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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.
Full description
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Exploratory Objectives
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Inclusion criteria
Female participants who are at least 18 years of age on the day of signing informed consent with histologically confirmed diagnosis of high grade non-mucinous epithelial ovarian cancer will be enrolled in this study.
A female participant is eligible to participate if she is not pregnant, not breastfeeding, and at least one of the following conditions applies:
The participant provides written informed consent for the trial.
Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1. Evaluation of ECOG is to be performed within 7 days prior to the first dose of study intervention.
Have received standard of care frontline surgical and chemotherapy treatment (at least six cycles of platinum and taxane (or equivalent, with or without bevacizumab/biosimilar therapy). Patients who received neoadjuvant therapy are included.
Have undergone a second-look surgery after achieving a complete clinical response to frontline surgery and adjuvant chemotherapy as evidenced by (a) normal physical exam, (b) normal CT or PET-CT of abdomen and pelvis or other equivalent imaging, and (c) normalization of CA-125 (unless the patient has an elevated CA-125 thought to be due to other confounding causes by the treating physician). CT scans with subtle or indeterminate findings will not disqualify participation.
Histologically confirmed residual ovarian cancer at time of second-look surgery. Patients with cytological evidence of malignant cells in washings obtained as part of the second look procedure are eligible even if biopsies are negative.
Subjects must have germline BRCA1 and 2 non-mutated AND homologous recombination proficient (HRP aka HRD negative) tumors, as determined by testing using MyChoice by Myriad Genetics (or other CLIA certified lab per PI's discretion). Subjects with HRD indeterminate status due to failed testing or insufficient tissues are eligible. Subjects with BRCA1/2 variants of uncertain significant (VUS) are eligible as long as they are HRD negative. Note germline mutation and HRD tests are performed as standard of care in all women with newly diagnosed advanced stage ovarian cancer and the testing itself is not part of the protocol.
Be willing to allow use of archival tissue from second-look surgery and primary surgery or biopsy for use in this study.
Have adequate organ function as determined by the following laboratory values:
Have adequately recovered from second look surgery to be able to start the investigational regimen no sooner than 28 days from the date of second look surgery, and within 7 weeks of this procedure.
Negative serum pregnancy test within 72 hours prior to receiving the first dose of study medication (unless surgically sterile or postmenopausal for greater than one year).
Exclusion criteria
Primary purpose
Allocation
Interventional model
Masking
20 participants in 1 patient group
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Central trial contact
Amir Jazaeri, MD
Data sourced from clinicaltrials.gov
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