Research & Innovation

Bladder Clinical Trials

Clinical Trials

Incyte INCB 54828-201

A Phase 2, Open-label, Single Agent, Multi-Center Study to Evaluate the Efficacy and Safety of INCB054828 in Subjects with Metastatic or Surgically Unresectable Urothelial Carcinoma Harboring FGF/FGFR Alterations

Physician & Study Coordinator


Sanjiv Agarwala, MD

Sanjiv Agarwala, MD

Study Coordinator

Megan Gavinski, BS




Treatment Agent: INCB054828

Synopsis: The primary purpose of this research study is to assess how metastatic or surgically unresectable Urothelial Carcinoma with FGF/FGFR alterations responds to treatment with INCB054828. The other goals of the study are to determine how safe and well tolerated the study drug, INCB054828, is, and to obtain data to try and identify patients who would benefit most from INCB054828.


Inclusion Criteria
  • Histologically documented metastatic or surgically unresectable urothelial carcinoma; may include primary site from ureters, upper tract, renal pelvis, and bladder.
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0-2.
  • Life expectancy ≥ 12 weeks.
  • Radiographically measurable or evaluable disease per RECIST v1.1.
  • Known FGF/FGFR alteration from the sponsor's central laboratory and have either 1) failed at least 1 previous treatment for their metastatic or surgically unresectable urothelial carcinoma (ie, chemotherapy, immunotherapy) or 2) are platinum ineligible.


Exclusion Criteria
  • Patients on supportive care only and not receiving anti-cancer therapy are not eligible to enroll
  • Patients with unknown date of diagnosis of cHL
  • Patients whose prior cHL therapy, and dates of therapy (eg, surgery, radiation, or drug therapy) are unknown
  • Any other non-HL (non-Hodgkin Lymphoma) active malignancy for which the patient is receiving treatment
  • Patients participating in a clinical study that does not allow enrollment into a non-interventional study
  • Patients enrolled who go on to receive only supportive, palliative, hospice, or end-of-life care remain on study and should not be discontinued from follow-up.

Other protocol defined inclusion/exclusion criteria could apply