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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT06824467
Registration number
NCT06824467
Ethics application status
Date submitted
7/02/2025
Date registered
13/02/2025
Date last updated
14/07/2025
Titles & IDs
Public title
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)
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Scientific title
A Phase 3, Randomized, Open-label, Multicenter Study to Evaluate the Efficacy and Safety of Sacituzumab Tirumotecan Maintenance Treatment With or Without Bevacizumab Versus Standard of Care After Second-line Platinum-based Doublet Chemotherapy in Participants With Platinum-sensitive Recurrent Ovarian Cancer (TroFuse-022/ENGOT-ov84/GOG-3103)
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Secondary ID [1]
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MK-2870-022
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Secondary ID [2]
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2870-022
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Ovarian Cancer
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Fallopian Tube Cancer
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Primary Peritoneal Cancer
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Condition category
Condition code
Cancer
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Ovarian and primary peritoneal
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Cancer
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Womb (Uterine or endometrial cancer)
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Other - Sacituzumab tirumotecan
Treatment: Other - Bevacizumab
Treatment: Drugs - H1 receptor antagonist
Treatment: Drugs - H2 receptor antagonist
Treatment: Drugs - Acetaminophen (or equivalent)
Treatment: Drugs - Dexamethasone (or equivalent)
Treatment: Drugs - Steroid mouthwash (dexamethasone or equivalent)
Experimental: 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
Experimental: 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.
Active comparator: 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.
Treatment: Other: Sacituzumab tirumotecan
IV Infusion
Treatment: Other: Bevacizumab
IV Infusion
Treatment: Drugs: H1 receptor antagonist
Rescue medication taken per approved product label before sacituzumab tirumotecan
Treatment: Drugs: H2 receptor antagonist
Rescue medication taken per approved product label before sacituzumab tirumotecan
Treatment: Drugs: Acetaminophen (or equivalent)
Rescue medication taken per approved product label before sacituzumab tirumotecan
Treatment: Drugs: Dexamethasone (or equivalent)
Rescue medication taken per approved product label before sacituzumab tirumotecan
Treatment: Drugs: Steroid mouthwash (dexamethasone or equivalent)
Rescue medication taken orally 4 times daily
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Intervention code [1]
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Treatment: Other
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Intervention code [2]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Part 1: Number of participants with one or more adverse events (AEs)
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Assessment method [1]
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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.
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Timepoint [1]
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Up to 6 weeks
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Primary outcome [2]
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Part 1: Number of participants who discontinue study intervention due to an AE
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Assessment method [2]
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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.
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Timepoint [2]
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Up to 6 weeks
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Primary outcome [3]
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Part 2: Progression-free Survival (PFS)
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Assessment method [3]
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PFS is defined as the time from randomization to the first documented progressive disease (PD) or death from any cause, whichever occurs first. Per RECIST 1.1, PD is defined as at least a 20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions is also considered PD. PFS as assessed by BICR will be presented.
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Timepoint [3]
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Up to approximately 4 years
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Secondary outcome [1]
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Part 2: Overall Survival (OS)
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Assessment method [1]
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OS is defined as the time from randomization to death due to any cause
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Timepoint [1]
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Up to approximately 4 years
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Secondary outcome [2]
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Part 2: Number of participants with one or more AEs
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Assessment method [2]
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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.
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Timepoint [2]
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Up to approximately 4 years
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Secondary outcome [3]
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Part 2: Number of participants who discontinue study intervention due to an AE
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Assessment method [3]
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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.
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Timepoint [3]
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Up to approximately 4 years
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Secondary outcome [4]
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Part 2: Change from Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) Global Health Status-Quality of Life Score
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Assessment method [4]
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The EORTC-QLQ-C30 is a 30-item questionnaire developed to assess the QoL of cancer patients. Participant responses to Item 30 (""How would you rate your overall quality of life during the past week?") is 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 value indicates a better level of function. The change from baseline in EORTC QLQ-C30 Item 30 score will be reported.
