Actively Recruiting
A Phase 3, Randomized, Open-label Study of Sacituzumab Tirumotecan With or Without Bevacizumab Versus Standard Care in Advanced Non-HRD Positive Ovarian Cancer After Platinum Chemotherapy
Led by Merck Sharp & Dohme LLC · Updated on 2026-06-08
900
Participants Needed
89
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are investigating new treatments for advanced ovarian cancer that is non-HRD positive. The study aims to find out if maintenance treatment with sacituzumab tirumotecan (sac-TMT), alone or combined with bevacizumab, helps people live longer without their cancer worsening compared to standard care. This is a phase 3 trial involving participants who have completed surgery and first-line platinum-based chemotherapy. Participants will be assigned randomly to one of two groups. One group will receive sac-TMT infusions every two weeks on days 1, 15, and 29 of a six-week cycle, potentially combined with bevacizumab infusions every three weeks on days 1 and 22 for up to 22 cycles. The other group will receive either bevacizumab alone on the same schedule or be observed without treatment, depending on their assigned standard care option. Treatment continues until cancer progression, unacceptable side effects, or other reasons to stop. During the trial, participants will have regular visits for treatment and monitoring, including assessments of cancer progression and side effects. Researchers will measure how long participants live without cancer worsening (progression-free survival) for up to about 49 months and monitor overall survival and quality of life for up to about 78 months. Various health questionnaires will be used to track physical function, symptoms, and well-being. Safety and treatment tolerability will also be carefully evaluated throughout the study period.
CONDITIONS
Brief Title
A Clinical Trial of Sac-TMT in People With Non-HRD Positive Advanced Ovarian Cancer (MK-2870-021)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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 platinum-based chemotherapy with stable disease, partial or complete response, or no evidence of disease
- Has provided tumor tissue that is not previously irradiated
- If HIV positive, is well-controlled on antiretroviral therapy
- Has undetectable hepatitis B viral load and received HBV antiviral therapy if HBsAg-positive
- Has undetectable hepatitis C viral load if history of HCV infection
- Female gender
- Age 18 years or older
You will not qualify if you...
- Has nonepithelial cancers, low-grade serous tumors, low-grade endometrioid tumors, borderline tumors, mucinous or seromucinous tumors predominantly mucinous, malignant Brenner's tumor, or undifferentiated carcinoma
- Has active central nervous system metastases or carcinomatous meningitis
- Has a history of severe eye disease
- Has active inflammatory bowel disease requiring immunosuppressive medication or history of inflammatory bowel disease
- Has uncontrolled significant cardiovascular or cerebrovascular disease
- Has history or current pneumonitis or interstitial lung disease requiring steroids
- Received prior systemic anticancer therapy except first-line platinum chemotherapy
- Had live or live-attenuated vaccine within 30 days before randomization
- Has additional progressing malignancy requiring treatment within past 3 years
- Has active infection requiring systemic therapy
- Has concurrent active hepatitis B and C infections
- Has HIV infection with history of Kaposi's sarcoma or multicentric Castleman's disease
- Has not recovered from major surgery or has ongoing surgical complications
- Has homologous recombination deficiency-positive, unknown, or inconclusive tumor status
- Has active or ongoing stomatitis of any grade
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Repeated 6-week cycles until disease progression, prohibitive toxicity, or other protocol-defined reason for discontinuation
Participants receive study treatment with sacituzumab tirumotecan with or without bevacizumab, or standard of care which may include bevacizumab or observation.
Visits on Days 1, 15, and 29 of each 6-week cycle for sacituzumab tirumotecan; optional bevacizumab on Days 1 and 22 of each cycle; or bevacizumab every 3 weeks for up to 22 courses
Duration - Up to approximately 78 months
Participants are followed for long-term outcomes including survival and adverse events after treatment ends.
Visits at designated time points up to approximately 78 months
Trial Site Locations
Total: 89 locations
1
Mount Sinai Cancer Center ( Site 0029)
Miami Beach, Florida, United States, 33140
Actively Recruiting
2
Parkview Research Center at Parkview Regional Medical Center ( Site 0055)
Fort Wayne, Indiana, United States, 46845
Actively Recruiting
3
Women's Cancer Care ( Site 0018)
Covington, Louisiana, United States, 70433
Actively Recruiting
4
Nebraska Methodist Hospital ( Site 0004)
Omaha, Nebraska, United States, 68114
Actively Recruiting
5
University Of Nebraska Medical Center ( Site 0035)
Omaha, Nebraska, United States, 68198
Actively Recruiting
6
Oklahoma Cancer Specialists and Research Institute, LLC ( Site 0007)
Tulsa, Oklahoma, United States, 74146
Actively Recruiting
7
West Cancer Center and Research Institute ( Site 0013)
Germantown, Tennessee, United States, 38138
Actively Recruiting
8
Instituto Alexander Fleming ( Site 2902)
Ciudad Autónoma de Buenos Aires, Buenos Aires, Argentina, C1426ANZ
Actively Recruiting
9
Instituto de Investigaciones Clinicas Mar del Plata ( Site 2901)
Mar del Plata, Buenos Aires, Argentina, B7600FZO
Actively Recruiting
10
Fundación Respirar ( Site 2912)
Buenos Aires, Buenos Aires F.D., Argentina, C1426AAL
Actively Recruiting
11
Sanatorio Parque - Oncología ( Site 2911)
Rosario, Santa Fe Province, Argentina, S2000DVC
Actively Recruiting
12
Instituto de Oncologia de Rosario ( Site 2909)
Rosario, Santa Fe Province, Argentina, S2000KZE
Actively Recruiting
13
Hospital Britanico de Buenos Aires ( Site 2905)
CABA, Argentina, C1280AEB
Actively Recruiting
14
Fundación CORI para la Investigación y Prevención del Cáncer ( Site 2907)
La Rioja, Argentina, F5300COE
Actively Recruiting
15
Gallipoli Medical Research Ltd ( Site 0204)
Brisbane, Queensland, Australia, 4120
Actively Recruiting
16
Epworth Freemasons ( Site 0207)
East Melbourne, Victoria, Australia, 3002
Actively Recruiting
17
Medizinische Universitat Wien ( Site 0102)
Vienna, State of Vienna, Austria, 1090
Actively Recruiting
18
Medizinische Universitaet Innsbruck-Univ.-Klinik f. Gynäkologie und Geburtshilfe ( Site 0101)
Innsbruck, Tyrol, Austria, 6020
Actively Recruiting
19
Grand Hopital de Charleroi ( Site 0303)
Charleroi, Hainaut, Belgium, 6000
Actively Recruiting
20
AZ Maria Middelares ( Site 0302)
Ghent, Oost-Vlaanderen, Belgium, 9000
Actively Recruiting
21
UZ Leuven ( Site 0301)
Leuven, Vlaams-Brabant, Belgium, 3000
Actively Recruiting
22
Fundação Faculdade Regional de Medicina de São José do Rio Preto ( Site 0414)
São José do Rio Preto, São Paulo, Brazil, 15090-000
Actively Recruiting
23
McGill University Health Centre ( Site 0516)
Montreal, Quebec, Canada, H4A 3J1
Actively Recruiting
24
Fakultni nemocnice Ostrava-Gynekologicko-porodnicka klinika ( Site 3303)
Ostrava-Poruba, Ostrava Mesto, Czechia, 708 52
Actively Recruiting
25
Vseobecna fakultni nemocnice v Praze ( Site 3305)
Prague, Czechia, 128 08
Actively Recruiting
26
Fakultni nemocnice motol ( Site 3302)
Prague, Czechia, 150 06
Actively Recruiting
27
Herlev Hospital ( Site 0902)
Herlev, Capital Region, Denmark, 2730
Actively Recruiting
28
Aalborg Universitetshospital ( Site 0901)
Aalborg, North Denmark, Denmark, 9000
Actively Recruiting
29
Aarhus Universitetshospital, Skejby ( Site 0903)
