Immunotherapy-related CRP Kinetics in Metastatic Gynecological Malignancies

Recruiting

• Conditions: Gynecological Malignancies; Ovarian Cancer; Cervical Cancer; Endometrial Cancer; Vulvar Cancer

• Registration Number: NCT05914974
• Lead Sponsor: University Hospital Tuebingen

Brief 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.

Study Timeline

• Study First Submitted: 2023-06-13
• Study First Submitted QC: 2023-06-13
• Study First Posted: 2023-06-22
• Study Start: 2023-09-11
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-17
• Last Update Posted: 2024-07-18
• Primary Completion: 2025-04
• Study Completion: 2035-04

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 120

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)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Prognostic value of CRP kinetics under ICI therapy on progression-free survival (PFS)	duration of therapy and follow-up data (10 years)	Evaluation of CRP kinetics to predict progression-free survival in advanced or metastatic gynecological malignancies treated with ICIs in combination with chemotherapy. The CRP value is determined from blood samples.

Secondary Outcome Measures

Name	Time	Method
Prognostic value of CRP kinetics in advanced or metastatic gynecological malignancies under ICI therapy on the objective response rate (ORR) and overall survival (OS).	duration of therapy and follow-up data (10 years)	* evaluation of CRP kinetics to predict objective response in patients with advanced or metastatic gynecological malignancies receiving ICIs in combination with chemotherapy; * evaluation of CRP kinetics to predict overall survival in patients with advanced or metastatic gynecological malignancies receiving ICI in combination with chemotherapy; * Exploratory analysis of further biomarkers related to immune response The respective values are determined from blood samples.

Trial Locations

Locations (1)

Department of Women's Health; 🇩🇪 Tuebingen, Germany