Clinical trial NCT06824467: 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)
Official 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)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Ovarian Cancer
Fallopian Tube Cancer
Primary Peritoneal Cancer
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
Collaborators: name: European Network of Gynaecological Oncological Trial Groups (ENGOT)
name: GOG Foundation
First posted: 2025-02-13
Enrollment: 770
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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)

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

Primary outcomes:
measure: Part 1: Number of participants with one or more adverse events (AEs)
timeFrame: Up to 6 weeks
measure: Part 1: Number of participants who discontinue study intervention due to an AE
timeFrame: Up to 6 weeks
measure: Part 2: Progression-free Survival (PFS)
timeFrame: Up to approximately 4 years
Secondary outcomes:
measure: Part 2: Overall Survival (OS)
timeFrame: Up to approximately 4 years
measure: Part 2: Number of participants with one or more AEs
timeFrame: Up to approximately 4 years
measure: Part 2: Number of participants who discontinue study intervention due to an AE
timeFrame: Up to approximately 4 years
measure: 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
timeFrame: Baseline and up to approximately 4 years
measure: Part 2: Change from Baseline in EORTC QLQ-C30 Physical Functioning Score
timeFrame: Baseline and up to approximately 4 years
measure: Part 2: Change from Baseline in EORTC QLQ-C30 Role Functioning Score
timeFrame: Baseline and up to approximately 4 years
measure: Part 2: Change from Baseline in EORTC Quality of Life Questionnaire-Ovarian Cancer Module 28 (QLQ-OV28) abdominal/gastrointestinal (GI) symptom scale
timeFrame: Baseline and up to approximately 4 years
Other outcomes:
Locations:
city: Sarasota
country: United States
facility: Sarasota Memorial Hospital ( Site 0075)
state: Florida
city: Jackson
country: United States
facility: St. Dominic's Hospital ( Site 0064)
state: Mississippi
city: Omaha
country: United States
facility: Nebraska Methodist Hospital ( Site 0053)
state: Nebraska
city: New Brunswick
country: United States
facility: Rutgers Cancer Institute of New Jersey ( Site 0071)
state: New Jersey
city: Cincinnati
country: United States
facility: University of Cincinnati Medical Center ( Site 0090)
state: Ohio
city: Tulsa
country: United States
facility: Oklahoma Cancer Specialists and Research Institute, LLC ( Site 0056)
state: Oklahoma
city: Providence
country: United States
facility: Women & Infants Hospital ( Site 0050)
state: Rhode Island
city: Brisbane
country: Australia
facility: Gallipoli Medical Research Ltd ( Site 0214)
state: Queensland
city: East Melbourne
country: Australia
facility: Epworth Freemasons ( Site 0217)
state: Victoria
city: Kurume
country: Japan
facility: Kurume University Hospital ( Site 1640)
state: Fukuoka
city: Hidaka
country: Japan
facility: Saitama Medical University International Medical Center ( Site 1632)
state: Saitama
city: Koto
country: Japan
facility: Cancer Institute Hospital of JFCR ( Site 1639)
state: Tokyo
city: Niigata
country: Japan
facility: Niigata Cancer Center Hospital ( Site 1633)
city: Goyang-si
country: Korea, Republic of
facility: National Cancer Center ( Site 2305)
state: Kyonggi-do
city: Seodaemun-Gu
country: Korea, Republic of
facility: Severance Hospital ( Site 2302)
state: Seoul
city: Songpa-gu
country: Korea, Republic of
facility: Asan Medical Center ( Site 2304)
state: Seoul
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital ( Site 2301)
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center ( Site 2303)
city: Girona
country: Spain
facility: Institut Català d'Oncologia (ICO) - Girona ( Site 2402)
state: Gerona
city: Madrid
country: Spain
facility: Clinica Universidad de Navarra ( Site 2407)
state: Madrid, Comunidad De
city: Barcelona
country: Spain
facility: Hospital Vall D Hebron ( Site 2403)
city: Barcelona
country: Spain
facility: ICO L Hospitalet ( Site 2408)
city: Cordoba
country: Spain
facility: Hospital Universitario Reina Sofia ( Site 2406)
city: Madrid
country: Spain
facility: Hospital Ramon y Cajal ( Site 2405)
city: Taichung
country: Taiwan
facility: Taichung Veterans General Hospital ( Site 2603)
city: Tainan
country: Taiwan
facility: National Cheng Kung University Hospital ( Site 2602)
city: Taipei
country: Taiwan
facility: Mackay Memorial Hospital ( Site 2604)
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Director
role: STUDY_DIRECTOR
References: