Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
549 participants
INTERVENTIONAL
2018-10-02
2025-01-20
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Experimental arm
paclitaxel 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.
Atezolizumab
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).
Paclitaxel
Paclitaxel 175 mg/m2 will be administered every 21 days for 6-8 cycles or until progression of disease.
Carboplatin
Carboplatin AUC 5 or AUC 6 will be administered every 21 days for 6-8 cycles or until progression of disease.
Control arm
paclitaxel 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.
Placebos
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).
Paclitaxel
Paclitaxel 175 mg/m2 will be administered every 21 days for 6-8 cycles or until progression of disease.
Carboplatin
Carboplatin AUC 5 or AUC 6 will be administered every 21 days for 6-8 cycles or until progression of disease.
Interventions
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Atezolizumab
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).
Placebos
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).
Paclitaxel
Paclitaxel 175 mg/m2 will be administered every 21 days for 6-8 cycles or until progression of disease.
Carboplatin
Carboplatin AUC 5 or AUC 6 will be administered every 21 days for 6-8 cycles or until progression of disease.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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.
I-9. Patients must have normal organ and bone marrow function :
1. Haemoglobin ≥ 10.0 g/dL.
2. Absolute neutrophil count (ANC) ≥ 1.5 x 109/L.
3. Platelet count ≥ 100 x 109/L.
4. Total bilirubin ≤ 1.5 x institutional upper limit of normal (ULN).
5. 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.
6. Serum creatinine ≤ 1.5 x institutional ULN
Exclusion Criteria
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.
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 .
1. 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.
2. 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:
1. Myocardial infarction or unstable angina within ≤ 6 months of randomization,
2. New York Heart Association (NYHA) ≥ grade 2 congestive heart failure (CHF),
3. Poorly controlled cardiac arrhythmia despite medication (patients with rate controlled atrial fibrillation are eligible),
4. 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
18 Years
FEMALE
No
Sponsors
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Hoffmann-La Roche
INDUSTRY
Mario Negri Institute for Pharmacological Research
OTHER
Responsible Party
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Principal Investigators
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Nicoletta Colombo, MD
Role: PRINCIPAL_INVESTIGATOR
Istituto Europeo di Oncologia (IEO) - Milan
Locations
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Royal Adelaide hospital
Adelaide, , Australia
Border Medical Oncology Research Unit
Albury, , Australia
Icon Cancer Centre
Auchenflower, , Australia
Pindara Private Hospital
Benowa, , Australia
Box Hill Hospital
Box Hill, , Australia
Frankston Hospital
Frankston, , Australia
Gosford Hospital
Gosford, , Australia
Royal Brisbane and Women's Hospital
Herston, , Australia
Royal Hobart Hospital
Hobart, , Australia
Liverpool Hospital
Liverpool, , Australia
Northern Cancer Institute
Saint Leonards, , Australia
Darling Downs Hospital and Health Service - Toowoomba Hospital
Toowoomba, , Australia
Calvary Mater Newcastle
Waratah, , Australia
Wollongong Hospital
Wollongong, , Australia
Medizinische Universitaet Graz - Universitätsklinik für Frauenheilkunde und Geburtshilfe
Graz, , Austria
Medical University of Innsbruck
Innsbruck, , Austria
Charité Universitätsmedizin Berlin
Berlin, , Germany
Kliniken Essen Mitte
Essen, , Germany
UniversitätsKlinikum Heidelberg
Mannheim, , Germany
Klinikum der Ludwig-Maximilians-Universität München (LMU)
München, , Germany
AO SS Antonio e Biagio e Cesare Arrigo
Alessandria, , Italy
Policlinico S. Orsola Malpighi
Bologna, , Italy
