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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)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03024996
Recruitment Status : Completed
First Posted : January 19, 2017
Last Update Posted : February 21, 2023
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche

Study Description
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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.

Condition or disease Intervention/treatment Phase
Renal Cell Carcinoma Drug: Atezolizumab Other: Placebo Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 778 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official 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
Actual Study Start Date : January 3, 2017
Actual Primary Completion Date : May 3, 2022
Actual Study Completion Date : December 8, 2022

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
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).
 Drug: Atezolizumab
Atezolizumab 1200 mg IV infusion q3w
Placebo Comparator: Placebo
Participants will receive placebo matching to atezolizumab q3w for 16 cycles (each cycle=21 days) or 1 year (whichever occurs first).
 Other: Placebo
Placebo matching to atezolizumab q3w


Outcome Measures
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Primary Outcome Measures :
  1. Investigator-assessed DFS [ Time Frame: From Baseline up to first occurence of event by investigator assessment (up to approximately 88 months) ]
    Investigator-assessed DFS, defined as the time from randomization to death from any cause or the first documented recurrence assessed by investigator, whichever occurs first. Recurrence is defined as any of the following: Local recurrence of renal cell carcinoma (RCC), new primary RCC, or distant metastasis of RCC. Investigator-assessed DFS will be analyzed similarly to the analysis of IRF-assessed DFS.


Secondary Outcome Measures :
  1. Overall Survival [ Time Frame: From Baseline up to death due to any cause (up to approximately 88 months) ]
  2. Investigator-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) ]
  3. 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 death from any cause or the first documented recurrence assessed by IRF, whichever occurs first.

  4. 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 death from any cause or the first documented recurrence assessed by IRF, whichever occurs first.

  5. IRF-assessed Event-free Survival (EFS) [ Time Frame: From Baseline until first documented recurrence event (up to approximately 88 months) ]
    IRF-assessed event-free survival (EFS) is defined as the time from randomization to death from any cause, or the first documented recurrence in patients without baseline disease by IRF or the first documented disease progression in patients identified as having baseline disease by IRF, whichever occurs first. Disease progression is defined as either unequivocal progression of baseline disease or new unequivocal lesions.

  6. Disease-Specific Survival [ Time Frame: From Baseline up to death due to RCC (up to approximately 88 months) ]
  7. 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 death from any cause or the date of diagnosis of distant (i.e., non-locoregional) metastases assessed by the investigator, whichever occurs first

  8. Percentage of Participants Who Are Alive and IRF-assessed Recurrence Free at Year 1, 2, and 3 [ Time Frame: Up to 3 years ]
    Recurrence assessment will be as per IRF on the basis of radiographic evidence and whenever possible supported/confirmed by biopsy results.

  9. Percentage of Participants Who Are Alive and Investigator-assessed Recurrence Free at Year 1, 2, and 3 [ Time Frame: Up to 3 years ]
    Recurrence assessment will be as per investigator on the basis of radiographic evidence and whenever possible supported/confirmed by biopsy results.

  10. 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) ]
  11. 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) ]
  12. 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) ]
  13. Percentage of Participants With Anti-Drug Antibodies (ADA) 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) ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03024996


Locations
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Sponsors and Collaborators
Hoffmann-La Roche
Investigators
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Study Director: Clinical Trials Hoffmann-La Roche
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT03024996    
Other Study ID Numbers: WO39210
2016-001881-27 ( EudraCT Number )
First Posted: January 19, 2017    Key Record Dates
Last Update Posted: February 21, 2023
Last Verified: February 2023
Additional relevant MeSH terms:
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Carcinoma
Carcinoma, Renal Cell
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Adenocarcinoma
Kidney Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Female Urogenital Diseases
 Female Urogenital Diseases and Pregnancy Complications
Urogenital Diseases
Kidney Diseases
Urologic Diseases
Male Urogenital Diseases
Atezolizumab
Immune Checkpoint Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents, Immunological
Antineoplastic Agents