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History of Changes for Study: NCT03526432
Phase II Study of Atezolizumab + Bevacizumab in Endometrial Cancer
Latest version (submitted February 21, 2022) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 May 3, 2018 None (earliest Version on record)
2 July 13, 2018 Study Status and Oversight
3 August 8, 2018 Recruitment Status, Study Status and Contacts/Locations
4 August 30, 2019 Contacts/Locations, Outcome Measures, Study Status, IPDSharing, Eligibility and Study Identification
5 November 21, 2019 Study Status
6 March 3, 2020 Study Status, Contacts/Locations and Eligibility
7 March 13, 2020 Contacts/Locations and Study Status
8 June 12, 2020 Study Status and Eligibility
9 June 30, 2020 Contacts/Locations and Study Status
10 June 10, 2021 Study Status and Contacts/Locations
11 September 13, 2021 Study Status
12 February 21, 2022 Recruitment Status, Study Status and Contacts/Locations
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Study NCT03526432
Submitted Date:  May 3, 2018 (v1)

Open or close this module Study Identification
Unique Protocol ID: 9178
Brief Title: Phase II Study of Atezolizumab + Bevacizumab in Endometrial Cancer
Official Title: A Phase II, Single Arm Study of Atezolizumab + Bevacizumab in Women With Advanced, Recurrent or Persistent Endometrial Cancer
Secondary IDs:
Open or close this module Study Status
Record Verification: May 2018
Overall Status: Not yet recruiting
Study Start: May 25, 2018
Primary Completion: May 25, 2021 [Anticipated]
Study Completion: May 25, 2023 [Anticipated]
First Submitted: May 3, 2018
First Submitted that
Met QC Criteria:
May 3, 2018
First Posted: May 16, 2018 [Actual]
Last Update Submitted that
Met QC Criteria:
May 3, 2018
Last Update Posted: May 16, 2018 [Actual]
Open or close this module Sponsor/Collaborators
Sponsor: University of Oklahoma
Responsible Party: Sponsor
Collaborators: Genentech, Inc.
Open or close this module Oversight
U.S. FDA-regulated Drug: Yes
U.S. FDA-regulated Device: No
Data Monitoring: Yes
Open or close this module Study Description
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.
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.
Open or close this module Conditions
Conditions: Endometrial Cancer
Keywords:
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Treatment
Study Phase: Phase 2
Interventional Study Model: Single Group Assignment
Number of Arms: 1
Masking: None (Open Label)
Allocation: N/A
Enrollment: 55 [Anticipated]
Open or close this module Arms and Interventions
Arms Assigned Interventions
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.
Open or close this module Outcome Measures
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. Number of patients who experience progression-free or overall survival
[ Time Frame: 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. Number of patients who experience toxicity
[ Time Frame: 6 months ]

To determine the nature and degree of toxicity in combination of atezolizumab and bevacizumab.
3. 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.
Open or close this module Eligibility
Minimum Age: 18 Years
Maximum Age: 99 Years
Sex: Female
Gender Based:
Accepts Healthy Volunteers: No
Criteria:

Inclusion Criteria:

  • Histologic or cytologic diagnosis of endometrial carcinoma (including endometrioid, serous, mixed adenocarcinoma, clear-cell carcinoma, or carcinosarcoma).
  • Evidence that the endometrial cancer is advanced, recurrent, or persistent and has relapsed or is refractory to curative therapy or established treatments.
  • At least 1 prior platinum-based chemotherapeutic regimen, but not more than 2 prior chemotherapeutic regimens, for management of endometrial carcinoma.
  • 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).
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2
  • Females who are postmenopausal, surgically sterile, or practice true abstinence
  • Acceptable lab results as specified in study protocol
  • MSI status must be known
  • Life expectancy of greater than 12 weeks
  • Patients should have archival tumor tissue available or agree to have pre-treatment tumor biopsy if no archival tissue is available for correlative studies

Exclusion Criteria:

  • 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.
  • Previous treatment with anti-PD-1, or anti-PD-L1 therapeutic antibody or any immune directed anti-cancer therapy.
  • History of auto-immune disorders (SLE, sarcoidosis, RA, Crohn's).
  • 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
  • Sensory or motor neuropathy ≥ Grade 2
  • Patients with symptomatic, untreated Central nervous system (CNS) metastasis
  • 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
  • Patients with prior allogeneic bone marrow transplantation or prior solid organ transplantation
  • 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
  • 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
  • History of severe allergic, anaphylactic, or other hypersensitivity reactions to chimeric or humanized antibodies or fusion proteins, compounds similar to bevacizumab or atezolizumuab, or Chinese hamster ovary products.
  • 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
  • History of abdominal/pelvic fistula, gastrointestinal perforation and/or intraabdominal abscess within 6 months prior to day 1
Open or close this module Contacts/Locations
Central Contact Person: Ingrid Block, APRN
Telephone: 405 271-8777
Email: ingrid-block@ouhsc.edu
Study Officials: Camille Gunderson, MD
Principal Investigator
Obstetrics and Gynecology
Locations: United States, Oklahoma
Stephenson Cancer Center, University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, United States, 73117
Open or close this module IPDSharing
Plan to Share IPD:
Open or close this module References
Citations:
Links:
Available IPD/Information:

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