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
Part of paid clinical trials in New York, New York.
- Sponsor
- M.D. Anderson Cancer Center
- Study ID
- NCT06083844
- Phase
- PHASE2
- Status
- Recruiting
Conditions
Eligibility Criteria
- Sex
- FEMALE
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- Pembrolizumab — DRUGGiven by IV (vein)
- Bevacizumab — DRUGGiven by IV (vein)
- Cyclophosphamide — DRUGGiven by mouth
Study Details
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.
Key Dates
- Start date
- Dec 12, 2023
- Status verified
- May 2026
- Primary completion
- Sep 30, 2027
- Completion
- Sep 30, 2027
Study Design
- Enrollment
- 20 participants (estimated)
- Allocation
- NA
- Intervention model
- SINGLE_GROUP
- Primary purpose
- TREATMENT
Arms
- Experimental: Pembrolizumab in Combination with Bevacizumab and Oral CyclophosphamideParticipants will begin receiving the study drug Pembrolizumab in Combination with Bevacizumab and Oral Cyclophosphamide. Each study cycle is 21 days.
Primary Outcome Measure
Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0 [ Time Frame: Through study completion; an average of 1 year. ]
Central Contacts
- Amir Jazaeri, MD(713) 745-1613
Locations (2)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Memorial Sloan Kettering Cancer Center | New York | New York | 10065 | - |
| MD Anderson Cancer Center | Houston | Texas | 77030 | Amir Jazaeri, MD (PRINCIPAL_INVESTIGATOR) |
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