Immunotherapy-related CRP Kinetics in Metastatic Gynecological Malignancies
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age18+
SponsorUniversity Hospital Tuebingen
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial 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.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
120 Participants
are grouped into 2 trial groupsGroup A: Control Group
Group B: Experimental Group
Trial outcomes
Primary outcomes
1
Prognostic value of CRP kinetics under ICI therapy on progression-free survival (PFS)
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.
Time frame
duration of therapy and follow-up data (10 years)Secondary outcomes
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).
* 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.
Time frame
duration of therapy and follow-up data (10 years)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
University Hospital Tuebingen
Lead sponsor
University Hospital Ulm
Collaborator
University Hospital Freiburg
Collaborator
Source ClinicalTrials.gov