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

Primary Purpose

Endometrial Cancer

Status
Recruiting
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Atezolizumab - 28 Day Cycle
Bevacizumab
Ipatasertib
Talazoparib
Trastuzumab emtansine
Tiragolumab
Atezolizumab - 21 Day Cycle
Inavolisib
Letrozole
Giredestrant
Abemaciclib
Sponsored by
Alliance Foundation Trials, LLC.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Endometrial Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Key Inclusion Criteria:

  • Recurrent or persistent endometrial carcinoma which has progressed or recurred after at least 1, but no more than 2, prior lines of therapy. Prior hormonal therapies (e.g., tamoxifen, aromatase inhibitors) will not count toward the prior regimen limit. Chemotherapy given in conjunction with radiotherapy as a radiosensitizer will be counted as a systemic therapeutic regimen.
  • Measurable disease per RECIST 1.1
  • Formalin-fixed, paraffin-embedded tumor tissue, a specimen as proximal to the current recurrence as possible, must be submitted to the Central Lab for molecular testing (FoundationOne CDxTM)
  • Life expectancy > 12 weeks
  • Recovery from effects of recent radiotherapy, surgery, or chemotherapy

Key Exclusion Criteria:

  • Endometrial tumors with the following histologies: squamous carcinomas, sarcomas
  • Other invasive malignancies within the last 5 years, except for non-melanoma skin cancer with no evidence of disease within the past 5 years AND localized breast cancer with previous adjuvant chemotherapy treatment for breast cancer completed > 5 years ago
  • Synchronous primary invasive ovarian or cervical cancer
  • Have an active or history of autoimmune disease or immune deficiency
  • Have a history of idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced pneumonitis, idiopathic pneumonitis, or evidence of active pneumonitis based on a screening chest computed tomography (CT) scan
  • Active tuberculosis
  • Severe infections within 4 weeks
  • Have received therapeutic oral or IV antibiotic medication within 2 weeks, except prophylactic antibiotic medication
  • Have significant cardiovascular disease
  • Are administered treatment with a live attenuated vaccine within 4 weeks, or anticipation of need for such a vaccine during the course of the study
  • Have prior allogeneic bone marrow transplantation or solid organ transplant
  • Prior treatment with T-cell costimulating or immune checkpoint blockade therapies including, but not limited to, CD137 agonists, anti-PD-1, anti-PD-L1, and anti-CTLA-4 therapeutic antibodies
  • History of treatment with systemic immunostimulatory agents (including but not limited to interferons, interleukin-2) within 4 weeks or 5 half-lives of the drug, whichever is longer, prior to initiation of study treatment
  • History of treatment with systemic immunosuppressive medications within 2 weeks except acute, low-dose, systemic immunosuppressant medications, corticosteroids for chronic obstructive pulmonary disease and asthma, or mineralocorticoids and low-dose corticosteroids for patients with orthostatic hypotension or adrenocortical insufficiency
  • Have a history or clinical evidence of any untreated CNS disease, seizures not controlled with standard medical therapy, or history of cerebrovascular accident (stroke), transient ischemic attack or subarachnoid hemorrhage within 6 months

Sites / Locations

  • City of Hope Comprehensive Cancer CenterRecruiting
  • UCSF Helen Diller Family Comprehensive Cancer CenterRecruiting
  • Medstar Georgetown Cancer InstituteRecruiting
  • Mount Sinai Comprehensive Cancer CenterRecruiting
  • University of ChicagoRecruiting
  • Dana Farber Cancer InstituteRecruiting
  • University of MinnesotaRecruiting
  • Washington University School of Medicine Siteman Cancer CenterRecruiting
  • Nebraska Methodist HospitalRecruiting
  • Englewood HealthRecruiting
  • Atlantic Health Systems/Morristown Medical CenterRecruiting
  • Roswell ParkRecruiting
  • Weill Cornell MedicineRecruiting
  • Duke University Cancer CenterRecruiting
  • University of Oklahoma Health Stephenson Cancer CenterRecruiting
  • Providence Portland Cancer InstituteRecruiting
  • University of Pittsburgh Medical CenterRecruiting
  • Baptist Memorial HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm Type

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Arm Label

Atezolizumab and Bevacizumab Cohort

Atezolizumab and Ipatasertib Cohort

Atezolizumab and Talazoparib Cohort

Atezolizumab and Trastuzumab emtansine (TDM-1) Cohort

Atezolizumab and Tiragolumab Cohort

Inavolisib and Letrozole Cohort

Giredestrant and Abemaciclib

Arm 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.

