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

Phase II Study of Atezolizumab + Bevacizumab in Endometrial Cancer

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: NCT03526432
Recruitment Status : Recruiting
First Posted : May 16, 2018
Last Update Posted : July 1, 2020
Sponsor:
Collaborator:
Genentech, Inc.
Information provided by (Responsible Party):
University of Oklahoma

Brief Summary:
This is a single arm, Phase II study using the combination of atezolizumab and bevicacizumab in women with advanced, recurrent or persistent endometrial cancer. Safety and futility of this drug combination will be assessed to see what effect this treatment has on this patient population.

Condition or disease Intervention/treatment Phase
Endometrial Cancer Drug: Bevacizumab Drug: Atezolizumab Phase 2

Detailed Description:
This phase 2 study using atezolizumab and bevacizumab aims to study the objective tumor response in women with recurrent endometrial cancer. Drugs will be administered via IV every 21 days until disease progression, unacceptable toxicity, or loss of clinical benefit as determined by investigator. Subjects will receive routine cancer care as well as tests and procedures required for the purposes of this study. It is expected this combination will be produce an anti-cancer effect with manageable toxicities in this patient population.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 55 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II, Single Arm Study of Atezolizumab + Bevacizumab in Women With Advanced, Recurrent or Persistent Endometrial Cancer
Actual Study Start Date : August 8, 2018
Estimated Primary Completion Date : May 25, 2021
Estimated Study Completion Date : May 25, 2023

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Bevacizumab + Atezolizumab Drug: Bevacizumab
Bevacizumab will be administered by IV infusion at 15mg/kg on Day 1 of every 21-days cycle.

Drug: Atezolizumab
Atezolizumab will be administered by IV infusion at a fixed dose of 1200 mg on Day 1 of each 21-day cycle until disease progression, unacceptable toxicity, loss of clinical benefit as determined by the investigator.




Primary Outcome Measures :
  1. Number of patients who experience complete or partial tumor response [ Time Frame: 3 years ]
    To estimate the objective tumor response in women of this patient population


Secondary Outcome Measures :
  1. Progression-free Survival [ Time Frame: up to 3 years ]
    To estimate progression-free survival (PFS) and overall survival (OS) of patients with recurrent or persistent endometrial cancer treated with Atezolizumab and Bevacizumab.

  2. Overall survival [ Time Frame: up to 3 years ]
    To estimate overall survival (OS) of patients with recurrent or persistent endometrial cancer treated with Atezolizumab and Bevacizumab.

  3. Number of patients who experience toxicity [ Time Frame: 6 months ]
    To determine the nature and degree of toxicity in combination of atezolizumab and bevacizumab.

  4. Number of participants who experience immune related response [ Time Frame: 6 months ]
    To estimate response using immune related response criteria (irRC) in patients receiving Atezolizumab and Bevacizumab.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Histologic or cytologic diagnosis of endometrial carcinoma (including endometrioid, serous, mixed adenocarcinoma, clear-cell carcinoma, or carcinosarcoma).
  2. Evidence that the endometrial cancer is advanced, recurrent, or persistent and has relapsed or is refractory to curative therapy or established treatments.
  3. At least 1 prior platinum-based chemotherapeutic regimen, but not more than 2 prior chemotherapeutic regimens, for management of endometrial carcinoma. Prior treatment may include chemotherapy, and/or consolidation/maintenance therapy.
  4. Measurable disease by RECIST 1.1, defined as at least 1 lesion that can be accurately measured in at least 1 dimension (longest diameter to be recorded). Each lesion must be ≥ 10 mm in long axis when measured by CT, MRI, or caliper measurement by clinical exam. Lymph nodes must be ≥ 15 mm in short axis when measured by CT or MRI.
  5. Female patients 18 years or older.
  6. Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2
  7. For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive methods as defined in study protocol.
  8. Clinical laboratory values as specified in study protocol within 4 weeks before the first dose of study drug.
  9. Able to understand and willing to sign the Informed Consent Form and the written consent must be given before performance of any study-related procedure not part of standard medical care, with the understanding that consent may be withdrawn by the patient at any time without prejudice to future medical care.
  10. Must have ability to comply with the study protocol, in the investigator's judgment.
  11. Patients MSI status must be known (via immunohistochemistry)
  12. Patients should have archival tumor tissue available or agree to have pre-treatment tumor biopsy if no archival tissue is available for correlative studies If unable to be safely biopsied and patient desires enrollment, may be enrolled per principal investigator discretion.
  13. Life expectancy of greater than 12 weeks.

Exclusion Criteria:

  1. Positive serum pregnancy test during the screening period or a positive urine pregnancy test on Day 1 before first dose of study drug. Women who are lactating and breast feeding are not eligible.
  2. Previous treatment with anti−PD-1, or anti−PD-L1 therapeutic antibody.
  3. History of auto-immune disorders (SLE, sarcoidosis, RA, Crohn's).
  4. Initiation of treatment with systemic corticosteroids (either IV or oral steroids, excluding inhalers) within 1 week before administration of the first dose of study drug
  5. Sensory or motor neuropathy ≥ Grade 2.
  6. Patients with symptomatic, untreated Central nervous system (CNS) metastasis; Patients with a history of treated CNS lesions are eligible if all criteria provided per study protocol are met.
  7. Other clinically significant co-morbidities, such as uncontrolled pulmonary disease, active CNS disease, severe cardiac disease, bleeding diathesis, active infection, or any other condition that could compromise participation of the patient in the study.
  8. Diagnosed or treated for another malignancy within 2 years before administration of the first dose of study drug or previously diagnosed with another malignancy and have any evidence of residual disease. Patients with non-melanoma skin cancer or carcinoma in situ of any type are not excluded if they have undergone complete resection.
  9. Patients with prior allogeneic bone marrow transplantation or prior solid organ transplantation
  10. Patients who have had investigational therapy, chemotherapy or radiotherapy within 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to entering the study or those who have not recovered from adverse events (other than alopecia) due to agents administered more than 4 weeks earlier; however, some therapies are allowed per study protocol.
  11. Treatment with systemic immunostimulatory agents (including, but not limited to, interferon [IFN]-alpha or interleukin [IL]-2) within 6 weeks or five half-lives of the drug (whichever is shorter) prior to cycle 1, day 1
  12. History of severe allergic, anaphylactic, or other hypersensitivity reactions to chimeric or humanized antibodies or fusion proteins, compounds similar to bevacizumab or atezolizumab, or Chinese hamster ovary products.
  13. Major surgical procedure within 28 days prior to cycle 1, day 1 or anticipation of need for a major surgical procedure during the course of the study
  14. History of abdominal/pelvic fistula, gastrointestinal perforation and/or intraabdominal abscess within 6 months prior to day 1. Serious or non-healing wound, active ulcer or bone fracture
  15. Immunocompromised patients and subjects known to be HIV positive and currently receiving antiretroviral therapy. NOTE: Subjects known to be HIV positive, but without clinical evidence of an immunocompromised state, are eligible for this trial.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03526432


Contacts
Layout table for location contacts
Contact: Lead Gyn Onc Nurse 405 271-8777 SCC-IIT-Office@ouhsc.edu

Locations
Layout table for location information
United States, Alabama
UAB Women and Infants Center Recruiting
Birmingham, Alabama, United States, 35233
Contact: Rebecca Arend, MD       rarend@uabmc.edu   
Principal Investigator: Rebecca Arend, MD         
United States, Missouri
Washington University School of Medicine Recruiting
Saint Louis, Missouri, United States, 63108
Contact: Carolyn McCourt, MD    314-362-3181    cmccourt@wustl.edu   
Principal Investigator: Carolyn McCourt, MD         
United States, Oklahoma
Stephenson Cancer Center, University of Oklahoma Health Sciences Center Recruiting
Oklahoma City, Oklahoma, United States, 73117
Contact: Lead Gyn Onc Nurse    405-271-8777    SCC-IIT-Office@ouhsc.edu   
Sponsors and Collaborators
University of Oklahoma
Genentech, Inc.
Investigators
Layout table for investigator information
Principal Investigator: Camille Gunderson, MD Obstetrics and Gynecology
Layout table for additonal information
Responsible Party: University of Oklahoma
ClinicalTrials.gov Identifier: NCT03526432    
Other Study ID Numbers: OU-SCC-GEN-001
First Posted: May 16, 2018    Key Record Dates
Last Update Posted: July 1, 2020
Last Verified: June 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Additional relevant MeSH terms:
Layout table for MeSH terms
Endometrial Neoplasms
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Uterine Diseases
Genital Diseases, Female
Bevacizumab
Atezolizumab
Antineoplastic Agents, Immunological
Antineoplastic Agents
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors