-2 receptor antagonist, acetaminophen or equivalent, and dexamethasone or equivalent.
Active Comparator: Standard of Care
Participants will either receive bevacizumab q3w of every 6-week cycle for up to 22 courses until disease progression, prohibitive toxicity, or other protocol-defined reason for discontinuation of study intervention, or will be observed only and actively followed if not receiving bevacizumab.
Drug: Bevacizumab
Administered via IV infusion at a dose of 15mg/kg
Other Names:
  • Avastin
  • MVASI
  • Altuzan

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progression-Free Survival (PFS)
Time Frame: Up to approximately 49 months
PFS is defined as the time from randomization to the first documented progressive disease (PD) per Response Evaluation Criteria In Solid Tumors (RECIST) 1.1 by blinded independent central review (BICR) or death due to any cause, whichever occurs first. Per RECIST 1.1, PD is defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also have demonstrated an absolute increase of ≥5 mm. The appearance of one or more new lesions is also considered PD.
Up to approximately 49 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall Survival (OS)
Time Frame: Up to approximately 78 months
OS is defined as the time from randomization to death due to any cause.
Up to approximately 78 months
Progression-Free Survival 2 (PFS2)
Time Frame: Up to approximately 78 months
PFS2 as assessed by investigator is defined as the time from randomization to the documented subsequent objective disease progression after initiation of new anticancer therapy or death due to any cause, whichever occurs first.
Up to approximately 78 months
Number of Participants Who Experience an Adverse Event (AE)
Time Frame: Up to approximately 78 months
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 78 months
Number of Participants Who Discontinue Study Treatment Due to an AE
Time Frame: Up to approximately 78 months
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 78 months
Change From Baseline in Global Health Status/Quality of Life (GHS/QoL) Combined Score (Items 29 and 30) Using the European Organisation for Research and Treatment of Cancer QoL Questionnaire-Core 30 (EORTC QLQ-C30)
Time Frame: Baseline, and at designated time points up to approximately 78 months
EORTC QLQ-C30 is a questionnaire to assess the overall quality of life (QoL) of cancer patients. Participant responses to the questions "How would you rate your overall health during the past week?" and "How would you rate your overall quality of life during the past week?" are scored on a 7- point scale (1= Very poor to 7=Excellent). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. A higher score indicates a better overall health status. The change from baseline in EORTC QLQ-C30 Items 29 and 30 combined score will be presented.
Baseline, and at designated time points up to approximately 78 months
Change From Baseline in Physical Functioning Combined Score (Items 1 to 5) Using EORTC QLQ-C30
Time Frame: Baseline, and at designated time points up to approximately 78 months
EORTC QLQ-C30 is a questionnaire to assess the overall QoL of cancer patients. Participant responses to 5 questions about their physical functioning are scored on a 4-point scale (1 = Not at All to 4 = Very Much). The combined score is computed by averaging the raw scores of the 5 questions and then applying a linear transformation to standardize the average score, so that the combined score ranges from 0 to 100. A higher score indicates a better outcome. The change from baseline in the EORTC QLQ-C30 physical functioning combined score will be presented.
Baseline, and at designated time points up to approximately 78 months
Change From Baseline in Role Functioning Combined Score (Items 6 and 7) Using EORTC QLQ-C30
Time Frame: Baseline, and at designated time points up to approximately 78 months
EORTC QLQ-C30 is a questionnaire to assess the overall QoL of cancer patients. Participant responses to 2 questions about their role functioning are scored on a 4-point scale (1 = Not at All to 4 = Very Much). The combined score is computed by averaging the raw scores of the 2 items and then applying a linear transformation to standardize the average score, so that the combined score ranges from 0 to 100. A higher score indicates a better outcome. The change from baseline in the EORTC QLQ-C30 role functioning combined score will be presented.
Baseline, and at designated time points up to approximately 78 months
Change From Baseline in Abdominal/Gastrointestinal (GI) Symptoms Combined Score Using the EORTC QLQ-Ovarian Cancer Module 28 (OV28)
Time Frame: Baseline, and at designated time points up to approximately 78 months
EORTC QLQ-OV28 is an OC-specific module to supplement the EORTC QLQ-C30. Participant responses to the 6 abdominal/GI symptoms scale questions are scored on a 4-point scale (1=not at all, 4=very much). The combined score is computed by averaging the raw scores of the 6 items and then applying a linear transformation to standardize the average score, so that the combined score ranges from 0 to 100. The change from baseline in abdominal and gastrointestinal symptoms (EORTC QLQ-OC28 Items 31-36) score will be presented. A lower score indicates a better outcome.
Baseline, and at designated time points up to approximately 78 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Merck Sharp & Dohme LLC

Investigators

  • Study Director: Medical Director, Merck Sharp & Dohme LLC

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 16, 2026

Primary Completion (Estimated)

February 25, 2033

Study Completion (Estimated)

February 25, 2033

Study Registration Dates

First Submitted

January 2, 2026

First Submitted That Met QC Criteria

January 2, 2026

First Posted (Actual)

January 6, 2026

Study Record Updates

Last Update Posted (Actual)

May 29, 2026

Last Update Submitted That Met QC Criteria

May 27, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2870-021
  • MK-2870-021 (Other Identifier: MSD)
  • GOG-3102 (Other Identifier: Gynecologic Oncology Group)
  • ENGOT-ov85 (Other Identifier: European Network for Gynaecological Oncological Trial groups)
  • U1111-1297-5158 (Registry Identifier: WHO/UTN)
  • 2023-508047-40-00 (Registry Identifier: EU CT)
  • jRCT2031250647 (Registry Identifier: Japan Registry of Clinical Trial (jRCT))

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

https://trialstransparency.msdclinicaltrials.com/pdf/ProcedureAccessClinicalTrialData.pdf

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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