NCT03126812CompletedPhase 1/2
Neo-adjuvant Pembrolizumab in Primary Stage IV Ovarian Cancer
Feasibility Study of Neo-adjuvant Treatment With Carboplatin, Paclitaxel and Pembrolizumab in Primary Stage IV Serous Ovarian Cancer
Source: ClinicalTrials.gov · Last updated 29 May 2024
Brief summary (registry, in English)
This is a single arm feasibility study in patients with primary FIGO stage IV serous ovarian, peritoneal, or fallopian tube cancer to evaluate neo-adjuvant + adjuvant pembrolizumab for its capacity to induce and broaden T cell responses against tumor neo-antigens.
- Status (registry)
- Completed
- Phase (registry)
- Phase 1/2
- Study type
- Interventional
- Enrollment
- 33 (actual)
- First submitted
- 19 Dec 2016
- Start date
- 1 Nov 2017
- Primary completion date
- 1 Jun 2023
- Lead sponsor
- The Netherlands Cancer Institute
- Diseases
- Ovarian cancer
- NCT number
- NCT03126812
What you commit to
- Study type: Interventional · Phase 1/2
- Participants enrolled: 33
- From 1 Nov 2017 to the primary completion date, 1 Jun 2023
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Previously received treatment for ovarian, peritoneal, or fallopian tube cancer.
- 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.
- 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.
- 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.
- 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.
- 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.
- Has had a prior anti-cancer monoclonal antibody (mAb) within 4 weeks prior to study
Other illness
- A known history of active TB (Bacillus Tuberculosis)
- Hypersensitivity to pembrolizumab or any of its excipients.
Who the study is looking for
- Written informed consent for the trial.
- Diagnosis of primary stage IV high-grade serous ovarian, peritoneal, or fallopian tube cancer.
- Age \>= 18 years on day of signing informed consent.
- Willing and able to provide three tumor biopsies (1 FFPE, 2 fresh frozen) prior to start of treatment
- Performance status of 0 or 1 on the ECOG Performance Scale.
- Adequate organ function as defined in Table 1 of the protocol
- 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.
Age in the registry: 18 years to - · Sex: Female · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Antoni van Leeuwenhoek Coordinator of this site? Confirm its status | Amsterdam | Netherlands | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.