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Study of Pembrolizumab with Standard Chemoradiation for Patients with Advanced Anal Cancer

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What is this study about?

This clinical trial is focused on studying a type of cancer called anal cancer, specifically in its advanced stages. The treatment being tested is a medication known as pembrolizumab, which is also referred to as a checkpoint inhibitor. This medication is used in combination with a standard treatment method called chemoradiation, which involves using both chemotherapy and radiation therapy to treat cancer. The purpose of the study is to evaluate the safety and how well patients can tolerate different schedules of pembrolizumab when used alongside standard chemoradiation in patients with advanced anal cancer.

Participants in the study will receive pembrolizumab through an infusion, which means the medication is given directly into the bloodstream. The study will explore two different schedules for administering pembrolizumab to see which is more effective and better tolerated by patients. Throughout the study, researchers will monitor participants for any side effects and how well they adhere to the treatment plan. The study will also assess how feasible it is to combine pembrolizumab with standard chemoradiation and will track the overall response of the cancer to the treatment over time.

In addition to monitoring the safety and effectiveness of the treatment, the study will also look at how the cancer responds to the treatment using imaging techniques like MRI (Magnetic Resonance Imaging). Researchers will evaluate changes in the cancer at different points during and after the treatment. Patient-reported outcomes will also be collected to understand the impact of the treatment on symptoms and quality of life. The study aims to provide valuable information on the potential benefits of using pembrolizumab in combination with standard treatments for advanced anal cancer.

1 initiation of treatment

The treatment begins with the administration of pembrolizumab, a medication used to help the immune system fight cancer. It is given as a solution for infusion, which means it is delivered directly into the bloodstream through a vein.

The specific dosage and schedule of pembrolizumab will be determined by the healthcare team based on the trial protocol.

2 concurrent chemoradiation therapy (CRT)

Alongside pembrolizumab, standard chemoradiation therapy (CRT) is administered. This involves the use of chemotherapy and radiation therapy to target cancer cells.

The schedule and duration of CRT will be specified by the healthcare team and is designed to work in conjunction with pembrolizumab.

3 monitoring and assessments

Throughout the trial, regular monitoring and assessments are conducted to evaluate the safety and tolerability of the treatment. This includes checking for any side effects or adverse events.

Imaging tests, such as MRI, may be performed to assess the response of the cancer to the treatment at various intervals, including 3 and 6 months after CRT and during follow-up.

4 patient-reported outcomes

Patients will be asked to report on their experiences and any symptoms they may have during the trial using a tool designed to assess quality of life and symptomatic toxicity.

These reports help in understanding the impact of the treatment on daily life and any acute or late side effects.

5 follow-up

After the completion of the treatment phase, follow-up visits are scheduled to continue monitoring the patient’s health and the status of the cancer.

These follow-up visits may include further imaging tests and assessments to track the long-term effects of the treatment.

Who Can Join the Study?

  • Be willing and able to provide written informed consent.
  • Be 18 years or older on the day of signing the informed consent.
  • Have a confirmed diagnosis of Squamous Cell Cancer of the Anus (SCCA), which is a type of anal cancer, classified as T3/4 N0 M0 or any N+ M0, or highly suspicious and confirmed by a medical team.
  • Have a performance status of 0 or 1 on the ECOG Performance Scale, which measures how well a patient can perform daily activities.
  • Show adequate organ function within 10 days before starting treatment. This includes:
    • Haematological (blood-related):
      • Absolute neutrophil count (ANC) of at least 1.5 x 109/L.
      • Platelets of at least 100 x 109/L.
      • Haemoglobin of at least 9 g/dL.
      • Coagulation (blood clotting):
        • International Normalized Ratio (INR) or Prothrombin Time (PT) of 1.5 times the upper limit of normal (ULN), unless on blood-thinning medication.
        • Activated Partial Thromboplastin Time (aPTT) of 1.5 times ULN, unless on blood-thinning medication.
    • Renal (kidney-related):
      • Serum creatinine of 1.5 times ULN or a creatinine clearance of at least 60 mL/min.
    • Hepatic (liver-related):
      • Serum total bilirubin of 1.5 times ULN or direct bilirubin within normal limits for those with higher total bilirubin.
  • Female patients who can have children must have a negative pregnancy test within 72 hours before the first dose of trial medication. If the urine test is positive or unclear, a blood test will be needed.
  • Female patients who can have children must agree to use a reliable method of birth control during the trial and for 120 days after the last dose of trial medication.
  • Male patients must agree to use a reliable method of birth control starting with the first dose of trial therapy and for 120 days after the last dose of trial therapy.

Who Cannot Join the Study?

  • Patients who have a different type of cancer other than anal cancer cannot participate.
  • Patients who are not in the age range specified for the study cannot participate. The study is for adults.
  • Patients who are not able to follow the study procedures or attend the required visits cannot participate.
  • Patients who have a medical condition that makes it unsafe for them to receive the study treatment cannot participate.
  • Patients who are pregnant or breastfeeding cannot participate.
  • Patients who have received certain treatments for cancer recently may not be eligible.
  • Patients who have an active infection or other serious illness that could interfere with the study cannot participate.
  • Patients who have a history of severe allergic reactions to similar drugs cannot participate.
  • Patients who are participating in another clinical trial at the same time cannot participate.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Oslo Universitetssykehus HF Oslo Norway

Other Sites

No sites found in this category

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Norway Norway
Not yet recruiting
15.04.2019

Trial locations

Investigated drugs:

Pembrolizumab is a medication used in this trial. It is an immune checkpoint inhibitor that helps the body’s immune system recognize and attack cancer cells. In this study, it is being tested for its safety and tolerability when used alongside standard cancer treatment in patients with advanced anal cancer.

Anti PD-1 Antibody is another type of immune checkpoint inhibitor used in the trial. It works by blocking a specific pathway that cancer cells use to hide from the immune system, allowing the immune system to better detect and destroy the cancer cells. This medication is being studied in combination with other treatments to see how well it works in treating anal cancer.

IMRT (Intensity-Modulated Radiation Therapy) is a type of radiation therapy used in the trial. It uses advanced technology to manipulate photon and proton beams of radiation to conform to the shape of a tumor. This allows for more precise targeting of cancer cells while minimizing damage to surrounding healthy tissue. In this study, it is part of the standard treatment regimen for anal cancer.

Investigated diseases:

Anal Cancer – Anal cancer is a disease where malignant cells form in the tissues of the anus. It often begins as a small growth or lesion that may not cause symptoms initially. As the disease progresses, symptoms such as bleeding, pain, or a lump near the anus may occur. The cancer can spread to nearby tissues and lymph nodes, affecting the surrounding area. It is more common in individuals with certain risk factors, such as human papillomavirus (HPV) infection. Early detection and monitoring are crucial for managing the disease effectively.

Trial ID:
2024-515369-33-00
NCT ID:
NCT04046133
Trial Phase:
Phase II and Phase III (Integrated)

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