Condition

Advanced HRD-Negative Ovarian Cancer

Purpose of the study

To compare sac-TMT maintenance treatment with or without bevacizumab to SoC, with respect to PFS per RECIST 1.1 as assessed by BICR.

Official Title

A Phase 3, Randomized, Open-label, Multicenter Study of Sacituzumab Tirumotecan (sac-TMT, MK-2870) Maintenance Treatment With or Without Bevacizumab Versus Standard of Care in Participants With Newly Diagnosed Advanced HRD-Negative Ovarian Cancer Following First-line Platinum-based Chemotherapy (TroFuse-021/ENGOTov85/GOG-3102).

Who is eligible to participate?

Inclusion Criteria

• Is assigned female sex at birth,
• Has histologically confirmed FIGO Stage III or Stage IV, EOC primary peritoneal cancer, or fallopian tube cancer.
• Has undergone PDS or IDS.
• Must have completed at least 4 cycles but no more than 6 cycles of 1L platinum-based chemotherapy.
• The interval between the last dose of 1L platinum-based chemotherapy and randomization must be no longer than 12 weeks. ·
• Participants are not eligible to receive PARPi as 1L maintenance treatment according to the investigator.
• A POCBP is eligible to participate if not pregnant and if a negative highly sensitive pregnancy test has been obtained within 24 hours (for a urine test) or 72 hours (for a serum test) before the first dose of study intervention.
• A POCBP is eligible to participate if they use a contraceptive method that is highly effective (with a failure rate of <1% per year)

Exclusion criteria:

• Has nonepithelial cancers (germ cell tumors and sex cord-stromal tumors), borderline tumors (low malignant potential) mucinous, seromucinous that is predominately mucinous, malignant Brenner’s tumor, and undifferentiated carcinoma.
• Has known active CNS metastases
• 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 (eg, Crohn’s disease, ulcerative colitis, or chronic diarrhea).
• Has uncontrolled, significant cardiovascular disease or cerebrovascular disease.
• Received a live or live-attenuated vaccine within 30 days before randomization. Administration of killed vaccines is allowed.
• Has intraperitoneal chemotherapy planned or has been administered as 1L therapy.
• Has an HRD-positive, unknown, or inconclusive status as determined by the central laboratory.
• Has either an unknown or unevaluable TROP2 test result from the central laboratory.
• Active infection requiring systemic therapy.
• Participants who have not adequately recovered from major surgery (other than IDS or PDS) or have ongoing surgical complications.

Register your interest

To register your interest or find out more information about this clinical trial, please email: enquiries@gallipoliresearch.org.au. 

Study location

Gallipoli Medical Research, Greenslopes Private Hospital, Brisbane