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

• ClinicalTrials.gov Identifier: NCT03024996
• Recruitment Status: Terminated
• First Posted: January 19, 2017
• Results First Posted: August 3, 2023
• Last Update Posted: August 3, 2023
• Sponsor: Hoffmann-La Roche
• Information provided by (Responsible Party): Hoffmann-La Roche

• Study Type: Interventional
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Double (Participant, Investigator); Primary Purpose: Treatment
• Condition: Renal Cell Carcinoma
• Interventions: Drug: Atezolizumab; Other: Placebo
• Enrollment: 778

Participant Flow

Recruitment Details
Pre-assignment Details	5 participants were randomized but did not receive any treatment.

Arm/Group Title	Atezolizumab	Placebo
Arm/Group Description	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).	Participants received placebo matching to atezolizumab q3w for 16 cycles (each cycle=21 days) or 1 year (whichever occurred first).
Period Title: Overall Study
Started	390	388
Completed	0	0
Not Completed	390	388
Reason Not Completed
Death	57	55
Disease relapse	1	0
Lost to Follow-up	5	10
Other	3	3
Physician Decision	0	1
Study terminated by sponsor	303	283
Withdrawal by Subject	21	36

Baseline Characteristics

Arm/Group Title		Atezolizumab	Placebo	Total
Arm/Group Description		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).	Participants received placebo matching to atezolizumab q3w for 16 cycles (each cycle=21 days) or 1 year (whichever occurred first).	Total of all reporting groups
Overall Number of Baseline Participants		390	388	778
Baseline Analysis Population Description		[Not Specified]
Age, Continuous; Mean (Standard Deviation); Unit of measure: Years
	Number Analyzed	390 participants	388 participants	778 participants
		59.7 (11.3)	59.6 (10.7)	59.7 (11.0)
Sex: Female, Male; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	390 participants	388 participants	778 participants
	Female	103 26.4%	110 28.4%	213 27.4%
	Male	287 73.6%	278 71.6%	565 72.6%
Ethnicity (NIH/OMB); Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	390 participants	388 participants	778 participants
	Hispanic or Latino	41 10.5%	38 9.8%	79 10.2%
	Not Hispanic or Latino	334 85.6%	327 84.3%	661 85.0%
	Unknown or Not Reported	15 3.8%	23 5.9%	38 4.9%
Race (NIH/OMB); Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	390 participants	388 participants	778 participants
	American Indian or Alaska Native	1 0.3%	1 0.3%	2 0.3%
	Asian	43 11.0%	51 13.1%	94 12.1%
	Native Hawaiian or Other Pacific Islander	0 0.0%	0 0.0%	0 0.0%
	Black or African American	8 2.1%	9 2.3%	17 2.2%
	White	324 83.1%	304 78.4%	628 80.7%
	More than one race	0 0.0%	1 0.3%	1 0.1%
	Unknown or Not Reported	14 3.6%	22 5.7%	36 4.6%

Outcome Measures

1. Primary Outcome

Title	Investigator-assessed Disease-Free Survival (DFS)
Description	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)

Outcome Measure Data

Analysis Population Description

The Intent-to-Treat (ITT) population was defined as all randomized participants regardless of whether the assigned study treatment was received.

Arm/Group Title	Atezolizumab	Placebo
Arm/Group Description:	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).	Participants received placebo matching to atezolizumab q3w for 16 cycles (each cycle=21 days) or 1 year (whichever occurred first).
Overall Number of Participants Analyzed	390	388
Median (95% Confidence Interval); Unit of Measure: Months
	57.2 [1]; (44.6 to NA)	49.5 [1]; (47.4 to NA)

[1]

NA = small number of events to calculate the upper CI limit

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Atezolizumab, Placebo
	Comments	[Not Specified]
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.4950
	Comments	[Not Specified]
	Method	Log Rank
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Hazard Ratio (HR)
	Estimated Value	0.93
	Confidence Interval	(2-Sided) 95%; 0.75 to 1.15
	Estimation Comments	[Not Specified]

2. Secondary Outcome

Title	Overall Survival (OS)
Description	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)

Outcome Measure Data

Analysis Population Description

The ITT population was defined as all randomized participants regardless of whether the assigned study treatment was received.

