AuthorisedPhase I and Phase II (Integrated)- Bioequivalence StudyInterventional

PHASE 1B/II TRIAL OF CHECKPOINT INHIBITOR (PEMBROLIZUMAB AND ANTI PD-1 ANTIBODY) PLUS STANDARD IMRT IN HPV INDUCED STAGE III SQUAMOUS CELL CARCINOMA OF ANUS

This clinical trial is investigating a new treatment approach for locally advanced anal cancer linked to the Human Papillomavirus (HPV). It combines the usual treatment of radiation and chemotherapy (often called CRT) with a medication called pembrolizumab (brand name Keytruda). Pembrolizumab is a type of drug that helps your body’s immune system fight cancer. The study is particularly interested in finding out how safe and manageable this combined treatment is for patients. Researchers will look for any side effects and see how well patients stick to the treatment plan. It’s a combined Phase I and Phase II study, meaning it's first checking for safety and then gathering more information on how well it works and how feasible it is to give patients.

At a glance

Status

Authorised

Phase

Phase I and Phase II (Integrated)- Bioequivalence Study

Sponsor

Cardiff University

Enrolment target

Start

14 Jan 2025

Anal cancer

What is this study about?

This study is a clinical trial exploring a new way to treat a type of anal cancer that's often linked to the Human Papillomavirus, or HPV. Doctors are trying to see if adding a new medicine, called pembrolizumab (also known as Keytruda), to the standard treatment for this cancer makes it safer and more effective.

The standard treatment for locally advanced anal cancer usually involves a combination of radiation therapy and chemotherapy. This trial is adding pembrolizumab, which is an 'immunotherapy' drug. Immunotherapy works by boosting your body's own immune system to help it find and fight cancer cells more effectively. The study will look at two different schedules for giving pembrolizumab alongside the standard treatment.

The main aim is to understand how safe this new combination treatment is and what side effects patients might experience. Researchers will also be checking how practical it is for patients to receive this treatment, how many patients stay on the study, and how many new patients can be successfully enrolled. They will also look at how patients feel throughout the treatment and how the cancer responds to the combined therapy.

Key takeaways

This study is testing a new combination treatment for HPV-linked anal cancer.
It combines standard radiation/chemotherapy with an immunotherapy drug, pembrolizumab (Keytruda).
The main goal is to check how safe and manageable this new treatment approach is.
Researchers will also look at how well the cancer responds and effects on patient well-being.
It's open to adults aged 18 and over, with specific health criteria.
Participation involves treatment, regular checks, and follow-up for over a year.

Who may be eligible?

To be considered for this study, you would need to be an adult, aged 18 or older. The study is open to both men and women.

The specific type of cancer being studied is anal cancer that is locally advanced and linked to the Human Papillomavirus (HPV). Your doctors will do tests to confirm these details.

There will be other specific health requirements that your doctor will discuss with you to make sure the treatment is safe for your individual health situation. For example, they will check your general health, how well your organs are working, and if you have certain other medical conditions.

Quick self-check

Are you 18 years old or older?
Do you have anal cancer that your doctors have identified as 'locally advanced'?
Has your anal cancer been linked to the Human Papillomavirus (HPV)?
Are you able to undergo standard radiation and chemotherapy?
Are you generally well enough to participate in a clinical trial, as determined by your doctor?

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

What does participation involve?

If you decide to take part in this study, you would receive the standard treatment for your anal cancer – a combination of radiation therapy and chemotherapy. In addition to this, you would also receive the study drug, pembrolizumab (Keytruda). The researchers are looking at two different ways or 'schedules' of giving this drug. You would be assigned to one of these schedules.

Throughout the study, you would have regular visits to the hospital. These visits would involve various assessments, including blood tests, physical examinations, and scans (like MRI scans) to check how you are responding to the treatment and to monitor for any side effects. You would also be asked to fill out questionnaires about how you are feeling, which helps the doctors understand the impact of the treatment on your daily life.

The treatment period itself involves the radiation and chemotherapy, along with the pembrolizumab. After this main treatment, you would continue to have follow-up visits and assessments for at least 12 months, allowing doctors to track your long-term health and the lasting effects of the treatment.

Potential risks and benefits

Taking part in a clinical trial offers the chance to access new treatments that are not yet widely available. While pembrolizumab has shown promise in fighting cancer, this study is specifically looking at how safe and effective it is when combined with standard anal cancer treatment. There's a chance the treatment might help your particular cancer, but there's no guarantee. Like all medicines and treatments, pembrolizumab and the standard therapy can have side effects. Doctors will closely monitor you for any side effects, including both common ones and those that might be more serious. You will be fully informed about all known risks before deciding to join. Remember, your participation is voluntary, and you have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (1)

—
Norway

Common questions

What is HPV and why does it matter for this study?

HPV, or Human Papillomavirus, is a very common virus. In some cases, certain types of HPV can cause anal cancer, and this study is specifically looking at treatments for anal cancer linked to HPV.

What is pembrolizumab (Keytruda)?

Pembrolizumab is a medicine that helps your body's immune system fight cancer. It's often called an 'immunotherapy' drug.

What does 'locally advanced' anal cancer mean?

This means the cancer has grown in the immediate area where it started but hasn't spread to distant parts of the body.

What is the purpose of a 'Phase I and Phase II' study?

Phase I studies mainly check if a new treatment is safe and find the right dose. Phase II studies then see how well the treatment works and gather more information on side effects. This study combines both stages.

Will I know if I'm getting the new drug or not?

In this study, everyone will receive standard radiation and chemotherapy, and everyone will also receive pembrolizumab. The difference is that they are testing two different schedules of when and how often the pembrolizumab is given.