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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/NCT02807636




Registration number
NCT02807636
Ethics application status
Date submitted
17/06/2016
Date registered
21/06/2016
Date last updated
29/04/2024

Titles & IDs
Public title
Study of Atezolizumab as Monotherapy and in Combination With Platinum-Based Chemotherapy in Participants With Untreated Locally Advanced or Metastatic Urothelial Carcinoma
Scientific title
A Phase III, Multicenter, Randomized, Placebo-Controlled Study of Atezolizumab (Anti-PD-L1 Antibody) as Monotherapy and in Combination With Platinum-Based Chemotherapy in Patients With Untreated Locally Advanced or Metastatic Urothelial Carcinoma
Secondary ID [1] 0 0
2016-000250-35
Secondary ID [2] 0 0
WO30070
Universal Trial Number (UTN)
Trial acronym
IMvigor130
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Urothelial Carcinoma 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
Treatment: Drugs - Carboplatin
Treatment: Drugs - Gemcitabine
Other interventions - Placebo
Treatment: Drugs - Cisplatin

Experimental: Atezolizumab+Gemcitabine+Carboplatin/Cisplatin - Participants will receive blinded atezolizumab in combination with open-label platinum-based chemotherapy (gemcitabine with either cisplatin or carboplatin).

Placebo Comparator: Placebo+Gemcitabine+Carboplatin/Cisplatin - Participants will receive blinded placebo matched to atezolizumab in combination with open-label platinum-based chemotherapy (gemcitabine with either cisplatin or carboplatin).

Experimental: Atezolizumab Monotherapy - Eligible participants will receive open-label atezolizumab as monotherapy.


Treatment: Drugs: Atezolizumab
Atezolizumab will be administered at a fixed dose of 1200 milligrams (mg) by intravenous (IV) infusion on Day 1 of each 21-day cycle until investigator-assessed disease progression per RECIST v1.1. In specific circumstances treatment may continue beyond disease progression.

Treatment: Drugs: Carboplatin
Carboplatin will be administered at doses to achieve area under the concentration-time curve (AUC) of 4.5 milligram per milliliter into minute (mg/mL*min) by IV infusion on Day 1 of each 21-day cycle until investigator-assessed disease progression per RECIST v1.1 or unacceptable toxicity.

Treatment: Drugs: Gemcitabine
Gemcitabine will be administered at a dose of 1000 milligrams per square meter (mg/m^2) by IV infusion on Day 1 and Day 8 of each 21-day cycle, until investigator-assessed disease progression per RECIST v1.1 or unacceptable toxicity.

Other interventions: Placebo
Placebo matched to atezolizumab will be administered by IV infusion on Day 1 of each 21-day cycle until investigator-assessed disease progression per RECIST v1.1. In specific circumstances treatment may continue beyond disease progression.

