1. 12-month (48 weeks) progression free survival (PFS) rate (Time Frame - 12 month): The primary objective of this clinical trial is 12-month Progression Free Survival (PFS) rate after start of treatment. Tumor progression will be assessed with local imaging per irRECIST 1.1 and is defined according to RECIST criteria. Start of therapy will be counted when the patient receives the first dose of pembrolizumab.
Secondary outcome:
1. Response rate (SD, PR or CR) after 6, 12, 18 and 24 months (Time Frame - 6, 12, 18 and 24 months): Stable Disease, Partial Response or CR will be evaluated per irRECIST 1.1 after 6, 12,18 and 24 months
2. Ki-67 (Time Frame - 24 month): Marker of proliferation Ki-67 Obtain archival tumor tissue sample or newly obtained core or excisional biopsy of a tumor lesion not previously irradiated for routine determination of PD-1, PD-L1 and Ki-67 status
3. Time of next medical intervention (Time Frame - 24 month): Time of next medical intervention due to tumor progress
4. Quality of life until 6 months after progress (Time Frame - 6 month): Patients are asked to answer the European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Core 30 (QLQ-C30). Responses of questions 1-28 are based on a 4-point scale (1=not at all; 4=Very much), with a higher score indicating a high degree of symptomatology and must therefore be assessed negatively. Responses of questions 29 and 30 are based on a 7-point scale (1=Very poor; 7=Excellent), with a higher score indicating a better global health status.
5. TFST and response to first subsequent treatment (Time Frame - 24 month): Time to first subsequent treatment and response to first subsequent treatment will be evaluated.
6. Safety Endpoints - safety of combination therapy (ctx and pembrolizumab) according to CTCAE 5.0 criteria will be used as endpoint (Time Frame - 24 month): The safety objective is to characterize the safety and tolerability of pembrolizumab in combination with chemotherapy in subjects with advanced low grade ovarian cancer. The following safety parameters will be analyzed: adverse events and serious adverse events graded per NCI CTCAE, Version 4.0 criteria with time to onset/recovery, causality and outcome; changes in laboratory values, vital signs since baseline, treatment discontinuations and reason for discontinuation, death and cause of death etc. concomitant medications will be collected with time and reasons of use. These are routine safety parameters collected and analyzed in Phase II /III oncology trials. Furthermore, specific immune-related adverse events (irAEs) will be collected
7. PFS (time-to-event) and PFS rate after 6, 12, 18 and 24 months (Time Frame - 6, 12, 18 and 24 months): Progression Free Survival (time to event) and PFS rate after 6, 12, 18 and 24 months after start of treatment. Tumor progression will be assessed with local imaging per irRECIST 1.1 and is defined according to RECIST criteria. Start of therapy will be counted when the patient receives the first dose of pembrolizumab
8. Quality of life 2 until 6 months after progress (Time Frame - 6 month): Patients are asked to answer the EORTC QoL Questionnaire-Ovarian Cancer (QLQ-OV28). Responses are based on a 4-point scale (1=Not at all; 4=Very much), with a lower score indicating better symptoms.
Pembrolizumab (Keytruda): Participants receive pembrolizumab 200 mg by intravenous (IV) infusion prior to chemotherapy on Day 1 of each 21-day cycle for up to 35 cycles
Quelle: ClinicalTrials.gov
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"Study of Pembrolizumab Combination With Chemotherapy in Platinum-sensitive Recurrent Low-grade Serous Ovarian Cancer"
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