Ongoing Clinical Trials for Anal Cancer
Currently, there are 3 clinical trials exploring new treatment approaches for anal cancer. These studies are being conducted in Norway, Germany, France, and Spain, and are testing different combinations of immunotherapy drugs and standard cancer treatments to help patients with advanced stages of the disease.
Clinical trial locations
- France
- Germany
- Norway
- Spain
Study of Pembrolizumab with Standard Chemoradiation for Patients with Advanced Anal Cancer
This trial is testing a medication called pembrolizumab, which is a type of immune checkpoint inhibitor that helps the body’s immune system recognize and attack cancer cells. It is being studied in combination with standard chemoradiation therapy for patients with advanced anal cancer.
Who can join: Participants must be at least 18 years old and have a confirmed diagnosis of squamous cell cancer of the anus. The cancer should be classified as either T3/4 N0 M0 or any N+ M0, which are medical terms describing the size and spread of the cancer. Patients need to be able to perform daily activities with little or no help, measured by an ECOG Performance Scale score of 0 or 1. Good organ function is essential, including adequate blood counts, kidney function, and liver function. Women who can become pregnant must have a negative pregnancy test before starting treatment, and both men and women must agree to use reliable birth control during the study and for 120 days after the last treatment dose.
Who cannot join: Patients with other types of cancer besides anal cancer are not eligible. Those who are pregnant or breastfeeding cannot participate. Patients with active infections, serious illnesses that could interfere with treatment, or a history of severe allergic reactions to similar drugs are excluded. Those who have received certain recent cancer treatments or are participating in other clinical trials at the same time cannot join.
What the study aims to do: The main goal is to evaluate the safety and tolerability of different schedules of pembrolizumab when used alongside standard chemoradiation. Researchers will monitor participants for side effects and assess how well the cancer responds to treatment using imaging techniques like MRI at different time points. The study will also collect patient-reported information about symptoms and quality of life to understand the overall impact of the treatment.
Investigational drugs: The trial uses pembrolizumab, an immune checkpoint inhibitor delivered through infusion. It is combined with IMRT (Intensity-Modulated Radiation Therapy), an advanced form of radiation therapy that precisely targets cancer cells while minimizing damage to surrounding healthy tissue.
Study on Pelareorep and Atezolizumab for Patients with Advanced or Metastatic Gastrointestinal Cancers
This trial explores the combination of two treatments, pelareorep and atezolizumab, for patients with advanced or metastatic gastrointestinal cancers, which includes anal cancer as part of the digestive system cancers being studied.
Who can join: Participants must be at least 18 years old and have advanced or metastatic gastrointestinal tumors. They need to provide written informed consent and have an ECOG performance status of 0 or 1, meaning they can carry out daily activities with minimal assistance. The cancer must be measurable according to RECIST v1.1 criteria, which are standard rules for measuring tumor response. Patients must have adequate organ function, including specific levels of white blood cells, platelets, hemoglobin, and proper liver and kidney function. Patients must have recovered from previous treatments to a minimal level of side effects. Women who can become pregnant and men with partners who can become pregnant must use highly effective contraception during the study and for 6 months after the last dose.
Who cannot join: Patients without advanced or metastatic gastrointestinal tumors cannot participate. Those outside the specified age range or who cannot tolerate the combination of study drugs and standard chemotherapy are excluded. Patients who are part of vulnerable populations that the study is not designed to include are also not eligible.
What the study aims to do: The study evaluates the safety and effectiveness of combining pelareorep and atezolizumab with standard chemotherapy. It measures the overall response rate, which shows how the cancer responds to treatment, and the disease control rate, which indicates how well treatment prevents the cancer from growing or spreading. Regular assessments will be conducted throughout the study to monitor health and measure tumor size changes.
Investigational drugs: Pelareorep is a viral therapy that uses a specially designed virus to target and kill cancer cells while leaving normal cells unharmed. Atezolizumab is an immunotherapy medication that helps the immune system fight cancer by blocking a protein that prevents the immune system from attacking cancer cells. Both are administered through infusion directly into the bloodstream.
Study of TG4001 and Avelumab for Patients with Advanced HPV-16 Positive Cancers
This trial focuses on cancers linked to Human Papillomavirus type 16 (HPV-16), including anal cancer. It tests a combination of avelumab, a cancer immunotherapy, and TG4001, a therapeutic vaccine designed to help the immune system fight cancer cells.
Who can join: Participants must be at least 18 years old with no upper age limit. Women who can have children must have a negative blood pregnancy test at the start, and both men and women must use highly effective birth control during the study and for 3 months after the last treatment. Patients must have an ECOG performance status of 0 or 1 and a life expectancy of at least 3 months. The cancer must be positive for HPV-16 and either recurrent or metastatic, meaning it has returned after treatment or spread to other parts of the body. For anal cancer patients specifically in Phase II part 2, they can have had no more than one previous treatment for metastatic cancer. Patients must have at least one tumor that can be measured by CT scan and adequate blood, liver, and kidney function.
Who cannot join: Patients with liver metastases at the start of the study are excluded. Those who are not positive for HPV-16 or do not have recurrent or metastatic cancer cannot participate. Patients must be diagnosed with one of the specific cancer types being studied, including anal cancer.
What the study aims to do: The trial is conducted in two phases. The first phase assesses the safety and tolerability of combining avelumab and TG4001. The second phase evaluates how well the combination works in terms of slowing down cancer progression compared to using avelumab alone. The study measures progression-free survival, which is the length of time patients live with the disease without it getting worse. Regular monitoring includes imaging techniques like CT scans to track tumor size changes.
Investigational drugs: TG4001 is a therapeutic vaccine that stimulates the immune system to recognize and fight HPV-16 positive cancer cells, administered as an injection under the skin. Avelumab is an immunotherapy drug that works as a checkpoint inhibitor, blocking a protein that prevents the immune system from effectively attacking cancer cells. It is delivered through intravenous infusion.
Summary
The three ongoing clinical trials for anal cancer represent different approaches to treating advanced stages of the disease. All three studies focus on immunotherapy, which works by helping the body’s own immune system recognize and attack cancer cells.
The trials are spread across four European countries, with France and Spain participating in the HPV-16 focused study, Germany conducting research on gastrointestinal cancers including anal cancer, and Norway testing pembrolizumab specifically for anal cancer. This geographic distribution provides access to patients in different regions.
A notable pattern is the focus on immune checkpoint inhibitors such as pembrolizumab, atezolizumab, and avelumab. These medications work by blocking proteins that prevent the immune system from attacking cancer cells. Two of the trials combine these checkpoint inhibitors with other treatments: one uses standard chemoradiation, another adds a viral therapy called pelareorep, and the third incorporates a therapeutic vaccine called TG4001.
The trials have varying eligibility requirements, but most require participants to be at least 18 years old, have good organ function, and maintain an acceptable performance status. The HPV-16 positive cancer study is particularly relevant for anal cancer patients, as many cases of anal cancer are associated with HPV infection.
Patients interested in participating should discuss these options with their healthcare team to determine which trial, if any, might be appropriate for their specific situation.
