Actively Recruiting
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
Led by M.D. Anderson Cancer Center · Updated on 2026-03-04
20
Participants Needed
2
Research Sites
198 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
To find out if combining pembrolizumab, bevacizumab (or an equivalent biosimilar drug), and low-dose cyclophosphamide can help control high-grade ovarian cancer that has MRD after treatment. The safety of this treatment combination will also be studied.
CONDITIONS
Official Title
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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Female participants aged 18 years or older with confirmed high grade non-mucinous epithelial ovarian cancer
- Not pregnant or breastfeeding, and either not a woman of childbearing potential or agrees to use contraception during treatment and for 120 days after last dose
- Provided written informed consent
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 within 7 days before first treatment
- Completed frontline surgery and chemotherapy with at least six cycles of platinum and taxane (with or without bevacizumab or biosimilar)
- Have minimal residual disease after complete clinical response to frontline therapy as confirmed by second-look surgery or detectable circulating tumor DNA within 3 months after last chemotherapy dose
- If second look surgery was done, histologically confirmed residual ovarian cancer or cytological evidence of malignant cells
- Willing to allow use of archival tissue from surgeries or biopsy for study
- Adequate organ function as shown by specific laboratory values
- Recovered from second look surgery to start treatment no sooner than 28 days and within 7 weeks after surgery
- Negative serum pregnancy test within 72 hours before first dose unless surgically sterile or postmenopausal for over one year
You will not qualify if you...
- Prior treatment with anti-PD-1, anti-PD-L1, anti-PD-L2 agents or other T-cell receptor targeting agents
- Radiotherapy within 2 weeks before study or unresolved radiation toxicities
- Live vaccine within 30 days before first study drug dose
- Use of investigational agents within 4 weeks before first dose
- Immunodeficiency or recent systemic steroid or immunosuppressive therapy
- Active progressing malignancy other than specified skin or in situ cancers
- Active central nervous system metastases or carcinomatous meningitis
- Active autoimmune disease requiring systemic treatment in past 2 years
- History or current pneumonitis or interstitial lung disease requiring steroids
- Serious active infection
- Uncontrolled HIV infection
- Active untreated hepatitis B or C infection
- Conditions or therapies interfering with study participation or results
- Psychiatric or substance abuse disorders affecting compliance
- Pregnancy, breastfeeding, or plans to conceive during study and 120 days after last dose
- History of allogenic tissue or solid organ transplant
- Uncontrolled hypertension persistently above specified limits
- Histology showing mucinous or low-grade epithelial ovarian carcinoma
- Known BRCA mutations or homologous recombination deficiency positive tumors
- History of arterial thrombosis (excluding pulmonary embolism in pulmonary arteries)
- History of gastrointestinal or urinary fistulae, non-healed or chronic wounds contraindicating bevacizumab
- Inability to understand or comply with study requirements
- Concurrent or planned anti-cancer systemic treatments or live cancer vaccines
- Any other medical condition increasing risk per investigator judgment
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 2 locations
1
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10065
Actively Recruiting
2
MD Anderson Cancer Center
Houston, Texas, United States, 77030
Actively Recruiting
Research Team
A
Amir Jazaeri, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here