Ongoing Clinical Trials for Anal Squamous Cell Carcinoma
There are currently 6 clinical trials investigating new treatments for anal squamous cell carcinoma. These studies are testing various combinations of chemotherapy, immunotherapy, and radiation therapy across multiple countries in Europe. The trials focus on both locally advanced and metastatic forms of the disease, exploring innovative treatment approaches that aim to improve patient outcomes and survival rates.
Clinical trial locations
- France
- Study Comparing Chemotherapy with Docetaxel, Cisplatin, and Fluorouracil to Standard Treatment for Patients with Advanced Anal Cancer
- Study of Ezabenlimab and Drug Combination for Stage III Anal Cancer Treatment
- Study of Spartalizumab and Drug Combination for Patients with Metastatic Anal Cancer
- Study of pembrolizumab and vorinostat combination therapy in patients with recurrent or metastatic squamous cell carcinoma of head and neck, cervix, anus, and genital areas
- Germany
- Spain
Study Comparing Chemotherapy with Docetaxel, Cisplatin, and Fluorouracil to Standard Treatment for Patients with Advanced Anal Cancer
This trial is comparing two different approaches to treating locally advanced disease. Participants must have confirmed cancer through a biopsy, with disease at Stage T3 or T4, or Stage N1 with any T stage. Patients should be between 18 and 75 years old, though those older than 75 may qualify with a good health assessment score. The cancer must be measurable by MRI, and patients must be able to receive both chemotherapy and radiation therapy without major health problems that would prevent treatment. A WHO performance status of less than 2 is required, meaning patients should be able to carry out normal activities without significant assistance.
Patients cannot participate if they have a different type of cancer, are outside the specified age range, cannot follow study procedures or attend required visits, have serious health conditions that might interfere with the study, are pregnant or breastfeeding, have recently participated in another clinical trial, have allergies to study medications, or are unable to provide informed consent.
The main focus of this trial is determining whether starting with chemotherapy before radiation therapy is more effective than using radiation therapy alone. The study examines a combination treatment using modified DCF (docetaxel, cisplatin, and fluorouracil) followed by standard chemoradiotherapy with mitomycin and fluorouracil. Researchers will monitor how long patients live without the cancer returning or worsening, overall survival, quality of life, and any side effects.
The investigational drugs include modified DCF, a combination of three chemotherapy drugs (docetaxel, cisplatin, and 5-fluorouracil) that work by stopping cancer cell growth, and standard chemoradiotherapy, which combines chemotherapy drugs with radiation therapy to control the cancer and prevent further spread.
Study of Ezabenlimab and Drug Combination for Stage III Anal Cancer Treatment
This study focuses on stage III disease and requires participants to be at least 18 years old with a performance status of ECOG-WHO 1 or less, meaning they can carry out daily activities with little or no help. Patients must have confirmed squamous cell anal carcinoma that is locally advanced, with disease spread to nearby areas but not distant organs. Eligibility for the mDCF treatment regimen is required. Recent imaging tests are mandatory, including CT scan, MRI of the pelvis, and PET scan, all performed within 30 days before joining. Blood and organ functions must be adequate, with serum albumin of at least 25 g/L and normal blood clotting tests. Patients must be part of or have benefits from the French social security health insurance system.
Patients with a different type of cancer, those outside the specified age range, or those considered part of a vulnerable population cannot participate in this trial.
The purpose is to evaluate the complete response rate by week 40 from the start of treatment. The study begins with mDCF chemotherapy followed by treatment with ezabenlimab, a monoclonal antibody, and then chemoradiotherapy. Various assessments will monitor treatment effectiveness, including imaging tests like MRI and PET scans, overall survival, progression-free survival, and quality of life during and after treatment.
The investigational drugs include ezabenlimab, an investigational medication that helps the immune system fight cancer; docetaxel, which stops cancer cells from growing and dividing; cisplatin, which kills cancer cells by damaging their DNA; 5-fluorouracil, which interferes with cancer cell growth; and chemoradiotherapy, combining chemotherapy with radiation therapy to increase treatment effectiveness.
