Clinical trial NCT04486352: A Study of Targeted Agents for Patients With Recurrent or Persistent Endometrial Cancer
Official title: A Phase IB/II Multi-Cohort Study of Targeted Agents and/or Immunotherapy With Atezolizumab for Patients With Recurrent or Persistent Endometrial Cancer
Conditions: Endometrial Cancer
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.
Interventions:
description: Atezolizumab will be given to participants intravenously at a dosage of 1680 mg on day 1 of each 28-day cycle.
name: Atezolizumab - 28 Day Cycle
other_name: L01XC32
Tecentriq
type: Drug
description: Bevacizumab will be given to participants intravenously at a dosage of 10mg per participant kilogram every 2 weeks of the 28-day cycle.
name: Bevacizumab
other_name: Avastin
L01XC07
type: Drug
description: Ipatasertib will be given as an orally at a dosage of 400 mg once daily for 21 days of each 28-day cycle.
name: Ipatasertib
other_name: GDC-0068
RG7440
type: Drug
description: Talazoparib will be given in an orally at a dosage of 1 mg once daily for each day of the 28-day cycle.
name: Talazoparib
other_name: L01XX60
Talzenna
type: Drug
description: 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.
name: Trastuzumab emtansine
other_name: Kadcyla
T-DM1
type: Drug
description: Tiragolumab will be given to participants intravenously at a dosage of 840 mg on day 1 of each 28-day cycle.
name: Tiragolumab
type: Drug
description: Atezolizumab will be given to participants intravenously at a dosage of 1200 mg on day 1 of each 21-day cycle.
name: Atezolizumab - 21 Day Cycle
other_name: L01XC32
Tecentriq
type: Drug
description: Inavolisib will be given in an orally at a dosage of 9 mg once daily for each day of the 28-day cycle.
name: Inavolisib
other_name: GDC-0077
type: Drug
description: Letrozole will be given orally at a dosage of 2.5 mg once daily for each day of the 28-day cycle.
name: Letrozole
other_name: Femara
type: Drug
description: Giredestrant will be given orally at a dosage of 30 mg once daily for each day of the 28-day cycle.
name: Giredestrant
other_name: GDC-9545
type: Drug
description: Giredestrant will be given orally at a dosage of 150 mg twice daily for each day of the 28-day cycle.
name: Abemaciclib
other_name: Verzenio
type: Drug
Study arms:
design_group_description: Following the submission of tumor tissue for the FoundationOne® companion diagnostic (F1CDx) test, participants with no specified gene signatures will be enrolled in this cohort. Twenty participants will be enrolled. Once twenty participants are enrolled, the cohort will be closed to further enrollment. Participants in this study cohort will commence treatment as specified on Day 1 of each cycle.
design_group_title: Atezolizumab and Bevacizumab Cohort - Closed to Accrual
design_group_type: Experimental
design_group_description: Following the submission of tumor tissue for the FoundationOne® companion diagnostic (F1CDx) test, participants with PIK3CA/AKT1/PTEN-altered tumors will be enrolled in this cohort. Twenty participants will be enrolled. Once twenty participants are enrolled, the cohort will be closed to further enrollment. Participants in this study cohort will commence treatment as specified on Day 1 of each cycle.
design_group_title: Atezolizumab and Ipatasertib Cohort - Closed to Accrual
design_group_type: Experimental
design_group_description: Following the submission of tumor tissue for the FoundationOne® companion diagnostic (F1CDx) test, participants with tumors that have a ≥16%genomic loss of heterozygosity (LOH) will be assigned to this cohort. Twenty participants will be enrolled. Once twenty participants are enrolled, the cohort will be closed to further enrollment. Participants in this study cohort will commence treatment as specified on Day 1 of each cycle.
design_group_title: Atezolizumab and Talazoparib Cohort
design_group_type: Experimental
design_group_description: Following the submission of tumor tissue for the FoundationOne® companion diagnostic (F1CDx) test, participants with tumors that with an amplification of ERBB2/HER2 will be assigned to this cohort. Twenty participants will be enrolled. Once twenty participants are enrolled, the cohort will be closed to further enrollment. Participants in this study cohort will commence treatment as specified on Day 1 of each cycle.
design_group_title: Atezolizumab and Trastuzumab emtansine (TDM-1) Cohort - Closed to Accrual
design_group_type: Experimental
design_group_description: Following the submission of tumor tissue for the FoundationOne® companion diagnostic (F1CDx) test, participants with tumor type MSI-H and/or tTMB >=10 mut/mb will be assigned to this cohort. Twenty participants will be enrolled initially. Once twenty participants are enrolled, the cohort may be expanded if a positive signal is shown. Participants in this study cohort will commence treatment as specified on Day 1 of each cycle.
design_group_title: Atezolizumab and Tiragolumab Cohort - Closed to Accrual
design_group_type: Experimental
design_group_description: Following the submission of tumor tissue for the FoundationOne® companion diagnostic (F1CDx) test, participants with tumors that with PIK3CA activating mutations in the absence of PTEN loss-of-function alterations or AKT1 activating mutations will be assigned to this cohort. Twenty-four participants will be enrolled. Once twenty-four participants are enrolled, the cohort will be closed to further enrollment. Participants in this study cohort will commence treatment as specified on Day 1 of each cycle.
design_group_title: Inavolisib and Letrozole Cohort
design_group_type: Experimental
design_group_description: Following the submission of tumor tissue for the FoundationOne® companion diagnostic (F1CDx) test, participants with tumors that are RB1 intact with a local grade 1-2 estrogne receptor positive (ER+) are assigned to this cohort. Twenty-four participants will be enrolled. Once twenty-four participants are enrolled, the cohort will be closed to further enrollment. Participants in this study cohort will commence treatment as specified on Day 1 of each cycle.
design_group_title: Giredestrant and Abemaciclib
design_group_type: Experimental
Sponsor: Alliance Foundation Trials LLC
Collaborators: Genentech, Inc.
Pfizer Inc.
Foundation Medicine, Inc.
Eli Lilly & Co.
Drug name mappings:
name: 吉雷司群
lang: CN
name: Giredestrant
lang: EN
name: 恩美曲妥珠单抗
lang: CN
name: ADO-Trastuzumab Emtansine
lang: EN
name: トラスツズマブ エムタンシン（遺伝子組換え）
lang: JP
name: 来曲唑
lang: CN
name: Letrozole
lang: EN
name: レトロゾール
lang: JP
name: 阿贝西利
lang: CN
name: Abemaciclib
lang: EN
name: アベマシクリブ
lang: JP
name: 阿替利珠单抗
lang: CN
name: Atezolizumab
lang: EN
name: アテゾリズマブ（遺伝子組換え）
lang: JP
name: 甲苯磺酸他拉唑帕利
lang: CN
name: Talazoparib Tosylate
lang: EN
name: タラゾパリブトシル酸塩
lang: JP
name: 贝伐珠单抗
lang: CN
name: Bevacizumab
lang: EN
name: ベバシズマブ（遺伝子組換え）
lang: JP
name: Ipatasertib Dihydrochloride
lang: EN
name: 替瑞利尤单抗
lang: CN
name: Tiragolumab
lang: EN
name: 伊那利塞
lang: CN
name: Inavolisib
lang: EN