Arm/Group Title	Atezolizumab	Placebo
Arm/Group Description:	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).	Participants received placebo matching to atezolizumab q3w for 16 cycles (each cycle=21 days) or 1 year (whichever occurred first).
Overall Number of Participants Analyzed	390	388
Median (95% Confidence Interval); Unit of Measure: Months
	NA [1]; (59.8 to NA)	NA [2]; (NA to NA)

[1]

NA = wasn't estimable due to small number of events

[2]

NA = no events

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Atezolizumab, Placebo
	Comments	[Not Specified]
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.8868
	Comments	[Not Specified]
	Method	Log Rank
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Hazard Ratio (HR)
	Estimated Value	0.97
	Confidence Interval	95%; 0.67 to 1.42
	Estimation Comments	[Not Specified]

3. Secondary Outcome

Title	Investigator-assessed DFS in Participants With Tumor-Infiltrating Immune Cell (IC) 1/2/3
Description	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)

Outcome Measure Data

Analysis Population Description

The ITT population was defined as all randomized participants regardless of whether the assigned study treatment was received.

Arm/Group Title	Atezolizumab	Placebo
Arm/Group Description:	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).	Participants received placebo matching to atezolizumab q3w for 16 cycles (each cycle=21 days) or 1 year (whichever occurred first).
Overall Number of Participants Analyzed	232	235
Median (95% Confidence Interval); Unit of Measure: Months
	57.2 [1]; (44.6 to NA)	47.9 [1]; (38.6 to NA)

[1]

NA = small number of events to calculate the upper CI limit

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Atezolizumab, Placebo
	Comments	[Not Specified]
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.2010
	Comments	[Not Specified]
	Method	Log Rank
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Hazard Ratio (HR)
	Estimated Value	0.83
	Confidence Interval	(2-Sided) 95%; 0.63 to 1.10
	Estimation Comments	[Not Specified]

4. Secondary Outcome

Title	Independent Review Facility (IRF)-Assessed DFS
Description	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)

Outcome Measure Data

Analysis Population Description

The ITT population was defined as all randomized participants regardless of whether the assigned study treatment was received.

Arm/Group Title	Atezolizumab	Placebo
Arm/Group Description:	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).	Participants received placebo matching to atezolizumab q3w for 16 cycles (each cycle=21 days) or 1 year (whichever occurred first).
Overall Number of Participants Analyzed	390	388
Median (95% Confidence Interval); Unit of Measure: Months
	NA [1]; (54.1 to NA)	NA [1]; (49.4 to NA)

[1]

NA = wasn't estimable due to small number of events

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Atezolizumab, Placebo
	Comments	[Not Specified]
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.2811
	Comments	[Not Specified]
	Method	Log Rank
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Hazard Ratio (HR)
	Estimated Value	0.87
	Confidence Interval	(2-Sided) 95%; 0.69 to 1.12
	Estimation Comments	[Not Specified]

5. Secondary Outcome

Title	IRF-assessed DFS in Participants With Tumor-Infiltrating IC 1/2/3
Description	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)

Outcome Measure Data

Analysis Population Description

The ITT population was defined as all randomized participants regardless of whether the assigned study treatment was received.

Arm/Group Title	Atezolizumab	Placebo
Arm/Group Description:	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).	Participants received placebo matching to atezolizumab q3w for 16 cycles (each cycle=21 days) or 1 year (whichever occurred first).
Overall Number of Participants Analyzed	232	235
Median (95% Confidence Interval); Unit of Measure: Months
	NA [1]; (NA to NA)	NA [2]; (41.4 to NA)

[1]

NA = no events

[2]

NA = wasn't estimable due to small number of events

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Atezolizumab, Placebo
	Comments	[Not Specified]
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.0735
	Comments	[Not Specified]
	Method	Log Rank
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Hazard Ratio (HR)
	Estimated Value	0.75
	Confidence Interval	(2-Sided) 95%; 0.55 to 1.03
	Estimation Comments	[Not Specified]

6. Secondary Outcome

Title	IRF-assessed Event-free Survival (EFS)
Description	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)

Outcome Measure Data

Analysis Population Description

The ITT population was defined as all randomized participants regardless of whether the assigned study treatment was received.

Arm/Group Title	Atezolizumab	Placebo
Arm/Group Description:	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).	Participants received placebo matching to atezolizumab q3w for 16 cycles (each cycle=21 days) or 1 year (whichever occurred first).
Overall Number of Participants Analyzed	390	388
Median (95% Confidence Interval); Unit of Measure: Months
	NA [1]; (54.1 to NA)	NA [1]; (45.4 to NA)

[1]

NA = wasn't estimable due to small number of events

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Atezolizumab, Placebo
	Comments	[Not Specified]
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.1396
	Comments	[Not Specified]
	Method	Log Rank
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Hazard Ratio (HR)
	Estimated Value	0.84
	Confidence Interval	(2-Sided) 95%; 0.67 to 1.06
	Estimation Comments	[Not Specified]

7. Secondary Outcome

Title	Disease-Specific Survival
Description	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)

Outcome Measure Data

Analysis Population Description

The ITT population was defined as all randomized participants regardless of whether the assigned study treatment was received.

Arm/Group Title	Atezolizumab	Placebo
Arm/Group Description:	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).	Participants received placebo matching to atezolizumab q3w for 16 cycles (each cycle=21 days) or 1 year (whichever occurred first).
Overall Number of Participants Analyzed	390	388
Median (95% Confidence Interval); Unit of Measure: Months
	NA [1]; (NA to NA)	NA [1]; (NA to NA)

[1]

NA = no events

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Atezolizumab, Placebo
	Comments	[Not Specified]
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.4762
	Comments	[Not Specified]
	Method	Log Rank
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Hazard Ratio (HR)
	Estimated Value	0.85
	Confidence Interval	(2-Sided) 95%; 0.55 to 1.33
	Estimation Comments	[Not Specified]

8. Secondary Outcome

Title	Distant Metastasis-Free Survival
Description	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)

Outcome Measure Data

Analysis Population Description

The ITT population was defined as all randomized participants regardless of whether the assigned study treatment was received.

Arm/Group Title	Atezolizumab	Placebo
Arm/Group Description:	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).	Participants received placebo matching to atezolizumab q3w for 16 cycles (each cycle=21 days) or 1 year (whichever occurred first).
Overall Number of Participants Analyzed	390	388
Median (95% Confidence Interval); Unit of Measure: Months
	NA [1]; (48.4 to NA)	52.9 [2]; (47.9 to NA)

[1]

NA = wasn't estimable due to small number of events

[2]

NA = small number of events to calculate the upper CI limit

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Atezolizumab, Placebo
	Comments	[Not Specified]
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.5111
	Comments	[Not Specified]
	Method	Log Rank
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Hazard Ratio (HR)
	Estimated Value	0.93
	Confidence Interval	(2-Sided) 95%; 0.74 to 1.16
	Estimation Comments	[Not Specified]

9. Secondary Outcome

Title	Percentage of Participants Who Are Alive and IRF-assessed Recurrence Free at Year 1, 2, and 3
Description	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

Outcome Measure Data

Analysis Population Description

The ITT population was defined as all randomized participants regardless of whether the assigned study treatment was received.

