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    DRUG:

    Jelmyto (mitomycin urothelial gel)

    i
    Other names: UGN-101
    Company:
    UroGen
    Drug class:
    DNA synthesis inhibitor
    Related drugs:
    4ms
    PIPAC for the Treatment of Peritoneal Carcinomatosis in Patients With Ovarian, Uterine, Appendiceal, Colorectal, or Gastric Cancer (clinicaltrials.gov)
    P1, N=49, Recruiting, City of Hope Medical Center | Trial completion date: Dec 2025 --> Aug 2026 | Trial primary completion date: Dec 2025 --> Aug 2026
    Trial completion date • Trial primary completion date
    |
    cisplatin • doxorubicin hydrochloride • oxaliplatin • irinotecan • daunorubicin • leucovorin calcium • Jelmyto (mitomycin urothelial gel) • fluorouracil topical
    6ms
    SHIELD-RT: Chemoradiotherapy With or Without Atezolizumab in Treating Patients With Localized Muscle Invasive Bladder Cancer (clinicaltrials.gov)
    P3, N=475, Active, not recruiting, National Cancer Institute (NCI) | Recruiting --> Active, not recruiting
    Enrollment closed
    |
    PD-L1 (Programmed death ligand 1) • CD4 (CD4 Molecule)
    |
    cisplatin • Tecentriq (atezolizumab) • gemcitabine • Jelmyto (mitomycin urothelial gel) • fluorouracil topical
    10ms
    PIPAC for the Treatment of Peritoneal Carcinomatosis in Patients With Ovarian, Uterine, Appendiceal, Colorectal, or Gastric Cancer (clinicaltrials.gov)
    P1, N=49, Recruiting, City of Hope Medical Center | Trial completion date: Dec 2023 --> Dec 2025 | Trial primary completion date: Dec 2023 --> Dec 2025
    Trial completion date • Trial primary completion date
    |
    cisplatin • doxorubicin hydrochloride • oxaliplatin • irinotecan • daunorubicin • leucovorin calcium • Jelmyto (mitomycin urothelial gel) • fluorouracil topical
    12ms
    Chemoembolization With or Without Sorafenib Tosylate in Treating Patients With Liver Cancer That Cannot Be Removed by Surgery (clinicaltrials.gov)
    P3, N=235, Completed, National Cancer Institute (NCI) | Active, not recruiting --> Completed | Trial completion date: Jun 2023 --> Dec 2022
    Trial completion • Trial completion date • Surgery
    |
    cisplatin • sorafenib • Jelmyto (mitomycin urothelial gel)
    12ms
    uTRACT Jelmyto Registry: A Registry of Patients With Upper Tract Urothelial Cancer (UTUC) Treated With Jelmyto (clinicaltrials.gov)
    P=N/A, N=400, Recruiting, UroGen Pharma Ltd. | Not yet recruiting --> Recruiting | Trial completion date: Jul 2028 --> Jan 2028 | Initiation date: Jul 2023 --> Nov 2023 | Trial primary completion date: Oct 2025 --> Apr 2025
    Enrollment open • Trial completion date • Trial initiation date • Trial primary completion date • Real-world evidence • Real-world
    |
    Jelmyto (mitomycin urothelial gel)
    1year
    A Study of Chemotherapy and Radiation Therapy Compared to Chemotherapy and Radiation Therapy Plus MEDI4736 (Durvalumab) Immunotherapy for Bladder Cancer Which Has Spread to the Lymph Nodes (The INSPIRE Study) (clinicaltrials.gov)
    P2, N=95, Active, not recruiting, National Cancer Institute (NCI) | Recruiting --> Active, not recruiting
    Enrollment closed
    |
    cisplatin • Imfinzi (durvalumab) • gemcitabine • Jelmyto (mitomycin urothelial gel) • fluorouracil topical
    over1year
    First analysis of the safety and efficacy of UGN-101 in the treatment of ureteral tumors. (PubMed, Urol Oncol)
    UGN-101 appears to be safe and may have similar efficacy in treating low-grade urothelial carcinoma of the ureter as compared to renal pelvic tumors.
    Journal
    |
    Jelmyto (mitomycin urothelial gel)
    over1year
    Intracavitary Chemotherapy after kidney-Sparing Therapy for Upper Tract Urothelial Carcinoma: A Meta-Analysis. (PubMed, Urol J)
    With the advent of new drugs, including UGN101, patients with UTUC have a better prognosis. Therefore, kidney preservation therapy for patients with UTUC would be promising.
