Immunotherapy-related CRP Kinetics in Metastatic Gynecological Malignancies

February 9, 2026 updated by: University Hospital Tuebingen

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

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).

Study Overview

Status

Recruiting

Conditions

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 Type

Observational

Enrollment (Estimated)

120

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

120 patients will be included in the study after written informed consent. Of 60 patients in the control group, which will undergo chemotherapy of physician's choice, 25 patients will be diagnosed with advanced or metastatic cervical cancer, 25 patients will be diagnosed with advanced or metastatic endometrial cancer and 10 patients will be diagnosed with advanced or metastatic ovarian or vulvar cancer.

Of 60 patients in the experimental group, which will undergo palliative chemotherapy in combination with ICIs, 25 patients will be diagnosed with advanced or metastatic cervical cancer, 25 patients will be diagnosed with advanced or metastatic endometrial cancer and 10 patients will be diagnosed with advanced or metastatic ovarian or vulvar cancer.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Control Group
Chemotherapy without immunotherapy
Experimental Group
Chemotherapy in combination with immunotherapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Prognostic value of CRP kinetics under ICI therapy on progression-free survival (PFS)
Time Frame: 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.
duration of therapy and follow-up data (10 years)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Prognostic value of CRP kinetics in advanced or metastatic gynecological malignancies under ICI therapy on the objective response rate (ORR) and overall survival (OS).
Time Frame: 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.
duration of therapy and follow-up data (10 years)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital Tuebingen

Collaborators

University Hospital Freiburg
University Hospital Ulm

Investigators

  • Principal Investigator: Dominik Dannehl, Dr., Department of Women's Health Tübingen

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 11, 2023

Primary Completion (Estimated)

April 1, 2027

Study Completion (Estimated)

April 1, 2035

Study Registration Dates

First Submitted

June 13, 2023

First Submitted That Met QC Criteria

June 13, 2023

First Posted (Actual)

June 22, 2023

Study Record Updates

Last Update Posted (Actual)

February 10, 2026

Last Update Submitted That Met QC Criteria

February 9, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ZGynO_ICK-Gyn

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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