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

NCT07318558
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Phase
Phase 3
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Recruitment status
Recruiting
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Participants
900
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Lead sponsor
Merck Sharp & Dohme LLC
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Start date
2026-02-16
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Number of sites
167
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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.
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Acronym
TroFuse-021
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Short title
A Clinical Trial of Sac-TMT in People With Non-HRD Positive Advanced Ovarian Cancer (MK-2870-021)
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Official title
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)
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Control arm
Active comparator
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Registry reports results
No
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Listing at source
Listed
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Recruitment status
Recruiting
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Phase
Phase 3
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Study type
Interventional
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Completion date
2033-02-25
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First posted
2026-01-06
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Registry last updated
2026-10-13
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Primary completion date
2033-02-25
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Start date
2026-02-16
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Participants
900
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Participant count basis
Estimated
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Planned participants
900
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Protocol amendments
2
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Number of sites
167
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Data monitoring committee
Yes
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Registry sponsor category
Industry
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Lead sponsor
Merck Sharp & Dohme LLC
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Source registry
ClinicalTrials.gov
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Registry ID
NCT07318558
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ClinicalTrials.gov ID
NCT07318558
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Registry record
Open registry record
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Allocation
Randomised
Model
Parallel groups
Purpose
Treatment
Masking
Single masking
Masked roles
Outcome assessors
Sources for study design
clinicaltrials.gov

  1. Progression-Free Survival (PFS)

    Timeframe: 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.

  1. Overall Survival (OS)

    Timeframe: Up to approximately 78 months

    OS is defined as the time from randomization to death due to any cause.

  2. Progression-Free Survival 2 (PFS2)

    Timeframe: 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.

  3. Number of Participants Who Experience an Adverse Event (AE)

    Timeframe: 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.

  4. Number of Participants Who Discontinue Study Treatment Due to an AE

    Timeframe: 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.

  5. 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)

    Timeframe: Baseline and 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.

  6. Change From Baseline in Physical Functioning Combined Score (Items 1 to 5) Using EORTC QLQ-C30

    Timeframe: Baseline and 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.

  7. Change From Baseline in Role Functioning Combined Score (Items 6 and 7) Using EORTC QLQ-C30

    Timeframe: Baseline and 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.

  8. Change From Baseline in Abdominal/Gastrointestinal (GI) Symptoms Combined Score Using the EORTC QLQ-Ovarian Cancer Module 28 (OV28)

    Timeframe: Baseline and 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.

Sources for outcomes
clinicaltrials.gov

Sex
Female
Age groups
Adults, Older adults
Minimum age
18 Years
Healthy volunteers
No

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

  • Has diagnosis of FIGO 2014 Stage III or Stage IV, histologically confirmed epithelial ovarian, primary peritoneal, or fallopian tube carcinoma with one of the following histologies: high-grade serous, high-grade endometrioid, clear cell carcinoma, or malignant mixed Müllerian tumour with a high-grade serous component. Tumors reported as Grade 2 may be enrolled only if predominately (>50%) Grade 3 features are present.
  • 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.
  • Has well-controlled human immunodeficiency virus (HIV) on antiretroviral therapy if diagnosed with HIV
  • 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, has current pneumonitis/ILD, or has suspected ILD, or pneumonitis that cannot be ruled out by standard diagnostic assessments at Screening.
  • 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.
  • Active or ongoing stomatitis of any grade.
Sources for eligibility
clinicaltrials.gov

  • University of Alabama - Birmingham ( Site 0058)Birmingham, United StatesRecruiting
  • John Muir Health Cancer Center ( Site 0069)Walnut Creek, United StatesRecruiting
  • Mount Sinai Cancer Center ( Site 0029)Miami Beach, United StatesRecruiting
  • Orlando Health Winnie Palmer Hospital for Women and Babies ( Site 0085)Orlando, United StatesRecruiting
  • Winship Cancer Institute of Emory University ( Site 0037)Atlanta, United StatesRecruiting
  • Illinois Cancer Specialists (ICS) ( Site 8009)Arlington Heights, United StatesRecruiting
  • Parkview Research Center at Parkview Regional Medical Center ( Site 0055)Fort Wayne, United StatesRecruiting
  • Franciscan Health Indianapolis ( Site 0081)Indianapolis, United StatesRecruiting
  • Women's Cancer Care ( Site 0018)Covington, United StatesRecruiting
  • Maine Medical Center Research Institute-MaineHealth/Maine Medical Partners - GynOnc ( Site 0060)Scarborough, United StatesRecruiting
  • Maryland Oncology Hematology (MOH) ( Site 8002)Columbia, United StatesRecruiting
  • Nebraska Methodist Hospital ( Site 0004)Omaha, United StatesRecruiting
  • University Of Nebraska Medical Center ( Site 0035)Omaha, United StatesRecruiting
  • The Center of Hope ( Site 0025)Reno, United StatesRecruiting
  • Womens Cancer Care Associates, LLC ( Site 0023)Albany, United StatesRecruiting
  • Memorial Sloan Kettering Cancer Center ( Site 0072)New York, United StatesRecruiting
  • Duke Cancer Center ( Site 0012)Durham, United StatesRecruiting
  • University of Cincinnati Medical Center ( Site 0042)Cincinnati, United StatesRecruiting
  • Oklahoma Cancer Specialists and Research Institute, LLC ( Site 0007)Tulsa, United StatesRecruiting
  • Kaiser Permanente Interstate Medical Office - Central ( Site 0089)Portland, United StatesRecruiting
  • Hospital of the University of Pennsylvania ( Site 0071)Philadelphia, United StatesRecruiting
  • Women & Infants Hospital ( Site 0001)Providence, United StatesRecruiting
  • West Cancer Center and Research Institute ( Site 0013)Germantown, United StatesRecruiting
  • University of Tennessee Medical Center ( Site 0087)Knoxville, United StatesRecruiting
  • Henry-Joyce Cancer Clinic ( Site 0011)Nashville, United StatesRecruiting

And 142 more, listed on the interactive page.

Sources for sites
clinicaltrials.gov

  • MK-2870-021
  • 2023
  • 2023-508047-40-00
  • U1111-1297-5158
  • GOG-3102
  • jRCT2031250647
  • ENGOT-ov85
Sources for references
clinicaltrials.gov

Related records

Drugs (2)

Lead sponsors (1)

Conditions (1)

Targets (2)