A Phase 1/2 interventional study of Carboplatin and Paclitaxel in Ovarian Cancer Stage IV, Peritoneal Cancer and Fallopian Tube Cancer, sponsored by The Netherlands Cancer Institute. Completed at 1 site in Netherlands. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-05-29.
Sponsored by The Netherlands Cancer Institute · Phase 1/2, Interventional, and Treatment
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.
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.
2,695 studies on the registry are indexed under Ovarian Neoplasms; 727 are open to participants now.
This study's enrollment of 33 is below the median of 60 across 2,030 interventional studies indexed under Ovarian Neoplasms.
Browse Ovarian Neoplasms studies →The Netherlands Cancer Institute is the lead sponsor of 224 studies on the registry; 66 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Previously received treatment for ovarian, peritoneal, or fallopian tube cancer.
Carboplatin AUC= 6 paclitaxel 80 mg/m2 Pembrolizumab 200 mg starting cycle 2
Drug: Carboplatin · Drug: Paclitaxel · Drug: Pembrolizumab
Carboplatin AUC=6
paclitaxel 80 mg/m2
200 mg flat dose, starting cycle 2
Number of T-cells in peripheral blood
determine the number of T cells in peripheral blood samples and tissue samples
Time frame: up to week 52
Toxicity; Incidence of toxicity, graded according to National Cancer Institute Common Toxicity Criteria (NCI-CTC) version 4.0
Toxicity will be analyzed in patients who have received at least one administration of pembrolizumab.
Time frame: up to 30 days after end of treatment
Response Rate
number of patients with no viable invasive tumor left in the resection specimen
Time frame: at week 12, debulking surgery
Response rate according to RECIST
Number of patients with partial or complete response according to RECIST
Time frame: at week 3 and 6
Plan to share: Undecided — to be determinated
No publications or documents are linked to this record.
This study is completed, as verified in May 2024. You cannot join it, but the record below documents what was studied.
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The Netherlands Cancer Institute