Study of Pembrolizumab Combination With Chemotherapy in Platinum-sensitive Recurrent Low-grade Se… (NCT04575961) | Clinical Trial Compass
Active — Not RecruitingPhase 2
Study of Pembrolizumab Combination With Chemotherapy in Platinum-sensitive Recurrent Low-grade Serous Ovarian Cancer
Germany33 participantsStarted 2022-02-22
Plain-language summary
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).
Who can participate
Age range18 Years
SexFEMALE
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Inclusion Criteria:
* Female, age at least 18 years.
* Histologically diagnosed low-grade serous ovarian cancer, fallopian tube cancer, or primary peritoneal cancer.
* Patients must have completed at least 1 previous course of platinum-containing therapy (e.g., combination with carboplatin or cisplatin. Maintenance therapy with bevacizumab and/or endocrine agents is allowed).
* Progression or recurrence after platinum-containing therapy, occurring no sooner than 6 months after completion of the last dose of platinum chemotherapy (platinum sensitive disease).
* Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1.
* Women of childbearing potential should not become pregnant while on the Product and should not be pregnant at the beginning of treatment. A pregnancy test should be performed on all women of childbearing potential prior to receiving the Product. Women of childbearing potential must agree to follow contraceptive guidance during the treatment period and for 6 months after receiving the last dose of the study therapy.
* The participant (or legally acceptable representative if applicable) provides written informed consent for the trial.
* Availability of archival tumor tissue sample or newly obtained core or excisional biopsy of a tumor lesion not previously irradiated. Formalin-fixed, paraffin embedded (FFPE) tissue blocks are preferred to slides. Newly obtained biopsies are preferred to archived tissue.
Exclusion Criteria:
* High-grade ovarian cance…