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.

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.

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.

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.

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.

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.

Outcomes

Primary Outcome Measures

Investigator-assessed overall response rate (ORR) of each biomarker cohort
AFT-50A Protocol: Overall response rate for each biomarker cohort is defined as the proportion of participants achieving a complete (CR) or partial (PR) response on two consecutive occasions at least 4 weeks apart, as determined by the investigator from AFT50A Protocol: Tumor assessments per RECIST v1.1.
The proportion of participants in each biomarker cohort who remain alive and progression-free for at least 6 months
AFT-50B Protocol: Progression free survival rate at 6 months is defined as the proportion of participants who have not experienced disease progression or death from any cause at 6 months, as determined by the investigator according to RECIST v1.1

Secondary Outcome Measures

Relative proportion of participants in each biomarker cohort who remain progression-free for at least 6 months compared to that from historical control studies
AFT-50A Protocol: PFS rate at 6 months is defined as the proportion of participants who have not experienced disease progression or death from any cause at 6 months, as determined by the investigator according to RECIST v1.1
Investigator assessed disease-control rate of each biomarker cohort
AFT-50A Protocol: Disease-control rate is defined as the proportion of participants achieving either stable disease, complete response, or partial response.
Duration of response for participants in each biomarker cohort who achieve a complete or partial response.
AFT-50A Protocol: Duration of response is defined as the time from the first occurrence of a documented objective response to disease progression or death from any cause (whichever occurs first), as determined by the investigator according to RECIST v1.1.
Overall survival (OS) rates of participants in each biomarker cohort after 24 months
AFT-50A Protocol: 24-month overall survival rate is defined as the proportion of participants who have not experienced death from any cause at 24 months.
Investigator assessed disease-control rate of each biomarker cohort
AFT-50B Protocol: Disease control rate is defined as the proportion of participants achieving either stable disease, complete response, or partial response at any time.
Duration of response for participants in each biomarker cohort who achieve a confirmed response (complete or partial)
AFT-50B Protocol: Duration of response is defined as the time from the first occurrence of a documented objective response (complete or partial) to disease progression or death from any cause (whichever occurs first), as determined by the investigator according to RECIST v1.1
Overall survival rates of participants in each biomarker cohort
AFT-50B Protocol: 24-month overall survival rate is defined as the proportion of participants who have not experienced death from any cause at 24 months.

Full Information

First Posted
July 22, 2020
Last Updated
October 17, 2023
Sponsor
Alliance Foundation Trials, LLC.
Collaborators
Genentech, Inc., Foundation Medicine, Pfizer, Eli Lilly and Company
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1. Study Identification

Unique Protocol Identification Number
NCT04486352
Brief Title
A Study of Targeted Agents for Patients With Recurrent or Persistent Endometrial Cancer
Acronym
EndoMAP
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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 20, 2021 (Actual)
Primary Completion Date
October 1, 2025 (Anticipated)
Study Completion Date
October 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Alliance Foundation Trials, LLC.
Collaborators
Genentech, Inc., Foundation Medicine, Pfizer, Eli Lilly and Company

