Ovarian Cancer Clinical Trial
Official title:
MITO27: Randomized Phase II Study on MK-3475 Plus Chemotherapy Versus Chemotherapy Alone in Recurrent, Platinum-resistant Ovarian Cancer
The study is designed to assess the therapeutic efficacy and toxicity of the combination chemotherapy with pembrolizumab in recurrent, platinum resistant OC patients. The main objective is to test whether the therapeutic intervention benefits the patients evaluating the increase in overall survival with respect to chemotherapy alone.
This is a multicenter, randomized, open-label trial, designed to assess the therapeutic
efficacy and toxicity of the combination chemotherapy with pembrolizumab in recurrent,
platinum resistant OC patients. The main objective is to test whether the therapeutic
intervention benefits the patients evaluating the increase in overall survival with respect
to chemotherapy alone.
Eligible patients will be randomized 1:1 to receive:
ARM A:
Pegylated Liposomal Doxorubicin 40 mg/mq iv q 28 Weekly Paclitaxel 80 mg/mq d 1,8,15 q 28
Gemcitabine 1000 mg/mq d 1,8 q 21 At physician' discretion or
ARM B:
Pegylated Liposomal Doxorubicin 40 mg/mq iv q 28 Weekly Paclitaxel 80 mg/mq d 1,8,15 q 28
Gemcitabine 1000 mg/mq d 1,8 q 21 plus Pembrolizumab 200 mg d1 q 21 iv infusion in 30 minutes
In both arms patients will receive treatments until disease progression, unacceptable
toxicity of patient's refusal. Patients will receive at least 6 to 8 cycles of chemotherapy
at physician's discretion. In the experimental arm patients who stop chemotherapy for
toxicity reasons and whose disease is at least in stabilization, may continue treatment with
Pembrolizumab as single agent.
Patients will be stratified according to the number of previous chemotherapy lines (1 vs >1)
and measurable/evaluable disease.
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