Arm/Group Title	Atezolizumab	Placebo
Arm/Group Description:	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).	Participants received placebo matching to atezolizumab q3w for 16 cycles (each cycle=21 days) or 1 year (whichever occurred first).
Overall Number of Participants Analyzed	390	388
Measure Type: Number; Unit of Measure: Percentage of Participants
Year 1	81.01	76.42
Year 2	70.40	68.22
Year 3	65.04	62.71

10. Secondary Outcome

Title	Percentage of Participants Who Are Alive and Investigator-assessed Recurrence Free at Year 1, 2, and 3
Description	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

Outcome Measure Data

Analysis Population Description

The ITT population was defined as all randomized participants regardless of whether the assigned study treatment was received.

Arm/Group Title		Atezolizumab	Placebo
Arm/Group Description:		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).	Participants received placebo matching to atezolizumab q3w for 16 cycles (each cycle=21 days) or 1 year (whichever occurred first).
Overall Number of Participants Analyzed		390	388
Measure Type: Number; Unit of Measure: Percentage of Participants
Year 1	Number Analyzed	288 participants	275 participants
		77.41	74.12
Year 2	Number Analyzed	244 participants	232 participants
		67.32	65.01
Year 3	Number Analyzed	194 participants	187 participants
		59.43	59.00

11. Secondary Outcome

Title	Percentage of Participants With Adverse Events
Description	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)

Outcome Measure Data

Analysis Population Description

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/Group Title	Atezolizumab	Placebo
Arm/Group Description:	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).	Participants received placebo matching to atezolizumab q3w for 16 cycles (each cycle=21 days) or 1 year (whichever occurred first).
Overall Number of Participants Analyzed	390	383
Measure Type: Count of Participants; Unit of Measure: Participants
	373 95.6%	341 89.0%

12. Secondary Outcome

Title	Maximum Serum Concentration (Cmax) of Atezolizumab
Description	[Not Specified]
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)

Outcome Measure Data

Analysis Population Description

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/Group Title	Atezolizumab
Arm/Group Description:	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).
Overall Number of Participants Analyzed	369
Mean (Standard Deviation); Unit of Measure: Micrograms per milliliter (ug/mL)
	399 (138)

13. Secondary Outcome

Title	Minimum Serum Concentration (Cmin) of Atezolizumab
Description	[Not Specified]
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)

Outcome Measure Data

Analysis Population Description

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/Group Title	Atezolizumab
Arm/Group Description:	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).
Overall Number of Participants Analyzed	85
Mean (Standard Deviation); Unit of Measure: ug/mL
	34.1 (30.1)

14. Secondary Outcome

Title	Percentage of Participants With Anti-Drug Antibodies (ADA) to Atezolizumab
Description	[Not Specified]
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)

Outcome Measure Data

Analysis Population Description

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/Group Title	Atezolizumab
Arm/Group Description:	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).
Overall Number of Participants Analyzed	390
Measure Type: Count of Participants; Unit of Measure: Participants
Baseline	7 1.8%
Treatment Emergent ADAs	103 26.4%

