Triple threat: new combo therapy targets advanced endometrial cancer
NCT ID NCT05819892
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This early-stage trial is testing whether combining chemotherapy and radiation, followed by more chemotherapy plus the immunotherapy drug dostarlimab, is safe and tolerable for people with stage IIIC node-positive endometrial cancer. The study aims to see if this approach can help control the cancer after surgery. Only 21 participants will be enrolled, and the main focus is on side effects.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- chemotherapy (paclitaxel, carboplatin, cisplatin) plus radiation therapy and dostarlimab
- What this could lead to
- If successful, this could point toward a new treatment option that helps control advanced endometrial cancer after surgery.
- What could go wrong
- This is a very early Phase 1 trial with only 21 participants, so it is primarily testing safety, not effectiveness. The combination may cause significant side effects and may not work better than existing treatments.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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About 21 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jul 2023
- Expected to finish
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Mar 2028
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Female participants only
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: Patients are eligible to participate on this study only if they meet all of the following inclusion criteria. 1. Has read and understands the informed consent form (ICF) and has given written informed consent prior to any study procedures 2. Have surgically staged IIIC, pathologically confirmed endometrial cancer of any histologic subtype and be eligible for adjuvant chemoradiation followed by chemotherapy (Note: Surgical staging is defined as total hysterectomy and lymph node assessment.) 3. Enrolled within 8 weeks of surgery and started treatment within 10 weeks of surgery 4. Age ≥ 18 years 5. Performance Status of ECOG 0 or 1 (see Performance Status Criteria) 6. Adequate hematologic function within 14 days prior to enrollment defined as follows: * Hemoglobin ≥ 9 g/dL * Platelets ≥ 100,000/mcl * Absolute neutrophil count (ANC) ≥ 1,500/mcl 7. Adequate renal function within 14 days prior to enrollment defined as follows: Creatinine ≤ 2 x laboratory upper limit of normal (ULN) or CrCl ≥60ml/min 8. Adequate hepatic function within 14 days prior to enrollment defined as follows: * Bilirubin ≤ 1.5 x ULN (patients with known Gilbert's disease who have bilirubin level ≤ 2 x ULN may be enrolled) * ALT and AST ≤ 2.5 x ULN 9. Adequate coagulation within 14 days prior to enrollment defined as INR or PT/aPTT ≤ 1.5 x ULN unless patient is receiving anticoagulant therapy as long as PT or PTT is within therapeutic range of intended use of anticoagulants. 10. Prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial (i.e. non-melanomatous skin cancer). Exclusion Criteria: Patients are not eligible to participate on this study if they meet any of the following exclusion criteria. 1. Has not recovered (i.e., to Grade ≤ 1 or to baseline) from prior radiation, major surgery and chemotherapy-induced AEs. 2. Surgery ≤ 3 weeks prior to initiating protocol therapy Investigational therapy ≤ 4 weeks, or within a time interval less than at least 5 half-lives of the investigational agent, whichever is shorter, prior to initiating protocol therapy. 3. Has received prior treatment with anti-PD-1, anti-PD-L1, or anti-CTLA-4 therapeutic antibody or other similar agents. 4. Has a history of a severe hypersensitivity reaction to monoclonal antibody or dostarlimab and/or its excipients. 5. Have active autoimmune disease or history of autoimmune disease that might recur, which may affect vital organ function or require immune suppressive treatment including systemic corticosteroids. This includes, but is not limited to: a history of immune related neurologic disease, multiple sclerosis, autoimmune (demyelinating) neuropathy, GuillainBarre syndrome, myasthenia gravis, systemic autoimmune disease such as SLE, connective tissue diseases, scleroderma, inflammatory bowel disease (IBD), Crohn's, ulcerative colitis, hepatitis; and patients with a history of toxic epidermal necrolysis (TEN), Stevens-Johnson syndrome, or phospholipid syndrome because of the risk of recurrence or exacerbation of disease. 6. History of interstitial lung disease or non-infectious pneumonitis except for those induced by radiation therapies. 7. Have a diagnosis of immunodeficiency or are receiving daily systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to enrollment: * Steroids received as CT scan contrast premedication may be enrolled. * The use of inhaled or topical corticosteroids is allowed. * The use of mineralocorticoids (e.g., fludrocortisone) for orthostatic hypotension or adrenocortical insufficiency is allowed. * The use of physiologic doses of corticosteroids may be allowed and in consultation with the study chair (e.g. 10 mg of prednisone used for replacement therapy for adrenal insufficiency). 8. Have received a live vaccine within 30 days of starting trial therapy. 9. Known clinically significant liver disease, including active viral, alcoholic, or other hepatitis; and cirrhosis. --Evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load, tested positive for the presence of hepatitis B surface antigen, or have a positive hepatitis C antibody test result at screening or within 3 months prior to the first dose of study treatment. 10. Uncontrolled intercurrent illness including (but not limited to): ongoing or active infection (except for uncomplicated urinary tract infection), interstitial lung disease or active, non-infectious pneumonitis, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements. 11. Have received any of the prohibited medications listed in Section 7.2. 12. Has leptomeningeal disease, carcinomatous meningitis, symptomatic brain metastases, or radiologic signs of CNS hemorrhage. Note: Asymptomatic brain metastases (i.e, off corticosteroids and anticonvulsants for at least 7 days) are permitted. 13. Known human immunodeficiency virus (HIV)-infected patients. 14. Women of childbearing potential (WoCBP) who have been not been permanently or surgically sterilized and are capable of procreation
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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M D Anderson Cancer Center
RECRUITINGHouston, Texas, 77030, United States
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