This is a phase II, single arm, multi-centre study to assess the efficacy of pembrolizumab in
combination with platinum-based chemotherapy (investigator's choice: carboplatin +
gemcitabine or carboplatin + pegylated liposomal doxorubicin) administered concurrent to
chemotherapy and in maintenance, in patients with low grade ovarian cancer (including
patients with primary peritoneal and / or fallopian tube adenocarcinoma) having
platinum-sensitive relapse (platinum-free interval > 6 months).
In this study, we will evaluate efficacy and safety of pembrolizumab in combination with
chemotherapy (physician's choice) in subjects with low-grade ovarian cancer.
Patients will receive Pembrolizumab 200mg q3w until progression or unacceptable toxicity, for
a maximum of 35 cycles PLUS one of the following standard chemotherapies for LGSOC
Carboplatin AUC 4 + Gemcitabine 1000mg/m² (q3w for 3-6 cycles) or Carboplatin AUC 5 +
pegylated liposomal Doxorubicin 30mg/m² (q4w for 3-6 cycles). As primary objective 12-month
progression free survival (PFS) rate will be analysed.
About 2 sites in Germany will participate in this study to recruit 33 patients in 24 months.
If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.
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