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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)

This study is currently recruiting participants.
Verified September 2017 by Hoffmann-La Roche
Sponsor:
ClinicalTrials.gov Identifier:
NCT03024996
First Posted: January 19, 2017
Last Update Posted: September 15, 2017
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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Hoffmann-La Roche
  Purpose
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 Intervention Phase
Renal Cell Carcinoma Drug: Atezolizumab Other: Placebo Phase 3

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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) ]

Estimated Enrollment: 664
Actual Study Start Date: January 3, 2017
Estimated Study Completion Date: April 13, 2024
Estimated Primary Completion Date: May 24, 2022 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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.
  • 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
  • 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
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


Contacts
Contact: Reference Study ID Number: WO39210 www.roche.com/about_roche/roche_worldwide.htm 888-662-6728 (U.S. and Canada) global-roche-genentech-trials@gene.com

  Show 220 Study Locations
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT03024996     History of Changes
Other Study ID Numbers: WO39210
2016-001881-27 ( EudraCT Number )
First Submitted: January 17, 2017
First Posted: January 19, 2017
Last Update Posted: September 15, 2017
Last Verified: September 2017

Additional relevant MeSH terms:
Carcinoma
Carcinoma, Renal Cell
Kidney Neoplasms
Kidney Diseases
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Adenocarcinoma
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Urologic Diseases
Antibodies, Monoclonal
Immunologic Factors
Physiological Effects of Drugs