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Trial record 2 of 2 for:    imvigor | Urothelial Carcinoma | Italy

A Study of Atezolizumab Versus Observation as Adjuvant Therapy in Participants With High-Risk Muscle-Invasive Urothelial Carcinoma (UC) After Surgical Resection (IMvigor010)

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ClinicalTrials.gov Identifier: NCT02450331
Recruitment Status : Active, not recruiting
First Posted : May 21, 2015
Results First Posted : November 18, 2020
Last Update Posted : January 11, 2021
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche

Tracking Information
First Submitted Date  ICMJE May 19, 2015
First Posted Date  ICMJE May 21, 2015
Results First Submitted Date  ICMJE October 21, 2020
Results First Posted Date  ICMJE November 18, 2020
Last Update Posted Date January 11, 2021
Actual Study Start Date  ICMJE October 5, 2015
Actual Primary Completion Date November 30, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 14, 2020)
Disease-Free Survival (DFS), as Assessed by Investigator [ Time Frame: Randomization up to first occurrence of DFS event (up to approximately 50 months) ]
DFS is defined as the time from randomization to the time of first occurrence of a DFS event. DFS events include: local (pelvic) recurrence of UC (including soft tissue and regional lymph nodes); urinary tract recurrence of UC (including all pathological stages and grades); distant metastasis of UC; or death from any cause. Tumor assessment will be performed using radiographic evaluations.
Original Primary Outcome Measures  ICMJE
 (submitted: May 19, 2015)
Disease-Free Survival (DFS) [ Time Frame: From randomization up to year 6 ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 13, 2020)
  • Overall Survival (OS) [ Time Frame: Randomization until death due to any cause (up to approximately 50 months) ]
    Overall survival is defined as the time from randomization to the date of death from any cause, regardless of whether the death occurs during study treatment or following treatment discontinuation.
  • Disease-Specific Survival (DSS), as Assessed by Investigator [ Time Frame: Randomization until death due to UC (up to approximately 50 months) ]
    DSS is defined as the time from randomization until the date of death from UC.
  • Distant Metastasis-Free Survival (DMFS) [ Time Frame: Randomization up to diagnosis of distant metastases or death from any cause (up to approximately 50 months) ]
    DMFS is defined as the time from randomization to the date of diagnosis of distant (that is, non-locoregional) metastases or death from any cause. Tumor assessment will be performed using radiographic evaluations.
  • Non-Urinary Tract Recurrence-Free Survival (NURFS) [ Time Frame: Randomization up to time of first occurrence of a NURFS event (up to approximately 50 months) ]
    NURFS is defined as the time from randomization to the time of first occurrence of a NURFS event. NURFS events include: local (pelvic) recurrence of UC (including soft tissue and regional lymph nodes); distant metastasis of UC; or death from any cause. Tumor assessment will be performed using radiographic evaluations.
  • Percentage of Participants With Adverse Events (AEs) [ Time Frame: Screening up to approximately 50 months ]
    Percentage of participants with at least one Adverse Event.
  • Percentage of Participants With Anti-Therapeutic Antibodies (ATAs) to Atezolizumab [ Time Frame: Baseline up to approximately 50 months ]
    Percentage of participants with anti-therapeutic antibodies to atezolizumab.
  • EuroQol 5-Dimension 5-Level (EQ-5D-5L) Visual Analogue Scale Score [ Time Frame: Day 1 of Cycle 1 up to approximately 50 months (Cycle length = 21 days) ]
    The EQ-5D-5L is a generic preference-based HRQoL questionnaire that provides a single index value for health status and is used to inform pharmacoeconomic evaluations and to measure general health status. Visual analog scale (VAS) allows the patient to indicate, on a scale of 0-100, how his or her health is on the day of assessment, with 100 being the "best imaginable health state" and 0 being the "worst imaginable health state."
  • Minimum Observed Serum Atezolizumab Concentration (Cmin) [ Time Frame: 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) ]
    Minimum observed serum atezolizumab concentration (Cmin) prior to infusion on Day 1 of Cycles 1, 2, 3, and 4; every 8 cycles starting on Cycle 8; at treatment discontinuation; and at 120 days after the last dose of atezolizumab.
  • Maximum Observed Serum Atezolizumab Concentration (Cmax) [ Time Frame: Day 1 of Cycle 1 (Cycle length = 21 days) ]
    Maximum observed serum atezolizumab concentration (Cmax) after infusion on Day 1 of Cycle 1.
Original Secondary Outcome Measures  ICMJE
 (submitted: May 19, 2015)
  • Overall Survival (OS) [ Time Frame: From randomization up to year 6 ]
  • Disease-Specific Survival (DSS) [ Time Frame: From randomization up to year 6 ]
  • Distant Metastasis-Free Survival (DMFS) [ Time Frame: From randomization up to year 6 ]
  • Number of Participants with Adverse Events (AEs) [ Time Frame: From randomization up to 30 days after the last dose of study treatment ]
  • Percentage of Anti-Therapeutic Antibody (ATA) Response to MPDL3280A [ Time Frame: From randomization up to 120 days after the last dose of study treatment ]
  • Maximum Observed Serum MPDL3280A Concentration (Cmax) [ Time Frame: From randomization up to 120 days after the last dose of study treatment ]
  • Score of Participant-Reported Health Status in the EuroQol 5-Dimension, 5-Level Version (EQ-5D-5L) Questionnaire [ Time Frame: From randomization up to year 6 ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study of Atezolizumab Versus Observation as Adjuvant Therapy in Participants With High-Risk Muscle-Invasive Urothelial Carcinoma (UC) After Surgical Resection
Official Title  ICMJE 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
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Carcinoma, Transitional Cell
Intervention  ICMJE Drug: Atezolizumab
Atezolizumab will be administered at a dose of 1200 milligrams (mg).
Other Name: TECENTRIQ®; MPDL3280A
Study Arms  ICMJE
  • Experimental: Atezolizumab
    Participants will receive intravenous (IV) atezolizumab on Day 1 of each 21-day cycle for 16 cycles (up to 1 year).
    Intervention: Drug: Atezolizumab
  • No Intervention: Observation
    Participants will undergo observation starting on Day 1 for 16 cycles (up to 1 year).
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: January 24, 2019)
809
Original Estimated Enrollment  ICMJE
 (submitted: May 19, 2015)
440
Estimated Study Completion Date  ICMJE May 10, 2022
Actual Primary Completion Date November 30, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Italy,   Australia,   Belgium,   Canada,   China,   Czechia,   Finland,   France,   Germany,   Greece,   Israel,   Japan,   Korea, Republic of,   Netherlands,   Poland,   Russian Federation,   Serbia,   Spain,   Switzerland,   Taiwan,   Turkey,   Ukraine,   United Kingdom,   United States
Removed Location Countries Belarus,   Czech Republic
 
Administrative Information
NCT Number  ICMJE NCT02450331
Other Study ID Numbers  ICMJE WO29636
2014-005603-25 ( EudraCT Number )
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Hoffmann-La Roche
Study Sponsor  ICMJE Hoffmann-La Roche
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Clinical Trials Hoffmann-La Roche
PRS Account Hoffmann-La Roche
Verification Date January 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP