West Cancer Center

Bladder: Metastatic: Phase I: 2nd Line: FIERCE-22

A Multi-Center, Open-Label Phase 1b/2 Study of a Novel FGFR3 Inhibitor (B-701) Combined With Pembrolizumab in Subjects With Locally Advanced or Metastatic Urothelial Carcinoma Who Have Progressed Following Platinum-based Chemotherapy

Title

Rainier B701-U22 (FIERCE-22)

Study Title

Site Link

NCT03123055

Malignancy

Bladder, Urothelial, Metastatic Bladder Cancer, MBC, Transitional Cell Carcinoma

Stage

Stage 4

Disease Setting

Metastatic/Palliative

Line Of Therapy

2nd Line

Investigational Agent

vofatamab, pembrolizumab

Drug Class

FGFR3 inhibitor, PD-1 inhibitor

Dan Vaena, MD

Sponsor

Rainier Therapeutics

Phase

Phase 1

Status

Closed to Accrual

Key Eligibility Criteria

Key Eligibility Criteria Details

Have histologically confirmed locally advanced (on TNM staging: T4b and any N, or any T and N2-3) or metastatic transitional cell carcinoma of the urothelium, including of the urinary bladder, urethra, ureter, and/or renal pelvis.
Have progression during or following platinum-containing chemotherapy or within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy
Have measurable disease according to RECIST v1.1.
Has available archival tumor or is willing to undergo diagnostic biopsy at screening
ECOG PS 0-1
No history of idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced pneumonitis, idiopathic pneumonitis, or evidence of active pneumonitis on the Screening chest CT scan
No CNS disease or any history of brain metastases
No autoimmune disease
No history of significant coagulation or platelet disorder in last 12 months

Objective

Primary: Safety and Tolerability; ORR
Secondary: DOR, DCR, PFS, OS, QOL, Biomarker

Assessment Frequency

Assessment Frequency 2

Assessment Frequency Link

Path

Transitional Cell Carcinoma

Dosing Frequency

Control Agents

Study Protocol

Randomized