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    DRUG:

    Jelmyto (mitomycin urothelial gel)

    i
    Other names: UGN-101
    Company:
    UroGen
    Drug class:
    DNA synthesis inhibitor
    Related drugs:
    19d
    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, INSPIRE Trial (clinicaltrials.gov)
    P2, N=11, Active, not recruiting, National Cancer Institute (NCI) | N=95 --> 11 | Trial completion date: Jun 2026 --> May 2027 | Trial primary completion date: Jun 2026 --> Feb 2026
    Enrollment change • Trial completion date • Trial primary completion date
    |
    cisplatin • Imfinzi (durvalumab) • gemcitabine • Jelmyto (mitomycin urothelial gel) • fluorouracil topical
    1m
    SeqUential GeMcitabine and MITomycin Treatment for Favorable High-Risk Upper Urinary Tract Urothelial Carcinoma (clinicaltrials.gov)
    P2, N=28, Recruiting, Rutgers, The State University of New Jersey | Not yet recruiting --> Recruiting
    Enrollment open
    |
    gemcitabine • Jelmyto (mitomycin urothelial gel)
    2ms
    Testing Shorter Duration Radiation Therapy Versus the Usual Radiation Therapy in Patients Receiving the Usual Chemotherapy Treatment for Bladder Cancer, ARCHER Study (clinicaltrials.gov)
    P3, N=486, Recruiting, NRG Oncology | Initiation date: May 2026 --> Oct 2025
    Trial initiation date
    |
    cisplatin • gemcitabine • Jelmyto (mitomycin urothelial gel) • fluorouracil topical
    2ms
    Therapy Adapted for High Risk and Low Risk HIV-Associated Anal Cancer (clinicaltrials.gov)
    P2, N=40, Active, not recruiting, National Cancer Institute (NCI) | Recruiting --> Active, not recruiting
    Enrollment closed
    |
    IFNG (Interferon, gamma) • CD4 (CD4 Molecule)
    |
    Opdivo (nivolumab) • capecitabine • Jelmyto (mitomycin urothelial gel) • fluorouracil topical • ABP 206 (nivolumab biosimilar)
    2ms
    In-home Intravesical Chemotherapy for the Treatment of Bladder Cancer, INVITE Trial (clinicaltrials.gov)
    P1/2, N=40, Recruiting, Mayo Clinic | Trial completion date: Jun 2026 --> Dec 2026 | Trial primary completion date: Jun 2026 --> Dec 2026
    Trial completion date • Trial primary completion date
    |
    gemcitabine • docetaxel • Jelmyto (mitomycin urothelial gel) • Tice BCG (live attenuated bacillus Calmette-Guerin)
    3ms
    Phase II Trial of Lung Chemoemobolization (clinicaltrials.gov)
    P2, N=30, Recruiting, City of Hope Medical Center | Trial completion date: Oct 2026 --> Oct 2027 | Trial primary completion date: Oct 2026 --> Oct 2027
    Trial completion date • Trial primary completion date
    |
    Jelmyto (mitomycin urothelial gel)
    4ms
    UT002: A Phase 3 Single-arm Study of UGN-104 for the Treatment of LG-UTUC (2024-519343-15-00)
    P2/3, N=59, Recruiting, Urogen Pharma Ltd.
    New P2/3 trial
    |
    Jelmyto (mitomycin urothelial gel)
    4ms
    Testing Shorter Duration Radiation Therapy Versus the Usual Radiation Therapy in Patients Receiving the Usual Chemotherapy Treatment for Bladder Cancer, ARCHER Study (clinicaltrials.gov)
    P3, N=486, Recruiting, NRG Oncology | Not yet recruiting --> Recruiting | Initiation date: Aug 2025 --> May 2026
    Enrollment open • Trial initiation date
    |
    cisplatin • gemcitabine • Jelmyto (mitomycin urothelial gel) • fluorouracil topical
    5ms
    Therapy Adapted for High Risk and Low Risk HIV-Associated Anal Cancer (clinicaltrials.gov)
    P2, N=40, Recruiting, National Cancer Institute (NCI) | Trial completion date: Sep 2029 --> Sep 2031 | Trial primary completion date: Sep 2029 --> Sep 2031
    Trial completion date • Trial primary completion date
    |
    IFNG (Interferon, gamma) • CD4 (CD4 Molecule)
    |
    Opdivo (nivolumab) • capecitabine • Jelmyto (mitomycin urothelial gel) • fluorouracil topical • ABP 206 (nivolumab biosimilar)
    6ms
    Pressurized Intraperitoneal Aerosolized Chemotherapy With Mitomycin for the Treatment of Unresectable Appendix or Colorectal Cancer With Peritoneal Metastases, The IMPACT Trial (clinicaltrials.gov)
    P3, N=129, Not yet recruiting, City of Hope Medical Center
    New P3 trial
    |
    Avastin (bevacizumab) • irinotecan • Aybintio (bevacizumab biosimilar) • leucovorin calcium • Vegzelma (bevacizumab-adcd) • Avzivi (bevacizumab-tnjn) • Jelmyto (mitomycin urothelial gel) • fluorouracil topical
    7ms
    SeqUential GeMcitabine and MITomycin Treatment for Favorable High-Risk Upper Urinary Tract Urothelial Carcinoma (clinicaltrials.gov)
    P2, N=28, Not yet recruiting, Rutgers, The State University of New Jersey | Initiation date: Aug 2025 --> Jun 2026
    Trial initiation date
    |
    gemcitabine • Jelmyto (mitomycin urothelial gel)
    7ms
    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: Aug 2026 --> Jan 2028 | Trial primary completion date: Aug 2026 --> Jan 2028
    Trial completion date • Trial primary completion date
    |
    cisplatin • paclitaxel • doxorubicin hydrochloride • albumin-bound paclitaxel • oxaliplatin • irinotecan • daunorubicin • leucovorin calcium • Jelmyto (mitomycin urothelial gel) • fluorouracil topical