Clinical trial Recruiting at 1 site Phase 1 Interventional Ages 18 and up Women only

Testing a new treatment approach for advanced endometrial cancer

Official title: Phase I Trial Testing the Safety and Tolerability of Chemoradiation Followed by Chemotherapy + Dostarlimab for Stage IIIC, Node Positive, Endometrial Cancer

Run by M.D. Anderson Cancer Center · NCT05819892 · Data updated 2026-11-12

This study is testing a new treatment that combines radiation, chemotherapy, and immunotherapy to see if it helps people with advanced endometrial cancer live longer and feel better.

Quick facts

PhasePhase 1
Study typeInterventional
Ages18 Years and up
SexWomen only
Enrollment21 (estimated)
SponsorM.D. Anderson Cancer Center
Academic / other
Drugs / interventionsdostarlimab, chemotherapy, radiation, prednisone, immunotherapy
Locations1 site (Houston, Texas)
StatusRecruiting
StartedJuly 17, 2023
Main results expectedMarch 1, 2027
Study endsMarch 1, 2028
Registry record updatedJune 8, 2026
Trial IDNCT05819892 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates include adults aged 18 and older with surgically staged IIIC endometrial cancer who are eligible for adjuvant chemoradiation.

Probably not a fit

Patients with non-stage IIIC endometrial cancer or those who do not meet the eligibility criteria may not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial aims to evaluate the safety and tolerability of a combination of chemoradiation and immunotherapy, followed by chemotherapy and maintenance therapy, in patients with stage IIIC, node-positive endometrial cancer. The study will assess the treatment's effects on progression-free survival, recurrence patterns, and overall survival. Additionally, it will explore the correlation between specific genetic markers and patient outcomes, while also gathering patient-reported outcomes throughout the treatment process.

Why it matters

Potential benefit: If successful, this treatment approach could improve survival rates and quality of life for patients with advanced endometrial cancer.

How similar studies have gone: Other studies have shown promise with similar combinations of chemoradiation and immunotherapy, indicating potential for success in this approach.

Who can join: the full rules

Show full inclusion / exclusion criteria
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

Where it's running

  • M D Anderson Cancer Center
    Houston, Texas, United States
    Recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.