RAINBO: Refining Adjuvant treatment IN endometrial cancer Based On molecular features, TransPORTEC platform trials (MMRd-GREEN)

Phase 1

Recruiting

• Conditions: Patients with a histological diagnosis of MMRd HREC, with mismatch- repair deficient high risk endometrial cancer (MMRdHREC; no POLEmut; all histology including carcinosarcoma), Stage IB/II with substantial LVSI or stage IIIA-C. Patients are treated with curative intent, after surgery (hysterectomy and bilateralsalpingo-oophorectomy, with or without lymphadenectomy or sentinel node biopsy), without signs of residual disease or distant metastases.; Therapeutic area: Diseases [C] - Neoplasms [C04]

• Registration Number: CTIS2023-503267-42-00
• Lead Sponsor: eiden University Medical Center

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2023-04-19
• Last Update Posted: 22 July 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: 304

Inclusion Criteria

Inclusion criteria for the RAINBO program: • Histologically confirmed diagnosis of EC of the following histologic subtypes: endometrioid endometrialcarcinoma, serous endometrial carcinoma, uterine clear cell carcinoma, dedifferentiated and undifferentiatedendometrial carcinoma, uterine carcinosarcoma, and mixed endometrial carcinomas of the aforementionedhistotypes. • Full molecular classification performed following the diagnostic algorithm described in WHO 2020 (5th Edition,IARC, Lyon, 2020, adapted from Vermij et al. 2020) • TLH-BSO or TAH-BSO with or without lymphadenectomy and/or full surgical staging, without macroscopicresidual disease after surgery • No distant metastases as determined by pre-surgical or post-surgical imaging (CT/MRI scan of chest, abdomenand pelvis or PET-CT scan) • Age > 18 years • Expected start of adjuvant treatment (if applicable) within 10 weeks after surgery •Patients must be accessible for treatment and follow-up •Written informed consent for participation in one of the RAINBO trials, permission for the contribution of a tissue block for translation research and permission for the use and sharing of data for the overarching research project according to the local Ethics Committee requirements.

Exclusion Criteria

Exclusion criteria for RAINBO program • History of another primary malignancy, except for non-melanoma skin cancer, in the past 5 years • Prior pelvic irradiation Exclusion criteria specific for MMRd-GREEN trial: • Major surgical procedure (as defined by the Investigator) within 28 days prior to the first dose of IP. • History of allogenic organ transplantation. • Uncontrolled intercurrent illness, including but not limited to, ongoing or active infection, symptomatic congestiveheart failure, uncontrolled hypertension, unstable angina pectoris, cardiac arrhythmia, interstitial lung disease,serious chronic gastrointestinal conditions associated with diarrhea, or psychiatric illness/social situations thatwould limit compliance with study requirement, substantially increase risk of incurring AEs or compromise theability of the patient to give written informed consent. Any previous treatment with a PD1 or PD-L1 inhibitor, including durvalumab. • Receipt of live attenuated vaccine within 30 days prior to the first dose of durvalumab. Note: Patients, if enrolled,should not receive live vaccine whilst receiving IP and up to 30 days after the last dose of IP. • Current or prior use of immunosuppressive medication within 14 days before the first dose of durvalumab withthe exceptions of : - Intranasal, inhaled, topical steroids, or local steroid injections (e.g., intra articular injection). - Systemic corticosteroids at physiologic doses not to exceed <<10 mg/day>> of prednisone or its equivalent - Steroids as premedication for hypersensitivity reactions (e.g., CT scan premedication). • History of active primary immunodeficiency • Active or prior documented autoimmune or inflammatory disorders (including inflammatory bowel disease [e.g.,colitis or Crohn's disease], diverticulitis [with the exception of diverticulosis], systemic lupus erythematosus,Sarcoidosis syndrome, or Wegener syndrome. The following are exceptions to this criterion: - Patients with vitiligo or alopecia - Patients with hypothyroidism (e.g., following Hashimoto syndrome)stable on hormone replacement - Any chronic skin condition that does not require systemic therapy - Patients without active disease in the last 5 years may be included but only after consultation with the studyphysician. • Active infection including tuberculosis (clinical evaluation that includes clinical history, physical examination andradiographic findings, and TB testing in line with local practice), hepatitis B (known positive HBV surface antigen(HBsAg) result), hepatitis C, or human immuno-deficiency virus (positive HIV 1/2 antibodies). Patients with a pastor resolved HBV infection (defined as the presence of hepatitis B core antibody [anti-HBc] and absence of HBsAg)are eligible. Patients positive for hepatitis C (HCV) antibody are eligible only if polymerase chain reaction isnegative for HCV RNA. • Known allergy for durvalumab. • Medical or psychological condition which in the opinion of the investigator would not permit the patient tocomplete the study or sign meaningful informed consent.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified