Ignite Creation Date:
2024-05-06 @ 10:40 AM
Last Modification Date:
2024-10-26 @ 12:34 PM
Study NCT ID:
NCT03324282
Status:
TERMINATED
Last Update Posted:
2022-05-03
First Post:
2017-10-19
Brief Title:
First-line GemcitabineCisplatin - Avelumab in Locally Advanced or Metastatic Bladder Carcinoma
Sponsor:
University Hospital Bordeaux
Organization:
University Hospital Bordeaux
Study Overview
Official Title:
Gemcitabine-cisplatin Plus Avelumab or Gemcitabine-cisplatin as First-line Treatment of Patients With Locally Advanced or Metastatic Urothelial Bladder Carcinoma GCISAVE
Status:
TERMINATED
Status Verified Date:
2022-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
ANSMs 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 pembrogem-platinum in phase III
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
GCISAVE
Brief 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
Detailed Description:
Recent results in cancer research highlight the importance of immune checkpoints in the control of immune response and provide access to molecules interfering with the inhibited immune response during the development of cancer Drugs targeted against CTLA-4 PD-1 or PD-L1 have shown efficacy in various tumor types In locally advanced or metastatic urothelial bladder cancer MBC the standard first-line treatment is the association of Gemcitabine and Cisplatin GC Objective responses and prolonged objective responses have been reported with monoclonal antibodies against PD-1 or PD-L1 in MBC patients after failure of chemotherapy Avelumab is an investigational fully human anti-PD-L1 IgG1 monoclonal antibody Avelumab treatment did not show unexpected cross-toxicity with chemotherapy when studied in phase I II in patients with different tumor types So the combination at full doses of GC and avelumab seems appropriate
The experimental treatment is a combination of GC and avelumab given for 6 cycles The duration of each cycle is 3 weeks Gemcitabine dose of 1000 mgm2 as an intravenous infusion over 30 minutes on Days 1 and 8 of each 21-day cycle Cisplatin dose of 70 mgm2 as a slow intravenous infusion over 2 to 4 hours on Day 1 of each 21-day cycle Avelumab 10 mgkg body weight administered Iv once every 3 weeks
Patients who have received all scheduled treatments and whose disease has not progressed at the end of treatment will enter into disease follow-up During this follow-up period patients will have disease and safety assessments performed every 3 months Patients will remain in follow-up for up to 1 year from last dose of treatment and will have survival follow-up
The experimental treatment is a combination of GC and avelumab given for 6 cycles The duration of each cycle is 3 weeks Gemcitabine dose of 1000 mgm2 as an intravenous infusion over 30 minutes on Days 1 and 8 of each 21-day cycle Cisplatin dose of 70 mgm2 as a slow intravenous infusion over 2 to 4 hours on Day 1 of each 21-day cycle Avelumab 10 mgkg body weight administered Iv once every 3 weeks
Patients who have received all scheduled treatments and whose disease has not progressed at the end of treatment will enter into disease follow-up During this follow-up period patients will have disease and safety assessments performed every 3 months Patients will remain in follow-up for up to 1 year from last dose of treatment and will have survival follow-up
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None