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

Status: Recruiting
Location: See location...
Study Type: Observational
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).

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Germany
Department of Women's Health
RECRUITING
Tübingen
Contact Information
Primary
Dominik Dannehl, Dr.
Dominik.Dannehl@med.uni-tuebingen.de
07071 29 82211
Time Frame
Start Date: 2023-09-11
Estimated Completion Date: 2035-04
Participants
Target number of participants: 120
Treatments
Control Group
Chemotherapy without immunotherapy
Experimental Group
Chemotherapy in combination with immunotherapy
Sponsors
Leads: University Hospital Tuebingen
Collaborators: University Hospital Ulm, University Hospital Freiburg

This content was sourced from clinicaltrials.gov