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 71 months)
Adverse Event Reporting Description	All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants regardless of whether the assigned study treatment was received. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study treatment, regardless of whether a full or partial dose was received.
Arm/Group Title	Atezolizumab		Placebo
Arm/Group Description	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).		Participants received placebo matching to atezolizumab q3w for 16 cycles (each cycle=21 days) or 1 year (whichever occurred first).
All-Cause Mortality
	Atezolizumab		Placebo
	Affected / at Risk (%)		Affected / at Risk (%)
Total	57/390 (14.62%)		55/388 (14.18%)
Serious Adverse Events
	Atezolizumab		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	69/390 (17.69%)		46/383 (12.01%)
Blood and lymphatic system disorders
Anaemia † 1	2/390 (0.51%)	2	0/383 (0.00%)	0
Leukopenia † 1	1/390 (0.26%)	1	0/383 (0.00%)	0
Cardiac disorders
Angina pectoris † 1	0/390 (0.00%)	0	1/383 (0.26%)	1
Atrial fibrillation † 1	2/390 (0.51%)	2	0/383 (0.00%)	0
Atrial flutter † 1	0/390 (0.00%)	0	1/383 (0.26%)	1
Coronary artery occlusion † 1	0/390 (0.00%)	0	1/383 (0.26%)	1
Myocardial infarction † 1	0/390 (0.00%)	0	1/383 (0.26%)	1
Myocarditis † 1	1/390 (0.26%)	1	0/383 (0.00%)	0
Tachycardia † 1	0/390 (0.00%)	0	1/383 (0.26%)	1
Ventricular arrhythmia † 1	1/390 (0.26%)	1	0/383 (0.00%)	0
Ear and labyrinth disorders
Vertigo † 1	1/390 (0.26%)	1	1/383 (0.26%)	1
Endocrine disorders
Adrenal insufficiency † 1	1/390 (0.26%)	1	0/383 (0.00%)	0
Basedow's disease † 1	1/390 (0.26%)	1	0/383 (0.00%)	0
Eye disorders
Blindness unilateral † 1	0/390 (0.00%)	0	1/383 (0.26%)	1
Gastrointestinal disorders
Abdominal pain † 1	1/390 (0.26%)	1	0/383 (0.00%)	0
Colitis † 1	3/390 (0.77%)	4	0/383 (0.00%)	0
Diarrhoea † 1	3/390 (0.77%)	3	1/383 (0.26%)	1
Eosinophilic colitis † 1	1/390 (0.26%)	1	0/383 (0.00%)	0
Haemorrhoidal haemorrhage † 1	0/390 (0.00%)	0	1/383 (0.26%)	1
Intestinal obstruction † 1	1/390 (0.26%)	1	1/383 (0.26%)	1
Large intestine polyp † 1	1/390 (0.26%)	1	0/383 (0.00%)	0
Pancreatitis † 1	0/390 (0.00%)	0	1/383 (0.26%)	1
Pancreatitis acute † 1	0/390 (0.00%)	0	2/383 (0.52%)	2
Umbilical hernia † 1	1/390 (0.26%)	1	0/383 (0.00%)	0
Vomiting † 1	2/390 (0.51%)	2	0/383 (0.00%)	0
General disorders
Asthenia † 1	2/390 (0.51%)	2	0/383 (0.00%)	0
Death † 1	0/390 (0.00%)	0	1/383 (0.26%)	1
Influenza like illness † 1	2/390 (0.51%)	2	0/383 (0.00%)	0
Non-cardiac chest pain † 1	1/390 (0.26%)	1	0/383 (0.00%)	0
Polyp † 1	1/390 (0.26%)	1	0/383 (0.00%)	0
Pyrexia † 1	3/390 (0.77%)	3	0/383 (0.00%)	0
Ulcer † 1	1/390 (0.26%)	1	0/383 (0.00%)	0
Hepatobiliary disorders
Cholecystitis † 1	0/390 (0.00%)	0	3/383 (0.78%)	3
Cholecystitis acute † 1	0/390 (0.00%)	0	1/383 (0.26%)	1
Hepatitis † 1	1/390 (0.26%)	1	0/383 (0.00%)	0
Immune system disorders
Hypersensitivity † 1	1/390 (0.26%)	1	0/383 (0.00%)	0
Immune-mediated adverse reaction † 1	1/390 (0.26%)	1	0/383 (0.00%)	0
Systemic immune activation † 1	1/390 (0.26%)	1	0/383 (0.00%)	0
Infections and infestations
Cellulitis † 1	1/390 (0.26%)	1	1/383 (0.26%)	1
Diarrhoea infectious † 1	0/390 (0.00%)	0	1/383 (0.26%)	1
Diverticulitis † 1	1/390 (0.26%)	1	0/383 (0.00%)	0
