Study on Durvalumab for Patients with High-Risk Endometrial Cancer After Surgery

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What is this study about?

This clinical trial is focused on studying a type of cancer called endometrial cancer, which affects the lining of the uterus. Specifically, the trial is looking at a subtype known as mismatch-repair deficient high-risk endometrial cancer (MMRd HREC). This subtype is characterized by certain genetic features that make it more aggressive. The treatment being tested in this study is a medication called durvalumab, also known by its code name MEDI4736. Durvalumab is given as an infusion, which means it is administered directly into the bloodstream through a vein.

The purpose of the study is to see if this treatment can help prevent the cancer from coming back after surgery. Participants in the study will receive durvalumab infusions and will be monitored over a period of time to check for any signs of cancer recurrence. The study aims to follow patients for up to three years to assess how well the treatment works in keeping the cancer from returning.

Throughout the study, participants will have regular check-ups and tests to monitor their health and the status of their cancer. These tests may include imaging scans like MRI or CT scans, which help doctors see inside the body. The study will also look at the overall health and quality of life of participants, as well as any side effects they may experience from the treatment. The goal is to gather information that could lead to better treatment options for people with this type of endometrial cancer in the future.

1 joining the study

Upon joining the study, you will be informed about the trial’s purpose, procedures, and potential risks and benefits. You will be required to provide written informed consent, which confirms your understanding and agreement to participate in the trial.

2 initial assessment

An initial assessment will be conducted to confirm your eligibility. This includes reviewing your medical history, performing a physical examination, and conducting necessary laboratory tests to ensure you meet the trial’s inclusion criteria.

3 treatment phase

During the treatment phase, you will receive the medication Imfinzi (durvalumab) as an IV infusion. The dosage is 50 mg/mL, and the frequency and duration of administration will be determined by the study protocol. This phase aims to evaluate the effectiveness of the treatment in preventing cancer recurrence.

4 follow-up visits

Regular follow-up visits will be scheduled to monitor your health and the effects of the treatment. These visits may include physical examinations, laboratory tests, and imaging studies to assess your response to the treatment and to check for any side effects.

5 end of trial

At the end of the trial, a final assessment will be conducted. This will involve a comprehensive evaluation of your health status and the collection of data to determine the trial’s outcomes. You will be informed about the results and any further steps, if necessary.

Who Can Join the Study?

  • Must have a confirmed diagnosis of endometrial cancer, which is a type of cancer that starts in the lining of the uterus. This includes several subtypes like endometrioid, serous, clear cell, dedifferentiated, undifferentiated, carcinosarcoma, and mixed types.
  • Must have a WHO Performance score of 0-1, which means you are fully active or have some symptoms but can still carry out light work.
  • Must have a confirmed stage of cancer according to specific criteria, which includes certain stages with specific characteristics like LVSI (lymphovascular space invasion) or involvement of pelvic areas.
  • Must have a specific molecular classification called MMRd (mismatch repair deficient), and the POLE status must be non-pathogenic, meaning it does not have harmful mutations.
  • Must not have had any prior pelvic radiotherapy.
  • Must weigh more than 30 kg (about 66 pounds).
  • Must have adequate organ function, which includes:
    • Kidneys: Creatinine clearance greater than 40 mL/min, which is a measure of kidney function.
    • Bone marrow: Hemoglobin level greater than 9.0 g/dl, Absolute neutrophil count (ANC) of at least 1.0 x 109/l, and platelet count of at least 75 x 109/l.
    • Liver: Bilirubin level no more than 1.5 times the normal limit, and ALT (SGPT) and/or AST (SGOT) levels no more than 2.5 times the normal limit.
  • Must have had surgery to remove the uterus and ovaries, with or without removal of lymph nodes, and no visible cancer left after surgery.
  • Must not have any distant metastases, meaning the cancer has not spread to other parts of the body, as shown by imaging tests like CT, MRI, or PET-CT scans.
  • Must be 18 years of age or older.
  • If applicable, must start additional treatment within 10 weeks after surgery.
  • Must be able to attend treatment sessions and follow-up appointments.
  • Must provide written informed consent to participate in the study, agree to contribute a tissue sample for research, and allow the use and sharing of data according to ethical guidelines.

Who Cannot Join the Study?

  • Patients who do not have a confirmed diagnosis of mismatch-repair deficient high risk endometrial cancer (MMRd HREC).
  • Patients with a POLE mutation (a specific genetic change).
  • Patients who have not undergone surgery, including hysterectomy (removal of the uterus) and bilateral salpingo-oophorectomy (removal of both ovaries and fallopian tubes).
  • Patients with signs of residual disease (remaining cancer after treatment).
  • Patients with distant metastases (cancer that has spread to other parts of the body).
  • Male patients, as the study is only for female patients.
  • Patients who are considered part of a vulnerable population (groups that may need special protection).

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Institut Gustave Roussy Villejuif France
Oncopole Claudius Regaud Toulouse France
Technische Universitaet Dresden Dresden Germany
Katholieke Universiteit te Leuven Leuven Belgium
Fondazione Policlinico Universitario Agostino Gemelli IRCCS Rome Italy
Comite Entreprise Paul Papin Angers France
Medical Center Haaglanden Hague The Netherlands

