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Study of Dostarlimab for Patients with Advanced or Metastatic Non-Colorectal/Non-Endometrial Cancer with dMMR/MSI, Compared to Standard Drug Combination

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 studying a type of cancer that is locally advanced or has spread to other parts of the body, known as metastatic cancer. The specific cancers being studied are those that are not colorectal or endometrial but have a characteristic called dMMR/MSI, which affects how cells repair DNA. The trial will test a treatment called dostarlimab, which is an immunotherapy drug. Immunotherapy is a type of treatment that helps the body's immune system fight cancer. The purpose of the study is to compare the effectiveness of dostarlimab with standard treatments that are currently used for these types of cancers.

Participants in the study will receive either dostarlimab or a standard treatment, which may include medications such as oxaliplatin, etoposide, ifosfamide, paclitaxel albumin-bound, fluorouracil, carboplatin, calcium folinate, capecitabine, docetaxel, mitotane, trabectedin, irinotecan, cisplatin, gemcitabine, paclitaxel, or doxorubicin. Some participants may receive a placebo, which is a substance with no active medication, to help compare the effects of the treatments. The study will involve regular visits to the clinic for treatment and monitoring, and participants will be closely observed to see how their cancer responds to the treatment.

The trial will last for several months, and participants will be monitored for any changes in their cancer, as well as any side effects they may experience. The study aims to provide valuable information about the potential benefits of dostarlimab for treating these specific types of cancer and to see if it can help patients live longer without their cancer getting worse. This research is important for developing new treatment options for patients with these challenging cancer types.

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

    Joining the study

    Upon joining the study, the patient will be randomly assigned to one of two groups: the dostarlimab group or the standard treatment group.

    The patient will receive detailed information about the study procedures and will be required to provide written consent before any trial-specific procedures begin.

  2. Step 2

    Treatment initiation

    For patients in the dostarlimab group, treatment will begin with the administration of dostarlimab through an intravenous infusion. The frequency and dosage will be determined by the study protocol.

    Patients in the standard treatment group will receive one or more of the following medications, depending on their specific condition: oxaliplatin, etoposide, ifosfamide, paclitaxel albumin-bound, fluorouracil, carboplatin, calcium folinate, capecitabine, docetaxel, mitotane, trabectedin, irinotecan, cisplatin, gemcitabine, paclitaxel, doxorubicin. These medications will be administered either intravenously or orally, as specified by the study protocol.

  3. Step 3

    Monitoring and assessments

    Throughout the study, the patient will undergo regular monitoring and assessments to evaluate the effectiveness of the treatment and to check for any side effects.

    These assessments will include blood tests, imaging studies, and other necessary evaluations as determined by the study protocol.

  4. Step 4

    Progression and crossover

    If the patient's disease progresses while on the standard treatment, they may have the option to switch to the dostarlimab treatment, depending on the study's crossover criteria.

    The decision to switch treatments will be based on the patient's condition and the study's guidelines.

  5. Step 5

    Completion of treatment

    The treatment phase will continue until the patient experiences disease progression, unacceptable side effects, or chooses to withdraw from the study.

    Upon completion of the treatment phase, the patient will undergo a final set of assessments to evaluate their overall response to the treatment.

  6. Step 6

    Follow-up

    After completing the treatment phase, the patient will enter a follow-up period during which their health status will be monitored at regular intervals.

    The follow-up period is designed to gather long-term data on the patient's health and the effects of the treatment.

Who can join the trial?

19 criteria

  • The patient must have signed a written informed consent form before any trial-specific procedures.
  • The patient must have a certain level of blood health, including:
    • Enough white blood cells called neutrophils.
    • A sufficient number of platelets, which help with blood clotting.
    • A hemoglobin level that is not too low, which is important for carrying oxygen in the blood.
    • The patient must have proper kidney function, shown by a specific level of creatinine in the blood or a certain rate of kidney filtration.
    • The patient must have proper liver function, shown by specific levels of bilirubin and liver enzymes in the blood. If there are cancer spots in the liver, these levels can be a bit higher.
    • If the patient is not taking a blood thinner called warfarin, certain blood clotting tests must be within normal limits. If taking warfarin, the dose must be stable, and a specific test result must be below a certain level.
    • Women who can have children must have a negative pregnancy test within 72 hours before starting the trial.
    • Men and women who can have children must agree to use effective birth control during the trial and for a period after the last dose of the trial medication. Men must also agree not to donate sperm, and women must agree not to donate eggs during this time.
    • The patient must be registered in a National Health Care System.
    • The patient must be willing and able to attend scheduled visits, follow the treatment plan, and undergo necessary tests and procedures.
    • The patient must be 18 years or older.
    • The patient must have advanced or spreading cancer that has not been treated with systemic anticancer therapy and cannot be completely removed by surgery.
    • The patient must have a specific type of cancer that is not colorectal or endometrial, such as certain cancers of the stomach, pancreas, bile ducts, adrenal glands, unknown primary site, neuroendocrine tumors, or soft tissue sarcomas.
    • If the patient had treatment for non-spreading cancer, it must have been completed more than 6 months before the cancer spread or returned.
    • The patient must provide a sample of tumor tissue for testing to confirm specific cancer characteristics.
    • The patient's cancer must be confirmed to have certain characteristics (dMMR/MSI) by a central review before joining the study.
    • The patient must have at least one measurable tumor spot within 28 days before starting treatment, according to specific guidelines.
    • The patient must have a good general health status, as measured by a specific performance scale (ECOG PS 0-1).

Who cannot join the trial?

6 criteria

  • Patients who have a type of cancer that is not colorectal or endometrial, but is locally advanced or has spread to other parts of the body.
  • Patients with a specific genetic condition in their cancer called dMMR/MSI. This means the cancer cells have trouble fixing mistakes in their DNA.
  • Patients who are not able to have surgery to remove their cancer.
  • Patients who are not suitable for the standard treatment options available.
  • Patients who are not in the age range specified for the study.
  • Patients who are part of a vulnerable population, meaning they might need special protection or care.
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Investigated drugs

Dostarlimab is a medication being studied as a first-line treatment for certain types of advanced or metastatic cancers. It is being tested to see how well it works in stopping the progression of these cancers compared to other standard treatments. This medication is specifically being looked at for cancers that are not colorectal or endometrial but have certain genetic characteristics known as dMMR/MSI.

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 first-line treatment for patients with certain types of advanced or metastatic cancers that are not colorectal or endometrial. The main therapeutic indication for dostarlimab is for cancers with specific genetic features known as dMMR/MSI. 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 enhances the body's immune response against cancer.

Investigated diseases

Mismatch Repair Deficient/Microsatellite Instability-High Non-Colorectal/Non-Endometrial Cancer – This type of cancer is characterized by defects in the DNA mismatch repair system, leading to microsatellite instability. It can occur in various organs other than the colon and endometrium, such as the stomach, pancreas, or prostate. The disease often presents as locally advanced or metastatic, meaning it has spread beyond its original site. Patients may experience symptoms related to the specific organ affected, such as pain or dysfunction. The progression of the disease can vary, with some tumors growing slowly while others may advance more rapidly. The condition is often identified through genetic testing that reveals the mismatch repair deficiency or microsatellite instability.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IITrial ID2023-505298-34-00Protocol codeUC-IMM-2302Estimated enrolment120 patientsSponsorUnicancer

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