    Retrospective data • Journal
    |
    Jelmyto (mitomycin urothelial gel)
    over1year
    Efficacy and Safety of Mitomycin Gel (UGN-101) as an Adjuvant Therapy After Complete Endoscopic Management of Upper Tract Urothelial Carcinoma. (PubMed, J Urol)
    No abstract available
    Journal
    |
    Jelmyto (mitomycin urothelial gel)
    over1year
    Therapy Adapted for High Risk and Low Risk HIV-Associated Anal Cancer (clinicaltrials.gov)
    P2, N=53, Recruiting, National Cancer Institute (NCI) | Trial completion date: Jul 2024 --> Sep 2029 | Trial primary completion date: Jul 2024 --> Sep 2029
    Trial completion date • Trial primary completion date
    |
    IFNG (Interferon, gamma) • CD4 (CD4 Molecule)
    |
    Opdivo (nivolumab) • capecitabine • Jelmyto (mitomycin urothelial gel) • fluorouracil topical
    over1year
    Route of Administration for UGN-101 and Impact on Oncological and Safety Outcomes. (PubMed, Eur Urol Focus)
    These preliminary results show a significantly lower rate of stricture occurrence with antegrade administration of UGN-101, with no apparent impact on oncological efficacy.
    Journal
    |
    Jelmyto (mitomycin urothelial gel)
    over1year
    The ablative effect of mitomycin reverse thermal gel: Expanding the role for nephron preservation therapy in low grade upper tract urothelial carcinoma. (PubMed, Urol Oncol)
    The results of the early real-world experience suggest that UGN-101 may play a role in initial chemo-ablative cytoreduction of larger volume low-grade tumors that may not initially appear to be amenable to renal preservation. Further studies will help to better quantify the chemo-ablative effect and to identify clinical factors for patient selection.
    Journal
    |
    Jelmyto (mitomycin urothelial gel)
    over1year
    uTRACT Jelmyto Registry: A Registry of Patients With Upper Tract Urothelial Cancer (UTUC) Treated With Jelmyto (clinicaltrials.gov)
    P=N/A, N=400, Not yet recruiting, UroGen Pharma Ltd.
    New trial • Real-world evidence • Real-world
    |
    Jelmyto (mitomycin urothelial gel)
    over2years
    SHIELD-RT: Chemoradiotherapy With or Without Atezolizumab in Treating Patients With Localized Muscle Invasive Bladder Cancer (clinicaltrials.gov)
    P3, N=475, Recruiting, National Cancer Institute (NCI) | Trial completion date: Jun 2025 --> Jun 2027 | Trial primary completion date: Jun 2025 --> Jun 2027
    Trial completion date • Trial primary completion date
    |
    PD-L1 (Programmed death ligand 1) • CD4 (CD4 Molecule)
    |
    cisplatin • Tecentriq (atezolizumab) • gemcitabine • Jelmyto (mitomycin urothelial gel) • fluorouracil topical
    almost3years
    Hyperthermic Intraperitoneal Chemotherapy for the Treatment of Pancreatic Cancer and Peritoneal Metastasis (clinicaltrials.gov)
    P2, N=4, Active, not recruiting, Mayo Clinic | Not yet recruiting --> Active, not recruiting | N=40 --> 4 | Initiation date: Dec 2021 --> Apr 2020 | Trial primary completion date: May 2025 --> Aug 2021
    Clinical • Enrollment closed • Enrollment change • Trial initiation date • Trial primary completion date
    |
    KRAS (KRAS proto-oncogene GTPase)
    |
    cisplatin • mitomycin • Jelmyto (mitomycin urothelial gel)
    almost3years
    Therapy Adapted for High Risk and Low Risk HIV-Associated Anal Cancer (clinicaltrials.gov)
    P2, N=53, Recruiting, National Cancer Institute (NCI) | Not yet recruiting --> Recruiting | Trial completion date: Apr 2023 --> Jul 2024 | Trial primary completion date: Apr 2023 --> Jul 2024
    Enrollment open • Trial completion date • Trial primary completion date
    |
    IFNG (Interferon, gamma) • CD4 (CD4 Molecule)
    |
    Opdivo (nivolumab) • 5-fluorouracil • capecitabine • Jelmyto (mitomycin urothelial gel) • fluorouracil topical
    3years
    Therapy Adapted for High Risk and Low Risk HIV-Associated Anal Cancer (clinicaltrials.gov)
    P2, N=53, Not yet recruiting, National Cancer Institute (NCI) | Initiation date: Oct 2021 --> Feb 2022
    Trial initiation date
    |
    IFNG (Interferon, gamma) • CD4 (CD4 Molecule)
    |
    Opdivo (nivolumab) • 5-fluorouracil • capecitabine • Jelmyto (mitomycin urothelial gel) • fluorouracil topical
    3years
    Hyperthermic Intraperitoneal Chemotherapy for the Treatment of Pancreatic Cancer and Peritoneal Metastasis (clinicaltrials.gov)
    P2, N=40, Not yet recruiting, Mayo Clinic | Initiation date: Aug 2021 --> Nov 2021
    Clinical • Trial initiation date
    |
    KRAS (KRAS proto-oncogene GTPase)
    |
    cisplatin • mitomycin • Jelmyto (mitomycin urothelial gel)