Erysipelas † 1	1/390 (0.26%)	1	0/383 (0.00%)	0
Gastroenteritis viral † 1	0/390 (0.00%)	0	1/383 (0.26%)	1
Herpes ophthalmic † 1	1/390 (0.26%)	1	0/383 (0.00%)	0
Influenza † 1	0/390 (0.00%)	0	1/383 (0.26%)	1
Lower respiratory tract infection viral † 1	1/390 (0.26%)	1	0/383 (0.00%)	0
Mediastinitis † 1	1/390 (0.26%)	1	0/383 (0.00%)	0
Meningitis aseptic † 1	1/390 (0.26%)	1	0/383 (0.00%)	0
Oesophageal candidiasis † 1	0/390 (0.00%)	0	1/383 (0.26%)	1
Pharyngeal abscess † 1	1/390 (0.26%)	1	0/383 (0.00%)	0
Pharyngitis † 1	0/390 (0.00%)	0	1/383 (0.26%)	1
Pneumonia † 1	3/390 (0.77%)	3	2/383 (0.52%)	2
Salpingitis † 1	1/390 (0.26%)	1	0/383 (0.00%)	0
Sepsis † 1	1/390 (0.26%)	1	2/383 (0.52%)	2
Sinusitis † 1	1/390 (0.26%)	1	0/383 (0.00%)	0
Streptococcal infection † 1	1/390 (0.26%)	1	0/383 (0.00%)	0
Urinary tract infection † 1	4/390 (1.03%)	4	3/383 (0.78%)	3
Urosepsis † 1	1/390 (0.26%)	1	0/383 (0.00%)	0
Injury, poisoning and procedural complications
Contusion † 1	0/390 (0.00%)	0	1/383 (0.26%)	1
Fall † 1	1/390 (0.26%)	1	0/383 (0.00%)	0
Infusion related reaction † 1	1/390 (0.26%)	1	0/383 (0.00%)	0
Lower limb fracture † 1	0/390 (0.00%)	0	1/383 (0.26%)	1
Post procedural fever † 1	1/390 (0.26%)	1	0/383 (0.00%)	0
Upper limb fracture † 1	1/390 (0.26%)	1	1/383 (0.26%)	1
Investigations
Alanine aminotransferase increased † 1	1/390 (0.26%)	1	0/383 (0.00%)	0
Aspartate aminotransferase increased † 1	1/390 (0.26%)	1	0/383 (0.00%)	0
Metabolism and nutrition disorders
Diabetic ketoacidosis † 1	1/390 (0.26%)	1	0/383 (0.00%)	0
Hyperglycaemia † 1	5/390 (1.28%)	5	2/383 (0.52%)	2
Musculoskeletal and connective tissue disorders
Arthralgia † 1	0/390 (0.00%)	0	1/383 (0.26%)	1
Arthritis † 1	1/390 (0.26%)	1	0/383 (0.00%)	0
Flank pain † 1	1/390 (0.26%)	1	0/383 (0.00%)	0
Muscular weakness † 1	1/390 (0.26%)	1	0/383 (0.00%)	0
Myositis † 1	1/390 (0.26%)	1	0/383 (0.00%)	0
Polymyositis † 1	1/390 (0.26%)	1	0/383 (0.00%)	0
Rhabdomyolysis † 1	1/390 (0.26%)	1	0/383 (0.00%)	0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Acute myeloid leukaemia † 1	1/390 (0.26%)	1	0/383 (0.00%)	0
Adenocarcinoma of colon † 1	1/390 (0.26%)	1	1/383 (0.26%)	1
Bladder papilloma † 1	0/390 (0.00%)	0	1/383 (0.26%)	1
Colorectal adenoma † 1	0/390 (0.00%)	0	1/383 (0.26%)	1
Gallbladder cancer † 1	0/390 (0.00%)	0	1/383 (0.26%)	1
Nervous system disorders
Aphasia † 1	1/390 (0.26%)	1	0/383 (0.00%)	0
Axonal neuropathy † 1	1/390 (0.26%)	1	0/383 (0.00%)	0
Cerebrovascular accident † 1	0/390 (0.00%)	0	2/383 (0.52%)	2
Dizziness † 1	1/390 (0.26%)	1	0/383 (0.00%)	0
Encephalopathy † 1	0/390 (0.00%)	0	1/383 (0.26%)	1
Haemorrhage intracranial † 1	1/390 (0.26%)	1	0/383 (0.00%)	0
Headache † 1	1/390 (0.26%)	1	2/383 (0.52%)	2
Hypoaesthesia † 1	1/390 (0.26%)	1	0/383 (0.00%)	0
Neuropathy peripheral † 1	1/390 (0.26%)	1	0/383 (0.00%)	0
Paraesthesia † 1	1/390 (0.26%)	1	0/383 (0.00%)	0
Presyncope † 1	0/390 (0.00%)	0	2/383 (0.52%)	2
Seizure † 1	1/390 (0.26%)	1	0/383 (0.00%)	0
Syncope † 1	2/390 (0.51%)	2	1/383 (0.26%)	1
Tremor † 1	1/390 (0.26%)	1	0/383 (0.00%)	0
Psychiatric disorders
Depression † 1	1/390 (0.26%)	1	0/383 (0.00%)	0
Renal and urinary disorders
Acute kidney injury † 1	0/390 (0.00%)	0	3/383 (0.78%)	3
Tubulointerstitial nephritis † 1	1/390 (0.26%)	1	0/383 (0.00%)	0
