Renal Cell Carcinoma
Conditions
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.
Interventions
OTHERPlacebo
Placebo matching to atezolizumab q3w
DRUGAtezolizumab
Atezolizumab 1200 mg IV infusion q3w
Sponsors
Hoffmann-La Roche
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Investigator-assessed Disease-Free Survival (DFS) | From baseline up to first occurence of event by investigator assessment (up to approximately 64 months) | Investigator-assessed DFS, defined as the time from randomization to death from any cause or the first documented recurrence assessed by investigator, whichever occurred first. Recurrence was defined as any of the following: Local recurrence of renal cell carcinoma (RCC), new primary RCC, or distant metastasis of RCC. Investigator-assessed DFS was analyzed similarly to the analysis of IRF-assessed DFS. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Investigator-assessed DFS in Participants With Tumor-Infiltrating Immune Cell (IC) 1/2/3 | From baseline until first occurrence of DFS event (up to approximately 64 months) | Investigator assessed DFS for participants with PD-L1 expression of IC1/2/3 vs IC0, defined as the time from randomization to death from any cause or the first documented recurrence assessed by investigator, whichever occurred first. Investigator-assessed DFS was analyzed similarly to the analysis of IRF-assessed DFS. PD-L1 IC0 was defined as \<1% and IC1/2/3 was defined as \>=1% of tumor-infiltrating IC expressing PD-L1 as assessed by immunohistochemistry using SP142 assay. Recurrence was defined as any of the following: Local recurrence of renal cell carcinoma (RCC), new primary RCC, or distant metastasis of RCC. |
| Independent Review Facility (IRF)-Assessed DFS | From baseline until first documented recurrence event (up to approximately 64 months) | IRF-assessed DFS was defined as the time from randomization to death from any cause or the first documented recurrence assessed by IRF, whichever occurred first. |
| IRF-assessed DFS in Participants With Tumor-Infiltrating IC 1/2/3 | From baseline until first occurrence of DFS event (up to approximately 64 months) | IRF-assessed DFS was defined as the time from randomization to death from any cause or the first documented recurrence assessed by IRF, whichever occurred first. PD-L1 IC0 was defined as \<1% and IC1/2/3 was defined as \>=1% of tumor-infiltrating IC expressing PD-L1 as assessed by immunohistochemistry using SP142 assay. |
| IRF-assessed Event-free Survival (EFS) | From baseline until first documented recurrence event (up to approximately 64 months) | IRF-assessed EFS was defined as the time from randomization to death from any cause, or the first documented recurrence in participants without baseline disease by IRF or the first documented disease progression in participants identified as having baseline disease by IRF, whichever occurred first. Disease progression was defined as either unequivocal progression of baseline disease or new unequivocal lesions. |
| Disease-Specific Survival | From baseline up to death due to RCC (up to approximately 64 months) | Disease-specific survival was defined as the time from randomization to death from renal cell carcinoma (RCC). |
| Distant Metastasis-Free Survival | From baseline up to date of diagnosis of distant metastases or death due to any cause (up to approximately 64 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 occurred first. |
| Overall Survival (OS) | From baseline up to death due to any cause (up to approximately 64 months) | OS was defined as the time from randomization to death from any cause. |
| Percentage of Participants Who Are Alive and Investigator-assessed Recurrence Free at Year 1, 2, and 3 | Up to 3 years | Investigator-assessed DFS rate was defined as the percentage of participants being alive and free of recurrence assessed by investigator at Year 1, 2, and 3 after randomization. |
| Percentage of Participants With Adverse Events | From baseline up to death due to any cause (up to approximately 71 months) | An adverse event (AE) was defined as any untoward medical occurrence in a participant administered a pharmaceutical product, regardless of causal attribution. An AE can therefore be any unfavorable and unitended sign (including an abnormal laboratory finding), symptom or disease temporally associated with the use of a pharmaceutical product whether or not considered related to the pharmaceutical product. Preexisting conditions which worsen during a study are also considered as a AEs. |
| Maximum Serum Concentration (Cmax) of Atezolizumab | 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 | 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-Drug Antibodies (ADA) to Atezolizumab | 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) | — |
| Percentage of Participants Who Are Alive and IRF-assessed Recurrence Free at Year 1, 2, and 3 | Up to 3 years | IRF-assessed DFS was defined as the percentage of participants being alive and free of recurrence assessed by IRF at Year 1, 2, and 3 after randomization. |
Countries
Argentina, Australia, Austria, Belgium, Brazil, Canada, Chile, China, Czechia, Denmark, France, Germany, Ireland, Israel, Italy, Japan, Netherlands, Poland, Russia, Serbia, South Korea, Spain, Taiwan, Thailand, Turkey (Türkiye), Ukraine, United Kingdom, United States
Participant flow
Pre-assignment details
5 participants were randomized but did not receive any treatment.
