Actively Recruiting
Newly Diagnosed Stage III/IV Ovarian Cancer, Neoadjuvant Carbo/Taxol/Pembro, Maintenance Olaparib/Pembro
Led by University of Alabama at Birmingham · Updated on 2026-03-11
20
Participants Needed
1
Research Sites
306 weeks
Total Duration
On this page
Sponsors
U
University of Alabama at Birmingham
Lead Sponsor
M
Merck Sharp & Dohme LLC
Collaborating Sponsor
AI-Summary
What this Trial Is About
this is a trial evaluating three chemotherapy agents in patients with newly diagnosed ovarian cancer patients that are Stage III or Stage IV prior to surgery to remove the tumor. After surgery there will be additional chemotherapy given.
CONDITIONS
Official Title
Newly Diagnosed Stage III/IV Ovarian Cancer, Neoadjuvant Carbo/Taxol/Pembro, Maintenance Olaparib/Pembro
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Female, age 18 years or older
- Histologically confirmed FIGO Stage III or IV epithelial ovarian cancer, primary peritoneal cancer, or fallopian tube cancer
- Candidate for carboplatin and paclitaxel chemotherapy in the neoadjuvant setting with planned interval debulking surgery
- CA-125 to carcinoembryonic antigen (CEA) ratio greater than or equal to 25, or negative workup for non-ovarian cancer if ratio is less than 25
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 within 7 days prior to enrollment
- Not pregnant, not breastfeeding, and either not a woman of childbearing potential or agrees to contraceptive guidance during treatment and specified periods after
- Adequate organ function based on blood counts, kidney and liver function, and coagulation tests within 7 days prior to enrollment
- Provides written informed consent
You will not qualify if you...
- Mucinous, germ cell, or borderline tumor of the ovary
- History or current non-infectious pneumonitis requiring steroids
- Myelodysplastic syndrome (MDS) or acute myeloid leukemia (AML), or features suggestive of these
- Active progressing additional malignancy requiring treatment in last 3 years (with exceptions)
- Active or untreated brain metastases or carcinomatous meningitis (with some exceptions for stable treated brain metastases)
- Immunodeficiency or recent systemic steroid or immunosuppressive therapy use
- Active autoimmune disease requiring systemic treatment in past 2 years
- Active tuberculosis or infection requiring systemic therapy
- Serious uncontrolled medical disorder or active infection
- Recent surgery for borderline tumors or early-stage cancer under 6 months
- Psychiatric or substance abuse disorder interfering with study participation
- Known HIV, active hepatitis B or C infection
- Prior treatment for advanced or metastatic ovarian cancer
- Severe hypersensitivity to study drugs or excipients
- Uncontrolled cardiac conditions or congenital long QT syndrome
- Previous allogenic tissue or bone marrow transplant
- Prior use of olaparib or other PARP inhibitors
- Current use of strong or moderate CYP3A4 inhibitors or inducers that cannot be stopped
- Recent blood transfusion or colony-stimulating factor use
- Inability to swallow oral medication or gastrointestinal absorption issues
- Uncontrolled hypertension or gastrointestinal complications relevant to bevacizumab use
- Recent participation in other investigational studies
- Unlikely to comply with study procedures and requirements
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
O'Neal Comprehensive Cancer Center at UAB
Birmingham, Alabama, United States, 35294
Actively Recruiting
Research Team
M
Margaret A Thomas, MPH
CONTACT
R
Rebecca Arend
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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