Aarhus, North Denmark, Denmark, 8200
Actively Recruiting
30
Odense Universitets Hospital ( Site 0904)
Odense, Region Syddanmark, Denmark, 9000
Actively Recruiting
31
Oulun yliopistollinen sairaala ( Site 1003)
Oulu, North Ostrobothnia, Finland, 90220
Actively Recruiting
32
Kuopion Yliopistollinen Sairaala ( Site 1004)
Kuopio, Northern Savonia, Finland, 70200
Actively Recruiting
33
Tampereen yliopistollinen sairaala ( Site 1002)
Tampere, Pirkanmaa, Finland, 33520
Actively Recruiting
34
Turku University Hospital-Department of Obstetrics and Gynecology ( Site 1001)
Turku, Southwest Finland, Finland, 20520
Actively Recruiting
35
CENTRE LEON BERARD ( Site 1101)
Lyon, Auvergne-Rhône-Alpes, France, 69008
Actively Recruiting
36
Hôpital Privé Des Côtes d'Armor ( Site 1102)
Plérin, Cotes-d Armor, France, 22190
Actively Recruiting
37
Centre Oscar Lambret ( Site 1106)
Lille, Nord, France, 59020
Actively Recruiting
38
Centre Jean Perrin - Centre Régional de Lutte contre le Cancer d'Auvergne ( Site 1113)
Clermont-Ferrand, Puy-de-Dome, France, 63003
Actively Recruiting
39
Bacs-Kiskun Varmegyei Oktatokorhaz-Onkoradiologiai Kozpont ( Site 3910)
Kecskemét, Bács-Kiskun county, Hungary, 6000
Actively Recruiting
40
Országos Onkológiai Intézet-Ngyógyászat ( Site 3913)
Budapest, Hungary, 1122
Actively Recruiting
41
Debreceni Egyetem Klinikai Kozpont-Szülészeti és Nőgyógyászati Klinika ( Site 3912)
Debrecen, Hungary, 4032
Actively Recruiting
42
Rambam Health Care Campus ( Site 1422)
Haifa, Israel, 3109601
Actively Recruiting
43
Edith Wolfson Medical Center ( Site 1423)
Holon, Israel, 5810001
Actively Recruiting
44
Azienda Ospedaliera Spedali Civili di Brescia ( Site 1501)
Brescia, Italy, 25123
Actively Recruiting
45
Istituto Europeo di Oncologia ( Site 1503)
Milan, Italy, 20141
Actively Recruiting
46
Gunma Prefectural Cancer Center ( Site 1605)
Ōta, Gunma, Japan, 373-8550
Actively Recruiting
47
Hokkaido University Hospital ( Site 1609)
Sapporo, Hokkaido, Japan, 060-8648
Actively Recruiting
48
Hyogo Cancer Center ( Site 1620)
Akashi, Hyōgo, Japan, 673-8558
Actively Recruiting
49
Iwate Medical University Hospital ( Site 1610)
Shiwa-gun, Iwate, Japan, 028-3695
Actively Recruiting
50
Saitama Medical University International Medical Center ( Site 1607)
Hidaka, Saitama, Japan, 350-1298
Actively Recruiting
51
Cancer Institute Hospital of JFCR ( Site 1614)
Koto, Tokyo, Japan, 135-8550
Actively Recruiting
52
Kagoshima City Hospital ( Site 1613)
Kagoshima, Japan, 890-8760
Actively Recruiting
53
Niigata Cancer Center Hospital ( Site 1608)
Niigata, Japan, 951-8566
Actively Recruiting
54
Osaka Prefectural Hospital Organization Osaka International Cancer Institute ( Site 1604)
Osaka, Japan, 541-8567
Actively Recruiting
55
Stavanger Universitetssjukehus ( Site 2002)
Stavanger, Rogaland, Norway, 4068
Actively Recruiting
56
Sorlandet Sykehus Kristiansand ( Site 2003)
Kristiansand, Vest-Agder, Norway, 4615
Actively Recruiting
57
Oslo University Hospital ( Site 2001)
Oslo, Norway, 0424
Actively Recruiting
58
Uniwersytecki Szpital Kliniczny w Poznaniu-Oddzial Ginekologii Onkologicznej ( Site 2106)
Poznan, Greater Poland Voivodeship, Poland, 60-569
Actively Recruiting
59
Wielkopolskie Centrum Onkologii im. Marii Skłodowskiej-Curie ( Site 2105)
Poznan, Greater Poland Voivodeship, Poland, 61-866
Actively Recruiting
60
Mazowiecki Szpital Wojewódzki w Siedlcach-Siedleckie Centrum Onkologii ( Site 2102)
Siedlce, Masovian Voivodeship, Poland, 08-110
Actively Recruiting
61
Bialostockie Centrum Onkologii ( Site 2104)
Bialystok, Podlaskie Voivodeship, Poland, 15-027
Actively Recruiting
62
Severance Hospital ( Site 2302)
Seodaemun-Gu, Seoul, South Korea, 03722
Actively Recruiting
63
Keimyung University Dongsan Hospital ( Site 2304)
Daegu, Taegu-Kwangyokshi, South Korea, 42601
Actively Recruiting
64
Seoul National University Hospital ( Site 2301)
Seoul, South Korea, 03080
Actively Recruiting
65
Asan Medical Center ( Site 2305)
Seoul, South Korea, 05505
Actively Recruiting
66
Samsung Medical Center ( Site 2303)
Seoul, South Korea, 06351
Actively Recruiting
67
Institut Català d'Oncologia (ICO) - Girona ( Site 2402)
Girona, Gerona, Spain, 17007
Actively Recruiting
68
Complejo Hospitalario Universitario A Coruna ( Site 2412)
A Coruña, La Coruna, Spain, 15006
Actively Recruiting
69
Clinica Universidad de Navarra ( Site 2407)
Madrid, Madrid, Comunidad de, Spain, 28027
Actively Recruiting
70
Instituto Valenciano de Oncologia - IVO ( Site 2411)
Valencia, Valenciana, Comunitat, Spain, 46009
Actively Recruiting
71
Hospital Vall D Hebron ( Site 2403)
Barcelona, Spain, 08035
Actively Recruiting
72
Hospital Clinic I Provincial de Barcelona ( Site 2409)
Barcelona, Spain, 08036
Actively Recruiting
73
ICO L Hospitalet ( Site 2408)
Barcelona, Spain, 08907
Actively Recruiting
74
Hospital Ramon y Cajal ( Site 2405)
Madrid, Spain, 28034
Actively Recruiting
75
Hospital Clinico San Carlos... ( Site 2410)
Madrid, Spain, 28040
Actively Recruiting
76
Hospital Universitario La Paz-Oncología Médica ( Site 2404)
Madrid, Spain, 28046
Actively Recruiting
77
Karolinska Universitetssjukhuset Solna ( Site 2502)
Stockholm, Stockholm County, Sweden, 171 76
Actively Recruiting
78
Inselspital Bern ( Site 3504)
Bern, Canton of Bern, Switzerland, 3010
Actively Recruiting
79
Ospedale Regionale Bellinzona e Valli ( Site 3501)
Bellinzona, Canton Ticino, Switzerland, 6500
Actively Recruiting
80
Kantonsspital Graubünden ( Site 3503)
Chur, Kanton Graubünden, Switzerland, 7000
Actively Recruiting
81
Hôpitaux Universitaires de Genève (HUG) ( Site 3502)
Geneva, Switzerland, 1205
Actively Recruiting
82
Taichung Veterans General Hospital ( Site 2603)
Taichung, Taiwan, 40705
Actively Recruiting
83
National Cheng Kung University Hospital ( Site 2602)
Tainan, Taiwan, 704302
Actively Recruiting
84
National Taiwan University Hospital ( Site 2601)
Taipei, Taiwan, 10002
Actively Recruiting
85
Mackay Memorial Hospital ( Site 2604)
Taipei, Taiwan, 104
Actively Recruiting
86
Linkou Chang Gung Memorial Hospital ( Site 2605)
Taoyuan, Taiwan, 333
Actively Recruiting
87
Ramathibodi Hospital. ( Site 3402)
Bangkok, Bangkok, Thailand, 10400
Actively Recruiting
88
Faculty of Medicine Siriraj Hospital ( Site 3401)
Bangkoknoi, Bangkok, Thailand, 10700
Actively Recruiting
89
Faculty of Medicine - Khon Kaen University ( Site 3403)
Muang, Changwat Khon Kaen, Thailand, 40002
Actively Recruiting
Research Team
T
Toll Free Number
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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