Ignite Creation Date:
2024-05-06 @ 11:48 AM
Last Modification Date:
2024-10-26 @ 12:50 PM
Study NCT ID:
NCT03603184
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-03-13
First Post:
2018-05-21
Brief Title:
Atezolizumab Trial in Endometrial Cancer - AtTEnd
Sponsor:
Mario Negri Institute for Pharmacological Research
Organization:
Mario Negri Institute for Pharmacological Research
Study Overview
Official Title:
Phase III Double-blind Randomized Placebo Controlled Trial of Atezolizumab in Combination With Paclitaxel and Carboplatin in Women With AdvancedRecurrent Endometrial Cancer
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-03
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:
AtTEnd
Brief Summary:
Atezolizumab is an engineered humanised monoclonal immunoglobulin G1 antibody that binds selectively to PD-L1 and prevents its interaction with PD-1 and B7-1
In May 2016 atezolizumab was approved by the FDA for patients with locally advanced or metastatic urothelial carcinoma who have disease progression during or following any platinum-containing chemotherapy or within 12 months of receiving chemotherapy before surgery neoadjuvant or after surgery adjuvant in October 2016 it was approved by the FDA for patients with metastatic non-small cell lung cancer NSCLC who have disease progression during or following platinum-containing chemotherapy and have progressed on an appropriate FDA-approved targeted therapy if their tumor has EGFR or ALK gene abnormalities Finally in April 2017 atezolizumab was granted accelerated approval by FDA for the first-line treatment of patients with locally advanced or metastatic urothelial carcinoma who are not eligible for cisplatin chemotherapy Combinations of atezolizumab with chemotherapeutic agents andor targeted therapies were studied in different solid tumors such as melanoma NSCLC renal cell carcinoma and colorectal carcinoma From these studies the AE profile of atezolizumab combinations were consistent with that of the individual agents
Finally preliminary results of a Phase Ia study of Atezolizumab NCT01375842 monotherapy in relapsed endometrial cancer were reported as abstract at ASCO 2017 Fifteen patients were evaluated for safety and efficacy with a minimum follow-up of 112 months No G4-5 related AEs occurred Regarding efficacy ORR was 13 215 by RECIST Atezolizumab seemed to have a favorable safety profile with durable clinical benefit in some patients Further studies with atezolizumab are warranted given its promising results in advanced endometrial cancer and the limited efficacy of current treatment options
In May 2016 atezolizumab was approved by the FDA for patients with locally advanced or metastatic urothelial carcinoma who have disease progression during or following any platinum-containing chemotherapy or within 12 months of receiving chemotherapy before surgery neoadjuvant or after surgery adjuvant in October 2016 it was approved by the FDA for patients with metastatic non-small cell lung cancer NSCLC who have disease progression during or following platinum-containing chemotherapy and have progressed on an appropriate FDA-approved targeted therapy if their tumor has EGFR or ALK gene abnormalities Finally in April 2017 atezolizumab was granted accelerated approval by FDA for the first-line treatment of patients with locally advanced or metastatic urothelial carcinoma who are not eligible for cisplatin chemotherapy Combinations of atezolizumab with chemotherapeutic agents andor targeted therapies were studied in different solid tumors such as melanoma NSCLC renal cell carcinoma and colorectal carcinoma From these studies the AE profile of atezolizumab combinations were consistent with that of the individual agents
Finally preliminary results of a Phase Ia study of Atezolizumab NCT01375842 monotherapy in relapsed endometrial cancer were reported as abstract at ASCO 2017 Fifteen patients were evaluated for safety and efficacy with a minimum follow-up of 112 months No G4-5 related AEs occurred Regarding efficacy ORR was 13 215 by RECIST Atezolizumab seemed to have a favorable safety profile with durable clinical benefit in some patients Further studies with atezolizumab are warranted given its promising results in advanced endometrial cancer and the limited efficacy of current treatment options
Detailed Description:
None
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