Phase 2
Completed N=95
Derazantinib and Atezolizumab in Patients With Urothelial Cancer
Source: ClinicalTrials.gov NCT04045613 ↗Enrolled (actual)
95
Serious AEs
47.4%
Results posted
Oct 2023
Primary outcomePrimary: 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
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.
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 | — |
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. Informational only — not medical advice.