Azienda Sanitaria dell'Alto Adige
Bolzano, , Italy
ASST degli Spedali Civili di Brescia
Brescia, , Italy
Fondazione Poliambulanza
Brescia, , Italy
AOU Cagliari, Policlinico Universitario
Cagliari, , Italy
AOU Careggi
Florence, , Italy
ASST di Lecco
Lecco, , Italy
Ospedale San Luca
Lucca, , Italy
Istituto Europeo di Oncologia
Milan, , Italy
Ospedale San Gerardo
Monza, , Italy
Istituto Oncologico Veneto (IOV)
Padua, , Italy
AOU di Parma
Parma, , Italy
AOU Pisana
Pisa, , Italy
AO Arcispedale Santa Maria Nuova
Reggio Emilia, , Italy
Ausl Romagna
Rimini, , Italy
Policlinico Umberto I, Università di Roma "La Sapienza"
Roma, , Italy
Ospedale di Sondrio ASST Valtellina e Alto Lario
Sondrio, , Italy
Ospedale SS Trinità
Sora, , Italy
AO Ordine Mauriziano
Torino, , Italy
AOU Città della Salute e della Scienza di Torino - Ospedale Sant'Anna
Torino, , Italy
P.O Sant'Andrea Vercelli
Vercelli, , Italy
Hirosaki University Hospital
Aomori, , Japan
National Cancer Center Hospital East
Chiba, , Japan
Shikoku Cancer Center
Ehime, , Japan
Kurume University Hospital
Fukuoka, , Japan
Hokkaido University Hospital
Hokkaido, , Japan
Tohoku University Hospital
Miyagi, , Japan
Niigata University Medical＆Dental Hospital
Niigata, , Japan
Osaka University Hospital
Osaka, , Japan
Shizuoka Cancer Center
Shizuoka, , Japan
Keio University Hospital
Tokyo, , Japan
Auckland city Hospital
Auckland, , New Zealand
Keimyung University Dongsan Medical Center
Daegu, , South Korea
Ilsan Cha Medical Center
Gyeonggi-do, , South Korea
Seoul National University Bundang Hospital
Gyeonggi-do, , South Korea
Gachon University Gil Medical Center
Incheon, , South Korea
Asan Medical Center
Seoul, , South Korea
Gangnam Severance Hospital
Seoul, , South Korea
Konkuk University Medical Center
Seoul, , South Korea
Samsung Medical Center
Seoul, , South Korea
Seoul St. Mary's Hospital
Seoul, , South Korea
Severance Hospital
Seoul, , South Korea
Hospital De Sant Pau I La Santa Creu
Barcelona, , Spain
Hospital Universitario Vall d´Hebron Institute of Oncology (VHIO)
Barcelona, , Spain
Institut Català d'Oncologia (ICO) Girona
Girona, , Spain
Institut Català d'Oncologia (ICO), L'Hospitalet- Hospital Duran I Reynals
L'Hospitalet de Llobregat, , Spain
Hospital 12 de Octubre
Madrid, , Spain
Hospital Universitario La Paz
Madrid, , Spain
MD Anderson Cancer Center
Madrid, , Spain
Hospital Universitario Central de Asturias
Oviedo, , Spain
Hospital Clínico Universitario Santiago de Compostela
Santiago de Compostela, , Spain
Hospital Universitario Miguel Servet Zaragoza
Zaragoza, , Spain
Kantonsspital
Baden, , Switzerland
Universitätsspital
Basel, , Switzerland
IOSI
Bellinzona, , Switzerland
Inselspital
Bern, , Switzerland
Kantonsspital
Lucerne, , Switzerland
Frauenfeld
Münsterlingen, , Switzerland
Kantonsspital
Winterthur, , Switzerland
Universitätsspital
Zurich, , Switzerland
Chang Gung Memorial Hospital-Kaohsiung
Kaohsiung City, , Taiwan
Chang Gung Memorial Hospital-Linkou
Taoyuan, , Taiwan
Royal Derby Hospital
Derby, , United Kingdom
Royal Devon & Exeter Hospital
Exeter, , United Kingdom
Beatson West of Scotland Cancer Centre, Gartnavel General Hospital
Glasgow, , United Kingdom
Velindre Cancer Centre
Glasgow, , United Kingdom
Imperial College Healthcare NHS Trust
London, , United Kingdom
Royal Marsden Hospital
London, , United Kingdom
St Bartholomew's Hospital
London, , United Kingdom
The Christie NHS Foundation Trust
Manchester, , United Kingdom
NUHT - Nottingham University Hospital NHS Trust
Nottingham, , United Kingdom
Derriford Hospital
Plymouth, , United Kingdom
Countries
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References
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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.
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.
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.
Other Identifiers
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IRFMN-EN-7556
Identifier Type: -
Identifier Source: org_study_id
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