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Study of Dostarlimab for Patients with High-Risk Locally Advanced Cervical Cancer After Chemo-Radiation

Fast replyRegistered drugNo placebo
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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 cervical cancer, specifically in patients who have a high risk of the disease progressing after receiving initial treatment. The treatment being tested in this study is called dostarlimab, which is also known by its code name TSR-042. Dostarlimab is given as a solution through an infusion, which means it is delivered directly into the bloodstream. The purpose of the study is to see if dostarlimab can help prevent the cancer from coming back or getting worse after patients have already received chemotherapy and radiation therapy.

Participants in this study will receive dostarlimab as a maintenance therapy, which means it is used to help keep the cancer under control after the initial treatment. The study will compare the effects of dostarlimab with those of a placebo to understand how well it works in maintaining the health of patients with high-risk locally advanced cervical cancer. The study will monitor patients over a period of time to see how long they remain free from cancer progression and to assess their overall survival and quality of life.

Throughout the study, patients will be regularly checked to see how they are responding to the treatment and to ensure their safety. The study aims to provide valuable information on whether dostarlimab can be an effective option for patients with this type of cervical cancer, potentially offering a new way to manage the disease after initial treatments have been completed.

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 patient must have completed chemoradiation treatment within the last 12 weeks.

    The patient must have resolved any side effects from the previous treatment to a mild level before starting the trial.

  2. Step 2

    Initial assessment

    An initial assessment is conducted to ensure the patient meets all eligibility criteria, including adequate organ function and a negative pregnancy test if applicable.

    The patient must provide written informed consent to participate in the study.

  3. Step 3

    Treatment phase

    The patient receives dostarlimab, a medication administered as a solution for infusion.

    The treatment involves regular infusions of dostarlimab as maintenance therapy.

  4. Step 4

    Monitoring and follow-up

    Throughout the trial, the patient's health and response to the treatment are closely monitored.

    Regular assessments are conducted to evaluate progression-free survival and overall health-related quality of life.

  5. Step 5

    End of treatment

    The treatment phase concludes as per the study's timeline, with the estimated end date being December 31, 2025.

    Post-treatment follow-up is conducted to ensure the patient's well-being and to gather data on long-term outcomes.

Who can join the trial?

23 criteria

  • You must sign a form agreeing to participate in the study before any study-specific procedures begin.
  • You should have completed your main treatment, which includes chemotherapy and radiation, within the last 12 weeks before signing the consent form.
  • Any side effects from the chemotherapy and radiation should be mild or have resolved before starting the study.
  • Your body must be functioning well, which means:
    • Your white blood cell count should be at a healthy level.
    • Your platelet count, which helps with blood clotting, should be at a healthy level.
    • Your hemoglobin, which carries oxygen in your blood, should be at a healthy level.
    • Your kidney function should be normal or only slightly reduced.
    • Your liver function should be normal or only slightly reduced.
    • Your blood clotting times should be normal or only slightly prolonged.
    • You must agree not to donate blood during the study and for 90 days after the last dose of the study treatment.
    • You must test negative for Hepatitis.
    • If you are a woman who can become pregnant, you must have a negative pregnancy test before starting the study and agree to avoid becoming pregnant during the study and for 150 days after the last dose of the study treatment.
    • You must agree not to breastfeed during the study and for 150 days after the last dose of the study treatment.
    • If you have a male partner, he must agree to use a reliable method of birth control during the study and for 150 days after the last dose of the study treatment.
    • You must be able to understand the study procedures and agree to participate by signing a written consent form.
    • You must be able to perform daily activities with little or no assistance, as measured by a standard scale called the Eastern Cooperative Oncology Group (ECOG) performance status.
    • You must be a woman aged 18 years or older.
    • You should have a life expectancy of at least 3 months.
    • You must have a confirmed diagnosis of a specific type of cervical cancer, such as squamous cell carcinoma, adenocarcinoma, or adenosquamous carcinoma.
    • You must have tumor tissue samples available that have been preserved in a specific way.
    • Your cancer should be at a certain stage according to a classification system called FIGO 2009, which includes specific stages with lymph node involvement.
    • You must have received a combination of chemotherapy and radiotherapy with the goal of curing the cancer, including at least 4 doses of a drug called cisplatin.
    • You must have shown a partial or complete response to the chemotherapy and radiation treatment.

Who cannot join the trial?

5 criteria

  • Patients who are not female cannot participate in the study.
  • Patients who do not have cervical cancer cannot participate in the study.
  • Patients who have not received chemotherapy and radiation therapy together cannot participate in the study.
  • Patients who have not shown a partial or complete response to the treatment cannot participate in the study.
  • Patients who are not within the specified age range cannot participate in the study.
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Investigated drugs

Dostarlimab (TSR-042) is a medication being studied as a maintenance therapy for patients with high-risk locally advanced cervical cancer. It is used after patients have undergone chemotherapy and radiation therapy. The goal of using dostarlimab is to help prevent the cancer from coming back or getting worse.

What is already known about the treatment

Dostarlimab – Dostarlimab is administered intravenously, meaning it is given directly into a vein through an injection. It is currently being studied in clinical trials as a maintenance therapy for patients with high-risk locally advanced cervical cancer who have responded to initial treatments like chemotherapy and radiation. The medication works by blocking a protein called PD-1 on immune cells, which helps the immune system recognize and attack cancer cells more effectively. Dostarlimab is classified as an immune checkpoint inhibitor, a type of drug that enhances the body's immune response against cancer.

Investigated diseases

Cervical cancer – Cervical cancer is a type of cancer that occurs in the cells of the cervix, which is the lower part of the uterus connecting to the vagina. It often begins with precancerous changes in the cervix, which can develop into cancer over time if not detected and treated early. The disease progresses as cancer cells grow and invade deeper tissues of the cervix and potentially spread to nearby organs and lymph nodes. Symptoms may include abnormal vaginal bleeding, pelvic pain, or pain during intercourse, but early stages often have no symptoms. The progression of cervical cancer can vary, with some cases remaining localized while others may spread to distant parts of the body. Regular screening and early detection are crucial in managing the progression of this disease.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IITrial ID2023-510268-11-00Protocol codeGEICO78-C (ATOMICC)Estimated enrolment132 patientsSponsorFundacion Grupo Espanol De Investigacion En Cancer Ginecologico

sourced from the EU Clinical Trials Register and site verification

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