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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT03603184




Registration number
NCT03603184
Ethics application status
Date submitted
21/05/2018
Date registered
27/07/2018
Date last updated
16/09/2021

Titles & IDs
Public title
Atezolizumab Trial in Endometrial Cancer - AtTEnd
Scientific title
Phase III Double-blind Randomized Placebo Controlled Trial of Atezolizumab in Combination With Paclitaxel and Carboplatin in Women With Advanced/Recurrent Endometrial Cancer
Secondary ID [1] 0 0
IRFMN-EN-7556
Universal Trial Number (UTN)
Trial acronym
AtTEnd
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Endometrial Cancer 0 0
Condition category
Condition code
Cancer 0 0 0 0
Womb (Uterine or endometrial cancer)

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Atezolizumab
Treatment: Drugs - Placebos
Treatment: Drugs - Paclitaxel
Treatment: Drugs - Carboplatin

Experimental: 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.

Placebo Comparator: 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.


Treatment: Drugs: 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).

Treatment: Drugs: 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).

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

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

Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
OS - OS is defined as the time from randomization until the date of death from any cause.
Timepoint [1] 0 0
Up to two years after the last patient enrolled
Primary outcome [2] 0 0
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.
Timepoint [2] 0 0
Up to two years after the last patient enrolled
Secondary outcome [1] 0 0
Objective response rate - Objective Response Rate (ORR), defined as the percentage of patients with an objective response as determined by RECIST 1.1
Timepoint [1] 0 0
Up to two years after the last patient enrolled
Secondary outcome [2] 0 0
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
Timepoint [2] 0 0
Up to two years after the last patient enrolled
Secondary outcome [3] 0 0
Safety: Maximum toxicity grade - Maximum toxicity grade experienced by each patient, for each toxicity, according to NCI-CTCAE v. 4.03
Timepoint [3] 0 0
Up to 30 days after the end of treatment
Secondary outcome [4] 0 0
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
Timepoint [4] 0 0
Up to 30 days after the end of treatment
Secondary outcome [5] 0 0
Safety: Type, frequency and nature of SAEs - Type, frequency and nature of SAEs, according to NCI-CTCAE v. 4.03
Timepoint [5] 0 0
Up to 30 days after the end of treatment
Secondary outcome [6] 0 0
Safety: Number of patients with at least a SAE - Number of patients with at least a SAE according to NCI-CTCAE v. 4.03
Timepoint [6] 0 0
Up to 30 days after the end of treatment
Secondary outcome [7] 0 0
Safety: Number of patients with at least a SADR - Number of patients with at least a SADR, according to NCI-CTCAE v. 4.03
Timepoint [7] 0 0
Up to two years after the last patient enrolled
Secondary outcome [8] 0 0
Safety: Number of patients with at least a SUSAR - Number of patients with at least a SUSAR, according to NCI-CTCAE v. 4.03
Timepoint [8] 0 0
Up to two years after the last patient enrolled
Secondary outcome [9] 0 0
Quality of life: EORTC QLQ-C30 questionnaire - Mean changes from the baseline scores in quality of life by cycle and between treatment arms.
Timepoint [9] 0 0
Up to two years after the last patient enrolled
Secondary outcome [10] 0 0
Quality of life: QLQ-EN24 questionnaire - Mean changes from the baseline score in quality of life by cycle and between treatment arms.
Timepoint [10] 0 0
Up to two years after the last patient enrolled
Secondary outcome [11] 0 0
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.
Timepoint [11] 0 0
Up to two years after the last patient enrolled
Secondary outcome [12] 0 0
Compliance: Number of administered cycles - Number of administered cycles
Timepoint [12] 0 0
Up to two year after the last patient enrolled
Secondary outcome [13] 0 0
Compliance: Reasons for discontinuation and treatment modification - Number of patients for each reasons
Timepoint [13] 0 0
Up to two year after the last patient enrolled
Secondary outcome [14] 0 0
Compliance: Dose intensity - Entire dose administered during treatment
Timepoint [14] 0 0
Up to two year after the last patient enrolled

Eligibility
Key inclusion criteria
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.

