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

Completed

Conditions: ovarian cancer
10038594

Registration Number: NL-OMON54749

Lead Sponsor: ederlands Kanker Instituut

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 30

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
proven
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.

Exclusion Criteria

1. previously received treatment for ovarian, peritoneal, or fallopian tube
cancer.
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
to study

Study & Design

Study Type: Observational invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Primary objective: The primary objective of this study is to determine the<br /><br>immune-activating capacity of treatment with pembrolizumab and<br /><br>carboplatin/paclitaxel in the neo-adjuvant setting of primary stage IV ovarian<br /><br>cancer as measured by the alteration in magnitude and breadth of the tumor<br /><br>specific T cell response during therapy in peripheral blood.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary objectives of this study are:<br /><br>- To evaluate the safety of the carboplatin-paclitaxel-pembrolizumab treatment<br /><br>- To evaluate the tolerability of the carboplatin-paclitaxel-pembrolizumab<br /><br>treatment based on adverse events according to CTCAE version 4.03<br /><br>- To assess the tumor response based on RECIST 1.1 and serum CA-125 levels<br /><br>- To assess the efficacy of the treatment based on the result of the debulking<br /><br>surgery (no viable invasive tumor left in the resection specimen)<br /><br>- To evaluate the feasibility of the carboplatin-paclitaxel-pembrolizumab<br /><br>treatment<br /><br>- To evaluate Overall survival (OS, time from start chemotherapy to death from<br /><br>any cause)<br /><br>- To evaluate Disease free Survival (DFS, time from start chemotherapy to tumor<br /><br>progression)</p><br>