CI

At a glance

ClinicalIndex Comparison Record
Phase 2Recruiting· 64 target
Drug / intervention
Avelumabdrug
Likely dose
Avelumab 800mgfrom record
Key inclusion· 7
  • ✓Age ≥18 years
  • ✓Histologically confirmed urothelial carcinoma of bladder, upper urinary tract or urethra with maximum 50% aberrant histology
  • ✓Clinical stage cT4NxM0 or cTxN1-N3M0
  • ✓At least stable disease after 3-4 cycles of induction chemotherapy with cisplatin/carboplatin + gemcitabine per RECIST v1.1
Key exclusion· 21
  • ✕Predominant (>50%) non-urothelial carcinoma histology
  • ✕Acute or chronic hepatitis B or C infection
  • ✕Estimated creatinine clearance <30 mL/min
  • ✕Prior exposure to immune-mediated therapy except BCG intravesical instillations

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT05600127
NCT05600127Phase 2RecruitingUpdate OverdueUpdated 33mo ago · Completion was 15mo ago
Enrollment Stalled
Long Recruiting
Update Overdue
CompareCT.gov

Chemotherapy and Sequential Immunotherapy for Locally Advanced Urothelial Cancer: the CHASIT Study

Erasmus Medical Center·interventional·Posted Oct 31, 2022·Updated Sep 8, 2023

In Brief

A Phase 2 clinical trial evaluating Avelumab for Urothelial Carcinoma. Currently recruiting, targeting 64 participants across 4 sites.

Signals

Enrollment appears stalled

Detailed Summary

Patients with locally advanced or clinically node positive urothelial carcinoma treated with chemotherapy, will receive 3 cycles of avelumab, followed by radical surgery.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsUrothelial Carcinoma
CountriesNetherlands
CollaboratorsMerck KGaA, Darmstadt, Germany

Timeline

Phase 2Recruiting
20232024202520262027
First PostedOct 31, 2022
Enrollment StartDec 1, 2022
Primary CompletionApr 1, 2025
Study CompletionDec 1, 2026
TodayJul 2, 2026
Enrollment to primary: 2.3 yearsPosted 3.7 years ago

Interventions

Avelumabdrug

3 cycles of avelumab (800mg, every 2 weeks)