Treatment: Drugs: Cisplatin
Cisplatin will be administered at a dose of 70 mg/m^2 by IV infusion on Day 1 of each 21-day cycle until investigator-assessed disease progression per RECIST v1.1 or unacceptable toxicity.
Intervention code [1] 0 0
Treatment: Drugs
Intervention code [2] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Investigator Assessed Progression-Free Survival (PFS) in the Placebo+Gemcitabine+Carboplatin/Cisplatin Arm Versus Atezolizumab +Gemcitabine+Carboplatin/Cisplatin Arm
Timepoint [1] 0 0
Baseline up to first documented disease progression or death, whichever occurs first (up to approximately 35 months)
Primary outcome [2] 0 0
Overall Survival (OS) in Atezolizumab+Gemcitabine+Carboplatin/Cisplatin Arm Versus Placebo+Gemcitabine+Carboplatin/Cisplatin Arm
Timepoint [2] 0 0
Baseline until death due to any cause (up to approximately 73 months)
Primary outcome [3] 0 0
Overall Survival (OS) in Atezolizumab Monotherapy Arm Versus Placebo+Gemcitabine+Carboplatin/Cisplatin Arm
Timepoint [3] 0 0
Baseline until death due to any cause (up to approximately 73 months)
Secondary outcome [1] 0 0
Objective Response Rate (ORR) in Atezolizumab+Gemcitabine+Carboplatin/Cisplatin Arm Versus Placebo+Gemcitabine+Carboplatin/Cisplatin Arm
Timepoint [1] 0 0
Baseline up to disease progression, death, or loss of follow-up, whichever occurs first (up to approximately 73 months)
Secondary outcome [2] 0 0
Objective Response Rate (ORR) in Atezolizumab Monotherapy Arm Versus Placebo+Gemcitabine+Carboplatin/Cisplatin Arm
Timepoint [2] 0 0
Baseline up to disease progression, death, or loss of follow-up, whichever occurs first (up to approximately 73 months)
Secondary outcome [3] 0 0
Duration of Response (DOR) in Atezolizumab+Gemcitabine+Carboplatin/Cisplatin Arm Versus Placebo+Gemcitabine+Carboplatin/Cisplatin Arm
Timepoint [3] 0 0
From first documented objective response (CR or PR) to disease progression, death, or loss of follow-up, whichever occurs first (up to approximately 73 months)
Secondary outcome [4] 0 0
Duration of Response (DOR) in Atezolizumab Monotherapy Arm Versus Placebo+Gemcitabine+Carboplatin/Cisplatin Arm
Timepoint [4] 0 0
From first documented objective response (CR or PR) to disease progression, death, or loss of follow-up, whichever occurs first (up to approximately 73 months)
Secondary outcome [5] 0 0
IRF-PFS
Timepoint [5] 0 0
Randomization to first documented disease progression or death from any cause (up to 35 months)
Secondary outcome [6] 0 0
OS Event Free Rate Atezolizumab+Gemcitabine+Carboplatin/Cisplatin Arm Versus Placebo+Gemcitabine+Carboplatin/Cisplatin Arm
Timepoint [6] 0 0
Year 1
Secondary outcome [7] 0 0
OS Event Free Rate in Atezolizumab Monotherapy Arm Versus Placebo+Gemcitabine+Carboplatin/Cisplatin Arm
Timepoint [7] 0 0
Year 1
Secondary outcome [8] 0 0
PFS Event Free Rate
Timepoint [8] 0 0
Year 1
Secondary outcome [9] 0 0
Time to Deterioration in Global Health Status as Measured by the EORTC QLQ-C30 Score in the Placebo+Gemcitabine+Carboplatin/Cisplatin Arm Versus Atezolizumab +Gemcitabine+Carboplatin/Cisplatin Arm
Timepoint [9] 0 0
Up to approximately 73 months
Secondary outcome [10] 0 0
Time to Deterioration in Global Health Status as Measured by the EORTC QLQ-C30 Score in the Placebo+Gemcitabine+Carboplatin/Cisplatin Arm Versus Atezolizumab Monotherapy Arm
Timepoint [10] 0 0
Up to approximately 73 months
Secondary outcome [11] 0 0
Time to Deterioration in Physical Function as Measured by the EORTC QLQ-C30 Score in the Placebo+Gemcitabine+Carboplatin/Cisplatin Arm Versus Atezolizumab +Gemcitabine+Carboplatin/Cisplatin Arm
Timepoint [11] 0 0
Up to approximately 73 months
Secondary outcome [12] 0 0
Time to Deterioration in Physical Function as Measured by the EORTC QLQ-C30 Score in the Placebo+Gemcitabine+Carboplatin/Cisplatin Arm Versus Atezolizumab Monotherapy Arm
Timepoint [12] 0 0
Up to approximately 73 months
Secondary outcome [13] 0 0
Maximum Atezolizumab Serum Concentration
Timepoint [13] 0 0
Cycle 1 Day 1
Secondary outcome [14] 0 0
Minimum Atezolizumab Serum Concentration
Timepoint [14] 0 0
Cycle 2 Day 1, Cycle 3 Day 1, Cycle 4 Day 1, Cycle 8 Day 1, Cycle 16 Day 1, Cycle 24 Day 1, Cycle 32 Day 1, Day 120 post dose of last blinded atezolizumab treatment, and study drug early discontinuation
Secondary outcome [15] 0 0
Percentage of Participants With Anti-Therapeutic (Anti-Atezolizumab) Antibodies (ATAs)
Timepoint [15] 0 0
Up to approximately 35 months
Secondary outcome [16] 0 0
Investigator-Assessed Progression-Free Survival (INV-PFS) in Participants Treated With Atezolizumab Monotherapy Arm Compared With Placebo+Gemcitabine+Carboplatin/Cisplatin Arm
Timepoint [16] 0 0
Baseline up to disease progression, death, or loss of follow-up, whichever occurs first (assessed at baseline, every 9 weeks for 54 weeks and every 12 weeks thereafter up to 35 months)
Secondary outcome [17] 0 0
Percentage of Participants With Adverse Events (AEs) Assessed Using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v4.0
Timepoint [17] 0 0
Baseline up to 90 months

