Phase 2 Endometrial Cancer Trial, Recruiting NCT04774419 Sponsor: Memorial Sloan Kettering Cancer Center Condition: Endometrial Cancer
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Phase 2 Endometrial Cancer Trial, Recruiting

NCT04774419
Recruiting Phase 2

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

  • People aged 18 or older
  • People whose general health and ability to carry out daily activities meets a certain standard (rated 0 or 1 on a scale used by doctors to measure this — confirm with trial site)
  • People diagnosed with endometrial cancer of any tissue type (a pathology report may be required)
  • People whose cancer has a specific genetic profile: either mismatch repair deficiency (MMR-D), high microsatellite instability (MSI-H), or a POLE gene mutation — testing results may be required, and POLE-mutated cases are limited to a small number per group (confirm with trial site)
  • People whose cancer has been found to have certain gene changes related to how DNA is silenced (hypermethylation of MMR gene promoters), which also makes them potentially eligible
  • People who have completed full surgical staging and have been found to have Stage III or Stage IVA disease, with no remaining measurable cancer detectable after surgery
  • People whose surgery was completed between 3 and 12 weeks before the first day of treatment, and who have sufficiently recovered from surgery
  • People who are not able to become pregnant, or people who have had a negative blood pregnancy test within 7 days before starting treatment and agree to use effective contraception from the start of the trial until 150 days after the last dose
  • People who agree not to breastfeed during the trial or for 150 days after the last dose
  • People whose blood test results show that their kidneys, liver, bone marrow, and thyroid are functioning at a level that meets the trial's requirements (tests must be done within 14 days of starting treatment — confirm with trial site)

Who may not be able to join:

  • People who have previously received chemotherapy, targeted therapy, or experimental treatment specifically for endometrial cancer (people previously treated for a different cancer who are now in remission may be considered at the treating doctor's discretion)
  • People who have previously received certain types of immunotherapy drugs (anti-PD-1, anti-PD-L1, or anti-CTLA-4 agents) for endometrial cancer
  • People who are not suitable for radiation therapy, including those who have had pelvic radiation before, have had radiation to a large portion of their bone marrow recently, or have a known history of certain abnormal connections between organs (fistulas) involving the bladder, bowel, or vagina
  • People with a known serious allergic reaction to the study drug (Dostarlimab) or any of its ingredients
  • People with a diagnosed immune system disorder, or who are currently taking steroid medications or other immune-suppressing treatments (with some exceptions for low-dose or inhaled steroids — confirm with trial site)
  • People with active tuberculosis
  • People with current active, non-infectious lung inflammation (pneumonitis)
  • People with a history of scarring or inflammation of the lung tissue (interstitial lung disease)
  • People with an active infection currently being treated with intravenous antibiotics
  • People with certain serious medical conditions that could interfere with the trial, including a recent heart attack (within 90 days), uncontrolled seizures, unstable spinal cord compression, severe lung disease, or superior vena cava syndrome (confirm with trial site)
  • People who have previously had a bone marrow transplant from a donor, or a solid organ transplant
  • People with an active or recent history (within the past 3 years) of certain autoimmune or inflammatory conditions, such as lupus, rheumatoid arthritis, inflammatory bowel disease, myasthenia gravis, or similar conditions, or people who require immune-suppressing treatment for such conditions (some conditions such as vitiligo, stable hypothyroidism, or psoriasis not requiring systemic treatment may be exceptions — confirm with trial site)
  • People living with HIV who do not have an undetectable viral load on effective treatment within the past 6 months
  • People with active hepatitis B or C who do not meet specific viral load requirements (confirm with trial site)
  • People who have received a live vaccine within 30 days before starting the trial (some flu vaccines are allowed — confirm with trial site)
  • People who are unwilling or unable to give written informed consent, or who are unable to follow the trial requirements for its full duration

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 15 July 2026
Phase 2: approximately ~30% of drugs entering this phase reach regulatory approval, based on published industry-wide historical data. This is not specific to this trial.
Phase success rates shown are historical industry-wide averages based on published data. They are not a prediction for this specific trial or your individual situation.

Contact this trial

Principal Investigator: Ying Liu, MD, MPH, Memorial Sloan Kettering Cancer Center

Phone: 646-888-4946

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Recruiting
Phase
Phase 2
Registry
ClinicalTrials.gov
Start date
2 April 2021
Est. completion
1 February 2027

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

Incidence of dose limiting toxicities (DLTs) (Safety Run-in only); Progression-free (PFS)

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 15 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov