Find-A-Study

A Phase 3, Randomized, Open-label, Multicenter Study to Evaluate the Efficacy and Safety of Sacituzumab Tirumotecan (MK-2870) 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)

Purpose

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.

Study Contact

Marisa Fernandez
210-450-8016
fernandezm10@uthscsa.edu

Principal Investigator
Georgia McCann

Sally Kabro
210-567-3742
kabro@uthscsa.edu

Eligibility

Eligible Ages: >18 years of age
Eligible Genders: female
Accepts Healthy Volunteers: No

Inclusion Criteria

Has locally advanced or metastatic, histologically confirmed epithelial ovarian, primary peritoneal, or fallopian tube carcinoma of certain histologies
Has received 4 or more cycles of platinum-based doublet chemotherapy in first-line and a total of 6 to 8 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 or 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), low-grade serous tumors, low-grade endometrioid 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 (ILD) that required steroids, has current pneumonitis/ILD, or has suspected pneumonitis or ILD that cannot be ruled out by standard diagnostic assessments at Screening
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
Has active or ongoing stomatitis

Study Design

Design Details

Primary Purpose : Treatment

Allocation : Randomized

Interventional Model : Parallel Assignment

Masking : None (Open Label)

Arm Groups

Participant Group/Arm	Intervention/Treatment
Experimental: Part 2: Sacituzumab tirumotecan Participants receive 4 mg/kg of sacituzumab tirumotecan Q2W via IV infusion for up to approximately 2 years or 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.	Biological: Sacituzumab tirumotecan IV Infusion Other Names: MK-2870 sac-TMT SKB264 Biological: Bevacizumab IV Infusion Other Names: Avastin Altusan MVASI Drug: H1 receptor antagonist Rescue medication taken per approved product label before sacituzumab tirumotecan Drug: H2 receptor antagonist Rescue medication taken per approved product label before sacituzumab tirumotecan Drug: Acetaminophen (or equivalent) Rescue medication taken per approved product label before sacituzumab tirumotecan Drug: Dexamethasone (or equivalent) Rescue medication taken per approved product label before sacituzumab tirumotecan Drug: Steroid mouthwash (dexamethasone or equivalent) Rescue medication taken orally 2-4 times daily
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.	Biological: Bevacizumab IV Infusion Other Names: Avastin Altusan MVASI

Participant Group/Arm

Intervention/Treatment

Experimental: Part 2: Sacituzumab tirumotecan

Participants receive 4 mg/kg of sacituzumab tirumotecan Q2W via IV infusion for up to approximately 2 years or 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.

Biological: Sacituzumab tirumotecan

IV Infusion
Other Names:
- MK-2870
- sac-TMT
- SKB264

Biological: Bevacizumab

IV Infusion
Other Names:
- Avastin
- Altusan
- MVASI

Drug: H1 receptor antagonist

Rescue medication taken per approved product label before sacituzumab tirumotecan

Drug: H2 receptor antagonist

Rescue medication taken per approved product label before sacituzumab tirumotecan

Drug: Acetaminophen (or equivalent)

Rescue medication taken per approved product label before sacituzumab tirumotecan

Drug: Dexamethasone (or equivalent)

Rescue medication taken per approved product label before sacituzumab tirumotecan

Drug: Steroid mouthwash (dexamethasone or equivalent)

Rescue medication taken orally 2-4 times daily

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.