Ignite Creation Date:
2024-05-06 @ 2:58 PM
Last Modification Date:
2024-10-26 @ 1:41 PM
Study NCT ID:
NCT04486352
Status:
RECRUITING
Last Update Posted:
2024-07-03
First Post:
2020-07-22
Brief Title:
A Study of Targeted Agents for Patients With Recurrent or Persistent Endometrial Cancer
Sponsor:
Alliance Foundation Trials LLC
Organization:
Alliance Foundation Trials LLC
Study Overview
Official Title:
A Phase IBII Multi-Cohort Study of Targeted Agents andor Immunotherapy With Atezolizumab for Patients With Recurrent or Persistent Endometrial Cancer
Status:
RECRUITING
Status Verified Date:
2024-07
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:
EndoMAP
Brief Summary:
This is a Phase IBII multi-cohort study designed to evaluate the efficacy and safety of targeted agents with or without cancer immune checkpoint therapy with atezolizumab in participant with recurrent andor persistent endometrial cancer The main protocol provides a platform for genomic screening with homogeneous basic eligibility criteria in order to direct study participants into biomarker-matched study cohorts consisting of testing targeted agents
Detailed Description:
This is a Phase IBII multi-cohort study designed to evaluate the efficacy and safety of targeted agents with or without cancer immune checkpoint therapy with atezolizumab in participants with recurrent andor persistent endometrial cancer
This biomarker-driven study provides a platform whereby participants with persistentrecurrent endometrial cancer will be placed into study cohorts evaluating targeted agents selected on the basis of the tumors specific genomic profile Prospective participants with persistent andor recurrent endometrial cancer will be prescreened within 60 days of treatment assignment to have a tumor tissue sample submitted for next-generation sequencing NGS using FoundationOne companion diagnostic CDx testing prior to entering screening If a participant has FoundationOne CDx testing within five years of enrollment the previous tumor tissue may be re-analyzed for use in the study
Depending on the cohort assignment per the tumors biomarker profile participants will be assigned to the AFT-50A Protocol atezolizumabtargeted agent or the AFT-50B Protocol non-atezolizumab targeted agents The current study cohorts are as follows
AFT-50A Cohorts
Atezolizumab Bevacizumab doublet - Closed to Accrual
Atezolizumab Ipatasertib doublet - Closed to Accrual
Atezolizumab Talazoparib doublet
Atezolizumab Trastuzumab emtansine TDM-1 doublet - Closed to Accrual
Atezolizumab Tiragolumab doublet
AFT-50B Cohorts
Inavolisib Letrozole doublet
Giredestrant Abemaciclib doublet
It is anticipated that approximately 20 participants will be enrolled in each study cohort in AFT-50A and 24 participants in each study cohort in AFT-50B unless otherwise specified for a given cohort due to statistical considerations Each study cohort will openclose independently of other study cohorts Once a study cohort reaches the prespecified number of participants it will be closed to further enrollment unless an expansion phase is planned
The study is structured to allow for additional cohorts to be added as the study progresses These additional study cohorts may be proposed by investigators but requires approval by the Steering Committee in order to be added to the protocol
This biomarker-driven study provides a platform whereby participants with persistentrecurrent endometrial cancer will be placed into study cohorts evaluating targeted agents selected on the basis of the tumors specific genomic profile Prospective participants with persistent andor recurrent endometrial cancer will be prescreened within 60 days of treatment assignment to have a tumor tissue sample submitted for next-generation sequencing NGS using FoundationOne companion diagnostic CDx testing prior to entering screening If a participant has FoundationOne CDx testing within five years of enrollment the previous tumor tissue may be re-analyzed for use in the study
Depending on the cohort assignment per the tumors biomarker profile participants will be assigned to the AFT-50A Protocol atezolizumabtargeted agent or the AFT-50B Protocol non-atezolizumab targeted agents The current study cohorts are as follows
AFT-50A Cohorts
Atezolizumab Bevacizumab doublet - Closed to Accrual
Atezolizumab Ipatasertib doublet - Closed to Accrual
Atezolizumab Talazoparib doublet
Atezolizumab Trastuzumab emtansine TDM-1 doublet - Closed to Accrual
Atezolizumab Tiragolumab doublet
AFT-50B Cohorts
Inavolisib Letrozole doublet
Giredestrant Abemaciclib doublet
It is anticipated that approximately 20 participants will be enrolled in each study cohort in AFT-50A and 24 participants in each study cohort in AFT-50B unless otherwise specified for a given cohort due to statistical considerations Each study cohort will openclose independently of other study cohorts Once a study cohort reaches the prespecified number of participants it will be closed to further enrollment unless an expansion phase is planned
The study is structured to allow for additional cohorts to be added as the study progresses These additional study cohorts may be proposed by investigators but requires approval by the Steering Committee in order to be added to the protocol
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
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