Immunotherapy-related CRP Kinetics in Metastatic Gynecological Malignancies

University Hospital Tuebingen

Status

Enrolling

Conditions

Endometrial Cancer

Vulvar Cancer

Gynecological Malignancies

Ovarian Cancer

Cervical Cancer

Study type

Observational

Funder types

Other

Identifiers

NCT05914974

ZGynO_ICK-Gyn

Details and patient eligibility

About

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).

Full 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.

Enrollment

120 estimated patients

Sex

Female

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

women ≥ 18 years of age
histologically proven metastatic gynecological malignancies irrespective of therapy line
patients with advanced or metastatic gynecological malignancies must fulfill treatment requirements for ICI therapy in the experimental group
planned ICI therapy in combination with palliative chemotherapy in the experimental group
patients with advanced or metastatic gynecological malignancies that undergo chemotherapy without ICIs in the first therapy line in the control group
written informed consent into ICK-Gyn

Exclusion criteria

missing indication for ICI therapy in the experimental group
any ICI therapy before inclusion into the trial
patients with advanced or metastatic endometrial or cervical cancer in the second or higher therapy line without indication to ICI therapy
pregnant or lactating patients
inadequate general condition (not fit for chemotherapy)