Ignite Creation Date:
2024-05-06 @ 1:17 PM
Last Modification Date:
2024-10-26 @ 1:11 PM
Study NCT ID:
NCT03979131
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2023-04-26
First Post:
2019-06-06
Brief Title:
Phase II Study of Avelumab Plus Chemotherapy in the Peri-operative Treatment for Patients With Resectable Gastric Cancer GC or Gastroesophageal Junction Cancer GEJC
Sponsor:
Vall dHebron Institute of Oncology
Organization:
Vall dHebron Institute of Oncology
Study Overview
Official Title:
Phase II Study of Avelumab Plus Chemotherapy in the Peri-operative Treatment for Patients With Resectable Gastric Cancer GC or Gastroesophageal Junction Cancer GEJC
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2023-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
MONEO
Brief Summary:
Phase II Study of Avelumab plus chemotherapy in the peri-operative treatment for patients with resectable Gastric cancer GC or Gastroesphageal Junction cancer GEJC
The addition of Avelumab to the perioperative chemotherapy in GC and GEJC patients may increase pathological responses by a synergic effect activating the immune response Conclusively the survival of these patients would improve
The primary objective is to investigate whether the addition of avelumab to FLOT chemotherapy docetaxel oxaliplatin and fluorouracilleucovorin improves efficacy in terms of pathological complete response pCR rate in GC and GEJC patients compared to the historical data of chemotherapy alone in the neoadjuvant setting
The addition of Avelumab to the perioperative chemotherapy in GC and GEJC patients may increase pathological responses by a synergic effect activating the immune response Conclusively the survival of these patients would improve
The primary objective is to investigate whether the addition of avelumab to FLOT chemotherapy docetaxel oxaliplatin and fluorouracilleucovorin improves efficacy in terms of pathological complete response pCR rate in GC and GEJC patients compared to the historical data of chemotherapy alone in the neoadjuvant setting
Detailed Description:
Phase II Study of Avelumab plus chemotherapy in the peri-operative treatment for patients with resectable Gastric cancer GC or Gastroesphageal Junction cancer GEJC
The addition of Avelumab to the perioperative chemotherapy in GC and GEJC patients may increase pathological responses by a synergic effect activating the immune response Conclusively the survival of these patients would improve
The primary objective is to investigate whether the addition of avelumab to FLOT chemotherapy docetaxel oxaliplatin and fluorouracilleucovorin improves efficacy in terms of pathological complete response pCR rate in GC and GEJC patients compared to the historical data of chemotherapy alone in the neoadjuvant setting
Secondary objectives are as follows
To evaluate the addition of avelumab to the perioperative chemotherapy in regard to the following
Overall survival OS
Disease-free survival DFS
Progression-free survival PFS
Surgical resection rate R0
Overall Response Rate ORR to neoadjuvancy
To determine the safety and tolerability of avelumab with FLOT chemotherapy
To perform a comprehensive analysis of biomarkers as exploratory endpoints
Study design This is an open-label non-randomized multicentric phase II clinical trial in subjects with operable gastric or GEJ adenocarcinoma Tissue biopsies before and after treatment will be required Blood samples will be required at different points of the treatment for biomarker analyses Tumor imaging assessments will be performed at baseline after the neoadjuvant treatment and after finalizing the adjuvancy with avelumabFLOT and every 6 months thereafter to determine response to treatment Clinical decision making will be based on Investigator assessment of the scans using RECIST v11 Safety of avelumabFLOT will be monitored continuously by careful monitoring of all adverse events AEs and serious adverse events SAEs reported
Study population Patients with resectable gastric and GEJ cancer suitable for preoperative chemotherapy
Statistical Considerations Summary tables descriptive statistics and frequency tables will be provided for all demographic baseline and safety variables as appropriate Continuous variables will be summarized with descriptive statistics mean standard deviation range and median Ninety-five 95 percent confidence intervals 95 CI may also be presented as appropriate Frequency counts and percentage of subjects within each category will be provided for categorical data The primary efficacy analysis pCR will be performed using the binomial test procedure Additionally for the pCR rate one-sided 90 CI will be also presented to be consistent with sample size calculation Secondary endpoints will be summarized with descriptive statistics Survival analysis will be performed to analyse OS PFS and DFS Kaplan- Meier curves will be presented and possible comparisons will be tested using the log-rank test or the Cox proportional hazard model for multivariate analysis hazard ratios HR and their 95 confidence interval CI95 will be provided Any survival analyses will be considered as exploratory