Eligibility
Key inclusion criteria
Inclusion Criteria

- Considered to be eligible to receive platinum-based chemotherapy, in the
investigator's judgment

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

- Histologically documented, locally advanced (T4b, any N; or any T, N2-3) or metastatic
urothelial carcinoma (mUC) (M1, Stage IV) (also termed transitional cell carcinoma
[TCC] or urothelial cell carcinoma [UCC] of the urinary tract; including renal pelvis,
ureters, urinary bladder, and urethra)

- Representative formalin-fixed paraffin-embedded (FFPE) tumor specimens 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 PD-L1
expression prior to study enrollment; participants who have fewer than 15 unstained
slides available at baseline (but no less than [<] 10) may be eligible following
discussion with the Medical Monitor

- No prior chemotherapy for inoperable locally advanced or mUC

- For participants who received prior adjuvant/neoadjuvant chemotherapy or
chemo-radiation for urothelial carcinoma, a treatment-free interval more than (>) 12
months between the last treatment administration and the date of recurrence is
required in order to be considered treatment naive in the metastatic setting

- Prior local intravesical chemotherapy or immunotherapy is allowed if completed at
least 4 weeks prior to the initiation of study treatment

- Measurable disease, as defined by RECIST v1.1

- Adequate hematologic and end-organ function

- For women of childbearing potential: agreement to remain abstinent (refrain from
heterosexual intercourse) or use contraceptive methods that result in a failure rate
of <1% per year during the treatment period and for at least 6 months after the last
dose of carboplatin, cisplatin, or gemcitabine or for 5 months after the last dose of
atezolizumab

- For men: agreement to remain abstinent (refrain from heterosexual intercourse) or use
contraceptive measures and agreement to refrain from donating sperm
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, including chemotherapy or hormonal therapy, within 3
weeks prior to initiation of study treatment

- Treatment with any other investigational agent or participation in another clinical
study with therapeutic intent within 28 days prior to enrolment

- Active or untreated CNS metastases as determined by computed tomography (CT) or
magnetic resonance imaging evaluation during screening and prior radiographic
assessments

- Participants with treated asymptomatic central nervous system (CNS) metastases are
eligible, provided they meet all of the following criteria: * Evaluable or measurable
disease outside the CNS * No metastases to midbrain, pons, medulla, or within 10 mm of
the optic apparatus (optic nerves and chiasm) * No history of intracranial or spinal
cord hemorrhage * No ongoing requirement for corticosteroid as therapy for CNS
disease; anti-convulsants at a stable dose are allowed * No evidence of significant
vasogenic edema * No stereotactic radiation, whole-brain radiation or neurosurgical
resection within 4 weeks prior to Cycle 1, Day 1 * Radiographic demonstration of
interim stability (i.e., no progression) between the completion of CNS-directed
therapy and the screening radiographic study * Screening CNS radiographic study >/=4
weeks since completion of radiotherapy or surgical resection and >/=2 weeks since
discontinuation of corticosteroids

- Prior treatment with CD137 agonists, anti-CTLA-4, anti-programmed death-1 (PD-1), or
anti-PD-L1 therapeutic antibody or pathway-targeting agents

- 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 study

- Leptomeningeal disease

- Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent
drainage procedures (once monthly or more frequently)

- Uncontrolled tumour-related pain or hypercalcemia

- Significant cardiovascular disease including known left ventricular ejection fraction
(LVEF) <40%

- Severe infections within 4 weeks before randomization or therapeutic oral or IV
antibiotics within 2 weeks before randomization

- Major surgical procedure within 4 weeks prior to randomization or anticipation of need
for a major surgical procedure during the course of the study other than for diagnosis

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

- Life expectancy of <12 weeks

- Pregnant or lactating, or intending to become pregnant during the study

- Serum albumin <25 gram per liter (g/L)

