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AuthorisedTherapeutic use (Phase IV)Interventional

PROTECx - Pembrolizumab Registry for Outcomes and Treatment Evaluation in Cervical Cancer

The PROTECx study is for women with advanced cervical cancer. It's looking at how effective certain treatments, like pembrolizumab (Keytruda) and bevacizumab (Avastin), are in day-to-day medical practice. Researchers want to see how long patients live before their cancer starts to grow again, and their overall survival. They will also look at how many patients respond positively to the treatment and how long those responses last. A key part of the study is also understanding the side effects related to the immune system and the general quality of life for patients. The aim is to gather real-world information to help doctors and patients make the best treatment choices.

At a glance

Status
Authorised
Phase
Therapeutic use (Phase IV)
Sponsor
Universitair Medisch Centrum Groningen
Enrolment target
261
Start
11 May 2026

What is this study about?

This study, called PROTECx, is designed for women who have cervical cancer that has spread to other parts of the body (this is called 'metastatic'). It's not testing a new drug, but rather watching how already approved medicines, like Pembrolizumab (brand name Keytruda) and Bevacizumab (brand name Avastin), work in real patients. These types of studies are important because they give doctors a better understanding of how treatments perform outside of very controlled clinical trials.

The main goal is to see how long patients live without their cancer growing. This is a very important measure for people with advanced cancer. The study will also look at how many patients see their cancer shrink or disappear, how long these good effects last, and the overall time people live after starting treatment. This helps doctors know what to expect from these medicines.

Another key part of PROTECx is looking at how these treatments affect patients' quality of life and if they cause any side effects related to the immune system. Understanding both the benefits and the potential challenges of treatment, including how they impact daily living, is crucial for improving care for women with advanced cervical cancer.

Key takeaways

  • This study helps understand standard cervical cancer treatments better.
  • It's for women with advanced (metastatic) cervical cancer.
  • Researchers are tracking medicines like Keytruda and Avastin.
  • The study looks at how long treatments work and patient quality of life.
  • Participation involves sharing medical information, not changing your care.

Who may be eligible?

This study is for women who have cervical cancer that has spread to other parts of their body. You must be at least 18 years old to take part. There isn't an upper age limit, meaning older women are also welcome to join.

Basically, if you're an adult woman receiving treatment for metastatic cervical cancer with the medicines being studied, you might be able to participate. The study is watching patients in real clinics, so it's less about strict requirements and more about collecting information from those already receiving these specific treatments.

Quick self-check
  • Are you an adult (18 or older)?
  • Are you a woman?
  • Do you have cervical cancer that has spread (metastatic)?
  • Are you currently receiving, or planning to receive, treatments like Pembrolizumab (Keytruda) or Bevacizumab (Avastin) for your cancer?

This is a guide only — the research team will confirm whether you can take part.

What does participation involve?

Taking part in this study primarily involves allowing researchers to collect information from your existing medical records regarding your cancer treatment. You will continue to receive your usual care from your doctor, including your prescribed medications like Pembrolizumab and Bevacizumab, as you normally would. The study will track things like how long your treatment works, any side effects you might experience, and your overall health and quality of life over time. You won't have extra visits just for the study, but the researchers will gather data from your regular check-ups and medical charts. The exact length of follow-up will depend on your treatment journey and how long your clinic monitors your health.

Potential risks and benefits

The potential benefits of participating in an 'observational' study like this are not directly about receiving new treatment, as you'd be getting your standard care anyway. However, your contribution helps scientists and doctors better understand how treatments work in the real world, which can lead to better care for other patients in the future. As for risks, since this study mainly involves collecting information from your existing medical records and follows your standard treatment, there are generally no additional physical risks beyond those associated with your ongoing medical care. Your personal information will be kept private. You always have the right to withdraw your consent for your data to be used at any time, without it affecting your medical care.

Locations (1)

  • Netherlands

Common questions

What is 'metastatic cervical cancer'?

This means the cervical cancer has spread from where it started to other parts of the body.

Are the treatments, like Keytruda and Avastin, new for cervical cancer?

No, these are established medicines that doctors already use for cervical cancer. The study is watching how well they work in many patients.

Will I have to take any special drugs or do anything different if I join?

No, you will continue with your regular medical care and treatments as prescribed by your doctor. The study just collects information about it.

What does 'PFS' mean?

PFS stands for 'Progression-Free Survival'. It's the time a patient lives without their cancer growing or getting worse.

Will my privacy be protected if I take part?

Yes, all your personal and medical information collected for the study will be kept confidential and private.

How to find out more

Always speak to your GP or specialist before deciding to take part in a study.

Discussion

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