Participants by arm
| Arm | Count |
|---|---|
| Atezolizumab Participants received atezolizumab 1200 milligrams (mg) intravenous (IV) infusion every 3 weeks (q3w) for 16 cycles (each cycle=21 days) or 1 year (whichever occurred first). | 390 |
| Placebo Participants received placebo matching to atezolizumab q3w for 16 cycles (each cycle=21 days) or 1 year (whichever occurred first). | 388 |
| Total | 778 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Death | 57 | 55 |
| Overall Study | Disease relapse | 1 | 0 |
| Overall Study | Lost to Follow-up | 5 | 10 |
| Overall Study | Other | 3 | 3 |
| Overall Study | Physician Decision | 0 | 1 |
| Overall Study | Study terminated by sponsor | 303 | 283 |
| Overall Study | Withdrawal by Subject | 21 | 36 |
Baseline characteristics
| Characteristic | Placebo | Total | Atezolizumab |
|---|---|---|---|
| Age, Continuous | 59.6 Years STANDARD_DEVIATION 10.7 | 59.7 Years STANDARD_DEVIATION 11 | 59.7 Years STANDARD_DEVIATION 11.3 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 38 Participants | 79 Participants | 41 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 327 Participants | 661 Participants | 334 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 23 Participants | 38 Participants | 15 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants | 2 Participants | 1 Participants |
| Race (NIH/OMB) Asian | 51 Participants | 94 Participants | 43 Participants |
| Race (NIH/OMB) Black or African American | 9 Participants | 17 Participants | 8 Participants |
| Race (NIH/OMB) More than one race | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 22 Participants | 36 Participants | 14 Participants |
| Race (NIH/OMB) White | 304 Participants | 628 Participants | 324 Participants |
| Sex: Female, Male Female | 110 Participants | 213 Participants | 103 Participants |
| Sex: Female, Male Male | 278 Participants | 565 Participants | 287 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 57 / 390 | 55 / 388 |
| other Total, other adverse events | 329 / 390 | 290 / 383 |
| serious Total, serious adverse events | 69 / 390 | 46 / 383 |
Outcome results
Primary
Investigator-assessed Disease-Free Survival (DFS)
Investigator-assessed DFS, defined as the time from randomization to death from any cause or the first documented recurrence assessed by investigator, whichever occurred first. Recurrence was defined as any of the following: Local recurrence of renal cell carcinoma (RCC), new primary RCC, or distant metastasis of RCC. Investigator-assessed DFS was analyzed similarly to the analysis of IRF-assessed DFS.
Time frame: From baseline up to first occurence of event by investigator assessment (up to approximately 64 months)
Population: The Intent-to-Treat (ITT) population was defined as all randomized participants regardless of whether the assigned study treatment was received.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Atezolizumab | Investigator-assessed Disease-Free Survival (DFS) | 57.2 Months |
| Placebo | Investigator-assessed Disease-Free Survival (DFS) | 49.5 Months |
p-value: 0.49595% CI: [0.75, 1.15]Log Rank
Secondary
Disease-Specific Survival
Disease-specific survival was defined as the time from randomization to death from renal cell carcinoma (RCC).
Time frame: From baseline up to death due to RCC (up to approximately 64 months)
Population: The ITT population was defined as all randomized participants regardless of whether the assigned study treatment was received.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Atezolizumab | Disease-Specific Survival | NA Months |
| Placebo | Disease-Specific Survival | NA Months |
p-value: 0.476295% CI: [0.55, 1.33]Log Rank
Secondary
Distant Metastasis-Free Survival
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 occurred first.
Time frame: From baseline up to date of diagnosis of distant metastases or death due to any cause (up to approximately 64 months)
Population: The ITT population was defined as all randomized participants regardless of whether the assigned study treatment was received.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Atezolizumab | Distant Metastasis-Free Survival | NA Months |
| Placebo | Distant Metastasis-Free Survival | 52.9 Months |
p-value: 0.511195% CI: [0.74, 1.16]Log Rank
Secondary
Independent Review Facility (IRF)-Assessed DFS
IRF-assessed DFS was defined as the time from randomization to death from any cause or the first documented recurrence assessed by IRF, whichever occurred first.
Time frame: From baseline until first documented recurrence event (up to approximately 64 months)
Population: The ITT population was defined as all randomized participants regardless of whether the assigned study treatment was received.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Atezolizumab | Independent Review Facility (IRF)-Assessed DFS | NA Months |
| Placebo | Independent Review Facility (IRF)-Assessed DFS | NA Months |
p-value: 0.281195% CI: [0.69, 1.12]Log Rank
Secondary
Investigator-assessed DFS in Participants With Tumor-Infiltrating Immune Cell (IC) 1/2/3
Investigator assessed DFS for participants with PD-L1 expression of IC1/2/3 vs IC0, defined as the time from randomization to death from any cause or the first documented recurrence assessed by investigator, whichever occurred first. Investigator-assessed DFS was analyzed similarly to the analysis of IRF-assessed DFS. PD-L1 IC0 was defined as \<1% and IC1/2/3 was defined as \>=1% of tumor-infiltrating IC expressing PD-L1 as assessed by immunohistochemistry using SP142 assay. Recurrence was defined as any of the following: Local recurrence of renal cell carcinoma (RCC), new primary RCC, or distant metastasis of RCC.
Time frame: From baseline until first occurrence of DFS event (up to approximately 64 months)
Population: The ITT population was defined as all randomized participants regardless of whether the assigned study treatment was received.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Atezolizumab | Investigator-assessed DFS in Participants With Tumor-Infiltrating Immune Cell (IC) 1/2/3 | 57.2 Months |
| Placebo | Investigator-assessed DFS in Participants With Tumor-Infiltrating Immune Cell (IC) 1/2/3 | 47.9 Months |
p-value: 0.20195% CI: [0.63, 1.1]Log Rank
Secondary
IRF-assessed DFS in Participants With Tumor-Infiltrating IC 1/2/3
IRF-assessed DFS was defined as the time from randomization to death from any cause or the first documented recurrence assessed by IRF, whichever occurred first. PD-L1 IC0 was defined as \<1% and IC1/2/3 was defined as \>=1% of tumor-infiltrating IC expressing PD-L1 as assessed by immunohistochemistry using SP142 assay.
Time frame: From baseline until first occurrence of DFS event (up to approximately 64 months)
Population: The ITT population was defined as all randomized participants regardless of whether the assigned study treatment was received.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Atezolizumab | IRF-assessed DFS in Participants With Tumor-Infiltrating IC 1/2/3 | NA Months |
| Placebo | IRF-assessed DFS in Participants With Tumor-Infiltrating IC 1/2/3 | NA Months |
p-value: 0.073595% CI: [0.55, 1.03]Log Rank
Secondary
IRF-assessed Event-free Survival (EFS)
IRF-assessed EFS was defined as the time from randomization to death from any cause, or the first documented recurrence in participants without baseline disease by IRF or the first documented disease progression in participants identified as having baseline disease by IRF, whichever occurred first. Disease progression was defined as either unequivocal progression of baseline disease or new unequivocal lesions.
Time frame: From baseline until first documented recurrence event (up to approximately 64 months)
Population: The ITT population was defined as all randomized participants regardless of whether the assigned study treatment was received.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Atezolizumab | IRF-assessed Event-free Survival (EFS) | NA Months |
| Placebo | IRF-assessed Event-free Survival (EFS) | NA Months |
p-value: 0.139695% CI: [0.67, 1.06]Log Rank
Secondary
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)
Population: The pharmacokinetic (PK) population included all randomized participants who received any any dose of study treatment and who had at least one measurable post-baseline PK sample available.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Atezolizumab | Maximum Serum Concentration (Cmax) of Atezolizumab | 399 Micrograms per milliliter (ug/mL) | Standard Deviation 138 |
Secondary
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)
Population: The PK population included all randomized participants who received any any dose of study treatment and who had at least one measurable post-baseline PK sample available.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Atezolizumab | Minimum Serum Concentration (Cmin) of Atezolizumab | 34.1 ug/mL | Standard Deviation 30.1 |
Secondary
Overall Survival (OS)
OS was defined as the time from randomization to death from any cause.
