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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT03024996




Registration number
NCT03024996
Ethics application status
Date submitted
17/01/2017
Date registered
19/01/2017
Date last updated
9/04/2021

Titles & IDs
Public title
A Study of Atezolizumab as Adjuvant Therapy in Participants With Renal Cell Carcinoma (RCC) at High Risk of Developing Metastasis Following Nephrectomy
Scientific title
A Phase III, Multicenter, Randomized, Placebo-Controlled, Double-Blind Study of Atezolizumab (Anti-PD-L1 Antibody) as Adjuvant Therapy in Patients With Renal Cell Carcinoma at High Risk of Developing Metastasis Following Nephrectomy
Secondary ID [1] 0 0
2016-001881-27
Secondary ID [2] 0 0
WO39210
Universal Trial Number (UTN)
Trial acronym
IMmotion010
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Renal Cell Carcinoma 0 0
Condition category
Condition code
Cancer 0 0 0 0
Non melanoma skin cancer
Cancer 0 0 0 0
Kidney

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

Experimental: Atezolizumab - Participants will receive atezolizumab 1200 milligrams (mg) intravenous (IV) infusion every 3 weeks (q3w) for 16 cycles (each cycle=21 days) or 1 year (whichever occurs first).

Placebo Comparator: Placebo - Participants will receive placebo matching to atezolizumab q3w for 16 cycles (each cycle=21 days) or 1 year (whichever occurs first).


Treatment: Drugs: Atezolizumab
Atezolizumab 1200 mg IV infusion q3w

Other interventions: Placebo
Placebo matching to atezolizumab q3w

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
IRF-assessed Disease-Free Survival (DFS) - Independent Review Facility (IRF)-assessed DFS is defined as the time from randomization to the earliest death from any cause or the first documented recurrence event assessed by IRF, defined as any of the following: Local recurrence of renal cell carcinoma (RCC), new primary RCC, or distant metastasis of RCC. Tumor assessment will be as per IRF on the basis of radiographic evidence and whenever possible supported/confirmed by biopsy results.
Timepoint [1] 0 0
From Baseline until first documented recurrence event (up to approximately 88 months)
Secondary outcome [1] 0 0
Overall Survival
Timepoint [1] 0 0
From Baseline up to death due to any cause (up to approximately 88 months)
Secondary outcome [2] 0 0
Investigator-assessed DFS - Investigator-assessed DFS is defined as the time from randomization to the first occurrence of a DFS event by investigator assessment. Investigator-assessed DFS will be analyzed similarly to the analysis of IRF-assessed DFS.
Timepoint [2] 0 0
From Baseline up to first occurence of event by investigator assessment (up to approximately 88 months)
Secondary outcome [3] 0 0
IRF-assessed DFS in Participants With Tumor-Infiltrating Immune Cell (IC) 1/2/3 - Independent Review Facility (IRF)-assessed DFS is defined as the time from randomization to the earliest death from any cause or the first documented recurrence event assessed by IRF, defined as any of the following: Local recurrence of renal cell carcinoma (RCC), new primary RCC, or distant metastasis of RCC. Tumor assessment will be as per IRF on the basis of radiographic evidence and whenever possible supported/confirmed by biopsy results.
Timepoint [3] 0 0
From Baseline until first occurrence of DFS event (up to approximately 88 months)
Secondary outcome [4] 0 0
Investigator-assessed DFS in Participants With Tumor-Infiltrating IC 1/2/3
Timepoint [4] 0 0
From Baseline until first occurrence of DFS event (up to approximately 88 months)
Secondary outcome [5] 0 0
Disease-Specific Survival
Timepoint [5] 0 0
From Baseline up to death due to RCC (up to approximately 88 months)
Secondary outcome [6] 0 0
Distant Metastasis-Free Survival - Distant metastasis-free survival, defined as the time from randomization to the date of diagnosis of distant (i.e., non-locoregional) metastases assessed by the investigator or death from any cause
Timepoint [6] 0 0
From Baseline up to date of diagnosis of distant metastases or death due to any cause (up to approximately 88 months)
Secondary outcome [7] 0 0
Percentage of Participants Who Are Alive and IRF-assessed Recurrence Free at Year 3 - Recurrence assessment will be as per IRF on the basis of radiographic evidence and whenever possible supported/confirmed by biopsy results.
Timepoint [7] 0 0
Year 3
Secondary outcome [8] 0 0
Percentage of Participants Who Are Alive and Investigator-assessed Recurrence Free at Year 3 - Recurrence assessment will be as per investigator on the basis of radiographic evidence and whenever possible supported/confirmed by biopsy results.
Timepoint [8] 0 0
Year 3
Secondary outcome [9] 0 0
Percentage of Participants With Adverse Events
Timepoint [9] 0 0
From Baseline up to 90 days after last dose of study drug or until initiation of new systemic anti-cancer therapy, whichever occurs first (last dose = up to approximately 1 year)
Secondary outcome [10] 0 0
Maximum Serum Concentration (Cmax) of Atezolizumab
Timepoint [10] 0 0
Predose (Hour[hr]0), 0.5 hr after end of infusion (infusion duration=1 hr) on Cycle 1 Day 1; predose (hr 0) on Day 1 of Cycles 2, 3, 4, 8; at treatment discontinuation (up to 1 year); 90-120 days after last dose (last dose = up to 1 year) (Cycle=21 days)
Secondary outcome [11] 0 0
Minimum Serum Concentration (Cmin) of Atezolizumab
Timepoint [11] 0 0
Predose (Hour[hr]0), 0.5 hr after end of infusion (infusion duration=1 hr) on Cycle 1 Day 1; predose (hr 0) on Day 1 of Cycles 2, 3, 4, 8; at treatment discontinuation (up to 1 year); 90-120 days after last dose (last dose = up to 1 year) (Cycle=21 days)
Secondary outcome [12] 0 0
Percentage of Participants With Anti-Therapeutic Antibodies (ATA) to Atezolizumab
Timepoint [12] 0 0
Predose (hr 0) on Day 1 of Cycles 1, 2, 3, 4, 8; at treatment discontinuation (up to 1 year); 90-120 days after last dose (last dose = up to 1 year) (Cycle=21 days)

Eligibility
Key inclusion criteria
- ECOG performance status of less than or equal to (</=) 1

- Pathologically confirmed RCC with a component of either clear cell histology or
sarcomatoid histology that has not been previously treated in the adjuvant or
neoadjuvant setting and classified as being at high risk of RCC recurrence

- Radical or partial nephrectomy with lymphadenectomy in select participants

- Absence of residual disease and absence of metastasis, as confirmed by a negative
baseline computed tomography (CT) of the pelvis, abdomen, and chest no more than 4
weeks prior to randomization. Confirmation of disease-free status will be assessed by
an independent central radiologic review of imaging data.

- Absence of brain metastasis, as confirmed by a negative CT with contrast or magnetic
resonance imaging (MRI) scan of the brain, no more than 4 weeks prior to
randomization. Applicable only to metastasectomy participants

- Full recovery from nephrectomy or metastasectomy within 12 weeks from randomization
following surgery
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Bilateral synchronous tumors with inheritable forms of RCC including von Hippel-Lindau

- 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 or five half-lives of the investigational
agent, whichever is longer, prior to enrollment

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

- 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 HIV

- Participants with active hepatitis B or hepatitis C

- Active tuberculosis

- Severe infections within 4 weeks prior to randomization including but not limited to
hospitalization for complications of infection, bacteremia, or severe pneumonia

- 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

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

- Any other diseases, metabolic dysfunction, physical examination finding, or clinical
laboratory finding giving reasonable suspicion of a disease or condition that
contraindicates the use of an investigational drug or that may affect the
interpretation of the results or render the participant at high risk from treatment
complications

- Prior treatment with cluster of differentiation (CD)137 agonists, anti-cytotoxic
T-lymphocyte-associated protein-4 (anti-CTLA-4), anti-programmed death-1 (anti-PD-1),
or anti-programmed death-ligand 1 (anti-PD-L1) therapeutic antibody or
pathway-targeting agents

- Treatment with systemic immunostimulatory agents (including but not limited to
interferons or interleukin-2) within 6 weeks or five half-lives of the drug, whichever
is shorter, prior to randomization

- Treatment with systemic immunosuppressive medications (including but not limited to
corticosteroids, cyclophosphamide, azathioprine, methotrexate, thalidomide, and
anti-tumor necrosis factor agents) within 2 weeks prior to randomization or
anticipated need for systemic immunosuppressive medications during the study

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
Active, not 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)
NSW,QLD,SA,VIC
Recruitment hospital [1] 0 0
Calvary Mater Newcastle; Medical Oncology - Waratah
Recruitment hospital [2] 0 0
Royal Brisbane & Women's Hosp; Cancer Care Serv - Herston
Recruitment hospital [3] 0 0
Ashford Cancer Center Research - Kurralta Park
Recruitment hospital [4] 0 0
Austin Hospital; Medical Oncology - Heidelberg
Recruitment postcode(s) [1] 0 0
2298 - Waratah
Recruitment postcode(s) [2] 0 0
4029 - Herston
Recruitment postcode(s) [3] 0 0
5037 - Kurralta Park
Recruitment postcode(s) [4] 0 0
3084 - Heidelberg
Recruitment outside Australia
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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
This is a Phase III, multicenter, randomized, placebo-controlled, double-blind study to
evaluate the efficacy and safety of atezolizumab versus placebo in participants with RCC who
are at high risk of disease recurrence following nephrectomy.
Trial website
https://clinicaltrials.gov/show/NCT03024996
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
Other publications