Informations générales (source: ClinicalTrials.gov)
RAINBO: Refining Adjuvant Treatment IN Endometrial Cancer Based On Molecular Features, TransPORTEC Platform Trials - MMRd-GREEN.
Interventional
Phase 3
Leiden University Medical Center (Voir sur ClinicalTrials)
novembre 2021
janvier 2031
09 octobre 2026
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.
Etablissements
| Les établissements d'Île-de-France ayant mis à jour leurs données Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| CLCC INSTITUT GUSTAVE ROUSSY | Alexandra LEARY | 05/10/2026 13:55:02 | Contacter | ||
Critères
Femme
- Written informed consent
- WHO Performance score 0-1
- 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)
- Molecular classification: MMRd EC*
- No prior pelvic radiotherapy
- Body weight > 30 kg
- Adequate systemic organ function:
- Creatinine clearance (> 40 cc/min): Measured creatinine clearance (CL) >40
mL/min or Calculated creatinine CL>40 mL/min by the Cockcroft-Gault formula
(Cockcroft and Gault 1976) or by 24-hour urine collection for determination of
creatinine clearance.
- 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). <<This will not apply to patients with confirmed Gilbert's syndrome
(persistent or recurrent hyperbilirubinemia that is predominantly unconjugated
in the absence of hemolysis or hepatic pathology), who will be allowed only in
consultation with their physician.>>
- ALT (SGPT) and/or AST (SGOT) ≤2.5 x ULN
Exclusion criteria:
- Major surgical procedure (as defined by the Investigator) within 28 days prior to
the first dose of Investigational medicinal product (IMP).
- History of allogenic organ transplantation.
- Uncontrolled intercurrent illness, including but not limited to, ongoing or active
infection, symptomatic congestive heart failure, uncontrolled hypertension, unstable
angina pectoris, cardiac arrhythmia, interstitial lung disease, serious chronic
gastrointestinal conditions associated with diarrhea, or psychiatric illness/social
situations that would limit compliance with study requirement, substantially
increase risk of incurring AEs or compromise the ability of the patient to give
written informed consent.
- Any previous treatment with a PD(L)1 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 IMP.
- Current or prior use of immunosuppressive medication within 14 days before the first
dose of durvalumab with the 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], divertic
- Major surgical procedure (as defined by the Investigator) within 28 days prior to
the first dose of Investigational medicinal product (IMP).
- History of allogenic organ transplantation.
- Uncontrolled intercurrent illness, including but not limited to, ongoing or active
infection, symptomatic congestive heart failure, uncontrolled hypertension, unstable
angina pectoris, cardiac arrhythmia, interstitial lung disease, serious chronic
gastrointestinal conditions associated with diarrhea, or psychiatric illness/social
situations that would limit compliance with study requirement, substantially
increase risk of incurring AEs or compromise the ability of the patient to give
written informed consent.
- Any previous treatment with a PD(L)1 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 IMP.
- Current or prior use of immunosuppressive medication within 14 days before the first
dose of durvalumab with the 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 study physician.
- Active infection including tuberculosis (clinical evaluation that includes clinical
history, physical examination and radiographic 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 past or 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 is
negative for HCV RNA.
- Medical or psychological condition which in the opinion of the investigator would
not permit the patient to complete the study or sign meaningful informed consent.