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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. 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 Atezolizumab + Ipatasertib doublet Atezolizumab + Talazoparib doublet Atezolizumab + Trastuzumab emtansine (TDM-1) doublet 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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Endometrial Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
148 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Atezolizumab and Bevacizumab Cohort
Arm Type
Experimental
Arm 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.
Arm Title
Atezolizumab and Ipatasertib Cohort
Arm Type
Experimental
Arm 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.
Arm Title
Atezolizumab and Talazoparib Cohort
Arm Type
Experimental
Arm 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.
Arm Title
Atezolizumab and Trastuzumab emtansine (TDM-1) Cohort
Arm Type
Experimental
Arm 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.
Arm Title
Atezolizumab and Tiragolumab Cohort
Arm Type
Experimental
Arm 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.
Arm Title
Inavolisib and Letrozole Cohort
Arm Type
Experimental
Arm 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.
Arm Title
Giredestrant and Abemaciclib
Arm Type
Experimental
Arm 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.
Intervention Type
Drug
Intervention Name(s)
Atezolizumab - 28 Day Cycle
Other Intervention Name(s)
Tecentriq, L01XC32
Intervention Description
Atezolizumab will be given to participants intravenously at a dosage of 1680 mg on day 1 of each 28-day cycle.
Intervention Type
Drug
Intervention Name(s)
Bevacizumab
Other Intervention Name(s)
Avastin, L01XC07
Intervention Description
Bevacizumab will be given to participants intravenously at a dosage of 10mg per participant kilogram every 2 weeks of the 28-day cycle.
Intervention Type
Drug
Intervention Name(s)
Ipatasertib
Other Intervention Name(s)
RG7440, GDC-0068
Intervention Description
Ipatasertib will be given as an orally at a dosage of 400 mg once daily for 21 days of each 28-day cycle.
Intervention Type
Drug
Intervention Name(s)
Talazoparib
Other Intervention Name(s)
Talzenna, L01XX60
Intervention Description
Talazoparib will be given in an orally at a dosage of 1 mg once daily for each day of the 28-day cycle.
Intervention Type
Drug
Intervention Name(s)
Trastuzumab emtansine
Other Intervention Name(s)
T-DM1, Kadcyla
Intervention 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.
Intervention Type
Drug
Intervention Name(s)
Tiragolumab
Intervention Description
Tiragolumab will be given to participants intravenously at a dosage of 840 mg on day 1 of each 28-day cycle.
Intervention Type
Drug
Intervention Name(s)
Atezolizumab - 21 Day Cycle
Other Intervention Name(s)
Tecentriq, L01XC32
Intervention Description
Atezolizumab will be given to participants intravenously at a dosage of 1200 mg on day 1 of each 21-day cycle.
Intervention Type
Drug
Intervention Name(s)
Inavolisib
Other Intervention Name(s)
GDC-0077
Intervention Description
Inavolisib will be given in an orally at a dosage of 9 mg once daily for each day of the 28-day cycle.
Intervention Type
Drug
Intervention Name(s)
Letrozole
Other Intervention Name(s)
Femara
Intervention Description
Letrozole will be given orally at a dosage of 2.5 mg once daily for each day of the 28-day cycle.
Intervention Type
Drug
Intervention Name(s)
Giredestrant
Other Intervention Name(s)
GDC-9545
Intervention Description
Giredestrant will be given orally at a dosage of 30 mg once daily for each day of the 28-day cycle.
Intervention Type
Drug
Intervention Name(s)
Abemaciclib
Other Intervention Name(s)
Verzenio
Intervention Description
Giredestrant will be given orally at a dosage of 150 mg twice daily for each day of the 28-day cycle.
Primary Outcome Measure Information:
Title
Investigator-assessed overall response rate (ORR) of each biomarker cohort
Description
AFT-50A Protocol: Overall response rate for each biomarker cohort is defined as the proportion of participants achieving a complete (CR) or partial (PR) response on two consecutive occasions at least 4 weeks apart, as determined by the investigator from AFT50A Protocol: Tumor assessments per RECIST v1.1.
Time Frame
48 Months
Title
The proportion of participants in each biomarker cohort who remain alive and progression-free for at least 6 months
Description
AFT-50B Protocol: Progression free survival rate at 6 months is defined as the proportion of participants who have not experienced disease progression or death from any cause at 6 months, as determined by the investigator according to RECIST v1.1
Time Frame
6 Months
Secondary Outcome Measure Information:
Title
Relative proportion of participants in each biomarker cohort who remain progression-free for at least 6 months compared to that from historical control studies
Description
AFT-50A Protocol: PFS rate at 6 months is defined as the proportion of participants who have not experienced disease progression or death from any cause at 6 months, as determined by the investigator according to RECIST v1.1
Time Frame
6 Months per cohort
Title
Investigator assessed disease-control rate of each biomarker cohort
Description
AFT-50A Protocol: Disease-control rate is defined as the proportion of participants achieving either stable disease, complete response, or partial response.
Time Frame
48 Months
Title
Duration of response for participants in each biomarker cohort who achieve a complete or partial response.
