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Immunotherapy-related CRP Kinetics in Metastatic Gynecological Malignancies

Sponsor
University Hospital Tuebingen (Other)
Overall Status
Recruiting
CT.gov ID
NCT05914974
Collaborator
University Hospital Ulm (Other), University Hospital Freiburg (Other)
120
Enrollment
1
Location
142
Anticipated Duration (Months)
0.8
Patients Per Site Per Month

Study Details

Study Description

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).

Condition or Disease Intervention/Treatment Phase

    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 Design

    Study Type:
    Observational
    Anticipated Enrollment :
    120 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    ICK-Gyn: Immunotherapy-related CRP Kinetics in Metastatic Gynecological Malignancies
    Anticipated Study Start Date :
    Jun 1, 2023
    Anticipated Primary Completion Date :
    Apr 1, 2025
    Anticipated Study Completion Date :
    Apr 1, 2035

    Arms and Interventions

    Arm Intervention/Treatment
    Control Group

    Chemotherapy without immunotherapy
    Experimental Group

    Chemotherapy in combination with immunotherapy

    Outcome Measures

    Primary Outcome Measures

    1. 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

    1. 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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    No
    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)

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Department of Women's Health Tuebingen Germany 72076

    Sponsors and Collaborators

    • University Hospital Tuebingen
    • University Hospital Ulm
    • University Hospital Freiburg

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    University Hospital Tuebingen
    ClinicalTrials.gov Identifier:
    NCT05914974
    Other Study ID Numbers:
    • ICK-Gyn
    First Posted:
    Jun 22, 2023
    Last Update Posted:
    Jun 22, 2023
    Last Verified:
    Jun 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Neoplasms
    Endometrial Neoplasms
    Vulvar Neoplasms

    Study Results

    No Results Posted as of Jun 22, 2023