N/A
N=596
A NON-INTERVENTIONAL STUDY ON AVELUMAB USE IN PATIENTS WITH ADVANCED OR METASTATIC UROTHELIAL CARCINOMA
Urothelial Carcinoma
Bottom Line
View on ClinicalTrials.gov: NCT04822350 ↗Enrolled (actual)
596
Serious AEs
57.9%
Results posted
Apr 2026
Primary outcome: Primary: Overall Survival (OS): Overall — 21.3 Months
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- Avelumab (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Pfizer
- Primary completion
- Apr 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Overall Survival (OS): Overall |
21.3 | — |
| PRIMARY OS: by Histology Group |
22.1; 20.0; 17.2 | — |
| SECONDARY OS From Initiation of First-Line Chemotherapy: Overall |
24.5 | — |
| SECONDARY OS From Initiation of First-Line Chemotherapy: by Histology Group |
17.2; 14.6; 19.2 | — |
| SECONDARY Progression-Free Survival (PFS) According to Response Evaluation Criteria in Solid Tumors (RECIST) 1.1: Overall |
5.7 | — |
| SECONDARY PFS 1 According to RECIST 1.1: by Histology Group |
5.7; 4.3; 7.2 | — |
| SECONDARY PFS During the Second Line of Treatment Post-Avelumab (PFS 2) According to RECIST 1.1: Overall |
4.7 | — |
| SECONDARY PFS 2 According to RECIST 1.1: by Histology Group |
4.5; 5.8; 4.5 | — |
| SECONDARY Overall Response Rate (ORR) According to RECIST 1.1: Overall |
42.3 | — |
| SECONDARY ORR According to RECIST 1.1: by Histology Group |
42.2; 35.3; 46.2; 50.0 | — |
| SECONDARY Duration of Response (DOR): Overall |
NA | — |
| SECONDARY DOR: by Histology Group |
NA; 23.8; NA | — |
| SECONDARY Duration of Treatment (DOT): Overall |
5.6 | — |
| SECONDARY DOT: by Histology Group |
5.6; 5.1; 11.2 | — |
| SECONDARY Number of Participants Classified Per Progression Type: Overall |
109; 144; 116; 7 | — |
| SECONDARY Number of Participants Classified Per Progression Type: by Histology Group |
103; 132; 102; 7; 3; 5 | — |
| SECONDARY Duration of Subsequent Treatment: Overall |
2.8 | — |
| SECONDARY Duration of Subsequent Treatment: by Histology Group |
2.8; 2.8; 2.2 | — |
| SECONDARY PFS of Subsequent Treatment: Overall |
4.4 | — |
| SECONDARY PFS of Subsequent Treatment: by Histology Group |
4.4; 2.7; 3.2 | — |
| SECONDARY ORR of Subsequent Treatment: Overall |
26.0 | — |
| SECONDARY ORR of Subsequent Treatment: by Histology Group |
26.2; 36.4; 16.7; 0.0 | — |
| SECONDARY OS of Subsequent Treatment: Overall |
9.7 | — |
| SECONDARY OS of Subsequent Treatment by Histology Group |
9.7; 7.6; 4.4 | — |
| SECONDARY Number of Participants With Adverse Events (AEs): Overall |
527 | — |
| SECONDARY Number of Participants With AEs: by Histology Group |
479; 18; 25; 5 | — |
| SECONDARY Number of Participants With Grade 3, 4 or 5 AEs: Overall |
345 | — |
| SECONDARY Number of Participants With Grade 3, 4 or 5 AEs: by Histology Group |
311; 12; 19; 3 | — |
| SECONDARY Number of Participants With AEs Leading to Temporary/Permanent Discontinuation of Avelumab: Overall |
305 | — |
| SECONDARY Number of Participants With AEs Leading to Temporary/Permanent Discontinuation of Avelumab by Histology Group |
274; 13; 17; 1 | — |
| SECONDARY Number of Participants With AEs Leading to Death: Overall |
254 | — |
| SECONDARY Number of Participants With AEs Leading to Death: by Histology Group |
229; 8; 15; 2 | — |
| SECONDARY Number of Participants Who Received at Least One Premedication With Paracetamol Among All Avelumab Injections: Overall |
572 | — |
| SECONDARY Number of Participants Who Received at Least One Premedication With Paracetamol Among All Avelumab Injections: by Histology Group |
520; 17; 29; 6 | — |
| SECONDARY Number of Participants Who Received at Least One Premedication With Antihistamines Among All Avelumab Injections: Overall |
568 | — |
| SECONDARY Number of Participants Who Received at Least One Premedication With Antihistamines Among All Avelumab Injections: by Histology Group |
515; 18; 29; 6 | — |
| SECONDARY Change From Baseline in National Comprehensive Cancer Network (NCCN)/Functional Assessment of Cancer Therapy -Bladder Symptom Index-18 (FACT FBlSI-18) at Week 6, Months 3, 6, 9, 12, 15, 18, 21 and 24: Overall |
49.44; -1.51; -0.70; 1.56; -0.12; -0.18 | — |
| SECONDARY Change From Baseline in NCCN/FACT FBlSI-18 at Week 6, Months 3, 6, 9, 12, 15, 18, 21 and 24: by Histology Group |
49.92; -2.11; -1.13; 1.88; -0.97; 1.17 | — |
| SECONDARY Change From Baseline in European Quality of Life-5 Dimensions 5 Levels (EQ-5D-5L) Index Score at Week 6, Months 3, 6, 9, 12, 15, 18, 21 and 24: Overall |
0.89; -0.07; -0.08; -0.03; -0.02; -0.03 | — |
| SECONDARY Change From Baseline in EQ-5D-5L Index Score at Week 6, Month 3, 6, 9, 12, 15, 18, 21 and 24: by Histology Group |
0.89; -0.07; -0.09; -0.03; -0.03; -0.02 | — |
| SECONDARY Change From Baseline in EQ-5D-5L-VAS Score at Week 6, Months 3, 6, 9, 12, 15, 18, 21 and 24: Overall |
67.85; -3.81; 0.64; 1.48; 9.43; 8.31 | — |
| SECONDARY Change From Baseline in EQ-5D-5L- VAS Score at Week 6, Months 3, 6, 9, 12, 15, 18, 21 and 24: by Histology Group |
69.16; -5.07; -0.02; 0.74; 5.17; 7.09 | — |
Summary
A multicenter ambispective (retrospective and prospective) non-interventional study of patients with locally advanced or metastatic urothelial carcinoma (adv/mUC) treated with avelumab in France, not impacting the treatment decision made by the treating physician and the medical management of treated patients.
Eligibility Criteria
Inclusion Criteria
- Patient ≥ 18 years of age
- Patient with locally advanced or metastatic urothelial carcinoma (irrespective of tumor histology) whose disease has not progressed (ongoing stable disease, partial response or complete response) following completion of first-line platinum-based chemotherapy and who has been (retrospective), is (retrospective and prospective), will be (prospective) treated with avelumab.
- For a patient alive at the moment of the inclusion in the study : the patient must be informed of the study, he/she must be given an information letter signed by the investigator and must not be opposed to the collection of his/her data
- For a patient who died before the inclusion in the study : the patient (during his life time) must not be opposed in writing to the collection of his data.
- Patient benefiting from a social security scheme according to local regulations
Exclusion Criteria
- For a patient alive at the moment of the inclusion in the study: patient without liberty, under tutelage, or unable to give oral consent.
- Patient enrolled in a prospective interventional clinical trial assessing an investigational product.
Data sourced from ClinicalTrials.gov (NCT04822350). 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.