fallopian tube- and/or primary peritoneal cancer, recurrent platin sensitive low-grade serous ovarian-
Conditions
Brief summary
12-month (48 weeks) progression free survival (PFS) rate
Detailed description
ORR, OS and PFS rate after 6, 12, 18 and 24 months, PFS and OS as time-to-event variables, Response rate (SD, PR or CR) after 6, 12, 18 and 24 months, Ki-67 expression <3.6% versus ≥3.6% and response rate and PFS, Safety Endpoints – safety of combination therapy (ctx and pembrolizumab) CTCAE v5.0 will be used as endpoint, Time of subsequent medical intervention, TFST and response (CR, PR, SD, PD) to first subsequent treatment, QoL (EORTC-QLQ-C30, EORTC-QLQ-OV-28) until 6 months after progress
Interventions
DRUGKEYTRUDA 25 mg/mL concentrate for solution for infusion
Sponsors
Nord-Ostdeutsche Gesellschaft Fuer Gynaekologische Onkologie e.V.
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 12-month (48 weeks) progression free survival (PFS) rate | — |
Secondary
| Measure | Time frame |
|---|---|
| ORR, OS and PFS rate after 6, 12, 18 and 24 months, PFS and OS as time-to-event variables, Response rate (SD, PR or CR) after 6, 12, 18 and 24 months, Ki-67 expression <3.6% versus ≥3.6% and response rate and PFS, Safety Endpoints – safety of combination therapy (ctx and pembrolizumab) CTCAE v5.0 will be used as endpoint, Time of subsequent medical intervention, TFST and response (CR, PR, SD, PD) to first subsequent treatment, QoL (EORTC-QLQ-C30, EORTC-QLQ-OV-28) until 6 months after progress | — |
Countries
Germany
Outcome results
None listed