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Study of Spartalizumab and Drug Combination for Patients with Metastatic Anal Cancer

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying a type of cancer called metastatic squamous cell anal carcinoma. This is a cancer that starts in the cells lining the anus and has spread to other parts of the body. The study is testing a combination of treatments to see how well they work together. The treatments being studied include a medication called Spartalizumab (also known by its code name PDR001), and a combination of chemotherapy drugs known as mDCF, which includes Docetaxel, Cisplatin, and Fluorouracil. Additionally, the study involves the use of radiotherapy, which is a treatment that uses high doses of radiation to kill cancer cells.

The purpose of this study is to evaluate how effective these treatments are in preventing the cancer from getting worse over a period of one year. Participants in the study will receive these treatments through an intravenous infusion, which means the medication is given directly into a vein. The study will take place over several months, and participants will be monitored regularly to assess their response to the treatment and to check for any side effects.

Throughout the study, participants will undergo various tests and scans, such as a CT scan or MRI, to help doctors see how the cancer is responding to the treatment. The goal is to find out if this combination of treatments can help control the cancer and improve the quality of life for patients with this type of cancer. The study will also help researchers understand more about the safety and effectiveness of these treatments when used together.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial assessment

    Upon joining the study, an initial assessment is conducted to confirm eligibility. This includes a review of medical history and a physical examination.

    A CT scan and PET scan are performed within 30 days prior to inclusion to evaluate the presence of lesions.

  2. Step 2

    Treatment initiation

    The treatment phase begins with the administration of medications. The regimen includes docetaxel, cisplatin, and fluorouracil, which are given as a solution for infusion.

    Docetaxel is administered intravenously. Cisplatin and fluorouracil are also given as solutions for infusion. The specific dosages and frequency are determined by the study protocol.

  3. Step 3

    Spartalizumab administration

    Spartalizumab is administered intravenously. This medication is part of the treatment regimen and is given according to the study schedule.

  4. Step 4

    Radiotherapy

    Radiotherapy is included in the treatment plan. The schedule and dosage are determined by the study protocol and are designed to work in conjunction with the medication regimen.

  5. Step 5

    Monitoring and follow-up

    Throughout the study, regular monitoring is conducted to assess the response to treatment and to check for any side effects. This includes physical examinations and imaging tests.

    The primary goal is to evaluate the Progression-Free Survival rate at 1 year, which means assessing how long patients live without the disease getting worse.

  6. Step 6

    Completion of study

    The study is estimated to conclude by June 2026. At the end of the study, a final assessment is conducted to evaluate the overall outcomes and any long-term effects of the treatment.

Who can join the trial?

13 criteria

  • Must be a male or female who is at least 18 years old.
  • Must have a performance status of 0 or 1 according to the Eastern Cooperative Oncology Group (ECOG) scale, which is a way to measure how well a person can perform daily activities.
  • Must have a confirmed diagnosis of metastatic or locally advanced recurrent squamous cell carcinoma of the anus, which means the cancer has spread or come back in the anus area.
  • Must have a lesion that can be evaluated using a CT scan or MRI, assessed by specific criteria called RECIST v1.1.
  • Must be eligible for a specific treatment regimen called mDCF.
  • Must not have had any previous systemic treatments like immunotherapy or chemotherapy.
  • Must have had a CT scan within 30 days before joining the study.
  • Must have had a PET scan within 30 days before joining the study.
  • Must have a life expectancy of at least 12 months.
  • Must have adequate organ and bone marrow function, which means the body is working well enough to handle the study treatment. This is checked by specific blood tests and other criteria.
  • Must have signed and dated an informed consent form, showing they understand the study and agree to participate.
  • Must be affiliated with or a beneficiary of the French social security system.
  • Must be able to follow the study protocol, as judged by the study doctor.

Who cannot join the trial?

5 criteria

  • Patients who have a different type of cancer than metastatic squamous cell anal carcinoma cannot participate. This type of cancer has spread from the anal area to other parts of the body.
  • Patients who are not within the specified age range for the study cannot participate. The study is open to certain age groups only.
  • Patients who belong to a specific clinical trial group that is not included in this study cannot participate.
  • Both male and female patients are eligible, so gender is not a reason for exclusion.
  • Patients who are considered part of a vulnerable population, such as those who may not be able to give informed consent, are not excluded from this study.
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Investigated drugs

  • Spartalizumab

    is an investigational medication being studied for its potential to help the immune system fight cancer. It is a type of therapy known as an immune checkpoint inhibitor, which may help the body recognize and attack cancer cells more effectively.

