JOURNAL ONKOLOGIE – STUDIE

Immunotherapy-related CRP Kinetics in Metastatic Gynecological Malignancies

Studien-Informationen Einschlusskriterien Studien-Rationale Studien-Arme

Rekrutierend

NCT-Nummer:
NCT05914974

Studienbeginn:
September 2023

Letztes Update:
14.02.2024

Wirkstoff:
-

Indikation (Clinical Trials):
Neoplasms, Endometrial Neoplasms, Vulvar Neoplasms

Geschlecht:
Frauen

Altersgruppe:
Erwachsene (18+)

Phase:
-

Sponsor:
University Hospital Tuebingen

Collaborator:
University Hospital Ulm, University Hospital Freiburg,

Studienleiter

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

Kontakt

Dominik Dannehl, Dr.
Kontakt:
Phone: 07071 29 82211
E-Mail: Dominik.Dannehl@med.uni-tuebingen.de» Kontaktdaten anzeigen

Studienlocations
(1 von 1)

Department of Women's Health
72076 Tuebingen
(Baden-Württemberg)
GermanyRekrutierend» Google-Maps
Ansprechpartner:
Tobias Engler, Dr.
Phone: 07071 29 82211
E-Mail: Tobias.Engler@med.uni-tuebingen.de» Ansprechpartner anzeigen

Studien-Informationen

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.

Ein-/Ausschlusskriterien

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)

Studien-Rationale

Primary outcome:

1. 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.

Secondary outcome:

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). (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.

Studien-Arme

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

Quelle: ClinicalTrials.gov

Sie können folgenden Inhalt einem Kollegen empfehlen:

"Immunotherapy-related CRP Kinetics in Metastatic Gynecological Malignancies"

Bitte tragen Sie auch die Absenderdaten vollständig ein, damit Sie der Empfänger erkennen kann.

Die mit (*) gekennzeichneten Angaben müssen eingetragen werden!