Description
AFT-50A Protocol: Duration of response is defined as the time from the first occurrence of a documented objective response to disease progression or death from any cause (whichever occurs first), as determined by the investigator according to RECIST v1.1.
Time Frame
48 Months
Title
Overall survival (OS) rates of participants in each biomarker cohort after 24 months
Description
AFT-50A Protocol: 24-month overall survival rate is defined as the proportion of participants who have not experienced death from any cause at 24 months.
Time Frame
24 Months per cohort
Title
Investigator assessed disease-control rate of each biomarker cohort
Description
AFT-50B Protocol: Disease control rate is defined as the proportion of participants achieving either stable disease, complete response, or partial response at any time.
Time Frame
48 Months
Title
Duration of response for participants in each biomarker cohort who achieve a confirmed response (complete or partial)
Description
AFT-50B Protocol: Duration of response is defined as the time from the first occurrence of a documented objective response (complete or partial) to disease progression or death from any cause (whichever occurs first), as determined by the investigator according to RECIST v1.1
Time Frame
48 Months
Title
Overall survival rates of participants in each biomarker cohort
Description
AFT-50B Protocol: 24-month overall survival rate is defined as the proportion of participants who have not experienced death from any cause at 24 months.
Time Frame
24 Months
Other Pre-specified Outcome Measures:
Title
Safety of each biomarker cohort: adverse events
Description
AFT-50A Protocol: The incidence and severity of adverse events, with severity determined according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events, Version 5.0 (NCI CTCAE v5.0), as well as summaries of changes in clinically relevant laboratory test results, changes in vital signs, and study treatment exposures for each biomarker cohort
Time Frame
48 Months
Title
The safety of each biomarker cohort: Adverse Events
Description
AFT-50B Protocol: The incidence and severity of adverse events, with severity determined according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events, Version 5.0 (NCI CTCAE v5.0). Summaries of changes in clinically relevant laboratory test results, changes in vital signs, and study treatment exposures for each biomarker cohort
Time Frame
48 Months
Title
Assess exploratory biomarkers in tumor tissue and peripheral blood, and their association with other molecular characteristics, disease status and/or participant response to study treatment
Description
AFT-50A and AFT-50B Protocols: Association of exploratory biomarkers with clinical outcomes, including but not limited to molecular analysis of tumor tissue and peripheral blood, as well as cytokine/chemokine and cellular analysis of peripheral blood.
Time Frame
48 Months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Key Inclusion Criteria: Recurrent or persistent endometrial carcinoma which has progressed or recurred after at least 1, but no more than 2, prior lines of therapy. Prior hormonal therapies (e.g., tamoxifen, aromatase inhibitors) will not count toward the prior regimen limit. Chemotherapy given in conjunction with radiotherapy as a radiosensitizer will be counted as a systemic therapeutic regimen. Measurable disease per RECIST 1.1 Availability of a representative tumor specimen that is suitable for determination of biomarker status via central testing (F1CDx) OR If a patient has a prior F1CDx report from 1 September 2019 or later, those NGS results can be used to determine biomarker status as long as the tumor tissue used in the report was obtained within 5 years prior to prescreening and appropriate signed consent is obtained from the patient. Life expectancy > 12 weeks Recovery from effects of recent radiotherapy, surgery, or chemotherapy Key Exclusion Criteria: Endometrial tumors with the following histologies: squamous carcinomas, sarcomas Other invasive malignancies within the last 5 years, except for non-melanoma skin cancer with no evidence of disease within the past 5 years AND localized breast cancer with previous adjuvant chemotherapy treatment for breast cancer completed > 5 years ago Synchronous primary invasive ovarian or cervical cancer Have an active or history of autoimmune disease or immune deficiency Have a history of idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced pneumonitis, idiopathic pneumonitis, or evidence of active pneumonitis based on a screening chest computed tomography (CT) scan Active tuberculosis Severe infections within 4 weeks Have received therapeutic oral or IV antibiotic medication within 2 weeks, except prophylactic antibiotic medication Have significant cardiovascular disease Are administered treatment with a live attenuated vaccine within 4 weeks, or anticipation of need for such a vaccine during the course of the study Have prior allogeneic bone marrow transplantation or solid organ transplant Prior treatment with T-cell costimulating or immune checkpoint blockade therapies including, but not limited to, CD137 agonists, anti-PD-1, anti-PD-L1, and anti-CTLA-4 therapeutic antibodies History of treatment with systemic immunostimulatory agents (including but not limited to interferons, interleukin-2) within 4 weeks or 5 half-lives of the drug, whichever is longer, prior to initiation of study treatment History of treatment with systemic immunosuppressive medications within 2 weeks except acute, low-dose, systemic immunosuppressant medications, corticosteroids for chronic obstructive pulmonary disease and asthma, or mineralocorticoids and low-dose corticosteroids for participants with orthostatic hypotension or adrenocortical insufficiency Have a history or clinical evidence of any untreated CNS disease, seizures not controlled with standard medical therapy, or history of cerebrovascular accident (stroke), transient ischemic attack or subarachnoid hemorrhage within 6 months Note: Additional study cohort specific inclusion and exclusion criteria may apply based on cohort assignment.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Quality Management and Compliance
