Phase 2
N=95
Derazantinib and Atezolizumab in Patients With Urothelial Cancer
Urothelial Carcinoma
Bottom Line
View on ClinicalTrials.gov: NCT04045613 ↗Enrolled (actual)
95
Serious AEs
47.4%
Results posted
Oct 2023
Primary outcome: Primary: Objective Response Rate (ORR) Based on RECIST 1.1 (Substudies 1,3,4 and 5) — 9.4; 0.0; 14.3; 0.0 Percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Derazantinib 300 mg once daily monotherapy (Drug); Derazantinib 200 mg once daily + atezolizumab 1200 mg (Drug); Derazantinib 300 mg once daily+ atezolizumab 1200 mg (Drug); Derazantinib 200 mg twice daily + atezolizumab 1200 mg (Drug); Derazantinib 300 mg once daily monotherapy (QD) (Drug); Derazantinib 300 mg once daily + atezolizumab 1200 mg (Drug); Derazantinib 200 mg twice daily monotherapy (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Basilea Pharmaceutica
- Primary completion
- Oct 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Objective Response Rate (ORR) Based on RECIST 1.1 (Substudies 1,3,4 and 5) |
9.4; 0.0; 14.3; 0.0; 5.9 | — |
| PRIMARY Recommended Phase 2 Dose (RP2D) of Derazantinib-atezolizumab in Combination Based on DLT Criteria, Safety and Efficacy Data (Substudy 2) |
300 | — |
| PRIMARY Number of Patients With Dose-limiting Toxicities (DLTs) in Substudy 2 |
0; 0 | — |
| SECONDARY Disease Control Rate (DCR) Per RECIST 1.1 in All Substudies |
18.8; 18.2; 50.0; 50.0; 28.6; 20.0 | — |
| SECONDARY Duration of Response (DOR) Per RECIST 1.1 |
6.9; NA; 7.4; NA; 3.3; NA | — |
| SECONDARY ORR Based on RECIST 1.1 (Substudy 2) |
0.0; 16.7 | — |
| SECONDARY Progression-free Survival (PFS) by RECIST in All Substudies |
2.0; 2.0; 4.2; 2.5; 2.0; 1.9 | — |
| SECONDARY Overall Survival (OS) in All Substudies |
4.7; 8.7; 12.6; 4.2; NA; 6.2 | — |
| SECONDARY Number of Patients With at Least Grade 3 Adverse Events (AEs) |
11; 5; 7; 0; 2; 5 | — |
Summary
The purpose of this study was to evaluate efficacy of derazantinib monotherapy or derazantinib-atezolizumab in combination in patients with advanced urothelial cancer harboring fibroblast growth factor receptor (FGFR) genetic aberrations (GA) of various clinical stages of disease progression and prior treatments.
Eligibility Criteria
Inclusion Criteria
- Histologically-confirmed transitional cell carcinoma of the urothelium of the upper or lower urinary tract
- Recurrent or progressing stage IV disease, or surgically unresectable, recurrent or progressing disease
- Documented central FGFR genetic aberration (FGFR1, FGFR2, or FGFR3 mutations / short variants and rearrangements / fusions) (Note; Substudy 2 started with patients requiring an FGFR GA, but this requirement was removed from the protocol later on)
- Measurable disease, as defined by the Investigator using Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0, 1 or 2
- Adequate organ functions as indicated by Screening visit local laboratory values
Exclusion Criteria
- Receipt of prior cancer treatment within specific interval periods
- Concurrent evidence of any clinically significant corneal or retinal disorder
- History of clinically significant cardiac disorders
- Known CNS metastases
- Concurrent uncontrolled or active infection with human immunodeficiency virus
- Active hepatitis B or chronic hepatitis B without current antiviral therapy
- Active hepatitis C
- Active tuberculosis
- Severe bacterial, fungal, viral and/or parasitic infections on therapeutic oral or IV medication at the time of first dose of study drug administration
Data sourced from ClinicalTrials.gov (NCT04045613). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.