  • Docetaxel

    is a chemotherapy drug used to treat various types of cancer. It works by interfering with the growth and spread of cancer cells in the body.

  • Cisplatin

    is another chemotherapy medication that helps to kill cancer cells by damaging their DNA, which prevents them from dividing and growing.

  • 5-Fluorouracil

    is a chemotherapy drug that targets cancer cells by inhibiting their ability to synthesize DNA, thereby slowing or stopping their growth.

  • Radiotherapy

    is a treatment that uses high doses of radiation to kill cancer cells and shrink tumors. It works by damaging the DNA inside the cancer cells, which prevents them from growing and dividing.

What is already known about the treatment

  • Spartalizumab

    Spartalizumab is administered intravenously and is currently being studied in clinical trials for its effectiveness in treating metastatic squamous cell anal carcinoma. It is an investigational drug, meaning it is not yet approved for general medical use. The main therapeutic indication is to potentially improve progression-free survival in patients with this type of cancer. Spartalizumab works by targeting and inhibiting specific proteins on cancer cells, which may help the immune system recognize and attack these cells. It is classified as an immunotherapy agent.

  • Docetaxel

    Docetaxel is given through an intravenous infusion and is a well-established chemotherapy medication used in various cancer treatments, including metastatic squamous cell anal carcinoma. It is approved for medical use and is often part of combination therapies. The drug works by disrupting the normal function of microtubules in cells, which are essential for cell division, thereby inhibiting cancer cell growth. Docetaxel is classified as a taxane chemotherapy agent.

  • Cisplatin

    Cisplatin is administered intravenously and is a widely used chemotherapy drug for treating different types of cancer, including metastatic squamous cell anal carcinoma. It is an approved medication with a long history of use in oncology. Cisplatin works by forming cross-links in DNA, which prevents cancer cells from dividing and leads to cell death. It is classified as a platinum-based chemotherapy agent.

  • 5-Fluorouracil

    5-Fluorouracil is given intravenously and is a commonly used chemotherapy drug for various cancers, including metastatic squamous cell anal carcinoma. It is an approved medication and often used in combination with other drugs. The mechanism of action involves interfering with the synthesis of DNA and RNA by inhibiting the enzyme thymidylate synthase, which is crucial for cell division. 5-Fluorouracil is classified as an antimetabolite chemotherapy agent.

Investigated diseases

Metastatic Squamous Cell Anal Carcinoma – This is a type of cancer that begins in the squamous cells lining the anal canal and has spread to other parts of the body. It typically starts as a small growth or lesion in the anal area and can progress to involve nearby tissues and lymph nodes. As the disease advances, cancer cells can travel through the bloodstream or lymphatic system to distant organs, forming new tumors. Symptoms may include changes in bowel habits, bleeding, or discomfort in the anal region. The progression of the disease can vary, with some individuals experiencing rapid spread while others may have a slower course. The focus of studies often includes understanding how the disease spreads and identifying factors that influence its progression.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IITrial ID2024-516005-23-00Estimated enrolment34 patientsSponsorCentre Hospitalier Regional Universitaire

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On this site, “treatment” means an investigational medicine being studied in a clinical trial. Its safety and efficacy for the use being studied have not yet been confirmed, some participants may receive a placebo or a comparator medicine, and taking part does not guarantee any health benefit. The decision to take part is made by the doctor at the research site. This site is for information only and does not replace medical advice.

This service is not affiliated with the European Commission, the EMA, or the official CTIS system. Most information comes from publicly available international clinical-trial registries, supplemented by data from academic sites, national regulators and commercial sponsors. On this site, “treatment” and “therapy” mean a medicine being tested in a clinical trial. Its safety and effectiveness in the use being studied are not yet confirmed, some participants may receive a placebo or a comparator, and taking part does not guarantee a health benefit. The doctor at the research site decides who can take part. This site provides information, not medical advice. Certain content and visual elements on this website have been generated or enhanced using artificial intelligence (AI).