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

• Register: ClinicalTrials.gov
• Last refreshed on: 27 February 2023
• Main ID: NCT03024996
• Date of registration: 17/01/2017
• Prospective Registration: No
• Primary sponsor: Hoffmann-La Roche
• Public title: A Study of Atezolizumab as Adjuvant Therapy in Participants With Renal Cell Carcinoma (RCC) at High Risk of Developing Metastasis Following Nephrectomy IMmotion010
• 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
• Date of first enrolment: January 3, 2017
• Target sample size: 778
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT03024996
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Double (Participant, Investigator).
• Phase: Phase 3

Countries of recruitment

Argentina, Australia, Austria, Belgium, Brazil, Canada, Chile, China, Czech Republic, 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, Uruguay

Contacts

• Name: Clinical Trials
• Affiliation: Hoffmann-La Roche

Key inclusion & exclusion criteria

Inclusion Criteria:

- ECOG performance status of less than or equal to (
- 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



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Renal Cell Carcinoma

Intervention(s)

Other: Placebo

Drug: Atezolizumab

Primary Outcome(s)

Investigator-assessed DFS [Time Frame: From Baseline up to first occurence of event by investigator assessment (up to approximately 88 months)]

Secondary Outcome(s)

IRF-assessed Disease-Free Survival (DFS) [Time Frame: From Baseline until first documented recurrence event (up to approximately 88 months)]

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)]

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)]

Percentage of Participants Who Are Alive and IRF-assessed Recurrence Free at Year 1, 2, and 3 [Time Frame: Up to 3 years]

IRF-assessed Event-free Survival (EFS) [Time Frame: From Baseline until first documented recurrence event (up to approximately 88 months)]

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)]

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)]

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)]

Disease-Specific Survival [Time Frame: From Baseline up to death due to RCC (up to approximately 88 months)]

Overall Survival [Time Frame: From Baseline up to death due to any cause (up to approximately 88 months)]

Percentage of Participants Who Are Alive and Investigator-assessed Recurrence Free at Year 1, 2, and 3 [Time Frame: Up to 3 years]

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)]

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)]

Secondary ID(s)

WO39210

2016-001881-27

Source(s) of Monetary Support

Please refer to primary and secondary sponsors