Time frame: From baseline up to death due to any cause (up to approximately 64 months)
Population: The ITT population was defined as all randomized participants regardless of whether the assigned study treatment was received.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Atezolizumab | Overall Survival (OS) | NA Months |
| Placebo | Overall Survival (OS) | NA Months |
p-value: 0.886895% CI: [0.67, 1.42]Log Rank
Secondary
Percentage of Participants Who Are Alive and Investigator-assessed Recurrence Free at Year 1, 2, and 3
Investigator-assessed DFS rate was defined as the percentage of participants being alive and free of recurrence assessed by investigator at Year 1, 2, and 3 after randomization.
Time frame: Up to 3 years
Population: The ITT population was defined as all randomized participants regardless of whether the assigned study treatment was received.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Atezolizumab | Percentage of Participants Who Are Alive and Investigator-assessed Recurrence Free at Year 1, 2, and 3 | Year 1 | 77.41 Percentage of Participants |
| Atezolizumab | Percentage of Participants Who Are Alive and Investigator-assessed Recurrence Free at Year 1, 2, and 3 | Year 2 | 67.32 Percentage of Participants |
| Atezolizumab | Percentage of Participants Who Are Alive and Investigator-assessed Recurrence Free at Year 1, 2, and 3 | Year 3 | 59.43 Percentage of Participants |
| Placebo | Percentage of Participants Who Are Alive and Investigator-assessed Recurrence Free at Year 1, 2, and 3 | Year 1 | 74.12 Percentage of Participants |
| Placebo | Percentage of Participants Who Are Alive and Investigator-assessed Recurrence Free at Year 1, 2, and 3 | Year 2 | 65.01 Percentage of Participants |
| Placebo | Percentage of Participants Who Are Alive and Investigator-assessed Recurrence Free at Year 1, 2, and 3 | Year 3 | 59.00 Percentage of Participants |
Secondary
Percentage of Participants Who Are Alive and IRF-assessed Recurrence Free at Year 1, 2, and 3
IRF-assessed DFS was defined as the percentage of participants being alive and free of recurrence assessed by IRF at Year 1, 2, and 3 after randomization.
Time frame: Up to 3 years
Population: The ITT population was defined as all randomized participants regardless of whether the assigned study treatment was received.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Atezolizumab | Percentage of Participants Who Are Alive and IRF-assessed Recurrence Free at Year 1, 2, and 3 | Year 1 | 81.01 Percentage of Participants |
| Atezolizumab | Percentage of Participants Who Are Alive and IRF-assessed Recurrence Free at Year 1, 2, and 3 | Year 2 | 70.40 Percentage of Participants |
| Atezolizumab | Percentage of Participants Who Are Alive and IRF-assessed Recurrence Free at Year 1, 2, and 3 | Year 3 | 65.04 Percentage of Participants |
| Placebo | Percentage of Participants Who Are Alive and IRF-assessed Recurrence Free at Year 1, 2, and 3 | Year 1 | 76.42 Percentage of Participants |
| Placebo | Percentage of Participants Who Are Alive and IRF-assessed Recurrence Free at Year 1, 2, and 3 | Year 2 | 68.22 Percentage of Participants |
| Placebo | Percentage of Participants Who Are Alive and IRF-assessed Recurrence Free at Year 1, 2, and 3 | Year 3 | 62.71 Percentage of Participants |
Secondary
Percentage of Participants With Adverse Events
An adverse event (AE) was defined as any untoward medical occurrence in a participant administered a pharmaceutical product, regardless of causal attribution. An AE can therefore be any unfavorable and unitended sign (including an abnormal laboratory finding), symptom or disease temporally associated with the use of a pharmaceutical product whether or not considered related to the pharmaceutical product. Preexisting conditions which worsen during a study are also considered as a AEs.
Time frame: From baseline up to death due to any cause (up to approximately 71 months)
Population: The safety population included all randomized participants who received any amount of study treatment, regardless of whether a full or partial dose was received.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Atezolizumab | Percentage of Participants With Adverse Events | 373 Participants |
| Placebo | Percentage of Participants With Adverse Events | 341 Participants |
Secondary
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)
Population: The immunogenicity analysis population will consist of all participants with at least one ADA assessment for atezolizumab. The post-baseline ADA evaluable population included all participants who received at least one dose of atezolizumab and with at least one post-dose ADA assessment.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Atezolizumab | Percentage of Participants With Anti-Drug Antibodies (ADA) to Atezolizumab | Treatment Emergent ADAs | 103 Participants |
| Atezolizumab | Percentage of Participants With Anti-Drug Antibodies (ADA) to Atezolizumab | Baseline | 7 Participants |