Exploratory study of neo-adjuvant treatment with carboplatin, paclitaxel and pembrolizumab in primary stage IV serous ovarian cancer - Neo Pembro

ederlands Kanker Instituut0 个研究点目标入组 30 人开始时间: 待定最近更新: 2024年4月15日

适应症

试验速览

暂无简介。

•1. Written informed consent for the trial.
•2. Diagnosis of primary high-grade serous ovarian, peritoneal, or fallopian
•tube cancer. Stage IV disease should ideally be cytologically or histologically
•3. Age >= 18 years on day of signing informed consent.
•4. Willing and able to provide three tumor biopsies (1 FFPE, 2 fresh frozen)
•prior to start of treatment
•5. Performance status of 0 or 1 on the ECOG Performance Scale.
•6. Adequate organ function as defined in Table 1 of the protocol
•7. Female subject of childbearing potential should have a negative urine or
•serum pregnancy within 72 hours prior to receiving the first dose of study
•medication. If the urine test is positive or cannot be confirmed as negative, a
•serum pregnancy test will be required.

•1. previously received treatment for ovarian, peritoneal, or fallopian tube
•2. known additional malignancy, unless treated with curative intent without
•chemotherapy at least five years ago. In situ cancers, basal cell carcinoma of
•the skin or squamous cell carcinoma of the skin that have undergone potentially
•curative therapy within the past five years may also be eligible.
•3. currently participating and receiving study therapy or has participated in
•a study of an investigational agent and received study therapy or used an
•investigational device within 4 weeks of the first dose of treatment.
•4. a diagnosis of immunodeficiency or is receiving systemic steroid therapy or
•any other form of immunosuppressive therapy within 7 days prior to the first
•dose of trial treatment.
•5. A known history of active TB (Bacillus Tuberculosis)
•6. Hypersensitivity to pembrolizumab or any of its excipients.
•7. Has had a prior anti-cancer monoclonal antibody (mAb) within 4 weeks prior

发起方

ederlands Kanker Instituut