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Study on Dostarlimab to Prevent Second Cancer in Patients Cured from Primary Cancer

Verified siteRegistered 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 patients who have been cured of a primary cancer and are at risk of developing a second cancer. The study is investigating the effects of a treatment called dostarlimab, also known by its code names WBP-285 and TSR-042. Dostarlimab is a medication that is given through an intravenous infusion, which means it is administered directly into the bloodstream through a vein. The purpose of the study is to determine if a short course of treatment with dostarlimab can reduce the risk of developing a second primary cancer after the initial cancer has been successfully treated.

Participants in the study will receive dostarlimab, which is provided as a concentrate for solution for infusion, meaning it is prepared as a liquid that is infused into the body. The study will compare the outcomes of those receiving dostarlimab with those who do not, to see if the medication can help prevent a second cancer from occurring. The study will be conducted over a period of time, and participants will be monitored for the development of any new cancers and their overall health status.

The trial aims to provide valuable information on whether dostarlimab can be an effective preventive treatment for patients who have already been treated for a primary cancer. By participating in this study, researchers hope to better understand the potential benefits of dostarlimab in reducing the risk of second primary cancers, ultimately improving the long-term health outcomes for cancer survivors.

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 will sign a written informed consent form. This form confirms understanding of the study and willingness to comply with study visits and procedures.

    The patient must be at least 18 years old and have been cured of a primary cancer, with a risk of developing a second cancer.

  2. Step 2

    Initial assessment

    The patient will undergo an initial assessment to confirm eligibility. This includes a review of medical history, current health status, and any risk factors for a second primary cancer.

    A tumor sample from the prior cancer diagnosis will be required for comparison in case of new cancer development.

  3. Step 3

    Treatment with dostarlimab

    The patient will receive treatment with dostarlimab, administered as an intravenous infusion. The specific dosage and frequency will be determined by the study protocol.

    The treatment aims to assess whether a short course of dostarlimab reduces the risk of developing a second primary cancer.

  4. Step 4

    Follow-up visits

    The patient will attend regular follow-up visits to monitor health status and any potential side effects of the treatment.

    These visits will include physical examinations, laboratory tests, and possibly imaging studies to assess the occurrence of a second primary cancer.

  5. Step 5

    Completion of study

    Upon completion of the study, the patient's health will be evaluated to determine the impact of dostarlimab on the risk of developing a second primary cancer.

    The study aims to provide valuable information on the effectiveness of dostarlimab in preventing second cancers in patients who have been cured of a primary cancer.

Who can join the trial?

14 criteria

  • Patient must be a male or female who is at least 18 years old.
  • Patient must have been cured from a primary cancer and be at risk of developing a second cancer.
  • Patient must have had 1 or 2 primary solid tumors that were treated with the intent to cure. The last cancer treatment must have ended less than 6 months before joining the study.
  • Patient must have at least one risk factor for a second cancer, such as:
    • Long-term tobacco use (more than 20 years).
    • Genetic predisposition, like mutations in genes such as p53 or BRCA, or conditions like Lynch syndrome.
    • Having a cancer related to HPV (Human Papillomavirus).
    • Patient must provide a sample of their previous tumor for comparison if a new cancer develops.
    • Patient must have a good performance status, meaning they are fully active or have some restrictions but can still carry out light work.
    • Patient must have adequate blood and organ function, as shown by specific laboratory test results.
    • Patient must have a corrected QT interval (a measure of heart rhythm) of less than 450 milliseconds, or less than 480 milliseconds if they have a specific heart condition called bundle branch block.
    • Women who can have children must have a negative pregnancy test and agree to use effective birth control during the study and for up to 6 months after the last dose of the study drug.
    • Men who are fertile must agree to use effective birth control during the study and for up to 6 months after the last dose of the study drug.
    • Patient must understand and sign a consent form before any study-specific procedures are done and be willing to follow the study requirements.
    • Patient must have medical insurance if it is required in their country.

Who cannot join the trial?

4 criteria

  • Patients who have not been cured from their primary cancer.
  • Patients who are not at risk of developing a second cancer.
  • Patients who are not within the specified age range for the study.
  • Patients who belong to a vulnerable population group.
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Investigated drugs

Dostarlimab is a type of medication known as an immunotherapy. It works by helping your immune system recognize and attack cancer cells. In this clinical trial, dostarlimab is being tested to see if it can help prevent the development of a second primary cancer in patients who have already been treated for their first cancer. The goal is to see if a short course of this medication can reduce the risk of developing another cancer after the initial one has been cured.

What is already known about the treatment

Dostarlimab – Dostarlimab is administered as an intravenous infusion, meaning it is given directly into the bloodstream through a vein. It is currently being studied in clinical trials to determine its effectiveness in preventing second primary cancers in patients who have been cured of a first primary cancer. The main therapeutic use being explored is to reduce the risk of developing a new cancer after successful treatment of an initial cancer. At the molecular level, dostarlimab works by blocking a protein called PD-1, which helps the immune system recognize and attack cancer cells. It is classified as an immune checkpoint inhibitor, a type of medication that helps the body's immune system fight cancer.

Investigated diseases

Second Primary Cancer – Second primary cancer refers to a new cancer that occurs in an individual who has previously been treated for another cancer. It is distinct from a recurrence or metastasis of the original cancer. The development of a second primary cancer can be influenced by genetic factors, environmental exposures, or the effects of previous cancer treatments. This condition progresses independently of the first cancer and requires separate evaluation and management. The risk of developing a second primary cancer varies depending on the type of the first cancer and the treatments received. Monitoring and regular follow-ups are essential to detect any new cancer early.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IITrial ID2022-501316-34-00Protocol codePREDOSTAR/ET22-215Estimated enrolment400 patientsSponsorCentre Leon Berard

sourced from the EU Clinical Trials Register and site verification

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