Neo-adjuvant Pembrolizumab in Primary Stage IV Ovarian Cancer
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|ClinicalTrials.gov Identifier: NCT03126812|
Recruitment Status : Recruiting
First Posted : April 24, 2017
Last Update Posted : March 13, 2019
|Condition or disease||Intervention/treatment||Phase|
|Ovarian Cancer Stage IV Peritoneal Cancer Fallopian Tube Cancer||Drug: Carboplatin Drug: Paclitaxel Drug: Pembrolizumab||Phase 1 Phase 2|
Long-term survival in stage IV serous ovarian, peritoneal, and fallopian tube cancer is poor and has not significantly improved over the last decades. Standard treatment consists of debulking surgery and six courses of carboplatin and paclitaxel. Nevertheless, the disease recurs in >90% of women, usually within two years.
Since early observations that the presence of infiltrating T cells is associated with improved outcome, ovarian cancer is linked to a potential benefit of immunotherapy.10 More recently, T cell checkpoint blockade with anti-PD1 and anti-PDL1 have shown promising activity in platinum resistant ovarian cancer with objective and durable responses in 10-20% of patients. This finding raises the question whether anti-PD1 could also play a role in first line treatment of ovarian cancer.
To fully use the power of T cell checkpoint inhibition, sufficient TCR stimulation is required. Importantly, the amount of antigen that can provide this signal will correlate with tumor load, and because of this adjuvant immunotherapy may work most efficiently, when initiated prior to surgery. In addition, we postulate that antigen retrieval will increase after induction treatment with cytotoxic therapy.
To address these questions, we propose a feasibility study in patients with FIGO stage IV serous ovarian, peritoneal, or fallopian tube cancer in which we evaluate pembrolizumab added to standard treatment for its capacity to induce and broaden T cell responses against neo-antigens.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||15 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Feasibility Study of Neo-adjuvant Treatment With Carboplatin, Paclitaxel and Pembrolizumab in Primary Stage IV Serous Ovarian Cancer|
|Actual Study Start Date :||November 1, 2017|
|Estimated Primary Completion Date :||June 2020|
|Estimated Study Completion Date :||June 2025|
Experimental: Carboplatin, paclitaxel, pembrolizumab
Carboplatin AUC= 6 paclitaxel 80 mg/m2 Pembrolizumab 200 mg starting cycle 2
paclitaxel 80 mg/m2
200 mg flat dose, starting cycle 2
- Number of T-cells in peripheral blood [ Time Frame: up to week 52 ]determine the number of T cells in peripheral blood samples and tissue samples
- Toxicity; Incidence of toxicity, graded according to National Cancer Institute Common Toxicity Criteria (NCI-CTC) version 4.0 [ Time Frame: up to 30 days after end of treatment ]Toxicity will be analyzed in patients who have received at least one administration of pembrolizumab.
- Response Rate [ Time Frame: at week 12, debulking surgery ]number of patients with no viable invasive tumor left in the resection specimen
- Response rate according to RECIST [ Time Frame: at week 3 and 6 ]Number of patients with partial or complete response according to RECIST
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03126812
|Contact: Gabe Sonke, MD||+3120512 ext email@example.com|
|Contact: Ingrid Mandjes, MScfirstname.lastname@example.org|
|Antoni van Leeuwenhoek||Recruiting|
|Contact: G Sonke, MD email@example.com|
|Contact: S Koole firstname.lastname@example.org|
|Principal Investigator: G Sonke, MD|