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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT02450331




Registration number
NCT02450331
Ethics application status
Date submitted
19/05/2015
Date registered
21/05/2015
Date last updated
18/06/2023

Titles & IDs
Public title
A Study of Atezolizumab Versus Observation as Adjuvant Therapy in Participants With High-Risk Muscle-Invasive Urothelial Carcinoma (UC) After Surgical Resection
Scientific title
A Phase III, Open-Label, Multicenter, Randomized Study of Atezolizumab (Anti-PD-L1 Antibody) Versus Observation as Adjuvant Therapy in Patients With High-Risk Muscle-Invasive Urothelial Carcinoma After Surgical Resection
Secondary ID [1] 0 0
2014-005603-25
Secondary ID [2] 0 0
WO29636
Universal Trial Number (UTN)
Trial acronym
IMvigor010
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Carcinoma, Transitional Cell 0 0
Condition category
Condition code
Cancer 0 0 0 0
Non melanoma skin cancer
Cancer 0 0 0 0
Kidney
Cancer 0 0 0 0
Bladder - transitional cell cancer

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

Experimental: Atezolizumab - Participants will receive intravenous (IV) atezolizumab on Day 1 of each 21-day cycle for 16 cycles (up to 1 year).

No Intervention: Observation - Participants will undergo observation starting on Day 1 for 16 cycles (up to 1 year).


Treatment: Drugs: Atezolizumab
Atezolizumab will be administered at a dose of 1200 milligrams (mg).
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Disease-Free Survival (DFS), as Assessed by Investigator
Timepoint [1] 0 0
Randomization up to first occurrence of DFS event (up to approximately 50 months)
Secondary outcome [1] 0 0
Overall Survival (OS)
Timepoint [1] 0 0
Randomization until death due to any cause (up to approximately 80 months)
Secondary outcome [2] 0 0
Disease-Specific Survival (DSS), as Assessed by Investigator
Timepoint [2] 0 0
Randomization until death due to UC (up to approximately 50 months)
Secondary outcome [3] 0 0
Distant Metastasis-Free Survival (DMFS)
Timepoint [3] 0 0
Randomization up to diagnosis of distant metastases or death from any cause (up to approximately 50 months)
Secondary outcome [4] 0 0
Non-Urinary Tract Recurrence-Free Survival (NURFS)
Timepoint [4] 0 0
Randomization up to time of first occurrence of a NURFS event (up to approximately 50 months)
Secondary outcome [5] 0 0
Percentage of Participants With Adverse Events (AEs)
Timepoint [5] 0 0
Screening up to approximately 80 months
Secondary outcome [6] 0 0
Percentage of Participants With Anti-Therapeutic Antibodies (ATAs) to Atezolizumab
Timepoint [6] 0 0
Baseline up to approximately 50 months
Secondary outcome [7] 0 0
EuroQol 5-Dimension 5-Level (EQ-5D-5L) Visual Analogue Scale Score
Timepoint [7] 0 0
Day 1 of Cycle 1 up to approximately 50 months (Cycle length = 21 days)
Secondary outcome [8] 0 0
Minimum Observed Serum Atezolizumab Concentration (Cmin)
Timepoint [8] 0 0
Pre-dose (Hour 0) on Day 1 of Cycles 1, 2, 3, 4, every 8 cycles from Cycle 8, at treatment discontinuation, 120 days after treatment discontinuation (up to approximately 50 months))(Cycle length = 21 days)
Secondary outcome [9] 0 0
Maximum Observed Serum Atezolizumab Concentration (Cmax)
Timepoint [9] 0 0
Day 1 of Cycle 1 (Cycle length = 21 days)

Eligibility
Key inclusion criteria
- Histologically confirmed muscle-invasive UC (also termed transitional cell carcinoma)
of the bladder or upper urinary tract (i.e., renal pelvis or ureters)

- For participants treated with prior neoadjuvant chemotherapy: tumor stage of ypT2-4a
or ypN+ (ypT2-4 or ypN+ for participants with upper urinary tract UC) and M0

- For participants who have not received prior neoadjuvant chemotherapy: tumor stage of
pT3-4a or pN+ (pT3-4 or pN+ for participants with upper urinary tract UC) and M0