Other Sites

Site Name City Country Status
Centre Antoine Lacassagne Nice France
Fakultni Nemocnice Hradec Kralove Novy Hradec Kralove Czechia
Rotkreuzklinikum Muenchen gGmbH Munich Germany
Amphia Hospital Breda The Netherlands
Klinikum Worms gGmbH Worms Germany
CHU Helora La Louviere Belgium
AZ Turnhout Turnhout Belgium
Fakultni Nemocnice Bulovka Prague Czechia
Cbdvnsmgy Ubudfpwhjurjqe Sdvaubvqj Woluwe-Saint-Lambert Belgium
Idsyxqqs Jctib Bwpbdz Anderlecht Belgium
Iotazcvq Puzbhvzyfvwiybc Cigvnp Ceqqzb Marseille France
Fyvokffm nnwrevdwr Mbkvm a Hysjidg Prague Czechia
Uesthjemnumljldzgrhdo Twmtdrepy Ajh Tuebingen Germany
Ulcbfaflsuui Mqrcfbo Csztqkq Udqeyvm Utrecht The Netherlands
Eqzempb Uxltxhdvkzwv Mpsyape Cvamtoy Reajqxzxu (dfhyjmz Mzh Rotterdam The Netherlands
Urcciscdkscmfikigiujy Mebwmqnw Abk Munster Germany
Uvtlopqdnrxnvxfofkety Hdvvwfgoyz Ast Heidelberg Germany
Uxvgrdluhn Hkmyhwop Mlbskwckjt Maastricht The Netherlands
Chtzaa Lwhi Bhouzr Lyon France
Uedbqqpgym Oi Arskepx Edegem Belgium
Ufwichgeam Myztzpo Cttine Hmcvgmzbvxundrtvi Hamburg Germany
Chvlzu hdsltpehskh ucvfdwxpuquqf dt Lhsia Liege Belgium
Ivjwoipy fzfk Kffxhbpbl Twgmowxdctevzvdwhto uzm Ijbiehiwadlf Ukv gptcw Ulm Germany
Uvxxmgnkbitf Zptouqelkb Gasa Gent Belgium
Ugdlfyceaerv Mbantgi Cdhcxuj Gnhzmkkkd Groningen The Netherlands
Cubiwm Hqdfezphyog Uolzhscnymfyc Drozrw Gbvbfxn Soxrgpzavoafhvwhwiytlhsfho Namur Belgium
Vqdvo Sint-Niklaas Belgium
Mgdxdjf Symsndij Teogth Enschede The Netherlands
Uagwynnxjsbreizprygko Letruyd Abh Leipzig Germany
Inkfjnqg Rivfbpip Dv Cegror Du Mjdbxxhwewt Montpellier France
Ewffhvcbewjbx Wzilpvyuzwklbtj Snxuzfb Kccfrbtpecwbnklwaxr gtpey Berlin Germany
Kumphdqa Ljsrf Gfre Detmold Germany
Ddfykbyrkmsdfpejh Sviwblgvawi Hrxi gclkp Schwäbisch Hall Germany
Rfpsfbitilxtdspyxm Ibcadckxz Fhsgndpvb Leeuwarden The Netherlands
Crxlgd dn Rcjaixjvadltt &uwtsow Cxkxqubv Syyfwz Agut STRASBOURG, Alsace France
Aaodkrrhwm Zdxejqqvuv Ltjatr Leiden The Netherlands
Cjnjelbob Zhcolaabkw Ssopghonj Eindhoven The Netherlands
Biwyjfqk Upwtphujcd Hachpfiu Cglviu Besançon France
Acdycpvlq Uug Amsterdam The Netherlands
Mckpbfp Cjcmfqr Ljueffqaps Blbx Leeuwarden The Netherlands
Vlmpyuwxg Felwlzzb Nesspcwhx V Pyess Prague Czechia
Neeosiuhxiz Cgneyo Imrvklwll Amsterdam The Netherlands
Mqqcydt Maastricht The Netherlands
Gwvpq Hkylhyi Dt Chjzbgeiv Charleroi Belgium
Azqpanyc Ztiycodjpw Drqnwmt Obhducea Ostend Belgium
Raa Kpyqmpc Lhukkyofuvwljhmyqknlhq gxtgy Ludwigsburg Germany
Kgvtelhqxloqe Aftbwuu gluvx Kempten (Allgau) Germany
Dfx Bdbeply Vnmcfwfvn Itflzaklz Scigphozy Tilburg The Netherlands
Kmcpppza Etnvvdqfhozejxhjmlvwglwr Hbaglpszswaksgcmm Essen Germany

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Belgium Belgium
Recruiting
30.08.2022
Czechia Czechia
Recruiting
30.08.2022
France France
Recruiting
30.08.2022
Germany Germany
Recruiting
30.08.2022
Italy Italy
Recruiting
30.08.2022
The Netherlands The Netherlands
Recruiting
30.08.2022

Trial locations

Investigated Drugs:

RAINBO: This is a clinical trial focused on refining the treatment for endometrial cancer based on specific molecular features. The trial aims to improve the survival rate of patients with a particular type of endometrial cancer, known as MMRd HREC, by studying how different treatments can prevent the cancer from coming back over a period of three years. The trial does not specify individual medications or therapies by name, but it is part of a broader effort to tailor cancer treatment to the unique characteristics of each patient’s cancer.

Investigated Diseases:

Mismatch Repair Deficient High-Risk Endometrial Cancer – This type of endometrial cancer is characterized by a deficiency in the mismatch repair system, which is responsible for correcting errors during DNA replication. It is considered high-risk due to its potential for aggressive behavior and recurrence. The disease typically progresses from the inner lining of the uterus and can invade deeper layers or spread to nearby tissues and organs. In its early stages, it may be confined to the uterus, but as it advances, it can spread to the pelvic region and beyond. The progression is often marked by local invasion and potential for distant metastasis. The absence of POLE mutations and the inclusion of various histological types, such as carcinosarcoma, are notable features of this condition.

Trial ID:
2023-503267-42-00
Protocol code:
RAINBO MMRd-GREEN
NCT ID:
NCT05255653
Trial Phase:
Therapeutic confirmatory (Phase III)

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