Trial reportJournal of clinical oncology : official journal of the American Society of Clinical Oncology2024
TROPHY-U-01 Cohort 2: A Phase II Study of Sacituzumab Govitecan in Cisplatin-Ineligible Patients With Metastatic Urothelial Cancer Progressing After Previous Checkpoint Inhibitor Therapy.
Trial report in Journal of clinical oncology : official journal of the American Society of Clinical Oncology, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03547973 (A Phase II Open-Label Study of Sacituzumab Govitecan in Unresectable Locally Advanced/Metastatic Urothelial Cancer), which is not on this map. Cited by 14 papers, 2 of them syntheses that pooled it.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
A Phase II Open-Label Study of Sacituzumab Govitecan in Unresectable Locally Advanced/Metastatic Urothelial Cancer
Who cites it
14 citing papers in PubMed, 2 syntheses or guidelines pooled it.
- Antibody-Drug Conjugates for Locally Advanced and Metastatic Urothelial Carcinoma: A Systematic Review and Meta-Analysis.JAMA network open · 2026Pooled it
- Efficacy and safety of Sacituzumab govitecan in solid tumors: a systematic review and meta-analysis.Frontiers in oncology · 2025Pooled it
- Review
- Clinical Pharmacology and Translational Science Considerations in the Development of Dual-Payload Antibody Drug Conjugates.Clinical and translational science · 2026Review
- Antibody-Drug Conjugates in Oncology: Principles, Clinical Development, and Future Directions.MedComm · 2026Review
- Application of antibody-drug conjugates in locally advanced or metastatic urothelial carcinoma: mechanisms, treatment-related adverse events, and management strategies.Frontiers in pharmacology · 2026Review
- Progress of antibody-drug conjugates in the treatment of locally advanced or metastatic urothelial carcinoma: opportunities and challenges.Discover oncology · 2025Review
- Immune Checkpoint Inhibitors and Antibody-Drug Conjugates in Urothelial Carcinoma: Current Landscape and Future Directions.Cancers · 2025Review
- Targeted treatment for craniopharyngioma.Journal of neuro-oncology · 2025Review
- The Mode of Action and Clinical Outcomes of Sacituzumab Govitecan in Solid Tumors.Clinical cancer research : an official journal of the American Association for Cancer Research · 2025Review
- Nuclear Medicine and Molecular Imaging in Urothelial Cancer: Current Status and Future Directions.Cancers · 2025Review
- Efficacy and safety of antibody-drug conjugates in the treatment of advanced urological cancers: a systematic review and a meta-analysis.Frontiers in pharmacology · 2025Review
- 2023 American Society of Clinical Oncology Genitourinary (ASCO-GU) Cancers Symposium Meeting highlights.Canadian Urological Association journal = Journal de l'Association des urologues du Canada · 2023Article
- Therapeutic Applications and Target Strategies of Antibody-Drug Conjugates in Ovarian Cancer.Iranian journal of pharmaceutical research : IJPRReview
Corrections and comments
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Authors and funding
19 authors.
Funding
Abstract
purposeSacituzumab govitecan (SG) is a Trop-2-directed antibody-drug conjugate with an SN-38 payload, approved for patients with locally advanced (LA) or metastatic urothelial cancer (mUC) who progressed after platinum (PT)-based chemotherapy and a checkpoint inhibitor (CPI). Here, we report results from Cohort 2 of TROPHY-U-01 trial, evaluating the efficacy and safety of SG in patients with mUC.
methodsTROPHY-U-01 (ClinicalTrials.gov identifier: NCT03547973) is a multicohort, open-label phase II study. Cohort 2 includes patients with LA or mUC who have had progression or recurrence after a CPI and were cisplatin-ineligible at study initiation. Patients received SG 10 mg/kg on days 1 and 8 of 21-day cycles. The primary end point was objective response rate (ORR) per central review; secondary end points were clinical benefit rate (CBR), duration of response (DOR), and progression-free survival (PFS) per central review and safety.
resultsCohort 2 included 38 patients (61% male; median age 72.5 years; 66% visceral metastases [29% liver]; 50% received previous PT-based chemotherapy as previous [neo]adjuvant therapy]). At a median follow-up of 9.3 months, ORR was 32% (95% CI, 17.5 to 48.7), CBR 42% (95% CI, 26.3 to 59.2), median DOR 5.6 months (95% CI, 2.8 to 13.3), median PFS 5.6 months (95% CI, 4.1 to 8.3), and median overall survival 13.5 months (95% CI, 7.6 to 15.6). Grade ≥3 treatment-emergent adverse events occurred in 87% of patients, most commonly neutropenia (34%), anemia (24%), leukopenia (19%), fatigue (18%), and diarrhea (16%).
conclusionSG monotherapy demonstrated a relatively high ORR with rapid responses; this was feasible with a manageable toxicity profile in cisplatin-ineligible patients who had progression after CPI therapy. Limitations include a moderate sample size and lack of random assignment. These results warrant further evaluation of SG alone and in combinations in patients with LA/mUC.
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