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Blood test may predict immunotherapy success in Women's cancers

NCT ID NCT05914974

Knowledge-focused Sponsor: University Hospital Tuebingen Source: ClinicalTrials.gov ↗

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study looks at whether changes in a blood marker called CRP can help predict how well immunotherapy works in women with advanced gynecologic cancers (cervical, endometrial, ovarian, or vulvar). Researchers will track CRP levels in 120 women receiving immunotherapy plus chemotherapy. The goal is to see if CRP patterns can forecast tumor shrinkage or longer survival, which could help doctors personalize treatment.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 120 people

The number the study aims to enrol. It can still change while the study runs.

Started

Sep 2023

Expected to finish

Apr 2035

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

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.

Ages

18 years and older

Sex

Female participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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)

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Conditions

The condition(s) this trial relates to.

cervical cancer endometrial cancer endometrium neoplasm female reproductive organ cancer ovarian cancer Uterine Cervical Neoplasms vulva cancer

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Cervical cancer Endometrial cancer Gynecological malignancies Ovarian cancer Vulvar cancer

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Department of Women's Health

    RECRUITING

    Tübingen, 72076, Germany

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