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Endometrial CancerPhase 3AtTEndNCT03603184

Atezolizumab Trial in Endometrial Cancer - AtTEnd

A Phase 3 study testing Atezolizumab, Paclitaxel and Carboplatin in people with Endometrial Cancer, run by Mario Negri Institute for Pharmacological Research at 93 sites in 11 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

Atezolizumab is an engineered humanised monoclonal immunoglobulin G1 antibody that binds selectively to PD-L1 and prevents its interaction with PD-1 and B7-1. In May 2016 atezolizumab was approved by the FDA for patients with locally advanced or metastatic urothelial carcinoma who have disease progression during or… Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Endometrial Cancer
What is being tested?
Atezolizumab, Paclitaxel and Carboplatin
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
549 participants
Where
93 sitesin 11 countries
Study dates
2 Oct 2018to 20 Jan 2025
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • I-1. Newly diagnosed, histologically-confirmed with residual disease after surgery either measurable or evaluable, or inoperable stage III-IV endometrial carcinoma/carcinosarcoma, after diagnostic biopsy, and naïve to first line systemic anti-cancer treatment. Recurrent endometrial cancer patients if not yet treated for recurrent disease.
  • I-2. Eastern Cooperative Oncology Group (ECOG) performance status 0-2 I-3. Age ≥ 18 years I-4. Only one prior line of systemic platinum-based regimen is permitted if the platinum-free interval ≥ 6 months. Such prior line is the up-front/adjuvant treatment which can be concurrent chemoradiation or concurrent chemoradiation followed by chemotherapy or only chemotherapy.
  • I-5. Patients with history of primary breast cancer may be eligible provided they completed their definitive anticancer treatment more than 3 years ago and they remain breast cancer disease free prior to start of study treatment.
  • I-6. Previous pelvic and outside pelvis radiation is allowed if completed more than 6 weeks ago.
  • I-7. Signed informed consent and ability to comply with treatment and follow-up.
  • I-8. Representative FFPE tumor sample or, only if unfeasible, at least 20 unstained slides from initial surgery or from diagnostic biopsy, in case surgery was not performed, available and sent to central laboratory for Micro Satellite (MS) determination prior to randomization.
Show all 13Show fewer
  • I-9. Patients must have normal organ and bone marrow function :
  • Haemoglobin ≥ 10.0 g/dL.
  • Absolute neutrophil count (ANC) ≥ 1.5 x 109/L.
  • Platelet count ≥ 100 x 109/L.
  • Total bilirubin ≤ 1.5 x institutional upper limit of normal (ULN).
  • Aspartate aminotransferase /Serum Glutamic Oxaloacetic Transaminase (ASAT/SGOT)) and Alanine aminotransferase /Serum Glutamic Pyruvate Transaminase (ALAT/SGPT)) ≤ 2.5 x ULN, unless liver metastases are present in which case they must be ≤ 5 x ULN.
  • Serum creatinine ≤ 1.5 x institutional ULN

