Immunotherapy-related CRP Kinetics in Metastatic Gynecological Malignancies
Launched by UNIVERSITY HOSPITAL TUEBINGEN · Jun 13, 2023
Trial Information
Current as of November 06, 2025
Recruiting
Keywords
ClinConnect Summary
The clinical trial titled "Immunotherapy-related CRP Kinetics in Metastatic Gynecological Malignancies" is studying how certain blood markers, specifically C-reactive protein (CRP), change in women with advanced gynecological cancers like cervical, endometrial, ovarian, and vulvar cancer who are receiving a type of treatment called immune checkpoint inhibitors (ICIs). This trial aims to understand if these changes can provide important information about how well the treatment is working, including how long patients live without their cancer progressing and their overall survival.
To be eligible for this trial, participants must be women aged 18 and older with a confirmed diagnosis of metastatic gynecological cancer. They should be starting treatment with ICIs along with palliative chemotherapy or may be receiving chemotherapy without ICIs in the first line of treatment. Participants will need to provide written consent to join the trial. Those who have received prior ICI therapy or are pregnant, among other criteria, will not be eligible. If you join the trial, you will be monitored closely to track how your body responds to the treatment, helping researchers learn more about the potential benefits of this approach.
Gender
FEMALE
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)
About University Hospital Tuebingen
University Hospital Tübingen is a leading academic medical institution in Germany, renowned for its commitment to advancing healthcare through innovative research and clinical excellence. As a prominent sponsor of clinical trials, the hospital leverages its multidisciplinary expertise and cutting-edge facilities to develop new therapeutic strategies and improve patient outcomes. With a strong focus on translational medicine, University Hospital Tübingen collaborates with various stakeholders, including pharmaceutical companies and research organizations, to facilitate the efficient and ethical conduct of trials across a wide range of medical disciplines. Their dedication to patient-centered research and rigorous scientific standards positions them at the forefront of medical advancements.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Tuebingen, Germany
Patients applied
Trial Officials
Dominik Dannehl, Dr.
Principal Investigator
Department of Women's Health Tübingen
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported