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 — DRUG
    Given by IV (vein)
  • Bevacizumab — DRUG
    Given by IV (vein)
  • Cyclophosphamide — DRUG
    Given 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 Cyclophosphamide
    Participants 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

Locations (2)

FacilityCityStateZIPSite coordinators
Memorial Sloan Kettering Cancer CenterNew YorkNew York10065-
MD Anderson Cancer CenterHoustonTexas77030
Amir Jazaeri, MD
713-745-1613
Amir Jazaeri, MD (PRINCIPAL_INVESTIGATOR)

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