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Phase I Trial for Stage IIIC Endometrial Cancer

This study is testing a new treatment approach for stage IIIC (cancer has spread to nearby lymph nodes) endometrial cancer. It combines chemotherapy (Paclitaxel, Carboplatin, Cisplatin) with radiation, followed by more chemotherapy and an immunotherapy drug called Dostarlimab. Researchers want to see how safe this treatment is and what side effects it might cause. They also want to learn if it helps control the cancer. You may be able to join if you are a woman aged 18 or older with surgically staged IIIC endometrial cancer. The study will enroll about 21 participants. Success for this study means understanding the safety and side effects of the treatment. The current recruitment status is unclear.

Study design
This is an interventional study, meaning participants will receive a specific treatment. It plans to enroll 21 participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed through study completion, which is an average of 1 year, to measure adverse events.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT05819892

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

Recruiting
PHASE1Ages 18+InterventionalTreatment
M.D. Anderson Cancer Center
~21 participants
Updated 2026-06-08 on ClinicalTrials.gov
What's tested:PaclitaxelCarboplatinDostarlimabCisplatin

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0
Measured over through study completion; an average of 1 year

Conditions

Endometrial Cancer

Explore related trials

Endometrial Carcinoma

Where it's being run

1 sites across 1 states
Texas1

Study leadership

  • Pamela Soliman, MD · PRINCIPAL_INVESTIGATOR · M.D. Anderson Cancer Center

Who to contact

Pamela Soliman, MD
[email protected]
713-745-2352
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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
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

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

What this trial measures

  • Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0through study completion; an average of 1 year