AGEN1884 Plus AGEN2034 Combined With Cisplatin-Gemcitabine for Muscle-Invasive Bladder Cancer

  • STATUS
    Recruiting
  • End date
    Jul 26, 2030
  • participants needed
    42
  • sponsor
    The University of Texas Health Science Center at San Antonio
Updated on 26 January 2021
radical cystectomy
cancer
carcinoma
gilbert's syndrome
neutrophil count
gemcitabine
conjugated bilirubin
antineoplastic
bladder cancer
invasive bladder cancer
transitional cell carcinoma
cisplatin/gemcitabine
bladder tumor
bladder carcinoma
metastatic bladder carcinoma
metastatic urothelial carcinoma

Summary

This is a phase II trial to evaluate the tolerability, efficacy, and immune outcomes of AGEN1884 plus AGEN2034 concurrent with cisplatin and gemcitabine in the neoadjuvant treatment of muscle-invasive, non-metastatic bladder cancer prior to radical cystectomy.

Description

We will begin with an initial safety run-in to establish the safety of the combination prior to expansion to the full planned phase II. The overall phase II will be an open-label, single arm study in two stages to evaluate the efficacy of the combination in pathologic downstaging of MIBC. Patients will receive four 21-day cycles of neoadjuvant therapy consisting of cisplatin and gemcitabine plus AGEN2034 in all 4 cycles and AGEN1884 in cycles 1 and 3. Patients will proceed to radical cystectomy within 10 weeks after the final dose of this therapy. The primary endpoint of pathologic tumor downstaging will be assessed at the time of cystectomy.

Details
Condition urinary tract neoplasm, bladder cancer, bladder disorder, Urothelial Cancer, Bladder Disorders, Bladder Carcinoma, Urologic Cancer, bladder tumor
Treatment cisplatin, Gemcitabine, AGEN1884, AGEN2034
Clinical Study IdentifierNCT04430036
SponsorThe University of Texas Health Science Center at San Antonio
Last Modified on26 January 2021

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