First-line Gemcitabine/Cisplatin +/- Avelumab in Locally Advanced or Metastatic Bladder Carcinoma

Summary

This study will assess efficacy (based on response rate) and safety (based on grade ≥ 3 severe adverse effects) of the combination Gemcitabine Cisplatin (GC) + anti-PD-L1 (avelumab) in first-line treatment for locally advanced or metastatic urothelial bladder cancer patients, after 6 cycles of treatment (or at 18 weeks if less than 6 cycles have been given, or earlier if a second line treatment is needed, before this new anticancer treatment has been started).

Timeline

Start

2018-02-23

Primary completion

2021-12-31

Completion

2022-01-14

Outcome

Outcome not reported

Stopped (Enrollment): “ANSM's refusal to validate ATU requests for avelumab in bladder cancer, Decrease in recruitment, Most investigators would like to offer avelumab for maintenance, Absence of benefit to the chemo-immuno combination (pembro+gem-platinum) in phase III”

Publications

• Results Gross-Goupil M, Domblides C, Lefort F, Ravaud A. Open-label randomized multi-center phase 2 study: gemcitabine cisplatin plus avelumab or gemcitabine cisplatin as first-line treatment of patients with locally advanced or metastatic urothelial bladder carcinoma: GCisAve. Bull Cancer. 2020 Jun;107(5S):eS1-eS7. doi: 10.1016/S0007-4551(20)30280-0.

Drugs

Indications