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)
Status and phase
Enrolling
Phase 3
Conditions
Primary Peritoneal Cancer
Fallopian Tube Cancer
Ovarian Cancer
Treatments
Drug: H2 receptor antagonist
Biological: Bevacizumab
Drug: Acetaminophen (or equivalent)
Drug: Dexamethasone (or equivalent)
Drug: Steroid mouthwash (dexamethasone or equivalent)
Biological: Sacituzumab tirumotecan
Drug: H1 receptor antagonist
Study type
Interventional
Funder types
Other
NETWORK
Industry
Identifiers
NCT06824467
2023-508015-23-00 (Registry Identifier)
MK-2870-022 (Other Identifier)
TroFuse-022 (Other Identifier)
ENGOT-ov84 (Other Identifier)
jRCT2031240722 (Registry Identifier)
GOG-3103 (Other Identifier)
U1111-1297-4489 (Other Identifier)
2870-022
Details and patient eligibility
About
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.
Enrollment
770 estimated patients
Sex
Female
Ages
18+ years old
Volunteers
No Healthy Volunteers
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
Trial design
Primary purpose
Treatment
Allocation
Randomized
Interventional model
Parallel Assignment
Masking
None (Open label)
770 participants in 3 patient groups
Part 1: Sacituzumab tirumotecan + Bevacizumab
Experimental group
Description:
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
Treatment:
Drug: H1 receptor antagonist
Biological: Sacituzumab tirumotecan
Drug: Steroid mouthwash (dexamethasone or equivalent)
Drug: Dexamethasone (or equivalent)
Drug: Acetaminophen (or equivalent)
Biological: Bevacizumab
Drug: H2 receptor antagonist
Part 2: Sacituzumab tirumotecan
Experimental group
Description:
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.
Treatment:
Drug: H1 receptor antagonist
Biological: Sacituzumab tirumotecan
Drug: Steroid mouthwash (dexamethasone or equivalent)
Drug: Dexamethasone (or equivalent)
Drug: Acetaminophen (or equivalent)
Biological: Bevacizumab
Drug: H2 receptor antagonist
Part 2: Standard of care (SOC)
Active Comparator group
Description:
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:
Biological: Bevacizumab
Trial contacts and locations
27
Loading...
Central trial contact
Toll Free Number
Data sourced from clinicaltrials.gov
Clinical trials
Research sites
Resources
Legal
© Copyright 2025 Veeva Systems