Endometrial Cancer
Conditions
Brief summary
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
Detailed description
Primary Objectives: The primary objective of this study is to describe the safety and toxicity of chemoradiation with concurrent immunotherapy, followed by chemotherapy plus concurrent immunotherapy, followed by immunotherapy maintenence in patients with stage IIIC endometrial cancer. Secondary Objectives: The secondary objectives are listed below. * To estimate progression free survival * To describe the time to recurence and the recurrence patterns including extent and location (i.e. isolated versus multi-focal, pelvic versus distant) * To estimate disease specific survival and overall survival Exploratory: * To determine if the presence of deficient mismatch repair (dMMR) or microsatellite instability correlates with progression free survival, disease free survival and 5-year overall survival * To assess patient reported outcomes (PROs) during the course of treatment and follow up
Interventions
DRUGPaclitaxel
Given by IV (vein)
DRUGCarboplatin
Given by IV (vein)
DRUGDostarlimab
Given by IV (vein)
DRUGCisplatin
Given by IV (vein)
Sponsors
M.D. Anderson Cancer Center
GlaxoSmithKline
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0 | through study completion; an average of 1 year |
Countries
United States
Contacts
CONTACTPamela Soliman, MD
PRINCIPAL_INVESTIGATORPamela Soliman, MD
M.D. Anderson Cancer Center
Outcome results
None listed