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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 below

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I am a woman over 18 with a specific type of ovarian cancer.

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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.

This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion; an average of 1 year. for reporting.

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

0 / 6Eligibility criteria met

Find a Location

Who is running the clinical trial?

M.D. Anderson Cancer CenterLead Sponsor

2,985 Previous Clinical Trials

1,789,097 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

Recent research and studies

clinicaltrials.govStudy

Phase II Investigation of Pembrolizumab in Combination With Bevacizumab and Oral Cyclophosphamide in Patients With High Grade Ovarian Cancer and Surgically Documented Minimal Residual Disease After Frontline Therapy

2023. "Phase II Investigation of Pembrolizumab in Combination With Bevacizumab and Oral Cyclophosphamide in Patients With High Grade Ovarian Cancer and Surgically Documented Minimal Residual Disease After Frontline Therapy". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06083844.