Phone
617-732-8727
Email
ClinicalTrials.Queries@alliancefoundationtrials.org
Facility Information:
Facility Name
City of Hope Comprehensive Cancer Center
City
Duarte
State/Province
California
ZIP/Postal Code
91010
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Daphne Stewart
First Name & Middle Initial & Last Name & Degree
Daphne Stewart, MD, MS
Facility Name
UCSF Helen Diller Family Comprehensive Cancer Center
City
San Francisco
State/Province
California
ZIP/Postal Code
94143
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Edwin Alvarez, MD
First Name & Middle Initial & Last Name & Degree
Edwin Alvarez, MD
Facility Name
Medstar Georgetown Cancer Institute
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20007
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ebony Hoskins, MD
First Name & Middle Initial & Last Name & Degree
Ebony Hoskins, MD
Facility Name
Mount Sinai Comprehensive Cancer Center
City
Miami Beach
State/Province
Florida
ZIP/Postal Code
33140
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Brian Slomovitz, MD
First Name & Middle Initial & Last Name & Degree
Brian Slomovitz, MD
Facility Name
University of Chicago
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
John Moroney, MD
First Name & Middle Initial & Last Name & Degree
John Moroney, MD
Facility Name
Dana Farber Cancer Institute
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02125
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Joyce Liu, MD, MPH
First Name & Middle Initial & Last Name & Degree
Joyce Liu, MD, MPH
Facility Name
University of Minnesota
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55455
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Britt Erickson, MD
First Name & Middle Initial & Last Name & Degree
Britt Erickson, MD
Facility Name
Washington University School of Medicine Siteman Cancer Center
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Premal Thaker, MD, MS
First Name & Middle Initial & Last Name & Degree
Premal Thaker, MD, MS
Facility Name
Nebraska Methodist Hospital
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68114
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Brent Tierney, MD
First Name & Middle Initial & Last Name & Degree
Brent Tierney, MD
Facility Name
Englewood Health
City
Englewood
State/Province
New Jersey
ZIP/Postal Code
07631
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nimesh Nagarsheth, MD
First Name & Middle Initial & Last Name & Degree
Nimesh Nagarsheth, MD
Facility Name
Atlantic Health Systems/Morristown Medical Center
City
Morristown
State/Province
New Jersey
ZIP/Postal Code
07960
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nana Tchabo, MD
First Name & Middle Initial & Last Name & Degree
Nana Tchabo, MD
Facility Name
Roswell Park
City
Buffalo
State/Province
New York
ZIP/Postal Code
14263
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Peter Frederick, MD
First Name & Middle Initial & Last Name & Degree
Peter Frederick, MD
Facility Name
Weill Cornell Medicine
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Evelyn Cantillo, MD, MPH
First Name & Middle Initial & Last Name & Degree
Evelyn Cantillo, MD, MPH
Facility Name
Duke University Cancer Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Angeles Alvarez Secord, MD
First Name & Middle Initial & Last Name & Degree
Angeles Alvarez Secord, MD
Facility Name
University of Oklahoma Health Stephenson Cancer Center
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73104
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Debra Richardson, MD
First Name & Middle Initial & Last Name & Degree
Debra Richardson, MD
Facility Name
Providence Portland Cancer Institute
City
Portland
State/Province
Oregon
ZIP/Postal Code
97213
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Christopher Darus, MD
First Name & Middle Initial & Last Name & Degree
Christopher Darus, MD
Facility Name
University of Pittsburgh Medical Center
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15261
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alexander B. Olawaiye, MD
First Name & Middle Initial & Last Name & Degree
Alexander B Olawaiye, MD
Facility Name
Baptist Memorial Hospital
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38120
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
David Engle, MD
First Name & Middle Initial & Last Name & Degree
David Engle, MD

12. IPD Sharing Statement

Plan to Share IPD
No
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Links:
URL
https://ctep.cancer.gov/protocolDevelopment/electronic_applications/ctc.htm
Description
CTCAE Version 5.0

Learn more about this trial

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

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