Respiratory, thoracic and mediastinal disorders
Acute pulmonary oedema † 1	1/390 (0.26%)	1	0/383 (0.00%)	0
Aspiration † 1	0/390 (0.00%)	0	1/383 (0.26%)	1
Dyspnoea † 1	1/390 (0.26%)	1	0/383 (0.00%)	0
Pleural effusion † 1	1/390 (0.26%)	1	0/383 (0.00%)	0
Pulmonary embolism † 1	3/390 (0.77%)	3	1/383 (0.26%)	1
Pulmonary mass † 1	0/390 (0.00%)	0	1/383 (0.26%)	1
Respiratory failure † 1	0/390 (0.00%)	0	1/383 (0.26%)	1
Skin and subcutaneous tissue disorders
Dermatitis † 1	1/390 (0.26%)	1	0/383 (0.00%)	0
Dermatitis psoriasiform † 1	1/390 (0.26%)	1	0/383 (0.00%)	0
Psoriasis † 1	1/390 (0.26%)	1	0/383 (0.00%)	0
Vascular disorders
Hypertension † 1	0/390 (0.00%)	0	1/383 (0.26%)	1
Hypotension † 1	0/390 (0.00%)	0	1/383 (0.26%)	1
Vasculitis † 1	1/390 (0.26%)	1	0/383 (0.00%)	0
1 Term from vocabulary, MedDRA 25.1; † Indicates events were collected by systematic assessment
Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events	5%
	Atezolizumab		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	329/390 (84.36%)		290/383 (75.72%)
Blood and lymphatic system disorders
Anaemia † 1	24/390 (6.15%)	29	14/383 (3.66%)	15
Endocrine disorders
Hyperthyroidism † 1	20/390 (5.13%)	21	4/383 (1.04%)	4
Hypothyroidism † 1	56/390 (14.36%)	62	12/383 (3.13%)	13
Gastrointestinal disorders
Abdominal pain † 1	26/390 (6.67%)	31	23/383 (6.01%)	24
Constipation † 1	26/390 (6.67%)	29	26/383 (6.79%)	28
Diarrhoea † 1	85/390 (21.79%)	128	79/383 (20.63%)	125
Dry mouth † 1	26/390 (6.67%)	29	6/383 (1.57%)	6
Nausea † 1	46/390 (11.79%)	64	54/383 (14.10%)	77
Vomiting † 1	18/390 (4.62%)	19	28/383 (7.31%)	29
General disorders
Asthenia † 1	36/390 (9.23%)	47	26/383 (6.79%)	28
Fatigue † 1	110/390 (28.21%)	145	93/383 (24.28%)	124
Influenza like illness † 1	29/390 (7.44%)	39	18/383 (4.70%)	27
Oedema peripheral † 1	21/390 (5.38%)	26	17/383 (4.44%)	19
Pyrexia † 1	41/390 (10.51%)	44	16/383 (4.18%)	32
Infections and infestations
Nasopharyngitis † 1	23/390 (5.90%)	30	26/383 (6.79%)	32
Upper respiratory tract infection † 1	33/390 (8.46%)	39	27/383 (7.05%)	31
Investigations
Alanine aminotransferase increased † 1	26/390 (6.67%)	29	12/383 (3.13%)	15
Blood creatinine increased † 1	29/390 (7.44%)	36	29/383 (7.57%)	39
Weight increased † 1	11/390 (2.82%)	13	21/383 (5.48%)	22
Metabolism and nutrition disorders
Decreased appetite † 1	21/390 (5.38%)	26	16/383 (4.18%)	16
Musculoskeletal and connective tissue disorders
Arthralgia † 1	78/390 (20.00%)	101	57/383 (14.88%)	75
Back pain † 1	43/390 (11.03%)	52	45/383 (11.75%)	55
Myalgia † 1	35/390 (8.97%)	40	25/383 (6.53%)	39
Pain in extremity † 1	18/390 (4.62%)	20	20/383 (5.22%)	24
Nervous system disorders
Dizziness † 1	29/390 (7.44%)	30	29/383 (7.57%)	33
Headache † 1	51/390 (13.08%)	65	49/383 (12.79%)	72
Respiratory, thoracic and mediastinal disorders
Cough † 1	51/390 (13.08%)	63	48/383 (12.53%)	51
Dyspnoea † 1	26/390 (6.67%)	34	16/383 (4.18%)	18
Skin and subcutaneous tissue disorders
Pruritus † 1	74/390 (18.97%)	94	48/383 (12.53%)	61
Rash † 1	46/390 (11.79%)	55	20/383 (5.22%)	24
Rash maculo-papular † 1	25/390 (6.41%)	33	14/383 (3.66%)	17
Vascular disorders
Hypertension † 1	19/390 (4.87%)	20	36/383 (9.40%)	41
1 Term from vocabulary, MedDRA 25.1; † Indicates events were collected by systematic assessment

