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

Conditions

• Endometrial Cancer

Eligibility Criteria

Sex

FEMALE

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

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

Study Details

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.

Key Dates

Start date

Oct 20, 2021

Status verified

Jul 2025

Primary completion

Oct 1, 2026

Completion

Oct 31, 2027

Study Design

Enrollment

148 participants (estimated)

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Atezolizumab and Bevacizumab Cohort - Closed to Accrual
  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.
• Experimental: Atezolizumab and Ipatasertib Cohort - Closed to Accrual
  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.
• Experimental: Atezolizumab and Talazoparib Cohort
  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.
• Experimental: Atezolizumab and Trastuzumab emtansine (TDM-1) Cohort - Closed to Accrual
  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.
• Experimental: Atezolizumab and Tiragolumab Cohort - Closed to Accrual
  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.
• Experimental: Inavolisib and Letrozole Cohort
  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.
• Experimental: Giredestrant and Abemaciclib
  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.

Primary Outcome Measure

Investigator-assessed overall response rate (ORR) of each biomarker cohort [ Time Frame: 48 Months ]

Central Contacts

• Quality Management and Compliance
  617-732-8727
  [email protected]

Locations (21)

Find similar trials in Duarte, CA

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