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

KI-AV0 sites30 target enrollmentJune 30, 2017

DrugsCarboplatin Paclitaxel Olaparib Zejula

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Not specified
Sponsor: KI-AV
Enrollment: 30
Status: Active, not recruiting
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

June 30, 2017

End Date

TBD

Last Updated

2 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

Female

Investigators

Sponsor

KI-AV

Eligibility Criteria

Inclusion Criteria

•1\. Have given written informed consent for the trial.
•2\. Have a histologically proven diagnosis of primary high\-grade serous ovarian, peritoneal, or fallopian tube cancer. Stage IV disease should ideally be cytologically or histologically proven.
•3\. Be equal or more then 18 years of age on day of signing informed consent.
•4\. Be willing and able to provide three tumor biopsies (1 FFPE, 2 fresh frozen) prior to start of treatment in which the tumor’s immunogenic mutational load can be determined by DNA and RNA sequencing.
•5\. Have a performance status of 0 or 1 on the ECOG Performance Scale.
•6\. Demonstrate adequate organ function as defined in the protocol
•7\. Female subjects of childbearing potential should have a negative urine or serum pregnancy within 72 hours prior to first cycle of treatment. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required.
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1\.2 Adults (18\-64 years) yes

Exclusion Criteria

•1\. Has previously received treatment for ovarian, peritoneal, or fallopian tube cancer.
•1a Has had a prior anti\-cancer monoclonal antibody (mAb) within 4 weeks prior to study Day 1 or who has not recovered (i.e., \= Grade 1 or at baseline) from adverse events due to agents administered more than 4 weeks earlier.
•1b Has had prior chemotherapy, targeted small molecule therapy, or radiation therapy within 2 weeks prior to study Day 1 or who has not recovered (i.e., \= Grade 1 or at baseline) from adverse events due to a previously administered agent.
•2\. Has a 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\. Is 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\. Has 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\. Has a known history of active TB (Bacillus Tuberculosis)
•6\. Hypersensitivity to pembrolizumab or any of its excipients.
•7\. Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis.
•8\. Has active autoimmune disease that has required systemic treatment in the past 2 years (i.e. with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment.