Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 1 for:    NCT04486352
Previous Study | Return to List | Next Study

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04486352
Recruitment Status : Not yet recruiting
First Posted : July 24, 2020
Last Update Posted : September 2, 2020
Sponsor:
Collaborators:
Genentech, Inc.
Foundation Medicine
Pfizer
Information provided by (Responsible Party):
Alliance Foundation Trials, LLC.

Tracking Information
First Submitted Date  ICMJE July 22, 2020
First Posted Date  ICMJE July 24, 2020
Last Update Posted Date September 2, 2020
Estimated Study Start Date  ICMJE September 2020
Estimated Primary Completion Date September 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 23, 2020)
Investigator-assessed overall response rate (ORR) of each biomarker cohort [ Time Frame: 48 Months ]
Overall response rate for each biomarker cohort is defined as the proportion of patients achieving a complete (CR) or partial (PR) response on two consecutive occasions at least 4 weeks apart, as determined by the investigator from tumor assessments per RECIST v1.1.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 23, 2020)
  • Relative proportion of patients in each biomarker cohort who remain progression-free for at least 6 months compared to that from historical control studies [ Time Frame: 6 Months per cohort ]
    PFS rate at 6 months is defined as the proportion of patients 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 [ Time Frame: 48 Months ]
    Disease-control rate is defined as the proportion of patients achieving either stable disease, complete response, or partial response.
  • Duration of response for patients in each biomarker cohort who achieve a complete or partial response. [ Time Frame: 48 Months ]
    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 patients in each biomarker cohort after 24 months [ Time Frame: 24 Months per cohort ]
    24-month overall survival rate is defined as the proportion of patients who have not experienced death from any cause at 24 months.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: July 23, 2020)
Safety of each biomarker cohort: adverse events [ Time Frame: 48 Months ]
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
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE A Study of Targeted Agents With Atezolizumab for Patients With Recurrent or Persistent Endometrial Cancer
Official Title  ICMJE A Phase IB/II Multi-Cohort Study of Targeted Agents With Atezolizumab for Patients With Recurrent or Persistent Endometrial Cancer
Brief Summary This is a Phase IB/II multi-cohort study designed to evaluate the efficacy and safety of targeted agents plus cancer immune checkpoint therapy with atezolizumab for patients 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 subjects into biomarker-matched study cohorts consisting of testing targeted agents with atezolizumab.
Detailed Description

This is a Phase IB/II multi-cohort study designed to evaluate the efficacy and safety of targeted agents plus cancer immune checkpoint therapy with atezolizumab in patients with recurrent and/or persistent endometrial cancer.

This biomarker-driven study provides a platform whereby patients with persistent/recurrent endometrial cancer will be placed into study cohorts evaluating atezolizumab plus a targeted agent selected on the basis of the tumor's specific genomic profile. Prospective patients 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.

Based on the FoundationOne® results, patients will be assigned to a study cohort with a targeted therapy + atezolizumab. The current study cohorts are as follows:

  • Atezolizumab + Bevacizumab doublet
  • Atezolizumab + Ipatasertib doublet
  • Atezolizumab + Talazoparib doublet

It is anticipated that 20 patients will be enrolled in each study cohort. Each study cohort will open/close independently of other study cohorts. Once a study cohort reaches 20 patients, it will be closed to further enrollment.

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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Endometrial Cancer
Intervention  ICMJE
  • Drug: Atezolizumab
    Atezolizumab would be given to patients intravenously at a dosage of 1680 mg every 4 weeks on a 28-day cycle.
    Other Names:
    • Tecentriq
    • L01XC32
  • Drug: Bevacizumab
    Bevacizumab would be given to patients intravenously at a dosage of 10mg per patient kilogram every 2 weeks of the 28-day cycle.
    Other Names:
    • Avastin
    • L01XC07
  • Drug: Ipatasertib
    Ipatasertib will be given as an oral tablet at a dosage of 400 mg once daily for 21 days of each 28-day cycle.
    Other Names:
    • RG7440
    • GDC-0068
  • Drug: Talazoparib
    Talazoparib will be given in an oral tablet at a dosage of 1 mg once daily for each day of the 28-day cycle.
    Other Names:
    • Talzenna
    • L01XX60
Study Arms  ICMJE
  • Experimental: Atezolizumab and Bevacizumab Cohort
    Following the submission of tumor tissue to Foundation Medicine for the FoundationOne® assay, patients with no specified gene signatures will be enrolled in this cohort. Twenty patients will be enrolled. Once twenty patientsare enrolled, the cohort will be closed to further enrollment. Patients in this study cohort will commence treatment as specified on Day 1 of each cycle.
    Interventions:
    • Drug: Atezolizumab
    • Drug: Bevacizumab
  • Experimental: Atezolizumab and Ipatasertib Cohort
    Following the submission of tumor tissue to Foundation Medicine for the FoundationOne® assay, patients with PIK3CA/AKT1/PTEN-altered tumors will be enrolled in this cohort. Twenty patients will be enrolled. Once twenty patients are enrolled, the cohort will be closed to further enrollment. Patients in this study cohort will commence treatment as specified on Day 1 of each cycle.
    Interventions:
    • Drug: Atezolizumab
    • Drug: Ipatasertib
  • Experimental: Atezolizumab and Talazoparib Cohort
    Following the submission of tumor tissue to Foundation Medicine for the FoundationOne® assay, patients with tumors that have a ≥16%genomic loss of heterozygosity (LOH) will be assigned to this cohort. Twenty patients will be enrolled. Once twenty patients are enrolled, the cohort will be closed to further enrollment. Patients in this study cohort will commence treatment as specified on Day 1 of each cycle.
    Interventions:
    • Drug: Atezolizumab
    • Drug: Talazoparib
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: July 23, 2020)
60
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE September 2024
Estimated Primary Completion Date September 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
  • 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® assay).
  • 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
  • localized breast cancer with previous adjuvant chemotherapy treatment for breast cancer completed > 5 years ago
  • Have 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
  • Have active tuberculosis
  • Have 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
  • Have 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
  • Have 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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Carter Dufrane 617-525-8347 info@alliancefoundationtrials.org
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04486352
Other Study ID Numbers  ICMJE AFT-50
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Alliance Foundation Trials, LLC.
Study Sponsor  ICMJE Alliance Foundation Trials, LLC.
Collaborators  ICMJE
  • Genentech, Inc.
  • Foundation Medicine
  • Pfizer
Investigators  ICMJE Not Provided
PRS Account Alliance Foundation Trials, LLC.
Verification Date August 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP