Clinical trial NCT05914974: Immunotherapy-related CRP Kinetics in Metastatic Gynecological Malignancies
Official title: ICK-Gyn: Immunotherapy-related CRP Kinetics in Metastatic Gynecological Malignancies
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Gynecological Malignancies
Cervical Cancer
Endometrial Cancer
Ovarian Cancer
Vulvar Cancer
Lead sponsor: University Hospital Tuebingen
Sponsor class: OTHER
Collaborators: name: University Hospital Ulm
name: University Hospital Freiburg
First posted: 2023-06-22
Enrollment: 120
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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).

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Prognostic value of CRP kinetics under ICI therapy on progression-free survival (PFS)
timeFrame: duration of therapy and follow-up data (10 years)
Secondary outcomes:
measure: Prognostic value of CRP kinetics in advanced or metastatic gynecological malignancies under ICI therapy on the objective response rate (ORR) and overall survival (OS).
timeFrame: duration of therapy and follow-up data (10 years)
Other outcomes:
Locations:
city: Tuebingen
country: Germany
facility: Department of Women's Health
Study officials:
affiliation: Department of Women's Health Tübingen
name: Dominik Dannehl, Dr.
role: PRINCIPAL_INVESTIGATOR
References: