NL-OMON54749
Completed
Not Applicable
Exploratory study of neo-adjuvant treatment with carboplatin, paclitaxel and pembrolizumab in primary stage IV serous ovarian cancer - Neo Pembro
ederlands Kanker Instituut0 sites30 target enrollmentTBD
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- ederlands Kanker Instituut
- Enrollment
- 30
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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
Exclusion Criteria
- •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
Outcomes
Primary Outcomes
Not specified
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