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)
- Conditions
- Ovarian CancerFallopian Tube CancerPrimary Peritoneal Cancer
- Interventions
- Drug: H1 receptor antagonistDrug: H2 receptor antagonistDrug: Steroid mouthwash (dexamethasone or equivalent)
- Registration Number
- NCT06824467
- Lead Sponsor
- Merck Sharp & Dohme LLC
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- Female
- Target Recruitment
- 770
- 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)
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Part 1: Sacituzumab tirumotecan + Bevacizumab 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 Part 1: Sacituzumab tirumotecan + Bevacizumab H1 receptor antagonist 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 Part 1: Sacituzumab tirumotecan + Bevacizumab H2 receptor antagonist 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 Part 1: Sacituzumab tirumotecan + Bevacizumab Acetaminophen (or equivalent) 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 Part 1: Sacituzumab tirumotecan + Bevacizumab Dexamethasone (or equivalent) 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 Part 1: Sacituzumab tirumotecan + Bevacizumab Steroid mouthwash (dexamethasone or equivalent) 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 Part 2: Sacituzumab tirumotecan Bevacizumab 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. Part 2: Sacituzumab tirumotecan H1 receptor antagonist 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. Part 2: Sacituzumab tirumotecan H2 receptor antagonist 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. Part 2: Sacituzumab tirumotecan Acetaminophen (or equivalent) 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. Part 2: Sacituzumab tirumotecan Dexamethasone (or equivalent) 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. Part 2: Sacituzumab tirumotecan Steroid mouthwash (dexamethasone or equivalent) 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. Part 2: Standard of care (SOC) Bevacizumab 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. Part 1: Sacituzumab tirumotecan + Bevacizumab Sacituzumab tirumotecan 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 Part 2: Sacituzumab tirumotecan 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.
- Primary Outcome Measures
Name Time Method Part 1: Number of participants with one or more adverse events (AEs) Up to 6 weeks 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.
Part 1: Number of participants who discontinue study intervention due to an AE Up to 6 weeks 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.
Part 2: Progression-free Survival (PFS) Up to approximately 4 years 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.
- Secondary Outcome Measures
Name Time Method Part 2: Overall Survival (OS) Up to approximately 4 years OS is defined as the time from randomization to death due to any cause
Part 2: Number of participants with one or more AEs Up to approximately 4 years 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.
Part 2: Number of participants who discontinue study intervention due to an AE Up to approximately 4 years 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.
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 Baseline and up to approximately 4 years 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.
Part 2: Change from Baseline in EORTC QLQ-C30 Physical Functioning Score Baseline and up to approximately 4 years 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.
Part 2: Change from Baseline in EORTC QLQ-C30 Role Functioning Score Baseline and up to approximately 4 years 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.
Part 2: Change from Baseline in EORTC Quality of Life Questionnaire-Ovarian Cancer Module 28 (QLQ-OV28) abdominal/gastrointestinal (GI) symptom scale Baseline and up to approximately 4 years 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).
Related Research Topics
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Trial Locations
- Locations (21)
Rutgers Cancer Institute of New Jersey ( Site 0071)
🇺🇸New Brunswick, New Jersey, United States
Epworth Freemasons ( Site 0217)
🇦🇺East Melbourne, Victoria, Australia
Asan Medical Center ( Site 2304)
🇰🇷Songpa-gu, Seoul, Korea, Republic of
Clinica Universidad de Navarra ( Site 2407)
🇪🇸Madrid, Madrid, Comunidad De, Spain
ICO L Hospitalet ( Site 2408)
🇪🇸Barcelona, Spain
Hospital Universitario Reina Sofia ( Site 2406)
🇪🇸Cordoba, Spain
Mackay Memorial Hospital ( Site 2604)
🇨🇳Taipei, Taiwan
Sarasota Memorial Hospital ( Site 0075)
🇺🇸Sarasota, Florida, United States
St. Dominic's Hospital ( Site 0064)
🇺🇸Jackson, Mississippi, United States
Nebraska Methodist Hospital ( Site 0053)
🇺🇸Omaha, Nebraska, United States
University of Cincinnati Medical Center ( Site 0090)
🇺🇸Cincinnati, Ohio, United States
Oklahoma Cancer Specialists and Research Institute, LLC ( Site 0056)
🇺🇸Tulsa, Oklahoma, United States
Women & Infants Hospital ( Site 0050)
🇺🇸Providence, Rhode Island, United States
Kurume University Hospital ( Site 1640)
🇯🇵Kurume, Fukuoka, Japan
Cancer Institute Hospital of JFCR ( Site 1639)
🇯🇵Koto, Tokyo, Japan
Severance Hospital ( Site 2302)
🇰🇷Seodaemun-Gu, Seoul, Korea, Republic of
Seoul National University Hospital ( Site 2301)
🇰🇷Seoul, Korea, Republic of
Samsung Medical Center ( Site 2303)
🇰🇷Seoul, Korea, Republic of
Hospital Vall D Hebron ( Site 2403)
🇪🇸Barcelona, Spain
Taichung Veterans General Hospital ( Site 2603)
🇨🇳Taichung, Taiwan
National Cheng Kung University Hospital ( Site 2602)
🇨🇳Tainan, Taiwan