Who cannot join

  • E-1. Other malignancy within the last 5 years except: adequately treated non-melanoma skin cancer, curatively treated in situ cancer of the cervix, ductal carcinoma in situ (DCIS) of the breast. Patients with a history of localized malignancy diagnosed over 5 years ago may be eligible provided they completed their adjuvant systemic therapy prior to randomization and that the patient remains free of recurrent or metastatic disease.
  • E-2. Patients with uterine leiomyosarcoma . E-3. Major surgery within 4 weeks of starting study treatment or patients who have not completely recovered from the effects of any major surgery.
  • E-4. Previous allogeneic bone marrow transplant or previous solid organ transplantation.
  • E-5. Administration of other simultaneous chemotherapy drugs, any other anticancer therapy or anti-neoplastic hormonal therapy, or simultaneous radiotherapy during the trial treatment period (hormonal replacement therapy is permitted).
  • E-6. Prior treatment with CD137 agonists or immune checkpoint blockade therapies, anti-PD1, or anti-PDL1 therapeutic antibodies or anti-CTLA4 .
  • E-7. Treatment with systemic immunostimulatory agents (including but not limited to interferon-alpha (IFN-α) and interleukin-2 (IL-2) within 4 weeks or five half-lives of the drug (whichever is shorter) prior to Cycle 1, Day 1.
Show all 25Show fewer
  • E-8. Treatment with systemic corticosteroids or other systemic immunosuppressive medications (including but not limited to prednisone, dexamethasone, cyclophosphamide, azathioprine, methotrexate, thalidomide, and anti-tumor necrosis factor [TNF] agents) within 2 weeks prior to Cycle 1, Day 1, or anticipated requirement for systemic immunosuppressive medications during the trial. However, please note that the use of inhaled corticosteroids for chronic obstructive pulmonary disease or for asthma is allowed, as well as the use of mineralocorticoids (e.g., fludrocortisones) and low-dose supplemental corticosteroids for adrenocortical insufficiency and for patients with orthostatic hypotension. The use of corticosteroids as premedication for paclitaxel-based regimen is allowed).
  • E-9. History of autoimmune disease, including but not limited to myasthenia gravis, myositis,autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, vascular thrombosis associated with anti-phospholipid syndrome, Wegener's granulomatosis, Sjögren's syndrome, Guillain-Barré syndrome, multiple sclerosis, vasculitis, or glomerulonephritis [please note: patients with a history of autoimmune hypothyroidism on a stable dose of thyroid replacement hormone are eligible; patients with controlled Type 1 diabetes mellitus on a stable insulin regimen are eligible; history of idiopathic pulmonary fibrosis (including pneumonitis), drug-induced pneumonitis, organizing pneumonia (i.e., bronchiolitis obliterans, cryptogenic organizing pneumonia) is permitted].
  • E-10. Immunocompromised patients, e.g., patients who are known to be serologically positive for human immunodeficiency virus (HIV).
  • E-11. Patients with active hepatitis B (defined as having a positive hepatitis B surface antigen [HBsAg] test at screening) or hepatitis C .
  • Patients with past hepatitis B virus (HBV) infection or resolved HBV infection (defined as having a negative HBsAg test and a positive total hepatitis B core antibody [HBcAb]) are eligible only if hepatitis B virus (HBV) DNA is negative. The HBV DNA test will be performed only for patients who have a positive total HBcAb test.
  • Patients positive for hepatitis C virus (HCV) antibody are eligible only if polymerase chain reaction (PCR) is negative for HCV RNA. The HCV RNA test will be performed only for patients who have a positive HCV antibody test.
  • E-12. Active tuberculosis (all patients will have tuberculin [PPD] skin test or Interferon-Gamma Releasing Assay [IGRA] done locally prior to inclusion to study) E-13. Signs or symptoms of infection within 2 weeks prior to Cycle 1, Day 1 E-14. Administration of a live, attenuated vaccine within 4 weeks prior to Cycle 1, Day 1 or anticipation that such a live attenuated vaccine will be required during the study. Influenza vaccination should be given during influenza season only (example approximately October to March in the Northern Hemisphere). Patients must not receive live, attenuated influenza vaccine.
  • E-15. Clinically significant (e.g. active) cardiovascular disease, including:
  • Myocardial infarction or unstable angina within ≤ 6 months of randomization,
  • New York Heart Association (NYHA) ≥ grade 2 congestive heart failure (CHF),
  • Poorly controlled cardiac arrhythmia despite medication (patients with rate controlled atrial fibrillation are eligible),
  • Peripheral vascular disease grade ≥ 3 (e.g. symptomatic and interfering with activities of daily living [ADL] requiring repair or revision) E-16. Resting ECG with QTc > 470 msec on 2 or more time points within a 24 hour period or family history of long QT syndrome.
  • E-17. History or clinical suspicion of brain metastases or spinal cord compression. CT/MRI of the brain is mandatory (within 4 weeks prior to randomization) in case of suspected brain metastases. Spinal MRI is mandatory (within 4 weeks prior to randomization) in any case of suspected central nervous system (CNS) involvement .
  • E-18. History or evidence upon neurological examination of central nervous system (CNS) disease, unless asymptomatic and adequately treated with standard medical therapy.
  • E-19. Evidence of any other disease, metabolic dysfunction, physical examination finding or laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug or puts the patient at high risk for treatment related complications.
  • E-20. Women of childbearing potential (<2 years after last menstruation) not willing to use highly-effective means of contraception.
  • E-21. Pregnant or lactating women. E-22. History of severe allergic, anaphylactic, or other hypersensitivity reactions to chimeric or humanized antibodies or fusion proteins.
  • E-23. Known hypersensitivity or allergy to biopharmaceuticals produced in Chinese hamster ovary cells or to any component of the atezolizumab formulation.
  • E-24. Known hypersensitivity reaction or allergy to drugs chemically related to carboplatin, paclitaxel, or their excipients that contraindicates the subject's participation

Trial locations and contacts

93 sites in 11 countries.