Study of Spartalizumab and Drug Combination for Patients with Metastatic Anal Cancer
This trial targets patients with metastatic or locally advanced recurrent disease. Participants must be at least 18 years old with an ECOG performance status of 0 or 1. A confirmed diagnosis of metastatic or locally advanced recurrent squamous cell carcinoma of the anus is required, with a lesion evaluable by CT scan or MRI according to RECIST v1.1 criteria. Patients must be eligible for the mDCF treatment regimen and have no previous systemic treatments like immunotherapy or chemotherapy. Recent CT and PET scans within 30 days before joining are mandatory. A life expectancy of at least 12 months is required, along with adequate organ and bone marrow function verified through blood tests. Patients must sign an informed consent form and be affiliated with the French social security system.
Patients with a different type of cancer, those outside the specified age range, those in a clinical trial group not included in this study, or those considered part of a vulnerable population cannot participate.
The main focus is evaluating the progression-free survival rate at one year. Participants receive spartalizumab, docetaxel, cisplatin, and 5-fluorouracil through intravenous infusion, along with radiotherapy. Regular monitoring assesses response to treatment and checks for side effects throughout the several-month study period.
The investigational drugs include spartalizumab, an investigational immune checkpoint inhibitor that helps the immune system fight cancer; docetaxel, which interferes with cancer cell growth; cisplatin, which kills cancer cells by damaging DNA; 5-fluorouracil, which targets cancer cells by inhibiting DNA synthesis; and radiotherapy, using high doses of radiation to kill cancer cells and shrink tumors.
Study on Pelareorep and Atezolizumab for Patients with Advanced or Metastatic Gastrointestinal Cancers
This study includes patients with advanced or metastatic gastrointestinal tumors, including anal cancer. Participants must provide written informed consent and be at least 18 years old. An ECOG performance status of 0 or 1 is required. Patients must have measurable or evaluable lesions according to RECIST v1.1 criteria and adequate organ function. This includes specific levels for absolute neutrophil count, platelet count, hemoglobin, liver enzymes, bilirubin, and creatinine. Patients must have recovered to level 1 or baseline for all side effects from previous treatments. Female patients who can become pregnant and male patients with partners who can become pregnant must use highly effective contraception during the study and for 6 months afterward.
Patients without advanced or metastatic gastrointestinal tumors, those outside the specified age range, those unable to tolerate the combination of study drugs and standard chemotherapy, those unable to respond as required by the study, or those part of vulnerable populations not included in the study design cannot participate.
The purpose is to evaluate the safety and effectiveness of combining pelareorep and atezolizumab with standard chemotherapy. The study assesses the overall response rate and disease control rate, measuring how the cancer responds and how well treatment prevents growth or spread. Regular assessments monitor health and treatment effects, including checking for side effects and measuring cancer size.
The investigational drugs include pelareorep, a viral therapy that uses a specially designed virus to target and kill cancer cells while leaving normal cells unharmed, and atezolizumab, which helps the immune system fight cancer by blocking a protein that prevents immune system attacks on cancer cells.
Study of Atezolizumab and Tiragolumab with Chemoradiotherapy for Patients with Localized Anal Canal Squamous Cell Carcinoma
This trial focuses on localized disease and requires participants to be 18 years or older with normal organ and bone marrow function. Specific requirements include hemoglobin level of at least 9.0 g/dL (blood transfusions allowed), absolute neutrophil count of at least 1500 per mm³, platelet count of at least 100,000 per mm³, serum total bilirubin of 1.5 times normal limit or less, serum transaminases of 2.5 times normal limit or less, serum albumin of at least 25 g/L, and creatinine level of 1.5 mg/dL or less or creatinine clearance rate above 60 mL/min. No active infection requiring antibiotics is allowed. Women who can have children must have a negative pregnancy test and use effective birth control during the study and for a specified period afterward. Both male and female participants must agree to use effective birth control. Patients must be willing and able to follow study rules, provide written consent, have an ECOG performance status of 0 or 1, have confirmed diagnosis of squamous cell carcinoma of the anal canal at stages II, IIIA, or IIIB, provide a tumor biopsy sample, have at least one evaluable lesion, be eligible for radical chemoradiotherapy, and have normal life expectancy apart from cancer risk.
Patients with a different cancer type, those outside the specified age range, those part of vulnerable populations, those not meeting specific health criteria, or those unable to follow study procedures or attend required visits cannot participate.
The main focus is determining if the combination treatment can help achieve complete remission, meaning the cancer is no longer detectable. Participants receive atezolizumab and tiragolumab as solution for infusion, alongside standard chemotherapy and radiation therapy. The study monitors how long patients remain cancer-free, overall survival, and any side effects. Regular check-ups occur over several months to monitor health and treatment effectiveness.
The investigational drugs include atezolizumab, which helps the immune system attack cancer cells by blocking a protein that prevents effective targeting; tiragolumab, designed to enhance immune response against cancer cells; and chemoradiotherapy, combining chemotherapy drugs with radiation therapy to kill or stop cancer cell growth.
Study of pembrolizumab and vorinostat combination therapy in patients with recurrent or metastatic squamous cell carcinoma of head and neck, cervix, anus, and genital areas
This study includes patients with various types of squamous cell carcinoma that have spread or returned, including anal cancer. Participants must be 18 years or older with adequate bone marrow function: white blood cell count of at least 1,500/mm³, platelet count of at least 100,000/mm³, and hemoglobin levels of at least 9 g/dL. Normal blood clotting function is required. Female participants who can become pregnant must have a negative pregnancy test within 72 hours before starting treatment and use highly effective birth control during the study and for 4 months after the last pembrolizumab dose and 6 months after the last vorinostat dose. Male participants must use effective birth control during the study and for 4 months after the last pembrolizumab dose and 6 months after the last vorinostat dose. Patients must follow the study schedule, agree to tumor biopsy and blood samples throughout the study, be able to swallow medications, have health insurance or equivalent coverage, sign an informed consent form, have good physical function status (ECOG score of 0 or 1), have confirmed squamous cell carcinoma that has returned or spread with disease that can be measured and biopsied, and have normal kidney and adequate liver function.
Patients with history of treatment with pembrolizumab or vorinostat, active autoimmune disease requiring systemic treatment, history of severe allergic reactions to monoclonal antibody treatments, untreated brain metastases, active infection requiring systemic therapy, known active Hepatitis B or C infection, known history of HIV infection, use of systemic corticosteroids or immunosuppressive medication within 7 days before starting treatment, participation in another clinical trial within 4 weeks, pregnant or breastfeeding women, significant heart conditions within the past 6 months, any condition interfering with study result interpretation, inability to swallow oral medications, or known psychiatric or substance abuse disorders interfering with participation cannot join this trial.
The purpose is evaluating how well pembrolizumab and vorinostat work together. Pembrolizumab is given through intravenous injection at doses up to 200 mg, while vorinostat is taken as oral capsules at doses up to 400 mg daily. Treatment may continue for up to 105 weeks. Regular medical examinations and imaging tests monitor cancer response to the treatment combination.
The investigational drugs include pembrolizumab, an immunotherapy drug helping the body’s immune system recognize and attack cancer cells by blocking the PD-1 protein, and vorinostat, a histone deacetylase inhibitor that controls gene expression in cancer cells, potentially slowing or stopping cancer cell growth and making cancer cells more visible to the immune system.
Summary
The six ongoing clinical trials for anal squamous cell carcinoma represent a diverse range of treatment approaches across Europe. A notable concentration of trials is taking place in France, with four studies actively recruiting patients, while Germany and Spain each host one trial. The trials primarily focus on two disease stages: locally advanced disease and metastatic or recurrent disease.
Several common themes emerge across these studies. Immunotherapy medications, particularly checkpoint inhibitors like atezolizumab, pembrolizumab, spartalizumab, ezabenlimab, and tiragolumab, feature prominently in multiple trials. These drugs are being tested in combination with standard chemotherapy regimens, particularly the modified DCF combination of docetaxel, cisplatin, and 5-fluorouracil. Most trials also incorporate radiation therapy as part of the treatment approach.
The trials vary in their specific goals, with some evaluating complete response rates, others focusing on progression-free survival, and several examining overall survival and quality of life measures. All studies require participants to have adequate organ function and good performance status, reflecting the intensive nature of the combination treatments being investigated.
These trials collectively represent important efforts to improve treatment outcomes for patients with anal squamous cell carcinoma, exploring innovative combinations of immunotherapy, chemotherapy, and radiation therapy that may offer better results than standard treatments alone.
