Evaluation of pembrolizumab and bevacizumab in patients with metastatic cervical cancer

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What is this study about?

The study focuses on Metastatic cervical cancer, a condition where cancer that started in the cervix has spread to other parts of the body. Participants receive an intravenous infusion of the drug pembrolizumab, sometimes combined with bevacizumab, which are given through a vein in a hospital setting.

The purpose of the study is to evaluate PFS at 12 months compared with historical results. After the first infusion, patients return for regular treatment sessions over several months while doctors monitor the cancer for any signs of growth or spread, record any side effects that are related to the immune system, and assess overall well‑being. PFS means the length of time a person lives without the disease getting worse. Immune‑related side effects are reactions that happen because the treatment activates the body’s own defenses, and quality of life refers to how a person feels and functions during the study.

1 study entry

after signing the informed consent form, the patient becomes a participant in the registry.

personal information, medical history, and eligibility for metastatic cervical cancer are recorded.

2 baseline assessments

a physical examination and laboratory tests are performed to establish the patient’s health status before treatment.

imaging studies (such as scans) are done to document the extent of cancer at the start of the trial.

3 first pembrolizumab infusion

the patient receives pembrolizumab (brand name keytruda) at a dose of 400 mg (milligrams) given by intravenous administration (through a vein).

the infusion is performed in a clinical setting under medical observation.

4 first bevacizumab infusion

the patient receives bevacizumab (brand name avastin) at a dose of 15 mg/kg (milligrams per kilogram of body weight) given by intravenous administration.

the exact volume is calculated based on the patient’s weight and administered in the same setting as pembrolizumab.

5 subsequent treatment visits

the patient attends scheduled clinic visits for additional infusions of pembrolizumab and bevacizumab according to the trial protocol.

each visit includes monitoring of vital signs, repeat laboratory tests, and assessment for any side effects.

the frequency of these infusions is defined by the study schedule, which is followed precisely.

6 disease monitoring

periodic imaging studies are performed to evaluate tumor response and to determine if disease progression has occurred.

the primary measurement is progression‑free survival (time from start of treatment to documented disease progression or death).

7 quality‑of‑life assessments

at predetermined time points, the patient completes questionnaires that measure quality of life.

these assessments help describe how treatment affects daily functioning and well‑being.

8 monitoring for immune‑related adverse events

the patient is observed for side effects that may be related to the immune system, such as hormone disturbances or organ inflammation.

if such events occur, the study protocol may require a temporary pause or permanent discontinuation of the medication.

9 12‑month and 24‑month evaluations

at 12 months and again at 24 months, the patient undergoes a comprehensive assessment to determine whether the disease has remained stable.

the proportion of participants who are free of progression at these time points is recorded as a secondary outcome.

10 study completion and follow‑up

after the final scheduled visit, the patient may continue routine clinical care outside the study.

data collected during the trial are used to evaluate the effectiveness and safety of the treatment regimen.

Who Can Join the Study?

Must have persistent, recurrent, or metastatic cervical cancer and be starting or already receiving a treatment that includes pembrolizumab (a medicine that helps the immune system fight cancer).
Must be a woman (female).
Must be within the age range allowed by the study (the trial includes adult patients).
To join the early discontinuation group, the patient must first have been in the observation group and then decide to stop pembrolizumab for one of these reasons: a confirmed complete response (cancer no longer detectable) after at least 8 three‑weekly cycles and at least 9 weeks of additional treatment; an immune‑related toxicity that is grade 3 or higher (a severe side effect caused by the immune system); a personal preference because of ongoing mild‑to‑moderate (grade 1‑2) immune‑related side effects; or a confirmed partial response (cancer has shrunk but not disappeared) after at least 8 three‑weekly cycles and at least 9 weeks of additional treatment.
Must be willing to discontinue pembrolizumab (with or without also stopping the drug bevacizumab).

Who Cannot Join the Study?

Having another active cancer (a malignant disease) besides cervical cancer that required treatment in the past two years, except for certain skin cancers such as basal cell carcinoma or squamous cell carcinoma, or very early‑stage cancers (called carcinoma in situ) that have already been treated with the aim of cure.
Any health problem that the doctor believes could make it difficult for you to follow the study procedures (this is called compliance with the study).
Not being able to read or speak Dutch well enough to understand the study information, complete Dutch questionnaires, or give informed consent (the formal agreement to take part in the study).

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country	Status
University Hospital Maastricht	Maastricht	The Netherlands

Other Sites

Site Name	City	Country
Isala Klinieken Stichting	Zwolle	The Netherlands
Medisch Spectrum Twente	Enschede	The Netherlands
Universitair Medisch Centrum Utrecht	Utrecht	The Netherlands
Catharina Ziekenhuis Stichting	Eindhoven	The Netherlands
Stichting Radboud University Medical Center	Nijmegen	The Netherlands
Netherlands Cancer Institute	Amsterdam	The Netherlands
Lujaa Uvinhdcmzazg Mmtskeh Cdtosim (erwwg	Leiden	The Netherlands
Uykrwrgxngdc Mttatpr Cczzumv Gfhhimajn	Groningen	The Netherlands
Ajtizlhhn Upv	Amsterdam	The Netherlands
Etaajmb Ueeyweaekcel Mhtgprf Cybirny Rbxfrfxiv (gdxhgzp Mgv	Rotterdam	The Netherlands

Trial status

Country	Status	Recruitment Start
The Netherlands	Recruiting	01.04.2026

Trial locations

Investigated drugs:

Avastin is a medication given through an IV that works by blocking a protein that helps tumors grow new blood vessels. By stopping these blood vessels from forming, the drug can slow the growth of cancer. In this trial, Avastin is being used to see how well it helps control cervical cancer when given as part of the treatment plan.

Keytruda is an immunotherapy drug also given by IV. It helps the body’s own immune system recognize and attack cancer cells by targeting a specific pathway that tumors use to hide from immune attacks. In this study, Keytruda is being evaluated to understand its effect on how long patients stay free of disease progression over a year.

Investigated diseases:

Cervix carcinoma

Metastatic cervical cancer – A type of cervical cancer that has spread from the cervix to other parts of the body such as lymph nodes, lungs, liver, or bones. It starts with abnormal cells on the surface of the cervix that grow and invade nearby tissue. Over time, cancer cells travel through the bloodstream or lymphatic system and form new tumors in distant organs. As the disease advances, these new tumors may enlarge and cause symptoms related to the organs they affect.

Trial ID:

2025-522883-34-00

Protocol code:

22590

Trial Phase:

Therapeutic confirmatory (Phase III)

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Evaluation of pembrolizumab and bevacizumab in patients with metastatic cervical cancer

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?