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Study of Retifanlimab, Carboplatin, and Paclitaxel for Patients with Inoperable or Metastatic Anal Canal Squamous Cell Carcinoma Not Treated with Chemotherapy

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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 squamous cell carcinoma of the anal canal. This cancer is a condition where abnormal cells grow in the anal canal, which is the end part of the digestive tract. The study is testing a new treatment that combines two chemotherapy drugs, carboplatin and paclitaxel, with a new medication called Retifanlimab (INCMGA00012). Some participants will receive a placebo instead of Retifanlimab. A placebo looks like the real medication but does not contain any active ingredients.

The purpose of the study is to compare the effectiveness of the treatment with Retifanlimab to the treatment with a placebo in people who have this type of cancer that cannot be removed by surgery and has not been treated with chemotherapy before. Participants in the study will receive the treatment 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 see how their cancer responds to the treatment.

Throughout the study, participants will have regular check-ups and tests to monitor their health and the progress of their cancer. The study aims to find out if adding Retifanlimab to the standard chemotherapy treatment can help improve outcomes for people with this type of cancer. This research is important because it may lead to better treatment options for patients in the future.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the study

    Upon joining the study, the participant will be randomly assigned to one of two groups. One group will receive the medication retifanlimab along with carboplatin and paclitaxel, while the other group will receive a placebo with carboplatin and paclitaxel.

    The study is double-blind, meaning neither the participant nor the researchers will know which group the participant is in.

  2. Step 2

    Treatment administration

    The medications retifanlimab, carboplatin, and paclitaxel are administered through an intravenous infusion. This means the medication is given directly into a vein.

    The dosage and frequency of administration will be determined by the study protocol and the healthcare team overseeing the trial.

  3. Step 3

    Monitoring and assessments

    Throughout the trial, regular monitoring and assessments will be conducted to evaluate the participant's health and the effectiveness of the treatment.

    These assessments may include physical exams, blood tests, and imaging studies to track the progression of the disease.

  4. Step 4

    Completion of treatment

    The treatment phase will continue as per the study protocol until the participant completes the required number of cycles or until the study's end date, estimated to be February 24, 2025.

    Participants will be informed about the next steps and any follow-up care needed after completing the treatment phase.

  5. Step 5

    Follow-up

    After the treatment phase, follow-up visits may be scheduled to monitor the participant's long-term health and any potential side effects.

    These visits are important to ensure the participant's well-being and to gather additional data for the study.

Who can join the trial?

9 criteria

  • Must be able to understand and willing to sign a written consent form for the study.
  • Must be 18 years of age or older, depending on local country requirements.
  • Must have a confirmed diagnosis of **inoperable** locally recurrent or **metastatic** squamous carcinoma of the anal canal (SCAC). "Inoperable" means it cannot be removed by surgery, and "metastatic" means the cancer has spread to other parts of the body.
  • Must not have had prior systemic therapy, except for chemotherapy given with radiotherapy to make the radiotherapy work better, or if any previous therapy was completed at least 6 months before joining the study.
  • Must have measurable disease according to specific medical guidelines, as determined by a local doctor or radiology assessment. Tumor areas that were previously treated with radiation or other local treatments are usually not considered measurable unless they have shown growth.
  • Must be able and willing to provide a sufficient tissue sample and blood sample for testing before being randomly assigned to a treatment group. Any biopsy samples should have been taken within 9 months before joining the study.
  • Must have an **ECOG performance status** of 0 to 1, which is a scale used to assess how a patient's disease is affecting their daily living abilities. A score of 0 means fully active, and 1 means restricted in physically strenuous activity but able to carry out light work.
  • If **HIV-positive**, must be stable, meaning: a **CD4+ count** of at least 200 cells per microliter, an undetectable viral load, receiving antiretroviral therapy for at least 4 weeks before joining the study, and no HIV-related infections for at least 4 weeks before joining the study.
  • Must agree to avoid pregnancy or fathering children during the study and for a specified period after the last dose of study medication. Men must take precautions to avoid fathering children and refrain from donating sperm. Women of childbearing potential must have a negative pregnancy test and take precautions to avoid pregnancy. Women who cannot become pregnant are eligible.

Who cannot join the trial?

7 criteria

  • Patients who have already received **systemic chemotherapy** (treatment using drugs that travel through the bloodstream to reach cancer cells all over the body) for their condition cannot participate.
  • Patients with other types of cancer that are not **Squamous Carcinoma of the Anal Canal** are not eligible.
  • Patients who have had a severe allergic reaction to the study drugs or similar drugs in the past cannot join the trial.
  • Patients with serious heart problems, such as a recent heart attack or severe heart failure, are excluded.
  • Patients with uncontrolled infections or other serious medical conditions that could interfere with the study are not allowed to participate.
  • Pregnant or breastfeeding women cannot take part in the study.
  • Patients who are unable to follow the study procedures or attend the required visits are not eligible.
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Investigated drugs

  • Carboplatin

    is a chemotherapy medication used to treat various types of cancer. It works by interfering with the DNA of cancer cells, preventing them from growing and dividing. In this trial, it is used in combination with other treatments to help manage squamous cell carcinoma of the anal canal.

  • Paclitaxel

    is another chemotherapy drug that helps stop the growth of cancer cells by inhibiting their ability to divide. It is often used in combination with other chemotherapy agents to enhance its effectiveness against cancer.

  • INCMGA00012

    is an investigational medication being studied for its potential to treat cancer. It is being tested in combination with carboplatin and paclitaxel to see if it can improve outcomes for patients with squamous cell carcinoma of the anal canal.

What is already known about the treatment

  • INCMGA00012

    This medication is administered intravenously and is currently being studied in clinical trials for its effectiveness in treating squamous cell carcinoma of the anal canal. It is not yet widely used in standard medical practice, as it is still under investigation. The main therapeutic indication is for patients with inoperable locally recurrent or metastatic squamous cell carcinoma of the anal canal who have not received prior systemic chemotherapy. INCMGA00012 works by targeting specific proteins on cancer cells, helping the immune system recognize and attack these cells. It is classified as an immunotherapy agent.

  • Carboplatin

    This medication is given intravenously and is well-established in medical literature as a chemotherapy drug. It is used to treat various types of cancer, including squamous cell carcinoma of the anal canal. Carboplatin works by interfering with the DNA of cancer cells, preventing them from dividing and growing. It is classified as a platinum-based chemotherapy agent.

  • Paclitaxel

    Administered intravenously, paclitaxel is a widely recognized chemotherapy medication used in the treatment of several cancers, including squamous cell carcinoma of the anal canal. It functions by stabilizing the structure of microtubules in cells, which inhibits cell division and leads to cell death. Paclitaxel is classified as a taxane chemotherapy agent.

Investigated diseases

Squamous Carcinoma of the Anal Canal – This is a type of cancer that begins in the squamous cells lining the anal canal. It often starts as a small growth or lesion and can progress to invade nearby tissues. As the disease advances, it may spread to nearby lymph nodes and other parts of the body. Symptoms can include pain, bleeding, or a noticeable lump in the anal area. The progression of the disease can vary, with some cases remaining localized while others become more widespread.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-512331-72-00Estimated enrolment308 patientsSponsorIncyte Corp.

sourced from the EU Clinical Trials Register and site verification

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