TroFuse-020/GOG-3101/ENGOT-cx20: A phase 3, randomized, active-controlled, open-label, multicenter study comparing sacituzumab tirumotecan monotherapy vs treatment of physician’s choice as second-line treatment for recurrent or metastatic cervical cancer.
Background: Sacituzumab tirumotecan (sac-TMT; formerly MK-2870/SKB264) is an antibody‒drug conjugate comprising a trophoblast cell-surface antigen 2 (TROP2)–antibody, a hydrolytically-cleavable linker, and the cytotoxic drug KL610023 (average drug/antibody ratio, 7.4). In an ongoing phase 1/2 study (MK-2870-001), sac-TMT monotherapy showed promising antitumor activity in participants with locally advanced unresectable/metastatic solid tumors that were refractory to standard therapies. This phase 3, randomized, open-label, multicenter study (NCT06459180) evaluates the efficacy and safety of sac-TMT monotherapy vs treatment of physician’s choice (TPC) as second-line treatment in participants with recurrent/metastatic cervical cancer. Methods: Eligible participants are aged ≥18 years with progressive recurrent/metastatic cervical cancer, measurable per RECIST version 1.1 by the investigator, and had received 1 prior line of platinum doublet chemotherapy (±bevacizumab) and anti‒PD-1/anti‒PD-L1 therapy as a part of cervical cancer regimens. Participants must provide tissue from a core or excisional biopsy of a not previously irradiated tumor lesion. Approximately 666 participants will be randomly assigned 1:1 to receive either sac-TMT 4 mg/kg intravenously (IV) Q2W or TPC (pemetrexed 500 mg/m2 IV Q3W; tisotumab vedotin 2 mg/kg IV Q3W; topotecan 1 or 1.25 mg/m2 on days 1–5 of each 3-week treatment cycle; vinorelbine 30 mg/m2 on days 1 and 8 of each 3-week treatment cycle; gemcitabine 1000 mg/m2 on days 1 and 8 of each 3-week treatment cycle; or irinotecan 100 or 125 mg/m2 on days 1, 8, 15, and 22 of each 6-week treatment cycle). Tumor imaging will be performed ≤28 days before treatment allocation/randomisation, then Q9W until week 54 and Q12W thereafter. The primary endpoint is OS; secondary endpoints include PFS assessed by blinded independent central review, objective response, duration of response, safety, time to deterioration, and patient-reported outcomes. Enrollment began in Q3 2024.
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Author Details
Ritu Salani
Department of Obstetrics and Gynecology, University of California Los Angeles, Los Angeles, CA
Abstract Details
Meeting
2025 ASCO Annual Meeting
Session Type
Poster Session
Session Title
Gynecologic Cancer
Track
Gynecologic Cancer
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