Gynecological MalignanciesNCT05914974
Immunotherapy-related CRP Kinetics in Metastatic Gynecological Malignancies
An observational study of Gynecological Malignancies and Cervical Cancer, run by University Hospital Tuebingen at 1 site in Germany.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Gynecological Malignancies, Cervical Cancer, Endometrial Cancer
- How many people
- 120 participants
- Where
- 1 siteGermany
- Study dates
- 11 Sep 2023to Apr 2035
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Germany1 site, 1 recruiting
- Recruiting
Department of Women's Health
Tübingen, 72076
Tobias Engler, Dr., 07071 29 82211, Tobias.Engler@med.uni-tuebingen.de
About this study
Official title: ICK-Gyn: Immunotherapy-related CRP Kinetics in Metastatic Gynecological Malignancies
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).
Read the 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.
- Conditions
- Gynecological Malignancies, Cervical Cancer, Endometrial Cancer, Ovarian Cancer, Vulvar Cancer
- Medical subject headings
- Uterine Cervical Neoplasms, Endometrial Neoplasms, Ovarian Neoplasms, Vulvar Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Control Group | Chemotherapy without immunotherapy | |
| Experimental Group | Chemotherapy in combination with immunotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: duration of therapy and follow-up data (10 years)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2023
- Study start11 Sep 2023
- Primary completionApr 2027 (estimated)
- Study completionApr 2035 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gynecological MalignanciesStudies of the same condition, open and under way.
- More trials run by University Hospital TuebingenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital Tuebingen
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospital Ulm, University Hospital Freiburg
- Responsible party
- Sponsor
- Investigators
- Dominik Dannehl, Dr., Principal investigator, Department of Women's Health Tübingen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05914974
- Sponsor's protocol ID
- ZGynO_ICK-Gyn
- Status last verified
- Feb 2026
- First submitted
- 13 Jun 2023
- Last updated
- 10 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ICK-Gyn: Immunotherapy-related CRP Kinetics in Metastatic Gynecological Malignancies
- ClinicalTrials.gov ID
- NCT05914974
- Acronym / sponsor ID
- ZGynO_ICK-Gyn
- Conditions
- Gynecological Malignancies, Cervical Cancer, Endometrial Cancer, Ovarian Cancer, Vulvar Cancer
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- University Hospital TuebingenUniversity, hospital or other
- Collaborators
- University Hospital Ulm, University Hospital Freiburg
- Study start
- 11 Sep 2023 (actual)
- Primary completion
- Apr 2027 (estimated)
- Study completion
- Apr 2035 (estimated)
- First posted
- 22 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control Group | – | –Chemotherapy without immunotherapy |
| Experimental Group | – | –Chemotherapy in combination with immunotherapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (5 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
1 secondary outcome
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)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Dominik Dannehl, Dr. principal investigator
Department of Women's Health Tübingen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Gynecological Malignancies and Cervical Cancer, run by University Hospital Tuebingen at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 10 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Dominik Dannehl, Dr. (07071 29 82211, Dominik.Dannehl@med.uni-tuebingen.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prognostic value of CRP kinetics under ICI therapy on progression-free survival (PFS) (time frame: duration of therapy and follow-up data (10 years)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Feb 2026.