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Timepoint [4]
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Baseline and up to approximately 4 years
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Secondary outcome [5]
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Part 2: Change from Baseline in EORTC QLQ-C30 Physical Functioning Score
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Assessment method [5]
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The EORTC QLQ-C30 is a 30-item questionnaire to assess the overall quality of life of cancer patients. Participant responses to questions about their physical functioning are scored on a 4-point scale (1=Not at All to 4=Very Much). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. A higher score indicates a better level of physical functioning.
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Timepoint [5]
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Baseline and up to approximately 4 years
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Secondary outcome [6]
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Part 2: Change from Baseline in EORTC QLQ-C30 Role Functioning Score
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Assessment method [6]
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The EORTC QLQ-C30 is a 30-item questionnaire to assess the overall quality of life of cancer patients. Participant responses to the questions "Were you limited in doing either your work or other daily activities during the past week?" and " Were you limited in pursuing your hobbies or other leisure time activities during the past week?" will be scored on a 4-point scale (1=Not at All to 4=Very Much). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. Higher scores indicate a more impaired level of role functioning. Change from baseline in the role functioning score will be presented.
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Timepoint [6]
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Baseline and up to approximately 4 years
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Secondary outcome [7]
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Part 2: Change from Baseline in EORTC Quality of Life Questionnaire-Ovarian Cancer Module 28 (QLQ-OV28) abdominal/gastrointestinal (GI) symptom scale
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Assessment method [7]
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The EORTC QLQ-OV28 is an OC-specific, and psychometrically and clinically validated module to supplement the EORTC QLQ-C30. The EORTC QLQ-OV28 abdominal/GI symptom scale is scored on a 4-point scale (1=not at all, 2=a little, 3=quite a bit, 4=very much).
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Timepoint [7]
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Baseline and up to approximately 4 years
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Eligibility
Key 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)
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Females
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Can healthy volunteers participate?
No
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Key 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
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
9/04/2025
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
15/10/2032
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Actual
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Sample size
Target
770
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC
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Recruitment hospital [1]
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Blacktown Hospital ( Site 0211) - Sydney
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Recruitment hospital [2]
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Gallipoli Medical Research Ltd ( Site 0214) - Brisbane
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Recruitment hospital [3]
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Epworth Freemasons ( Site 0217) - East Melbourne
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Recruitment postcode(s) [1]
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2148 - Sydney
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Recruitment postcode(s) [2]
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4120 - Brisbane
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Recruitment postcode(s) [3]
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3002 - East Melbourne
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Recruitment outside Australia
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United States of America
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Florida
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United States of America
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Mississippi
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United States of America
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Nebraska
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United States of America
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New Jersey
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United States of America
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Ohio
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United States of America
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State/province [6]
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Oklahoma
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Country [7]
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United States of America
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Rhode Island
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Japan
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Fukuoka
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Japan
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Saitama
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Japan
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Tokyo
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Japan
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Niigata
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Korea, Republic of
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Kyonggi-do
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Korea, Republic of
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Seoul
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Spain
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Gerona
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Spain
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State/province [15]
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Madrid, Comunidad De
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Country [16]
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Spain
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Barcelona
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Spain
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Cordoba
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Spain
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Madrid
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Taiwan
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Taichung
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Taiwan
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Tainan
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Taiwan
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State/province [21]
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Taipei
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
Merck Sharp & Dohme LLC
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Address
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Other collaborator category [1]
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Other
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Name [1]
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European Network of Gynaecological Oncological Trial Groups (ENGOT)
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Address [1]
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Other collaborator category [2]
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Other
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Name [2]
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GOG Foundation
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Address [2]
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Ethics approval
Ethics application status
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Summary
Brief summary
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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Trial website
https://clinicaltrials.gov/study/NCT06824467
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Medical Director
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Address
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Merck Sharp & Dohme LLC
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Toll Free Number
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Address
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Phone
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1-888-577-8839
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Fax
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Email
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[email protected]
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Contact person for scientific queries
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
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What data in particular will be shared?
https://trialstransparency.msdclinicaltrials.com/pdf/ProcedureAccessClinicalTrialData.pdf
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When will data be available (start and end dates)?
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Available to whom?
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Available for what types of analyses?
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How or where can data be obtained?
IPD available at link: https://externaldatasharing-msd.com/
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What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT06824467
Download to PDF