NCT05914974

Immunotherapy-related CRP Kinetics in Metastatic Gynecological Malignancies

ICK-Gyn: Immunotherapy-related CRP Kinetics in Metastatic Gynecological Malignancies

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 120 (estimated)
• Sponsor: University Hospital Tuebingen · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

ICK-Gyn is a prospective, multicentric, non-interventional investigator-initiated trial (IIT) that aims to investigate the prognostic value of CRP kinetics in advanced or metastatic gynecological malignancies under immune checkpoint inhibitor (ICI) therapy on the objective response rate (ORR), progression-free survival (PFS) and overall survival (OS).

Detailed description

Immunotherapy, which involves activating the body's immune system for cancer treatment, has already been widely incorporated into the standard care of patients with advanced and metastatic gynecological cancers. This study aims to investigate how inflammatory markers such as C-reactive protein (CRP) change during and after immunotherapy. Study findings from other tumor types (kidney, lung, bladder) suggest that immunotherapy is particularly effective when a mild inflammatory response is triggered in the body. The investigators want to examine this using CRP measurement. CRP measurement can easily be integrated into clinical routine as it only requires a blood sample. The goal of this prospective study is to determine whether changes in CRP levels in the blood can predict the disease progression or response to immunotherapy.

Conditions

• Gynecological Malignancies
• Cervical Cancer
• Endometrial Cancer
• Ovarian Cancer
• Vulvar Cancer

Timeline

• Start date: 2023-09-11
• Primary completion: 2027-04-01
• Completion: 2035-04-01
• First posted: 2023-06-22
• Last updated: 2026-02-10

Locations

1 site across 1 country: Germany