93 sites in 11 countries

Italy22 sites

  • AO SS Antonio e Biagio e Cesare Arrigo

    Alessandria

  • Policlinico S. Orsola Malpighi

    Bologna

  • Azienda Sanitaria dell'Alto Adige

    Bolzano

  • ASST degli Spedali Civili di Brescia

    Brescia

  • Fondazione Poliambulanza

    Brescia

  • AOU Cagliari, Policlinico Universitario

    Cagliari

  • AOU Careggi

    Florence

  • ASST di Lecco

    Lecco

  • Ospedale San Luca

    Lucca

  • Istituto Europeo di Oncologia

    Milan

  • Ospedale San Gerardo

    Monza

  • Istituto Oncologico Veneto (IOV)

    Padova

  • AOU di Parma

    Parma

  • AOU Pisana

    Pisa

  • AO Arcispedale Santa Maria Nuova

    Reggio Emilia

  • Ausl Romagna

    Rimini

  • Policlinico Umberto I, Università di Roma "La Sapienza"

    Roma

  • Ospedale di Sondrio ASST Valtellina e Alto Lario

    Sondrio

  • Ospedale SS Trinità

    Sora

  • AO Ordine Mauriziano

    Torino

  • AOU Città della Salute e della Scienza di Torino - Ospedale Sant'Anna

    Torino

  • P.O Sant'Andrea Vercelli

    Vercelli

Other trials in Italy

Australia14 sites

  • Royal Adelaide hospital

    Adelaide

  • Border Medical Oncology Research Unit

    Albury

  • Icon Cancer Centre

    Auchenflower

  • Pindara Private Hospital

    Benowa

  • Box Hill Hospital

    Box Hill

  • Frankston Hospital

    Frankston

  • Gosford Hospital

    Gosford

  • Royal Brisbane and Women's Hospital

    Herston

  • Royal Hobart Hospital

    Hobart

  • Liverpool Hospital

    Liverpool

  • Northern Cancer Institute

    Saint Leonards

  • Darling Downs Hospital and Health Service - Toowoomba Hospital

    Toowoomba

  • Calvary Mater Newcastle

    Waratah

  • Wollongong Hospital

    Wollongong

Other trials in Australia

Japan10 sites

  • Hirosaki University Hospital

    Aomori

  • National Cancer Center Hospital East

    Chiba

  • Shikoku Cancer Center

    Ehime

  • Kurume University Hospital

    Fukuoka

  • Hokkaido University Hospital

    Hokkaido

  • Tohoku University Hospital

    Miyagi

  • Niigata University Medical＆Dental Hospital

    Niigata

  • Osaka University Hospital

    Osaka

  • Shizuoka Cancer Center

    Shizuoka

  • Keio University Hospital

    Tokyo

Other trials in Japan

South Korea10 sites

  • Keimyung University Dongsan Medical Center

    Daegu

  • Ilsan Cha Medical Center

    Gyeonggi-do

  • Seoul National University Bundang Hospital

    Gyeonggi-do

  • Gachon University Gil Medical Center

    Incheon

  • Asan Medical Center

    Seoul

  • Gangnam Severance Hospital

    Seoul

  • Konkuk University Medical Center

    Seoul

  • Samsung Medical Center

    Seoul

  • Seoul St. Mary's Hospital

    Seoul

  • Severance Hospital

    Seoul

Other trials in South Korea

Spain10 sites

  • Hospital De Sant Pau I La Santa Creu

    Barcelona

  • Hospital Universitario Vall d´Hebron Institute of Oncology (VHIO)

