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Monoclonal Antibodies
Triple Drug Combo for Advanced Ovarian Cancer
Phase 2
Recruiting
Led By Amir Jazaeri, MD
Research Sponsored by M.D. Anderson Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Female participants who are at least 18 years of age with histologically confirmed diagnosis of high grade non-mucinous epithelial ovarian cancer
Participants must have undergone a second-look surgery after achieving a complete clinical response to frontline surgery and adjuvant chemotherapy
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through study completion; an average of 1 year.
Awards & highlights
Study Summary
This trial will study the safety & effectiveness of a 3-drug combo to control advanced ovarian cancer that has returned after treatment.
Who is the study for?
This trial is for women over 18 with high-grade non-mucinous ovarian cancer, who've had surgery and chemo but still have minimal residual disease. They must not have BRCA mutations or HRD-positive tumors, need good organ function, no recent vaccines or other treatments, and can't be pregnant.Check my eligibility
What is being tested?
The study tests a combination of pembrolizumab (an immunotherapy), bevacizumab (a drug that inhibits blood vessel growth in tumors), and low-dose cyclophosphamide (a chemotherapy) to see if it controls ovarian cancer better after standard treatment.See study design
What are the potential side effects?
Possible side effects include immune system reactions affecting organs, infusion-related symptoms, fatigue from cyclophosphamide; bleeding or wound healing complications due to bevacizumab; plus general risks like nausea and increased infection chances.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am a woman over 18 with a specific type of ovarian cancer.
Select...
I had surgery to check for cancer after initial treatment was successful.
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My ovarian cancer was confirmed by a biopsy during my second surgery.
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I have undergone the recommended initial surgery and chemotherapy.
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My cancer does not have BRCA mutations and is proficient in DNA repair.
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My organ functions are within normal ranges according to recent tests.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ through study completion; an average of 1 year.
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through study completion; an average of 1 year.
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0
Trial Design
1Treatment groups
Experimental Treatment
Group I: Pembrolizumab in Combination with Bevacizumab and Oral CyclophosphamideExperimental Treatment3 Interventions
Participants will begin receiving the study drug Pembrolizumab in Combination with Bevacizumab and Oral Cyclophosphamide.
Each study cycle is 21 days.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Pembrolizumab
2017
Completed Phase 2
~2010
Cyclophosphamide
1995
Completed Phase 3
~3770
Bevacizumab
2013
Completed Phase 4
~5280
Find a Location
Who is running the clinical trial?
M.D. Anderson Cancer CenterLead Sponsor
2,986 Previous Clinical Trials
1,789,582 Total Patients Enrolled
46 Trials studying Ovarian Cancer
16,715 Patients Enrolled for Ovarian Cancer
Amir Jazaeri, MDPrincipal InvestigatorM.D. Anderson Cancer Center
3 Previous Clinical Trials
132 Total Patients Enrolled
2 Trials studying Ovarian Cancer
101 Patients Enrolled for Ovarian Cancer
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is the current research endeavor open to new participants?
"The clinicaltrials.gov records demonstrate that this specific trial, which was first published on March 1st 2024, is not actively looking for participants anymore. Nevertheless, there are 752 other medical studies out there recruiting now."
Answered by AI
Is the trio of Pembrolizumab, Bevacizumab and Oral Cyclophosphamide sanctioned by the FDA?
"A score of 2 was assigned to the safety of Pembrolizumab in Combination with Bevacizumab and Oral Cyclophosphamide because this is a Phase 2 trial, meaning there has been some evidence of security but no proof that it can be efficacious."
Answered by AI
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