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
Minimum age
18 Years
Maximum age
No limit
Gender
Females
Can healthy volunteers participate?
No
Key exclusion criteria
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-a) 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Royal Adelaide hospital - Adelaide
Recruitment hospital [2] 0 0
Border Medical Oncology Research Unit - Albury
Recruitment hospital [3] 0 0
Pindara Private Hospital - Benowa
Recruitment hospital [4] 0 0
Box Hill Hospital - Box Hill
Recruitment hospital [5] 0 0
Frankston Hospital - Frankston
Recruitment hospital [6] 0 0
Gosford Hospital - Gosford
Recruitment hospital [7] 0 0
Royal Brisbane and Women's Hospital - Herston
Recruitment hospital [8] 0 0
Royal Hobart Hospital - Hobart
Recruitment hospital [9] 0 0
Liverpool Hospital - Liverpool
Recruitment hospital [10] 0 0
Icon Cancer Centre - Queensland
Recruitment hospital [11] 0 0
Northern Cancer Institute - Saint Leonards
Recruitment hospital [12] 0 0
Darling Downs Hospital and Health Service - Toowoomba Hospital - Toowoomba
Recruitment hospital [13] 0 0
Calvary Mater Newcastle - Waratah
Recruitment hospital [14] 0 0
Wollongong Hospital - Wollongong
Recruitment postcode(s) [1] 0 0
- Adelaide
Recruitment postcode(s) [2] 0 0
- Albury
Recruitment postcode(s) [3] 0 0
- Benowa
Recruitment postcode(s) [4] 0 0
- Box Hill
Recruitment postcode(s) [5] 0 0
- Frankston
Recruitment postcode(s) [6] 0 0
- Gosford
Recruitment postcode(s) [7] 0 0
- Herston
Recruitment postcode(s) [8] 0 0
- Hobart
Recruitment postcode(s) [9] 0 0
- Liverpool
Recruitment postcode(s) [10] 0 0
- Queensland
Recruitment postcode(s) [11] 0 0
- Saint Leonards
Recruitment postcode(s) [12] 0 0
- Toowoomba
Recruitment postcode(s) [13] 0 0
- Waratah
Recruitment postcode(s) [14] 0 0
- Wollongong
Recruitment outside Australia
Country [1] 0 0
Austria
State/province [1] 0 0
Graz
Country [2] 0 0
Austria
State/province [2] 0 0
Innsbruck
Country [3] 0 0
Germany
State/province [3] 0 0
Berlin
Country [4] 0 0
Germany
State/province [4] 0 0
Essen
Country [5] 0 0
Germany
State/province [5] 0 0
Mannheim
Country [6] 0 0
Germany
State/province [6] 0 0
Muenchen
Country [7] 0 0
Italy
State/province [7] 0 0
Alessandria
Country [8] 0 0
Italy
State/province [8] 0 0
Bologna
Country [9] 0 0
Italy
State/province [9] 0 0
Bolzano
Country [10] 0 0
Italy
State/province [10] 0 0
Brescia
Country [11] 0 0
Italy
State/province [11] 0 0
Cagliari
Country [12] 0 0
Italy
State/province [12] 0 0
Como
Country [13] 0 0
Italy
State/province [13] 0 0
Firenze
Country [14] 0 0
Italy
State/province [14] 0 0
Genova
Country [15] 0 0
Italy
State/province [15] 0 0
Lecco
Country [16] 0 0
Italy
State/province [16] 0 0
Lucca
Country [17] 0 0
Italy
State/province [17] 0 0
Milan
Country [18] 0 0
Italy
State/province [18] 0 0
Monza
Country [19] 0 0
Italy
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Padova
Country [20] 0 0
Italy
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Parma
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Italy
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Pisa
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Italy
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Reggio Emilia
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Italy
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Rimini
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Italy
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Roma
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Italy
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Sondrio
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Italy
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Sora
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Italy
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Torino
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Italy
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Vercelli
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Japan
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Aomori
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Japan
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Chiba
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Japan
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Ehime
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Japan
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Fukuoka
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Japan
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Hokkaido
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Japan
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Miyagi
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Japan
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Niigata
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Japan
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Osaka
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Japan
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Shizuoka
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Japan
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Tokyo
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Korea, Republic of
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Daegu
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Korea, Republic of
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Gyeonggi-do
Country [41] 0 0
Korea, Republic of
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Namdong-gu Incheon
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Korea, Republic of
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Seoul
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New Zealand
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Auckland
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Spain
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Barcelona
Country [45] 0 0
Spain
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Girona
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Spain
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Hospitalet de Llobregat
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Spain
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Madrid
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Spain
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Oviedo
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Spain
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Santiago De Compostela
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Spain
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Zaragoza
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Switzerland
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Baden
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Switzerland
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Basel
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Switzerland
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Bern
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Switzerland
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Luzern
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Switzerland
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Thurgau
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Switzerland
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Ticino
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Switzerland
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Winterthur
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Switzerland
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Zürich
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Taiwan
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Kaohsiung City
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Taiwan
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Kaohsiung
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Taiwan
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Taipei City
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Taiwan
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Taipei
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Taiwan
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Taoyuan City
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United Kingdom
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Avon
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United Kingdom
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Bangor
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United Kingdom
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Bebington
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United Kingdom
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Birmingham
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United Kingdom
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Derby
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United Kingdom
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Exeter
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United Kingdom
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Glasgow
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United Kingdom
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Gloucester
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United Kingdom
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London
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United Kingdom
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Maidstone
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United Kingdom
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Manchester
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United Kingdom
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Northampton
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United Kingdom
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Nottingham
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United Kingdom
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Plymouth
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United Kingdom
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Reading
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United Kingdom
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Southampton
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United Kingdom
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Stoke-on-Trent
Country [81] 0 0
United Kingdom
State/province [81] 0 0
Swansea
Country [82] 0 0
United Kingdom
State/province [82] 0 0
Taunton

Funding & Sponsors
Primary sponsor type
Other
Name
Mario Negri Institute for Pharmacological Research
Address
Country
Other collaborator category [1] 0 0
Commercial sector/Industry
Name [1] 0 0
Hoffmann-La Roche
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief 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 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.
Trial website
https://clinicaltrials.gov/show/NCT03603184
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Nicoletta Colombo, MD
Address 0 0
Istituto Europeo di Oncologia (IEO) - Milan
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Elena Biagioli
Address 0 0
Country 0 0
Phone 0 0
+390239014650
Fax 0 0
Email 0 0
attend@marionegri.it
Contact person for scientific queries

Summary results
For IPD and results data, please see https://clinicaltrials.gov/show/NCT03603184