This is a single arm phase II, multicenter study evaluating Pembrolizumab in recurrent platinum resistant CPS score \>1 positive ovarian, Fallopian tube and primary peritoneal cancer patients.
This is a single arm, phase II, multicenter study trial evaluating Pembrolizumab in recurrent platinum resistant CPS score \>1 positive ovarian, Fallopian tube and primary peritoneal cancer patients. All the eligible patients will receive Pembrolizumab 200 mg d1 q 21 iv infusion in 30 minutes, until disease progression of disease, unacceptable toxicity or patient's refusal. Pembrolizumab will be administered for a maximum of 2 years. The primary objective of the study is to assess overall survival (OS) of patients treated with Pembrolizumab single agent.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
100
Experimental
Fondazione Policlinico Universitario A. Gemelli IRCCS
Rome, Italy
RECRUITINGOverall Survival
The length of time from the date of the start of treatment to death
Time frame: 44 months
Advers Events
The safety and tolerability of patients receiving Pembrolizumab will be assessed
Time frame: 44 months
Response Rate
The response rate will be assessed by RECIST 1.1 criteria
Time frame: 44 months
Progression Free Survival
The length of time from the start of treatment to the disease progression
Time frame: 44 months
Quality of life: physical impact of disease
Patient-reported outcomes of patients receiving pembrolizumab will be assessed utilizing the disease-related symptoms - physical (DRS-P) subscale of the National Comprehensive Cancer Network-Functional Assessment of Cancer Therapy (NCCNFACT) FACT-Ovarian Symptom Index 18 (FOSI-18) Changes and using Euro-Quality of Life 5D (eEQ-5D) tool
Time frame: 44 months
Quality of life: emotional impact of disease
Patient-reported outcomes of patients receiving pembrolizumab will be assessed utilizing the disease-related symptoms - physical (DRS-P) subscale of the National Comprehensive Cancer Network-Functional Assessment of Cancer Therapy (NCCNFACT) FACT-Ovarian Symptom Index 18 (FOSI-18) Changes and using Euro-Quality of Life 5D (eEQ-5D) tool
Time frame: 44 months
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