CI

At a glance

ClinicalIndex Comparison Record
Phase 2Recruiting· 50 target
Drug / intervention
Talazoparib + Avelumabdrug
Likely dose
Not stated in record
Key inclusion· 13
  • ✓Age ≥18 years
  • ✓Histologically confirmed urothelial carcinoma of renal pelvis, ureter, bladder, or urethra with transitional cell as predominant histology
  • ✓Stage IV disease (T4b, N0, M0; any T, N1-N3, M0; any T, any N, M1) not candidate for curative surgery or radiotherapy
  • ✓Completed 4-6 cycles of platinum-based (cisplatin ≥55 mg/m² or carboplatin AUC ≥4.5) chemotherapy with stable disease, partial response, or complete response per RECIST 1.1
Key exclusion· 22
  • ✕Never received chemotherapy with platinum salt (cisplatin or carboplatin) for advanced/metastatic urothelial carcinoma
  • ✕Previously received more than one line of chemotherapy for advanced/metastatic urothelial carcinoma
  • ✕Disease progression per RECIST v1.1 after first-line platinum-based chemotherapy; cancer must not be in progression phase at inclusion
  • ✕Known CNS metastases and/or carcinomatous meningitis

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

Search/NCT04678362
NCT04678362Phase 2RecruitingUpdate OverdueUpdated 9mo ago · Completion was 35mo ago
Enrollment Stalled
Long Recruiting
Update Overdue
CompareCT.gov

TALazoparib and Avelumab as Maintenance Therapy in Platinum-Sensitive Metastatic or Locally Advanced URothelial Carcinoma: A Single-arm Phase 2 Trial

Centre Francois Baclesse·interventional·Posted Dec 21, 2020·Updated Sep 22, 2025

In Brief

A Phase 2 clinical trial evaluating Talazoparib + Avelumab for Urothelial Carcinoma. Currently recruiting, targeting 50 participants across 14 sites.

Signals

Enrollment appears stalled

Detailed Summary

The main objectif is to determine the efficacy of a maintenance treatment combining Talazoparib and Avelumab after platinum-based chemotherapy in patients with locally advanced/metastatic urothelial carcinoma.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsUrothelial Carcinoma
CountriesFrance
CollaboratorsPfizer

Timeline

Phase 2RecruitingOverdue
202120222023202420252026
First PostedDec 21, 2020
Enrollment StartJun 1, 2021
Primary CompletionJul 28, 2023
Study CompletionDec 1, 2025
TodayJul 2, 2026
Enrollment to primary: 2.2 yearsPosted 5.5 years ago

Interventions

Talazoparib + Avelumabdrug

Patients will receive the combined treatment until the investigator considers that the patient no longer obtains benefit from it. The treatment will be continued until disease progression, unacceptable toxicity or discontinuation for any cause.