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

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

- History of autoimmune disease

- Participants with prior allogeneic stem cell or solid organ transplantation

- History of idiopathic pulmonary fibrosis (including pneumonitis), drug-induced
pneumonitis, organizing pneumonia (i.e., bronchiolitis obliterans, cryptogenic
organizing pneumonia), or evidence of active pneumonitis on screening chest CT scan

- Positive test for human immunodeficiency virus (HIV)

- Active hepatitis B or hepatitis C

- Active tuberculosis

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

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
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
30/06/2016
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
12/02/2024
Sample size
Target
Accrual to date
Final
1213
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC
Recruitment hospital [1] 0 0
Macquarie University Hospital - Macquarie Park
Recruitment hospital [2] 0 0
Royal Brisbane and Women's Hospital - Herston
Recruitment hospital [3] 0 0
Lyell McEwin Hospital - Adelaide
Recruitment hospital [4] 0 0
Ashford Cancer Center Research - Kurralta Park
Recruitment hospital [5] 0 0
Box Hill Hospital - Box Hill
Recruitment hospital [6] 0 0
Cabrini Medical Centre; Oncology - Malvern
Recruitment hospital [7] 0 0
Sunshine Hospital; Oncology Research - St Albans
Recruitment postcode(s) [1] 0 0
2109 - Macquarie Park
Recruitment postcode(s) [2] 0 0
4029 - Herston
Recruitment postcode(s) [3] 0 0
5112 - Adelaide
Recruitment postcode(s) [4] 0 0
5037 - Kurralta Park
Recruitment postcode(s) [5] 0 0
3128 - Box Hill
Recruitment postcode(s) [6] 0 0
3144 - Malvern
Recruitment postcode(s) [7] 0 0
- St Albans
Recruitment outside Australia
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United States of America
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Arkansas
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California
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Connecticut
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Delaware
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Florida
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Illinois
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Indiana
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United States of America
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Kentucky
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United States of America
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Louisiana
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United States of America
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Minnesota
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United States of America
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Nevada
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New York
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North Carolina
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South Carolina
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United States of America
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Tennessee
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Belgium
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Charleroi
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Belgium
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Gent
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Belgium
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Leuven
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Belgium
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Liege
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Bosnia and Herzegovina
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Banja Luka
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Sarajevo
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MG
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Recoleta
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Vitacura
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China
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Olomouc
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Praha 2
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Tallinn
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Oulu
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Tbilisi
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Italy
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Lazio
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Italy
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Liguria
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Italy
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Lombardia
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Piemonte
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Puglia
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Aichi
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Aomori
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Ehime
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Gunma
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Hokkaido
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Ibaraki
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Ishikawa
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Kumamoto
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Niigata
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Osaka
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Daegu
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Incheon
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Seoul
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Groningen
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Sittard-Geleen
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Zwolle
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Bialystok
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Konin
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Kraków
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Lodz
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Poznan
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Tomaszów Mazowiecki
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Warszawa
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Wroclaw
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Portugal
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Lisboa
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Portugal
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Porto
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Romania
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Baia Mare
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Romania
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Bucharest
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Romania
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Craiova
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Russian Federation
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Altaj
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Russian Federation
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Baskortostan
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Russian Federation
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Krasnodar
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Russian Federation
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Moskovskaja Oblast
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Russian Federation
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Niznij Novgorod
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Russian Federation
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Sankt Petersburg
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Russian Federation
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Sverdlovsk
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Russian Federation
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Ivanovo
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Serbia
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Belgrade
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Serbia
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Nis
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Serbia
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Sremska Kamenica
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Singapore
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Singapore
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Slovenia
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Ljubljana
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South Africa
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George
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South Africa
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Port Elizabeth
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South Africa
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Pretoria
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Sandton
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Alicante
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Barcelona
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Cantabria
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Castellon
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Spain
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Cordoba
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Islas Baleares
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Navarra
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Spain
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Pontevedra
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Spain
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Vizcaya
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Spain
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Albacete
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Spain
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Burgos
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Spain
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Caceres
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Spain
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Granada
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Spain
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Huelva
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Spain
State/province [132] 0 0
Jaen
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Hoffmann-La Roche
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
A Phase III, randomised study of atezolizumab alone and in combination with chemotherapy
versus chemotherapy alone in participants with untreated advanced urothelial cancer.
Trial website
https://clinicaltrials.gov/ct2/show/NCT02807636
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/NCT02807636