Subcategory
Urothelial carcinoma of the urinary bladder (incl. renal pelvis, ureter)
Trial Type
other systemic therapies
Description for experts
The objective of this study is to evaluate the efficacy and safety of sacituzumab govitecan-hziy monotherapy and with novel combinations in participants with metastatic urothelial cancer (mUC).
Description for laymen
Efficacy and safety of sacituzumab in metastatic or locally advanced unresectable urothelial carcinoma
JSON Data
{
"short_title": "TROPHY U-01",
"data_mode": "900",
"data_mode_number": "000002299",
"official_title": "A Phase II Open-Label Study of Sacituzumab Govitecan in Unresectable Locally Advanced/Metastatic Urothelial Cancer",
"accrual_state": "running",
"therapeutic_value": "therapeutic",
"therapieansatz_value": "palliativ",
"therapieintervention_value": "adjuvant",
"therapielinie_value": "not_applicable",
"ctgov_number": "NCT03547973",
"eudract_number": "2018-001167-23",
"general_contact_email": null,
"general_contact_phone": null,
"hauptpruefer_dd_name": "Prof. Dr. med. Christian Thomas",
"description_laie_de": "Wirksamkeit und Sicherheit von Sacituzumab bei metastasiertem oder lokal fortgeschrittenem nicht resektablem Urothelkarzinom",
"description_laie_en": "Efficacy and safety of sacituzumab in metastatic or locally advanced unresectable urothelial carcinoma",
"description_expert_de": "Ziel dieser Studie ist es, die Wirksamkeit und Sicherheit von Sacituzumab Govitecan-Hziy als Monotherapie und mit neuen Kombinationen bei Teilnehmern mit metastasiertem Urothelkarzinom (mUC) zu untersuchen.",
"description_expert_en": "The objective of this study is to evaluate the efficacy and safety of sacituzumab govitecan-hziy monotherapy and with novel combinations in participants with metastatic urothelial cancer (mUC).",
"rechtsgrundlage_value": "AMG",
"phase_amg_value": "II",
"main_cat_id": 11,
"sub_cat_id": 52
}