- Representative formalin-fixed paraffin-embedded tumor specimens from surgical
resection (i.e., radical cystectomy, nephroureterectomy, or lymph node dissection) in
paraffin blocks (blocks preferred) or at least 15 unstained slides, with an associated
pathology report, for central testing and determined to be evaluable for tumor
programmed death-ligand 1 (PD-L1) expression prior to study enrollment

- Absence of residual disease and absence of metastasis, as confirmed by a negative
baseline computed tomography (CT) or magnetic resonance imaging scan of the pelvis,
abdomen, and chest no more than 4 weeks prior to randomization

- Full recovery from cystectomy or nephroureterectomy within 14 weeks following surgery

- Eastern Cooperative Oncology Group performance status of less than or equal to (</=) 2

- Life expectancy greater than or equal to (>/=) 12 weeks

- Adequate hematologic and end-organ function

- For women who are not postmenopausal or surgically sterile: agreement to remain
abstinent or use contraceptive methods that result in a failure rate of less than (<)
1 percent (%) per year during the treatment period and for at least 5 months after the
last dose of atezolizumab
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Any approved anti-cancer therapy within 3 weeks prior to initiation of study treatment

- Adjuvant chemotherapy or radiation therapy for UC following surgical resection

- Treatment with any other investigational agent or participation in another clinical
trial with therapeutic intent within 28 days or five half-lives of the drug prior to
enrollment

- Malignancies other than UC within 5 years prior to Cycle 1, Day 1

- Pregnancy or breastfeeding

- Significant cardiovascular disease

- Severe infections within 4 weeks prior to Cycle 1, Day 1

- Major surgical procedure other than for diagnosis within 28 days prior to Cycle 1, Day
1

- History of severe allergic, anaphylactic, or other hypersensitivity reactions to
chimeric or humanized antibodies or fusion proteins

- Known hypersensitivity to biopharmaceuticals produced in Chinese hamster ovary cells
or any component of the atezolizumab formulation

- History of autoimmune disease

- Prior allogeneic stem cell or solid organ transplant

- History of idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced
pneumonitis, idiopathic pneumonitis, or evidence of active pneumonitis on screening
chest CT scan

- Positive test for human immunodeficiency virus and/or active hepatitis B or hepatitis
C or tuberculosis

- Administration of a live, attenuated vaccine within 4 weeks before Cycle 1 Day 1

- Prior treatment with cluster of differentiation 137 (CD137) agonists or immune
checkpoint blockade therapies, including anti-CD40, anti-cytotoxic
T-lymphocyte-associated protein 4 (anti-CTLA-4), anti-programmed death-1 (anti-PD-1),
and anti-PD-L1 therapeutic antibodies

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
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Terminated
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
5/10/2015
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
14/06/2022
Sample size
Target
Accrual to date
Final
809
Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC
Recruitment hospital [1] 0 0
Macquarie University Hospital - Macquarie Park
Recruitment hospital [2] 0 0
Royal Brisbane & Women's Hosp; Cancer Care Serv - Herston
Recruitment hospital [3] 0 0
Monash Medical Centre; Oncology - Clayton
Recruitment hospital [4] 0 0
Austin and Repatriation Medical Centre; Cancer Services - Melbourne
Recruitment postcode(s) [1] 0 0
2109 - Macquarie Park
Recruitment postcode(s) [2] 0 0
4029 - Herston
Recruitment postcode(s) [3] 0 0
3168 - Clayton
Recruitment postcode(s) [4] 0 0
3084 - Melbourne
Recruitment outside Australia
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Southampton

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Hoffmann-La Roche
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
This Phase III, open-label, randomized, multicenter study is to evaluate the efficacy and
safety of adjuvant treatment with atezolizumab compared with observation in participants with
muscle-invasive UC who are at high risk for recurrence following resection. Eligible
participants were randomized by a 1:1 ratio into atezolizumab group or control group.
Trial website
https://clinicaltrials.gov/ct2/show/NCT02450331
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Clinical Trials
Address 0 0
Hoffmann-La Roche
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT02450331