Actively Recruiting
Phase I Trial Testing the Safety and Tolerability of Chemoradiation Followed by Chemotherapy + Dostarlimab for Stage IIIC, Node Positive, Endometrial Cancer
Led by M.D. Anderson Cancer Center · Updated on 2026-03-11
21
Participants Needed
1
Research Sites
241 weeks
Total Duration
On this page
Sponsors
M
M.D. Anderson Cancer Center
Lead Sponsor
G
GlaxoSmithKline
Collaborating Sponsor
AI-Summary
What this Trial Is About
To learn if chemotherapy given in combination with radiation therapy, followed by maintenance therapy, can help to control endometrial cancer. The safety and effects of this study treatment will also be studied
CONDITIONS
Official Title
Phase I Trial Testing the Safety and Tolerability of Chemoradiation Followed by Chemotherapy + Dostarlimab for Stage IIIC, Node Positive, Endometrial Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Has read and understands the informed consent form and provided written consent
- Surgically staged IIIC, pathologically confirmed endometrial cancer of any histologic subtype
- Eligible for adjuvant chemoradiation followed by chemotherapy
- Enrolled within 8 weeks of surgery and started treatment within 10 weeks of surgery
- Age 18 years or older
- Performance Status of ECOG 0 or 1
- Adequate blood counts within 14 days prior to enrollment: hemoglobin 9 g/dL, platelets 100,000/mcl, absolute neutrophil count 1,500/mcl
- Adequate kidney function: creatinine 2 times upper limit of normal or creatinine clearance 60 ml/min
- Adequate liver function: bilirubin 1.5 times upper limit of normal (or 2 with Gilbert's disease), ALT and AST 2.5 times upper limit of normal
- Adequate coagulation within 14 days prior to enrollment (INR or PT/aPTT 1.5 times upper limit of normal) unless on anticoagulants within therapeutic range
- Prior or concurrent malignancy that does not interfere with safety or efficacy of study treatment (e.g., non-melanomatous skin cancer)
You will not qualify if you...
- Has not recovered to baseline or Grade 1 from prior radiation, major surgery, or chemotherapy-induced adverse events
- Surgery less than 3 weeks prior to starting study treatment or investigational therapy less than 4 weeks prior
- Previous treatment with anti-PD-1, anti-PD-L1, anti-CTLA-4 antibodies, or similar agents
- History of severe allergic reaction to monoclonal antibodies or dostarlimab and its components
- Active or history of autoimmune disease that could affect vital organs or require immunosuppressive therapy
- History of interstitial lung disease or non-infectious pneumonitis except if caused by radiation
- Diagnosis of immunodeficiency or receiving systemic immunosuppressive therapy within 7 days prior to enrollment
- Received live vaccine within 30 days of starting trial therapy
- Significant liver disease including active viral, alcoholic, or other hepatitis, cirrhosis, or positive hepatitis B or C tests
- Uncontrolled active infections or illnesses that would limit study compliance
- Use of prohibited medications as specified in the study
- Presence of leptomeningeal disease, symptomatic brain metastases, or CNS hemorrhage
- Known HIV infection
- Women of childbearing potential who are not permanently or surgically sterilized and capable of pregnancy
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
M D Anderson Cancer Center
Houston, Texas, United States, 77030
Actively Recruiting
Research Team
P
Pamela Soliman, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
3
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