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)
MK-2870 Maintenance Treatment With or Without Bevacizumab in 2L PSROC
- 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 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.
18age old over
No limit
Female
Ovarian cancer recurrent
Part 1:Sacituzumab tirumotecan + Bevacizumab
Sacituzumab tirumotecan 4 mg/kg IV q2w in combination with bevacizumab 15 mg/kg IV q3w.
Part 2 Arm 1: Sacituzumab tirumotecan
Sacituzumab tirumotecan 4 mg/kg IV q2w on Days 1, 15, and 29 of every 6-week cycle until disease progression, prohibitive toxicity, or other protocol-defined reason for discontinuation of study intervention. At the physician's discretion,Bevacizumab 15 mg/kg IV q3w on Days 1 and 22 of every 6-week cycle until disease progression, prohibitive toxicity, or other protocol-defined reason for discontinuation of study intervention.
Part 2 Arm 2: Standard of care (SoC)
Observation. At the physician's discretion, Bevacizumab 15 mg/kg IV q3w on Days 1 and 22 of every 6-week cycle until disease progression, prohibitive toxicity, or other protocol-defined reason for discontinuation of study intervention.
Part 1: To evaluate the safety and tolerability of sacituzumab tirumotecan maintenance treatment with bevacizumab.
Part 2: To compare sacituzumab tirumotecan maintenance treatment with or without bevacizumab to SoC (observation with or without bevacizumab) with respect to PFS per RECIST 1.1 as assessed by BICR.
Part 2:
- To compare sacituzumab tirumotecan maintenance treatment with or without bevacizumab to SoC with respect to OS.
- To evaluate the safety and tolerability of sacituzumab tirumotecan maintenance treatment with or without bevacizumab.
- To evaluate sacituzumab tirumotecan maintenance treatment with or without bevacizumab versus SoC with respect to the mean change from baseline of global health status/QoL score using the EORTC QLQ-C30 and abdominal/GI symptoms using the EORTC QLQ-OV28 abdominal/GI symptom scale.
MSD K.K.
Cancer Institute Hospital of JFCR, Institutional Review Board
3-8-31, Ariake, Koto-ku, Tokyo
Approval
Mar. 05, 2025
Yes
https://engagezone.msd.com/
NCT06824467
ClinicalTrials.gov
United States of America/Canada/Argentina/Brazil/Chile/Colombia/Mexico/Peru/Austria/Belgium/Bulgaria/Czech Republic/Denmark/Finland/France/Germany/Greece/Hungary/Ireland/Israel/Italy/Poland/Portugal/Romania/Spain/Sweden/Turkey/United Kingdom/Australia/Refer to 7-5
