Trial Outcomes & Findings for Safety and Pharmacology Study of Atezolizumab Alone and in Combination With Bacille Calmette-Guérin (BCG) in High-Risk Non-Muscle-Invasive Bladder Cancer (NMIBC) Participants (NCT NCT02792192)

NCT ID: NCT02792192

Last Updated: 2021-10-28

Results Overview

Percentage of participants with at least one adverse event during the study.

Recruitment status

TERMINATED

Study phase

PHASE1/PHASE2

Target enrollment

24 participants

Primary outcome timeframe

From Baseline up to end of study (up to approximately 4.3 years)

Results posted on

2021-10-28

Participant Flow

Participants were enrolled only in Cohort 1 of this study. The Sponsor decided not to enroll participants in Cohorts 2 and 3 after the enrollment of 24 patients in Cohort 1 (BCG-unresponsive cohort), as the study had met its goals of providing preliminary safety and efficacy information for atezolizumab monotherapy alone and in combination with BCG in NMIBC.

Participant milestones

Participant milestones
Measure	Cohort 1A: Atezolizumab (BCG-unresponsive NMIBC) Participants received atezolizumab 1200 mg IV infusion q3w, for a maximum of 32 doses or 96 weeks of therapy, whichever comes first.	Cohort 1B: Atezolizumab + BCG (BCG-unresponsive NMIBC) During BCG induction course (12 weeks), participants received atezolizumab 1200 mg IV infusion q3w for a total of four doses plus BCG at the assigned dose weekly for a total of six doses. During BCG maintenance course 1 (12 weeks), participants received atezolizumab 1200 mg IV infusion q3w for a total of four doses plus BCG at the assigned dose weekly for a total of three doses. Optional BCG maintenance courses 2-5 (each 24 weeks), participants received atezolizumab 1200 mg IV infusion q3w for a total of eight doses per course plus BCG at the assigned dose weekly for a total of three doses per course.
Overall Study STARTED	12	12
Overall Study COMPLETED	0	1
Overall Study NOT COMPLETED	12	11

Reasons for withdrawal

Reasons for withdrawal
Measure	Cohort 1A: Atezolizumab (BCG-unresponsive NMIBC) Participants received atezolizumab 1200 mg IV infusion q3w, for a maximum of 32 doses or 96 weeks of therapy, whichever comes first.	Cohort 1B: Atezolizumab + BCG (BCG-unresponsive NMIBC) During BCG induction course (12 weeks), participants received atezolizumab 1200 mg IV infusion q3w for a total of four doses plus BCG at the assigned dose weekly for a total of six doses. During BCG maintenance course 1 (12 weeks), participants received atezolizumab 1200 mg IV infusion q3w for a total of four doses plus BCG at the assigned dose weekly for a total of three doses. Optional BCG maintenance courses 2-5 (each 24 weeks), participants received atezolizumab 1200 mg IV infusion q3w for a total of eight doses per course plus BCG at the assigned dose weekly for a total of three doses per course.
Overall Study Death	1	0
Overall Study Informed Consent Withdrawn	4	0
Overall Study Physician Decision	1	0
Overall Study Progressive Disease	0	1
Overall Study Study Terminated By Sponsor	6	10

Baseline Characteristics

Safety and Pharmacology Study of Atezolizumab Alone and in Combination With Bacille Calmette-Guérin (BCG) in High-Risk Non-Muscle-Invasive Bladder Cancer (NMIBC) Participants

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Cohort 1A: Atezolizumab (BCG-unresponsive NMIBC) n=12 Participants Participants received atezolizumab 1200 mg IV infusion q3w, for a maximum of 32 doses or 96 weeks of therapy, whichever comes first.	Cohort 1B: Atezolizumab + BCG (BCG-unresponsive NMIBC) n=12 Participants During BCG induction course (12 weeks), participants received atezolizumab 1200 mg IV infusion q3w for a total of four doses plus BCG at the assigned dose weekly for a total of six doses. During BCG maintenance course 1 (12 weeks), participants received atezolizumab 1200 mg IV infusion q3w for a total of four doses plus BCG at the assigned dose weekly for a total of three doses. Optional BCG maintenance courses 2-5 (each 24 weeks), participants received atezolizumab 1200 mg IV infusion q3w for a total of eight doses per course plus BCG at the assigned dose weekly for a total of three doses per course.	Cohort 2: Atezolizumab + BCG (BCG-relapsing NMIBC) During BCG induction course (12 weeks), participants were to receive atezolizumab 1200 mg IV infusion q3w for a total of four doses plus BCG at the assigned dose weekly for a total of six doses. During BCG maintenance course 1 (12 weeks), participants were to receive atezolizumab 1200 mg IV infusion q3w for a total of four doses plus BCG at the assigned dose weekly for a total of three doses. During BCG maintenance courses 2-5 (each 24 weeks), participants were to receive atezolizumab 1200 mg IV infusion q3w for a total of eight doses per course plus BCG at the assigned dose weekly for a total of three doses per course.	Cohort 3: Atezolizumab + BCG (BCG-naive NMIBC) During BCG induction course (12 weeks), participants were to receive atezolizumab 1200 mg IV infusion q3w for a total of four doses plus BCG at the assigned dose weekly for a total of six doses. During BCG maintenance course 1 (12 weeks), participants were to receive atezolizumab 1200 mg IV infusion q3w for a total of four doses plus BCG at the assigned dose weekly for a total of three doses. During BCG maintenance courses 2-5 (each 24 weeks), participants were to receive atezolizumab 1200 mg IV infusion q3w for a total of eight doses per course plus BCG at the assigned dose weekly for a total of three doses per course.	Total n=24 Participants Total of all reporting groups
Age, Continuous	72.7 Year STANDARD_DEVIATION 13.2 • n=5 Participants	72.1 Year STANDARD_DEVIATION 9.0 • n=7 Participants	—	—	72.4 Year STANDARD_DEVIATION 11.0 • n=21 Participants
Sex: Female, Male Female	0 Participants n=5 Participants	2 Participants n=7 Participants	—	—	2 Participants n=21 Participants
Sex: Female, Male Male	12 Participants n=5 Participants	10 Participants n=7 Participants	—	—	22 Participants n=21 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	1 Participants n=21 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	12 Participants n=5 Participants	11 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	23 Participants n=21 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Race (NIH/OMB) Black or African American	3 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	4 Participants n=21 Participants
Race (NIH/OMB) White	8 Participants n=5 Participants	10 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	18 Participants n=21 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	1 Participants n=21 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	1 Participants n=21 Participants

PRIMARY outcome

Timeframe: From Baseline up to end of study (up to approximately 4.3 years)

Population: All participants were included in the safety-evaluable population, defined as all participants treated with any amount of study drug. Participants were enrolled only in Cohort 1 of this study. The Sponsor decided not to enroll participants in Cohorts 2 and 3 after the enrollment of 24 patients in Cohort 1, as the study met its goals of providing preliminary safety and efficacy information for atezolizumab monotherapy alone and in combination with BCG in NMIBC.

Percentage of participants with at least one adverse event during the study.

