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Monoclonal Antibodies
Atezolizumab + Bevacizumab for Endometrial Cancer
Phase 2
Waitlist Available
Led By Kathleen Moore, MD
Research Sponsored by University of Oklahoma
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Evidence that the endometrial cancer is advanced, recurrent, or persistent and has relapsed or is refractory to curative therapy or established treatments
Patients MSI status must be known (via immunohistochemistry)
Must not have
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
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 years
Awards & highlights
No Placebo-Only Group
Summary
This trial will test the safety and effectiveness of a combination of two drugs, atezolizumab and bevicacizumab, in women with endometrial cancer that has progressed or come back after treatment.
Who is the study for?
This trial is for women with advanced, recurrent or persistent endometrial cancer who have tried at least one platinum-based chemotherapy but no more than two regimens. Participants must be over 18, understand the study and consent to it, have measurable disease by certain medical imaging standards, an ECOG performance status of 0-2, and agree to use contraception if of childbearing potential.
What is being tested?
The trial is testing a combination of two drugs: Atezolizumab and Bevacizumab in women with specific types of endometrial cancer. It's a Phase II study focusing on the safety and effectiveness (futility) of this drug combo without comparing it to other treatments.
What are the potential side effects?
Potential side effects include allergic reactions related to antibodies or proteins in the drugs; risk of infection; possible nerve damage; gastrointestinal issues like fistula or perforation; bleeding disorders; severe fatigue; and complications from immune system interactions.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My endometrial cancer is advanced, recurrent, or persistent and does not respond to standard treatments.
Select...
My cancer's MSI status has been tested.
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I have a tumor or lymph node that meets the size requirements for measurement.
Select...
My cancer is a type of endometrial carcinoma.
Select...
I have had 1 or 2 platinum-based treatments for endometrial cancer.
Select...
I can take care of myself and am up and about more than half of my waking hours.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I started taking corticosteroids not more than a week ago.
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I have brain metastases but meet specific treatment criteria.
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I haven't had serious abdominal issues, wounds, or fractures in the last 6 months.
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I have moderate to severe numbness, tingling, or muscle weakness.
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I have been treated with anti-PD-1 or anti-PD-L1 therapy.
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I have an autoimmune disorder like SLE, sarcoidosis, RA, or Crohn's.
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I haven't taken any immune-boosting drugs in the last 6 weeks.
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I haven't had major surgery in the last 28 days and don't expect to need one during the study.
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I am not pregnant or breastfeeding.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 3 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 years
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Number of patients who experience complete or partial tumor response
Secondary study objectives
Number of participants who experience immune related response
Number of patients who experience toxicity
Overall survival
+1 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: Bevacizumab + AtezolizumabExperimental Treatment2 Interventions
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Bevacizumab
2013
Completed Phase 4
~5540
Atezolizumab
2016
Completed Phase 3
~5860
Find a Location
Who is running the clinical trial?
University of OklahomaLead Sponsor
473 Previous Clinical Trials
93,571 Total Patients Enrolled
6 Trials studying Endometrial Cancer
231 Patients Enrolled for Endometrial Cancer
Genentech, Inc.Industry Sponsor
1,558 Previous Clinical Trials
569,326 Total Patients Enrolled
6 Trials studying Endometrial Cancer
356 Patients Enrolled for Endometrial Cancer
Kathleen Moore, MDPrincipal InvestigatorObstetrics and Gynecology
8 Previous Clinical Trials
335 Total Patients Enrolled
2 Trials studying Endometrial Cancer
88 Patients Enrolled for Endometrial Cancer
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I started taking corticosteroids not more than a week ago.I have brain metastases but meet specific treatment criteria.I am HIV positive but not immunocompromised, or I am on antiretroviral therapy.I haven't had serious abdominal issues, wounds, or fractures in the last 6 months.I have moderate to severe numbness, tingling, or muscle weakness.I do not have any severe health issues that could affect my participation in the study.My endometrial cancer is advanced, recurrent, or persistent and does not respond to standard treatments.I understand and agree to sign the Informed Consent Form for the study.My cancer's MSI status has been tested.I have been treated with anti-PD-1 or anti-PD-L1 therapy.I have an autoimmune disorder like SLE, sarcoidosis, RA, or Crohn's.I have a tumor or lymph node that meets the size requirements for measurement.I haven't had any cancer besides non-melanoma skin cancer or carcinoma in situ, or if I did, it was more than 2 years ago and fully treated.I haven't taken any immune-boosting drugs in the last 6 weeks.I can provide previous cancer tissue samples or agree to a new biopsy.I haven't had certain cancer treatments or recovered from their side effects in the last 4-6 weeks.I haven't had major surgery in the last 28 days and don't expect to need one during the study.My cancer is a type of endometrial carcinoma.I have had 1 or 2 platinum-based treatments for endometrial cancer.I am not pregnant or breastfeeding.I am a woman aged 18 or older.I can take care of myself and am up and about more than half of my waking hours.
Research Study Groups:
This trial has the following groups:- Group 1: Bevacizumab + Atezolizumab
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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