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Phase II investigational study of pembrolizumab combination with chemotherapy in platinum-sensitive recurrent low-grade serous ovarian cancer

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2023-508155-40-00
Acronym
NOGGO-ov44
Enrollment
33
Registered
2024-02-02
Start date
2022-01-25
Completion date
Unknown
Last updated
2025-01-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

fallopian tube- and/or primary peritoneal cancer, recurrent platin sensitive low-grade serous ovarian-

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.
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
12-month (48 weeks) progression free survival (PFS) rate

Secondary

MeasureTime 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

Source: EU CTIS · Data processed: May 29, 2026