NCT07318558

Brief Summary

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.

Trial Health

83
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
900

participants targeted

Target at P75+ for phase_3

Timeline
83mo left

Started Feb 2026

Longer than P75 for phase_3

Geographic Reach
8 countries

28 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress3%
Feb 2026Feb 2033

First Submitted

Initial submission to the registry

January 2, 2026

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 6, 2026

Completed
1 month until next milestone

Study Start

First participant enrolled

February 16, 2026

Completed
7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 25, 2033

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 25, 2033

Last Updated

May 1, 2026

Status Verified

April 1, 2026

Enrollment Period

7 years

First QC Date

January 2, 2026

Last Update Submit

April 30, 2026

Conditions

Ovarian NeoplasmsOvarian Cancer

Outcome Measures

Primary Outcomes (1)

  • Progression-Free Survival (PFS)

    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 Outcomes (8)

  • Overall Survival (OS)

    Up to approximately 78 months

  • Progression-Free Survival 2 (PFS2)

    Up to approximately 78 months

  • Number of Participants Who Experience an Adverse Event (AE)

    Up to approximately 78 months

  • Number of Participants Who Discontinue Study Treatment Due to an AE

    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)

    Baseline, and at designated time points up to approximately 78 months

  • +3 more secondary outcomes

Study Arms (2)

Sac-TMT +/- Bevacizumab

EXPERIMENTAL

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 tirumotecanDrug: BevacizumabDrug: Rescue Medications

Standard of Care

ACTIVE COMPARATOR

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

Interventions

Sacituzumab tirumotecanDRUG

Administered via intravenous (IV) infusion at a dose of 4mg/kg

Also known as: sac-TMT, MK-2870, SKB264
Sac-TMT +/- Bevacizumab
BevacizumabDRUG

Administered via IV infusion at a dose of 15mg/kg

Also known as: Avastin, Altuzan, MVASI
Sac-TMT +/- BevacizumabStandard of Care
Rescue MedicationsDRUG

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.

Sac-TMT +/- Bevacizumab

Eligibility Criteria

Age18 Years+
Sexfemale(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.
  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (28)

Mount Sinai Cancer Center ( Site 0029)

Miami Beach, Florida, 33140, United States

RECRUITING

Women's Cancer Care ( Site 0018)

Covington, Louisiana, 70433, United States

RECRUITING

Nebraska Methodist Hospital ( Site 0004)

Omaha, Nebraska, 68114, United States

RECRUITING

Oklahoma Cancer Specialists and Research Institute, LLC ( Site 0007)

Tulsa, Oklahoma, 74146, United States

RECRUITING

Sanatorio Parque - Oncología ( Site 2911)

Rosario, Santa Fe Province, S2000DVC, Argentina

RECRUITING

Gallipoli Medical Research Ltd ( Site 0204)

Brisbane, Queensland, 4120, Australia

RECRUITING

Epworth Freemasons ( Site 0207)

East Melbourne, Victoria, 3002, Australia

RECRUITING

Rambam Health Care Campus ( Site 1422)

Haifa, 3109601, Israel

RECRUITING

Edith Wolfson Medical Center ( Site 1423)

Holon, 5810001, Israel

RECRUITING

Hokkaido University Hospital ( Site 1609)

Sapporo, Hokkaido, 060-8648, Japan

RECRUITING

Hyogo Cancer Center ( Site 1620)

Akashi, Hyōgo, 673-8558, Japan

RECRUITING

Iwate Medical University Hospital ( Site 1610)

Shiwa-gun, Iwate, 028-3695, Japan

RECRUITING

Saitama Medical University International Medical Center ( Site 1607)

Hidaka, Saitama, 350-1298, Japan

RECRUITING

Cancer Institute Hospital of JFCR ( Site 1614)

Koto, Tokyo, 135-8550, Japan

RECRUITING

Kagoshima City Hospital ( Site 1613)

Kagoshima, 890-8760, Japan

RECRUITING

Niigata Cancer Center Hospital ( Site 1608)

Niigata, 951-8566, Japan

RECRUITING

Severance Hospital ( Site 2302)

Seodaemun-Gu, Seoul, 03722, South Korea

RECRUITING

Keimyung University Dongsan Hospital ( Site 2304)

Daegu, Taegu-Kwangyokshi, 42601, South Korea

RECRUITING

Seoul National University Hospital ( Site 2301)

Seoul, 03080, South Korea

RECRUITING

Asan Medical Center ( Site 2305)

Seoul, 05505, South Korea

RECRUITING

Samsung Medical Center ( Site 2303)

Seoul, 06351, South Korea

RECRUITING

Inselspital Bern ( Site 3504)

Bern, Canton of Bern, 3010, Switzerland

RECRUITING

Ospedale Regionale Bellinzona e Valli ( Site 3501)

Bellinzona, Canton Ticino, 6500, Switzerland

RECRUITING

Kantonsspital Graubünden ( Site 3503)

Chur, Kanton Graubünden, 7000, Switzerland

RECRUITING

Hôpitaux Universitaires de Genève (HUG) ( Site 3502)

Geneva, 1205, Switzerland

RECRUITING

Taichung Veterans General Hospital ( Site 2603)

Taichung, 40705, Taiwan

RECRUITING

National Cheng Kung University Hospital ( Site 2602)

Tainan, 704302, Taiwan

RECRUITING

Linkou Chang Gung Memorial Hospital ( Site 2605)

Taoyuan, 333, Taiwan

RECRUITING

Related Links

MeSH Terms

Conditions

Ovarian Neoplasms

Interventions

Bevacizumab

Condition Hierarchy (Ancestors)

Endocrine Gland NeoplasmsNeoplasms by SiteNeoplasmsOvarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Neoplasms, FemaleUrogenital NeoplasmsGenital DiseasesEndocrine System DiseasesGonadal Disorders

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, HumanizedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulins

Study Officials

  • Medical Director

    Merck Sharp & Dohme LLC

    STUDY DIRECTOR

Central Study Contacts

Toll Free Number

CONTACT

1-888-577-8839Trialsites@msd.com

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 2, 2026

First Posted

January 6, 2026

Study Start

February 16, 2026

Primary Completion (Estimated)

February 25, 2033

Study Completion (Estimated)

February 25, 2033

Last Updated

May 1, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will share

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

More information

Locations

AR(1)JP(7)IL(2)US(4)TW(3)KR(5)AU(2)CH(4)