Status and phase
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About
The investigators hypothesize that tumor cell killing by cytotoxic chemotherapy exposes the immune system to high levels of tumor antigens.The combination of Paclitaxel/Carboplatin and Pembrolizumab may result in deeper and more durable responses compared with standard chemotherapy alone.
Enrollment
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Volunteers
Inclusion criteria
No prior treatment for primary advanced (Stage III or IV) high grade epithelial ovarian, primary peritoneal, or fallopian tube carcinoma such as irradiation, chemotherapy, hormonal therapy, immunotherapy, investigational therapy, and/or other concurrent agents or therapies.
Patients must undergo diagnostic laparoscopy for disease assessment for tissue biopsies to confirm diagnosis with planned interval tumor reductive surgery after completion of 3-4 cycles of treatment. For those not medically fit to undergo laparoscopy, as determined by the Investigator. (interventional radiology) IR-guided core biopsies may be used.
Patients must be appropriate candidates for planned neoadjuvant chemotherapy (NACT) with combination carboplatin and paclitaxel given intravenously (IV) every 3 weeks ( IV Q3W).
Tissue from an archival sample or newly obtained core or excisional biopsy of a tumor lesion.
Age ≥ 18 years.
Life expectancy > 3 months.
Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.
Patients must have normal organ and marrow function as defined below:
Hematologic
Renal
Hepatic
Coagulation
Negative urine or serum pregnancy ≤ 72 hours (i.e. 3 days) prior to receiving the first dose of study medication if not surgically sterilized. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required.
Female subjects of childbearing potential (have not been surgically sterilized or have not been without menses for > 1 year) should be willing to use 2 methods of birth control at the same time or be surgically sterile, or abstain from heterosexual activity for the course of the study and at least 120 days after the last study dose.
Ability to understand and the willingness to sign a written informed consent document.
Exclusion criteria
Primary purpose
Allocation
Interventional model
Masking
26 participants in 1 patient group
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Data sourced from clinicaltrials.gov
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