OncoMatch/Clinical Trials/NCT05255653
Refining Adjuvant Treatment in Endometrial Cancer Based on Molecular Features
Is NCT05255653 recruiting? Yes, currently enrolling (May 2026). This Phase 2/3 trial studies multiple treatments for endometrial cancer.
Treatment: Olaparib · Chemotherapy · Durvalumab · Medroxyprogesterone Acetate · Megestrol Acetate — The RAINBO umbrella program consists of four clinical trials investigating new adjuvant therapies in endometrial cancer patients. Eligible patients will be assigned to one of the four RAINBO trials based on the molecular profile of their cancer: * p53 abnormal endometrial cancer patients to the p53abn-RED trial * mismatch repair deficient endometrial cancer patients to the MMRd-GREEN trial * no specific molecular profile endometrial cancer patients to NSMP-ORANGE trial * POLE mutant endometrial cancer patients to the POLEmut-BLUE trial
Check if I qualifyExtracted eligibility criteria
Cancer type
Endometrial Cancer
Biomarker criteria
Required: TP53 abnormal
p53 abnormal EC
Required: MMR deficiency
Mismatch repair deficient EC [MMRd-GREEN]
Required: POLE pathogenic mutation
Pathogenic POLE mutation(s) [POLEmut-BLUE]
Required: ESR1 positive expression
ER positive EC [NSMP-ORANGE]
Excluded: POLE pathogenic mutation
Pathogenic POLE mutation(s) [excluded in p53abn-RED, MMRd-GREEN, NSMP-ORANGE]
Excluded: MMR deficiency
Mismatch repair deficiency [excluded in p53abn-RED, NSMP-ORANGE]
Excluded: TP53 abnormal
p53 abnormality [excluded in NSMP-ORANGE]
Disease stage
Required: Stage I (WITH INVASION), IB, II, II (MICROSCOPIC), III, IVA (FIGO 2009)
Histologically confirmed stage I (with invasion) II or III EC; stage IB/II EC with myometrial or cervical stroma involvement and lympovascular space invasion (LVSI) OR Stage III EC OR Stage IVA with limited pelvic peritoneal involvement; stage IA (not confined to polyp), grade 3, pN0, with or without LVSI; stage IB, grade 1 or 2, pNx/N0, with or without LVSI; stage IB, grade 3, pN0, without substantial LVSI; stage II (microscopic), grade 1 or 2, pN0, without substantial LVSI
Performance status
WHO 0–2
Prior therapy
Must have received: hysterectomy and bilateral salpingo-oophorectomy
Hysterectomy and bilateral salpingo-oophorectomy with or without lymphadenectomy or sentinel node biopsy, without macroscopic residual disease after surgery
Cannot have received: pelvic radiation
Prior pelvic radiation
Cannot have received: chemotherapy
Prior chemotherapy for EC [POLEmut-BLUE]
Cannot have received: PARP inhibitor (olaparib)
Any previous treatment with a PARP inhibitor, including olaparib [p53abn-RED]
Cannot have received: PD(L)1 inhibitor (durvalumab)
Any previous treatment with a PD(L)1 inhibitor, including durvalumab [MMRd-GREEN]
Lab requirements
Blood counts
hemoglobin >9.0 g/dl, ANC ≥1.0 x 10^9/l, platelet count ≥75 x 10^9/l
Kidney function
creatinine clearance >40 mL/min (measured or calculated by Cockcroft-Gault or 24-hour urine collection)
Liver function
bilirubin ≤1.5 x institutional ULN (except Gilbert's syndrome); ALT (SGPT) and/or AST (SGOT) ≤2.5 x ULN
Adequate systemic organ function: Creatinine clearance (> 40 cc/min)... Adequate bone marrow function : hemoglobin >9.0 g/dl, Absolute neutrophil count (ANC) ≥1.0 x 109/l, platelet count ≥75 x 109/l. Adequate liver function: bilirubin ≤1.5 x institutional upper limit of normal (ULN)... ALT (SGPT) and/or AST (SGOT) ≤2.5 x ULN
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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