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A Study of Atezolizumab as Adjuvant Therapy in Participants With Renal Cell Carcinoma (RCC) at High Risk of Developing Metastasis Following Nephrectomy (IMmotion010)

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ClinicalTrials.gov Identifier: NCT03024996
Recruitment Status : Active, not recruiting
First Posted : January 19, 2017
Last Update Posted : October 8, 2019
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche

Tracking Information
First Submitted Date  ICMJE January 17, 2017
First Posted Date  ICMJE January 19, 2017
Last Update Posted Date October 8, 2019
Actual Study Start Date  ICMJE January 3, 2017
Estimated Primary Completion Date May 24, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 4, 2017)
IRF-assessed Disease-Free Survival (DFS) [ Time Frame: From Baseline until first documented recurrence event (up to approximately 88 months) ]
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.
Original Primary Outcome Measures  ICMJE
 (submitted: January 17, 2017)
Disease-Free Survival (DFS) [ Time Frame: From Baseline until first occurrence of DFS event (up to approximately 64 months) ]
DFS is defined as the time from randomization to the first documented DFS event. DFS event includes any of the following: Local recurrence of RCC, New primary RCC, Distant metastasis of RCC, or Death from any cause. Tumor assessment will be as per investigator on the basis of radiographic evidence and whenever possible supported/confirmed by biopsy results.
Change History Complete list of historical versions of study NCT03024996 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: December 4, 2017)
  • Overall Survival [ Time Frame: From Baseline up to death due to any cause (up to approximately 88 months) ]
  • Investigator-assessed DFS [ Time Frame: From Baseline up to first occurence of event by investigator assessment (up to approximately 88 months) ]
    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.
  • IRF-assessed DFS in Participants With Tumor-Infiltrating Immune Cell (IC) 1/2/3 [ Time Frame: From Baseline until first occurrence of DFS event (up to approximately 88 months) ]
    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.
  • Investigator-assessed DFS in Participants With Tumor-Infiltrating IC 1/2/3 [ Time Frame: From Baseline until first occurrence of DFS event (up to approximately 88 months) ]
  • Disease-Specific Survival [ Time Frame: From Baseline up to death due to RCC (up to approximately 88 months) ]
  • Distant Metastasis-Free Survival [ Time Frame: From Baseline up to date of diagnosis of distant metastases or death due to any cause (up to approximately 88 months) ]
    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
  • Percentage of Participants Who Are Alive and IRF-assessed Recurrence Free at Year 3 [ Time Frame: Year 3 ]
    Recurrence assessment will be as per IRF on the basis of radiographic evidence and whenever possible supported/confirmed by biopsy results.
  • Percentage of Participants Who Are Alive and Investigator-assessed Recurrence Free at Year 3 [ Time Frame: Year 3 ]
    Recurrence assessment will be as per investigator on the basis of radiographic evidence and whenever possible supported/confirmed by biopsy results.
  • Percentage of Participants With Adverse Events [ Time Frame: 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) ]
  • Maximum Serum Concentration (Cmax) of Atezolizumab [ Time Frame: 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) ]
  • Minimum Serum Concentration (Cmin) of Atezolizumab [ Time Frame: 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) ]
  • Percentage of Participants With Anti-Therapeutic Antibodies (ATA) to Atezolizumab [ Time Frame: 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) ]
Original Secondary Outcome Measures  ICMJE
 (submitted: January 17, 2017)
  • Overall Survival [ Time Frame: From Baseline up to death due to any cause (up to approximately 88 months) ]
  • DFS in Participants With Tumor-Infiltrating Immune Cell (IC) 1/2/3 [ Time Frame: From Baseline until first occurrence of DFS event (up to approximately 88 months) ]
    DFS is defined as the time from randomization to the first documented DFS event. DFS event includes any of the following: Local recurrence of RCC, New primary RCC, Distant metastasis of RCC, or Death from any cause. Tumor assessment will be as per investigator on the basis of radiographic evidence and whenever possible supported/confirmed by biopsy results.
  • Disease-Specific Survival [ Time Frame: From Baseline up to death due to RCC (up to approximately 88 months) ]
  • Distant Metastasis-Free Survival [ Time Frame: From Baseline up to date of diagnosis of distant metastases or death due to any cause (up to approximately 88 months) ]
  • Percentage of Participants Who Are Alive and Recurrence Free at Year 3 [ Time Frame: Year 3 ]
    Recurrence assessment will be as per investigator on the basis of radiographic evidence and whenever possible supported/confirmed by biopsy results.
  • Percentage of Participants With Adverse Events [ Time Frame: 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) ]
  • Maximum Serum Concentration (Cmax) of Atezolizumab [ Time Frame: 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) ]
  • Minimum Serum Concentration (Cmin) of Atezolizumab [ Time Frame: 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) ]
  • Percentage of Participants With Anti-Therapeutic Antibodies (ATA) to Atezolizumab [ Time Frame: 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) ]
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 as Adjuvant Therapy in Participants With Renal Cell Carcinoma (RCC) at High Risk of Developing Metastasis Following Nephrectomy
Official Title  ICMJE 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
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Renal Cell Carcinoma
Intervention  ICMJE
  • Drug: Atezolizumab
    Atezolizumab 1200 mg IV infusion q3w
  • Other: Placebo
    Placebo matching to atezolizumab q3w
Study Arms  ICMJE
  • 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).
    Intervention: Drug: Atezolizumab
  • Placebo Comparator: Placebo
    Participants will receive placebo matching to atezolizumab q3w for 16 cycles (each cycle=21 days) or 1 year (whichever occurs first).
    Intervention: Other: Placebo
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: April 8, 2019)
778
Original Estimated Enrollment  ICMJE
 (submitted: January 17, 2017)
664
Estimated Study Completion Date  ICMJE April 13, 2024
Estimated Primary Completion Date May 24, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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

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
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 Argentina,   Australia,   Austria,   Belgium,   Brazil,   Canada,   Chile,   China,   Czechia,   Denmark,   France,   Germany,   Ireland,   Israel,   Italy,   Japan,   Korea, Republic of,   Netherlands,   Poland,   Russian Federation,   Serbia,   Spain,   Taiwan,   Thailand,   Turkey,   Ukraine,   United Kingdom,   United States
Removed Location Countries Czech Republic,   Uruguay
 
Administrative Information
NCT Number  ICMJE NCT03024996
Other Study ID Numbers  ICMJE WO39210
2016-001881-27 ( EudraCT Number )
Has Data Monitoring Committee Yes
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 October 2019

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