    Barcelona

  • Institut Català d'Oncologia (ICO) Girona

    Girona

  • Institut Català d'Oncologia (ICO), L'Hospitalet- Hospital Duran I Reynals

    L'Hospitalet de Llobregat

  • Hospital 12 de Octubre

    Madrid

  • Hospital Universitario La Paz

    Madrid

  • MD Anderson Cancer Center

    Madrid

  • Hospital Universitario Central de Asturias

    Oviedo

  • Hospital Clínico Universitario Santiago de Compostela

    Santiago de Compostela

  • Hospital Universitario Miguel Servet Zaragoza

    Zaragoza

Other trials in Spain

United Kingdom10 sites

  • Royal Derby Hospital

    Derby

  • Royal Devon & Exeter Hospital

    Exeter

  • Beatson West of Scotland Cancer Centre, Gartnavel General Hospital

    Glasgow

  • Velindre Cancer Centre

    Glasgow

  • Imperial College Healthcare NHS Trust

    London

  • Royal Marsden Hospital

    London

  • St Bartholomew's Hospital

    London

  • The Christie NHS Foundation Trust

    Manchester

  • NUHT - Nottingham University Hospital NHS Trust

    Nottingham

  • Derriford Hospital

    Plymouth

Other trials in United Kingdom

Switzerland8 sites

  • Kantonsspital

    Baden

  • Universitätsspital

    Basel

  • IOSI

    Bellinzona

  • Inselspital

    Bern

  • Kantonsspital

    Lucerne

  • Frauenfeld

    Münsterlingen

  • Kantonsspital

    Winterthur

  • Universitätsspital

    Zurich

Other trials in Switzerland

Germany4 sites

  • Charité Universitätsmedizin Berlin

    Berlin

  • Kliniken Essen Mitte

    Essen

  • UniversitätsKlinikum Heidelberg

    Mannheim

  • Klinikum der Ludwig-Maximilians-Universität München (LMU)

    München

Other trials in Germany

Austria2 sites

  • Medizinische Universitaet Graz - Universitätsklinik für Frauenheilkunde und Geburtshilfe

    Graz

  • Medical University of Innsbruck

    Innsbruck

Other trials in Austria

Taiwan2 sites

  • Chang Gung Memorial Hospital-Kaohsiung

    Kaohsiung City

  • Chang Gung Memorial Hospital-Linkou

    Taoyuan City

Other trials in Taiwan

New Zealand1 site

  • Auckland city Hospital

    Auckland

Other trials in New Zealand

About this study

Official title: Phase III Double-blind Randomized Placebo Controlled Trial of Atezolizumab in Combination With Paclitaxel and Carboplatin in Women With Advanced/Recurrent Endometrial Cancer

Atezolizumab is an engineered humanised monoclonal immunoglobulin G1 antibody that binds selectively to PD-L1 and prevents its interaction with PD-1 and B7-1.

In May 2016 atezolizumab was approved by the FDA for patients with locally advanced or metastatic urothelial carcinoma who have disease progression during or following any platinum-containing chemotherapy, or within 12 months of receiving chemotherapy before surgery (neoadjuvant) or after surgery (adjuvant); in October 2016 it was approved by the FDA for patients with metastatic non-small cell lung cancer (NSCLC) who have disease progression during or following platinum-containing chemotherapy, and have progressed on an appropriate FDA-approved targeted therapy if their tumor has EGFR or ALK gene abnormalities. Finally, in April 2017 atezolizumab was granted accelerated approval by FDA for the first-line treatment of patients with locally advanced or metastatic urothelial carcinoma who are not eligible for cisplatin chemotherapy. Combinations of atezolizumab with chemotherapeutic agents and/or targeted therapies were studied in different solid tumors such as melanoma, NSCLC, renal cell carcinoma and colorectal carcinoma. From these studies the AE profile of atezolizumab combinations were consistent with that of the individual agents.

Finally, preliminary results of a Phase Ia study of Atezolizumab (NCT01375842) monotherapy in relapsed endometrial cancer were reported as abstract at ASCO 2017. Fifteen patients were evaluated for safety and efficacy with a minimum follow-up of 11.2 months. No G4-5 related AEs occurred. Regarding efficacy ORR was 13% [2/15] by RECIST. Atezolizumab seemed to have a favorable safety profile, with durable clinical benefit in some patients. Further studies with atezolizumab are warranted given its promising results in advanced endometrial cancer and the limited efficacy of current treatment options.

Being tested
Atezolizumab, Placebos, Paclitaxel, Carboplatin
Keywords
endometrial cancer, neoplasm, immunotherapy
Medical subject headings
Endometrial Neoplasms, Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • AtezolizumabDrug

    Also called Tecentriq

    Atezolizumab will be administered as I.V. infusion at a fixed dose of 1200 mg, every 21 days until objective radiological disease progression as assessed by the investigator if they do not meet any other discontinuation criteria (patient refusal, toxicity).

  • PlacebosDrug

    Placebo will be administered as I.V. infusion every 21 days until objective radiological disease progression as assessed by the investigator if they do not meet any other discontinuation criteria (patient refusal, toxicity).

  • PaclitaxelDrug

    Paclitaxel 175 mg/m2 will be administered every 21 days for 6-8 cycles or until progression of disease.

  • CarboplatinDrug

    Carboplatin AUC 5 or AUC 6 will be administered every 21 days for 6-8 cycles or until progression of disease.

Study groups in NCT03603184
Study groupRoleWhat they receive
Experimental armExperimentalpaclitaxel 175 mg/m2 + carboplatin AUC 5 or 6 will be administered every 21 days for 6-8 cycles or PD. Atezolizumab will be administered as I.V. infusion at a fixed dose of 1200 mg, every 21 days until objective radiological disease progression as assessed by the investigator if they do not meet any other discontinuation criteria (patient refusal, toxicity). Patients who are clinically stable at initial RECIST v 1.1 - defined progression - should continue on treatment until the next imaging assessment that should be ≥4 weeks and no longer than 8 weeks later.
Receives: Drug: Atezolizumab; Drug: Paclitaxel; Drug: Carboplatin
Control armPlacebo comparatorpaclitaxel 175 mg/m2 + carboplatin AUC 5 or AUC 6 will be administered every 21 days for 6-8 cycles or PD. Placebo will be administered as I.V. infusion every 21 days until objective radiological disease progression as assessed by the investigator if they do not meet any other discontinuation criteria (patient refusal, toxicity). Patients who are clinically stable at initial RECIST v 1.1 - defined progression - should continue on treatment until the next imaging assessment that should be ≥4 weeks and no longer than 8 weeks later.
Receives: Drug: Placebos; Drug: Paclitaxel; Drug: Carboplatin

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. PFS in the MSI

    PFS is defined as the time from randomization to the date of first progression or death

    Measured: Up to 18 months after the last patient enrolled

  2. PFS

    PFS is defined as the time from randomization to the date of first progression or death from any cause, whichever comes first.

    Progression will be established as the radiological disease progression according to RECIST 1.1 or death from any cause, whichever occurs first.

    Measured: Up to 18 months after the last patient enrolled

  3. OS

    OS is defined as the time from randomization until the date of death from any cause.

    Measured: Up to two years after the last patient enrolled

Secondary outcomes (14)

  1. Objective response rate

    Objective Response Rate (ORR), defined as the percentage of patients with an objective response as determined by RECIST 1.1

    Measured: Up to three years after the last patient enrolled

  2. Duration of response

    Duration of response, defined as the time from the date of first documentation of response (complete response (CR) or partial response (PR), whichever occurs first) to the date of documented PD or death

    Measured: Up to two years after the last patient enrolled

  3. Safety: Maximum toxicity grade

    Maximum toxicity grade experienced by each patient, for each toxicity, according to NCI-CTCAE v. 4.03

    Measured: Up to 30 days after the end of treatment

  4. Safety: Number of patients experiencing grade 3-4 toxicity for each toxicity

    Number of patients experiencing grade 3-4 toxicity for each toxicity according to NCI-CTCAE v. 4.03

    Measured: Up to 30 days after the end of treatment

  5. Safety: Type, frequency and nature of SAEs

    Type, frequency and nature of SAEs, according to NCI-CTCAE v. 4.03

    Measured: Up to 30 days after the end of treatment

  6. Safety: Number of patients with at least a SAE

    Number of patients with at least a SAE according to NCI-CTCAE v. 4.03

    Measured: Up to 30 days after the end of treatment

  7. Safety: Number of patients with at least a SADR

    Number of patients with at least a SADR, according to NCI-CTCAE v. 4.03

    Measured: Up to two years after the last patient enrolled

  8. Safety: Number of patients with at least a SUSAR

    Number of patients with at least a SUSAR, according to NCI-CTCAE v. 4.03

    Measured: Up to two years after the last patient enrolled

  9. Quality of life: EORTC QLQ-C30 questionnaire

    Mean changes from the baseline scores in quality of life by cycle and between treatment arms.

    Measured: Up to two years after the last patient enrolled

  10. Quality of life: QLQ-EN24 questionnaire

    Mean changes from the baseline score in quality of life by cycle and between treatment arms.

    Measured: Up to two years after the last patient enrolled

  11. Quality of life: GP5 item

    Proportion of patients reporting each response option at each assessment timepoint by treatment arm for item GP5 from the FACT G instrument.

    Measured: Up to two years after the last patient enrolled

  12. Compliance: Number of administered cycles

    Number of administered cycles

    Measured: Up to two year after the last patient enrolled

  13. Compliance: Reasons for discontinuation and treatment modification

    Number of patients for each reasons

    Measured: Up to two year after the last patient enrolled

  14. Compliance: Dose intensity

    Entire dose administered during treatment

    Measured: Up to two year after the last patient enrolled

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Jul 2018
  2. Study start2 Oct 2018
  3. Primary completion20 Jan 2025
  4. Study completion20 Jan 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
549 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03603184
Sponsor's protocol ID
IRFMN-EN-7556
Acronym
AtTEnd
Status last verified
May 2025
First submitted
21 May 2018
Last updated
9 May 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Harano K, Fossati R, Pardo B, Galli F, Hudson E, Antill Y, Lee C, Rabaglio M, Heitz F, Kolovetsiou-Kreiner V, Lai CH, Biagioli E, Manso L, Nishio S, Allan K, Lee YC, Uggeri S, Redondo A, Nakagawa S, Au E, Lombard J, Gadducci A, Takehara K, Baldini EE, Palaia I, Casanova C, Ardizzoia A, Bologna A, Barretina-Ginesta MP, Colombo N. Phase III double-blind randomized placebo controlled trial of atezolizumab in combination with carboplatin and paclitaxel in women with advanced/recurrent endometrial carcinoma: the Asian cohort of the AtTEnd/ENGOT-EN7 trial. J Gynecol Oncol. 2025 Jul;36(4):e117. doi: 10.3802/jgo.2025.36.e117.

    PubMed 40590326

  • Colombo N, Biagioli E, Harano K, Galli F, Hudson E, Antill Y, Choi CH, Rabaglio M, Marme F, Marth C, Parma G, Farinas-Madrid L, Nishio S, Allan K, Lee YC, Piovano E, Pardo B, Nakagawa S, McQueen J, Zamagni C, Manso L, Takehara K, Tasca G, Ferrero A, Tognon G, Lissoni AA, Petrella M, Laudani ME, Rulli E, Uggeri S, Barretina Ginesta MP; AtTEnd study group. Atezolizumab and chemotherapy for advanced or recurrent endometrial cancer (AtTEnd): a randomised, double-blind, placebo-controlled, phase 3 trial. Lancet Oncol. 2024 Sep;25(9):1135-1146. doi: 10.1016/S1470-2045(24)00334-6. Epub 2024 Aug 2.

    PubMed 39102832

  • Bogani G, Monk BJ, Powell MA, Westin SN, Slomovitz B, Moore KN, Eskander RN, Raspagliesi F, Barretina-Ginesta MP, Colombo N, Mirza MR. Adding immunotherapy to first-line treatment of advanced and metastatic endometrial cancer. Ann Oncol. 2024 May;35(5):414-428. doi: 10.1016/j.annonc.2024.02.006. Epub 2024 Feb 29.

    PubMed 38431043

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Atezolizumab, Paclitaxel and Carboplatin in people with Endometrial Cancer, run by Mario Negri Institute for Pharmacological Research at 93 sites in 11 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 13 inclusion and 25 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 9 May 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 93 sites in Italy, Australia, Japan, South Korea, Spain and 6 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

PFS in the MSI (time frame: Up to 18 months after the last patient enrolled). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03603184, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 May 2025.

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