OncoMatch/Clinical Trials/NCT05255653
Refining Adjuvant Treatment IN Endometrial Cancer Based On Molecular Features
Official title: RAINBO: Refining Adjuvant Treatment IN Endometrial Cancer Based On Molecular Features, TransPORTEC Platform Trials - MMRd-GREEN.
Is NCT05255653 recruiting? Yes, currently enrolling (Oct 2026). This Phase 3 trial studies multiple treatments including Chemotherapy and Durvalumab for endometrial cancer.
Treatment: Chemotherapy · Durvalumab — RAINBO MMRd-GREEN is an international, multicenter, phase III randomised trial wherein adjuvant pelvic external beam radiotherapy combined with and followed by durvalumab for one year is compared to adjuvant pelvic external beam radiotherapy with or without chemotherapy.
Check if I qualifyExtracted eligibility criteria
Treatments studied
Immunotherapy
Other
Cancer type
Endometrial Cancer
Biomarker criteria
Required: MLH1 loss
Required: MSH2 loss
Required: MSH6 loss
Required: PMS2 loss
Disease stage
Required: Stage FIGO 2009 STAGE IB/II WITH LVSI, STAGE III, STAGE IV WITH LIMITED PELVIC PERITONEAL INVOLVEMENT, FIGO 2023 STAGE IB WITH LVSI, STAGE II WITH MYOMETRIAL OR CERVICAL STROMA INVOLVEMENT AND LVSI, STAGE III DISEASE (other)
Histologically confirmed FIGO 2009 stage IB/II with LVSI, stage III, or stage IV with limited pelvic peritoneal involvement (FIGO 2023 stage IB with LVSI, stage II with myometrial or cervical stroma involvement and LVSI, or stage III disease)
Performance status
WHO 0–1
Demographics
Prior therapy
Cannot have received: pelvic radiation
No prior pelvic radiotherapy
Cannot have received: pelvic radiation
Prior pelvic radiation
Cannot have received: PD-(L)1 inhibitor (durvalumab)
Any previous treatment with a PD(L)1 inhibitor, including durvalumab
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 cc/min (measured or calculated by Cockcroft-Gault or 24-hour urine collection)
Liver function
Bilirubin ≤1.5 x institutional upper limit of normal (ULN); ALT (SGPT) and/or AST (SGOT) ≤2.5 x ULN; Gilbert's syndrome exception allowed
Adequate systemic organ function: Creatinine clearance (> 40 cc/min)... Adequate bone marrow function: hemoglobin >9.0 g/dl, ANC ≥1.0 x 10^9/l, platelet count ≥75 x 10^9/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.
Frequently asked questions
Is NCT05255653 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior pelvic radiation, pelvic radiation, PD-(L)1 inhibitor disqualifies patients from enrollment.
Does this trial require MLH1?
Yes, MLH1 loss is a required biomarker for enrollment.
Does this trial require MSH2?
Yes, MSH2 loss is a required biomarker for enrollment.
Does this trial require MSH6?
Yes, MSH6 loss is a required biomarker for enrollment.
What disease stage is eligible?
Stage FIGO 2009 STAGE IB/II WITH LVSI or STAGE III or STAGE IV WITH LIMITED PELVIC PERITONEAL INVOLVEMENT or FIGO 2023 STAGE IB WITH LVSI or STAGE II WITH MYOMETRIAL OR CERVICAL STROMA INVOLVEMENT AND LVSI or STAGE III DISEASE is required.
Is this trial open to male patients?
No. This trial enrolls female patients only.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualifyRelated pages