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

NCT04486352

Last updated date
Contact
617-525-8347

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting the study website. Please see the references below:

By phone

Pfizer Clinical Trials Contact Center

617-525-8347

By email

Contact

[email protected]

Call Now

Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Endometrial Cancer
Sex
Female
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- 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

NEED INFO?

Questions about a trial? Call or email to reach a Pfizer Clinical Trial Contact Center Representative

Pfizer Clinical Trials Contact Center

1-800-718-1021

[email protected]

TRY A NEW SEARCH

Search for Clinical Trials by condition, keyword or trial number. Share your location or enter your city or zip code to find studies near you.

Based on your search, you may also be interested in

Advanced Information
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 Dufrane617-525-8347[email protected]
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