Limitations and Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.

Results Point of Contact

• Name/Title: Medical Communications
• Organization: Hoffmann-La Roche
• Phone: 800 821-8590
• EMail: genentech@druginfo.com

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Pal SK, Uzzo R, Karam JA, Master VA, Donskov F, Suarez C, Albiges L, Rini B, Tomita Y, Kann AG, Procopio G, Massari F, Zibelman M, Antonyan I, Huseni M, Basu D, Ci B, Leung W, Khan O, Dubey S, Bex A. Adjuvant atezolizumab versus placebo for patients with renal cell carcinoma at increased risk of recurrence following resection (IMmotion010): a multicentre, randomised, double-blind, phase 3 trial. Lancet. 2022 Oct 1;400(10358):1103-1116. doi: 10.1016/S0140-6736(22)01658-0. Epub 2022 Sep 10.

Marconi L, Sun M, Beisland C, Klatte T, Ljungberg B, Stewart GD, Dabestani S, Choueiri TK, Bex A. Prevalence, Disease-free, and Overall Survival of Contemporary Patients With Renal Cell Carcinoma Eligible for Adjuvant Checkpoint Inhibitor Trials. Clin Genitourin Cancer. 2021 Apr;19(2):e92-e99. doi: 10.1016/j.clgc.2020.12.005. Epub 2021 Jan 7.

• Responsible Party: Hoffmann-La Roche
• ClinicalTrials.gov Identifier: NCT03024996
• Other Study ID Numbers: WO39210; 2016-001881-27 ( EudraCT Number )
• First Submitted: January 17, 2017
• First Posted: January 19, 2017
• Results First Submitted: April 18, 2023
• Results First Posted: August 3, 2023
• Last Update Posted: August 3, 2023