Phase 1b/2 Study of Rogaratinib (BAY1163877) in Combination With Atezolizumab in Urothelial Carcinoma

An International, Multicenter, Phase 1b/2 Study of Rogaratinib (BAY1163877) in Combination With Atezolizumab as First-line Treatment in Cisplatin-ineligible Patients With FGFR-positive Locally Advanced or Metastatic Urothelial Carcinoma

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2080223991

Enrollment

Registered

2018-08-02

Start date

2018-10-29

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Urothelial Carcinoma

Interventions

investigational material(s) Generic name etc : INN of investigational material : Rogaratinib Therapeutic category code : 429 Other antitumor agents Dosage and Administration for Investigational mater

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - High FGFR1 or 3 mRNA expression levels (RNAscope score of 3+ or 4+) in archival or fresh tumor biopsy specimen - Documented locally advanced (T4, any N; or any T, N2-3) or metastatic urothelial carcinoma (transitional cell carcinoma) including urinary bladder, renal pelvis, ureters, urethra, meeting all of the following criteria: - No prior systemic treatment for locally advanced or metastatic urothelial carcinoma. - Ineligibility for cisplatin-based chemotherapy - Eastern Cooperative Oncology Group Performance Status (ECOG PS) 0 or 1

Exclusion criteria

Exclusion criteria: - History of autoimmune disease, including but not limited to myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, vascular thrombosis associated with anti-phospholipid syndrome, granulomatosis with polyangiitis, Sjogrens syndrome, Guillain-Barre syndrome, multiple sclerosis, vasculitis, or glomerulonephritis. - Current diagnosis of any retinal disorders including retinal detachment, retinal pigment epithelial detachment (RPED), serous retinopathy or retinal vein occlusion. - Current evidence of endocrine alteration of calcium phosphate homeostasis (e.g. parathyroid disorder, history of parathyroidectomy, tumor lysis, tumoral calcinosis, paraneoplastic hypercalcemia).

Design outcomes

Primary

Measure	Time frame
safety Part A: Number of subjects with Dose-limiting toxicities(DLTs) Part B: Progression Free Survival(PFS) Part A: Up to 21 days Part B: Up to 25 months	—

Secondary

Measure	Time frame
efficacy pharmacokinetics Part A: Objective Response Rate(ORR) Part B: Disease Control Rate(DCR), Duration of Response(DOR), Overall Survival(OS) Part A: Up to 5 months Part B: Up to 25 months	—

Countries

Asia except Japan, Europe, Japan, North America

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026