NCT04486352

A Study of Targeted Agents for Patients With Recurrent or Persistent Endometrial Cancer

A Phase IB/II Multi-Cohort Study of Targeted Agents and/or Immunotherapy With Atezolizumab for Patients With Recurrent or Persistent Endometrial Cancer

• Status: Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 148 (estimated)
• Sponsor: Alliance Foundation Trials, LLC. · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a Phase IB/II 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 and/or 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 IB/II 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 and/or persistent endometrial cancer. This biomarker-driven study provides a platform whereby participants with persistent/recurrent endometrial cancer will be placed into study cohorts evaluating targeted agents selected on the basis of the tumor's specific genomic profile. Prospective participants with persistent and/or 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. Non-FMI NGS testing may be submitted if approved. Depending on the cohort assignment per the tumor's biomarker profile, participants will be assigned to the AFT-50A Protocol (atezolizumab+targeted 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 - Closed to Accrual 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 open/close 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.

Conditions

• Endometrial Cancer

Interventions

Type	Name	Description
DRUG	Atezolizumab - 28 Day Cycle	Atezolizumab will be given to participants intravenously at a dosage of 1680 mg on day 1 of each 28-day cycle.
DRUG	Bevacizumab	Bevacizumab will be given to participants intravenously at a dosage of 10mg per participant kilogram every 2 weeks of the 28-day cycle.
DRUG	Ipatasertib	Ipatasertib will be given as an orally at a dosage of 400 mg once daily for 21 days of each 28-day cycle.
DRUG	Talazoparib	Talazoparib will be given in an orally at a dosage of 1 mg once daily for each day of the 28-day cycle.
DRUG	Trastuzumab emtansine	Trastuzumab emtansine be given to participants intravenously at a dosage of 3.6 mg per participant kilogram, on day 1 of each 21-day cycle.
DRUG	Tiragolumab	Tiragolumab will be given to participants intravenously at a dosage of 840 mg on day 1 of each 28-day cycle.
DRUG	Atezolizumab - 21 Day Cycle	Atezolizumab will be given to participants intravenously at a dosage of 1200 mg on day 1 of each 21-day cycle.
DRUG	Inavolisib	Inavolisib will be given in an orally at a dosage of 9 mg once daily for each day of the 28-day cycle.
DRUG	Letrozole	Letrozole will be given orally at a dosage of 2.5 mg once daily for each day of the 28-day cycle.
DRUG	Giredestrant	Giredestrant will be given orally at a dosage of 30 mg once daily for each day of the 28-day cycle.
DRUG	Abemaciclib	Giredestrant will be given orally at a dosage of 150 mg twice daily for each day of the 28-day cycle.

Timeline

• Start date: 2021-10-20
• Primary completion: 2026-10-01
• Completion: 2027-10-01
• First posted: 2020-07-24
• Last updated: 2026-04-01

Locations

21 sites across 1 country: United States

Regulatory

• FDA-regulated drug study