In short
Currently, there is 1 ongoing clinical trial for patients with Stage III anal cancer. This trial is being conducted in Germany and Austria, testing the addition of the immunotherapy drug durvalumab to the standard treatment of radiochemotherapy. The goal is to improve the time patients live without cancer recurrence.
Clinical trial locations
- Austria
- Germany
Study on Durvalumab with Radiochemotherapy for Patients with Locally-Advanced Anal Cancer
This trial is investigating whether adding durvalumab to the standard treatment can help patients with locally-advanced anal cancer live longer without the disease returning. The standard treatment combines chemotherapy drugs (mitomycin C and 5-fluorouracil) with radiation therapy, known as radiochemotherapy.
Main inclusion criteria:
- Confirmed diagnosis of anal squamous cell carcinoma in the anal canal or margin
- Cancer stage IIB-IIIC confirmed by medical tests within 30 days before joining
- At least 18 years old with no upper age limit
- Life expectancy of more than 12 months
- Body weight over 30 kg
- Good overall health status (ECOG performance score of 0-1), meaning able to carry out daily activities
- Adequate blood cell counts: white blood cells above 3.5 x 10⁹/L, neutrophils at least 1.5 x 10⁹/L, platelets at least 100 x 10⁹/L, and hemoglobin at least 9.0 g/dL
- Proper kidney function with creatinine clearance greater than 40 mL/min
- Liver enzyme levels (AST, ALT, and AP) no more than 3 times the normal upper limit
- Serum bilirubin no more than 1.5 times the normal upper limit
- For patients who can have children, willingness to use effective birth control during the study and for 90 days after the last dose
- HIV-positive patients must be on combined antiretroviral therapy with undetectable viral load
- Willingness to attend all treatment sessions and follow-up visits
Main exclusion criteria:
- History of another type of cancer (except certain treated skin cancers)
- Serious uncontrolled or untreated infection
- Pregnancy or breastfeeding
- Previous organ transplant
- Use of certain medications that affect the immune system
- History of severe allergic reactions to similar medications
- Serious heart, lung, liver, or kidney conditions
- Unstable or uncontrolled mental health condition
- Participation in another clinical trial
- Recent surgery that has not fully healed
- Uncontrolled drug or alcohol abuse
- Unable to follow study procedures or instructions
Focus and goal: The trial aims to determine whether adding durvalumab to standard radiochemotherapy can improve disease-free survival for patients with locally-advanced anal cancer. Patients are randomly assigned to receive either the standard treatment with durvalumab or the standard treatment alone. After treatment begins, patients undergo regular monitoring including imaging tests such as MRI and proctoscopy approximately 26 weeks after starting treatment to assess response. The study will also evaluate safety, quality of life, overall survival, and explore different MRI techniques to predict treatment response. The trial is expected to conclude by the end of 2026.
Investigational drug: Durvalumab is an immune checkpoint inhibitor that works by blocking the PD-L1 protein, helping the body's immune system better recognize and attack cancer cells. It is given as an intravenous infusion at a concentration of 50 mg/mL directly into the bloodstream. The standard radiochemotherapy treatment includes mitomycin C and 5-fluorouracil combined with radiation therapy.
Summary
There is currently one clinical trial available for patients with Stage III anal cancer, conducted across two countries: Germany and Austria. This trial focuses on enhancing the standard treatment approach by adding immunotherapy with durvalumab to the established radiochemotherapy regimen. The study reflects the growing interest in immune checkpoint inhibitors as a way to improve outcomes for patients with locally-advanced disease. Patients in these countries who meet the eligibility criteria have the opportunity to participate in this research, which could potentially lead to better disease control and longer periods without cancer recurrence.