The study population are patients with resectable gastric and GEJ cancer suitable for preoperative chemotherapy The study duration will be approximately 24 months of recruitment 5 years of additional followup
Regarding to the study product peri-operatory treatment consisting of four cycles each cycle is 14 days of neoadjuvant chemotherapy docetaxel oxaliplatin and fluorouracilleucovorin plus avelumab previous to surgery Surgery is recommended to be scheduled 4 to 6 weeks after the last dose Afterwards 4 to 10 weeks after surgery four cycles of adjuvant therapy with the same schema followed by avelumab up to one year
Finally this study will be conducted in 10 centres in Spain
The addition of Avelumab to the perioperative chemotherapy in GC and GEJC patients may increase pathological responses by a synergic effect activating the immune response Conclusively the survival of these patients would improve
The primary objective is to investigate whether the addition of avelumab to FLOT chemotherapy docetaxel oxaliplatin and fluorouracilleucovorin improves efficacy in terms of pathological complete response pCR rate in GC and GEJC patients compared to the historical data of chemotherapy alone in the neoadjuvant setting
Secondary objectives are as follows
To evaluate the addition of avelumab to the perioperative chemotherapy in regard to the following
Overall survival OS
Disease-free survival DFS
Progression-free survival PFS
Surgical resection rate R0
Overall Response Rate ORR to neoadjuvancy
To determine the safety and tolerability of avelumab with FLOT chemotherapy
To perform a comprehensive analysis of biomarkers as exploratory endpoints
Study design This is an open-label non-randomized multicentric phase II clinical trial in subjects with operable gastric or GEJ adenocarcinoma Tissue biopsies before and after treatment will be required Blood samples will be required at different points of the treatment for biomarker analyses Tumor imaging assessments will be performed at baseline after the neoadjuvant treatment and after finalizing the adjuvancy with avelumabFLOT and every 6 months thereafter to determine response to treatment Clinical decision making will be based on Investigator assessment of the scans using RECIST v11 Safety of avelumabFLOT will be monitored continuously by careful monitoring of all adverse events AEs and serious adverse events SAEs reported
Study population Patients with resectable gastric and GEJ cancer suitable for preoperative chemotherapy
Statistical Considerations Summary tables descriptive statistics and frequency tables will be provided for all demographic baseline and safety variables as appropriate Continuous variables will be summarized with descriptive statistics mean standard deviation range and median Ninety-five 95 percent confidence intervals 95 CI may also be presented as appropriate Frequency counts and percentage of subjects within each category will be provided for categorical data The primary efficacy analysis pCR will be performed using the binomial test procedure Additionally for the pCR rate one-sided 90 CI will be also presented to be consistent with sample size calculation Secondary endpoints will be summarized with descriptive statistics Survival analysis will be performed to analyse OS PFS and DFS Kaplan- Meier curves will be presented and possible comparisons will be tested using the log-rank test or the Cox proportional hazard model for multivariate analysis hazard ratios HR and their 95 confidence interval CI95 will be provided Any survival analyses will be considered as exploratory
The study population are patients with resectable gastric and GEJ cancer suitable for preoperative chemotherapy The study duration will be approximately 24 months of recruitment 5 years of additional followup
Regarding to the study product peri-operatory treatment consisting of four cycles each cycle is 14 days of neoadjuvant chemotherapy docetaxel oxaliplatin and fluorouracilleucovorin plus avelumab previous to surgery Surgery is recommended to be scheduled 4 to 6 weeks after the last dose Afterwards 4 to 10 weeks after surgery four cycles of adjuvant therapy with the same schema followed by avelumab up to one year
Finally this study will be conducted in 10 centres in Spain
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