Outcome measures

Outcome measures
Measure	Cohort 1A: Atezolizumab (BCG-unresponsive NMIBC) n=12 Participants Participants received atezolizumab 1200 mg IV infusion q3w, for a maximum of 32 doses or 96 weeks of therapy, whichever comes first.	Cohort 1B: Atezolizumab + BCG (BCG-unresponsive NMIBC) n=12 Participants During BCG induction course (12 weeks), participants received atezolizumab 1200 mg IV infusion q3w for a total of four doses plus BCG at the assigned dose weekly for a total of six doses. During BCG maintenance course 1 (12 weeks), participants received atezolizumab 1200 mg IV infusion q3w for a total of four doses plus BCG at the assigned dose weekly for a total of three doses. Optional BCG maintenance courses 2-5 (each 24 weeks), participants received atezolizumab 1200 mg IV infusion q3w for a total of eight doses per course plus BCG at the assigned dose weekly for a total of three doses per course.	Cohort 2: Atezolizumab + BCG (BCG-relapsing NMIBC) During BCG induction course (12 weeks), participants were to receive atezolizumab 1200 mg IV infusion q3w for a total of four doses plus BCG at the assigned dose weekly for a total of six doses. During BCG maintenance course 1 (12 weeks), participants were to receive atezolizumab 1200 mg IV infusion q3w for a total of four doses plus BCG at the assigned dose weekly for a total of three doses. During BCG maintenance courses 2-5 (each 24 weeks), participants were to receive atezolizumab 1200 mg IV infusion q3w for a total of eight doses per course plus BCG at the assigned dose weekly for a total of three doses per course.	Cohort 3: Atezolizumab + BCG (BCG-naive NMIBC) During BCG induction course (12 weeks), participants were to receive atezolizumab 1200 mg IV infusion q3w for a total of four doses plus BCG at the assigned dose weekly for a total of six doses. During BCG maintenance course 1 (12 weeks), participants were to receive atezolizumab 1200 mg IV infusion q3w for a total of four doses plus BCG at the assigned dose weekly for a total of three doses. During BCG maintenance courses 2-5 (each 24 weeks), participants were to receive atezolizumab 1200 mg IV infusion q3w for a total of eight doses per course plus BCG at the assigned dose weekly for a total of three doses per course.
Percentage of Participants With Adverse Events	100 Percentage of participants	100 Percentage of participants	—	—

PRIMARY outcome

Timeframe: Days 1-21

Population: All participants were included in the safety-evaluable population, defined as all participants treated with any amount of study drug. The Sponsor decided not to enroll participants in Cohorts 2 and 3 after the enrollment of 24 patients in Cohort 1, as the study met its goals of providing preliminary safety and efficacy information for atezolizumab monotherapy alone and in combination with BCG in NMIBC.

Percentage of participants with dose-limiting toxicities (DLT) of BCG in Cohort 1B.

Outcome measures

Outcome measures
Measure	Cohort 1A: Atezolizumab (BCG-unresponsive NMIBC) n=12 Participants Participants received atezolizumab 1200 mg IV infusion q3w, for a maximum of 32 doses or 96 weeks of therapy, whichever comes first.	Cohort 1B: Atezolizumab + BCG (BCG-unresponsive NMIBC) During BCG induction course (12 weeks), participants received atezolizumab 1200 mg IV infusion q3w for a total of four doses plus BCG at the assigned dose weekly for a total of six doses. During BCG maintenance course 1 (12 weeks), participants received atezolizumab 1200 mg IV infusion q3w for a total of four doses plus BCG at the assigned dose weekly for a total of three doses. Optional BCG maintenance courses 2-5 (each 24 weeks), participants received atezolizumab 1200 mg IV infusion q3w for a total of eight doses per course plus BCG at the assigned dose weekly for a total of three doses per course.	Cohort 2: Atezolizumab + BCG (BCG-relapsing NMIBC) During BCG induction course (12 weeks), participants were to receive atezolizumab 1200 mg IV infusion q3w for a total of four doses plus BCG at the assigned dose weekly for a total of six doses. During BCG maintenance course 1 (12 weeks), participants were to receive atezolizumab 1200 mg IV infusion q3w for a total of four doses plus BCG at the assigned dose weekly for a total of three doses. During BCG maintenance courses 2-5 (each 24 weeks), participants were to receive atezolizumab 1200 mg IV infusion q3w for a total of eight doses per course plus BCG at the assigned dose weekly for a total of three doses per course.	Cohort 3: Atezolizumab + BCG (BCG-naive NMIBC) During BCG induction course (12 weeks), participants were to receive atezolizumab 1200 mg IV infusion q3w for a total of four doses plus BCG at the assigned dose weekly for a total of six doses. During BCG maintenance course 1 (12 weeks), participants were to receive atezolizumab 1200 mg IV infusion q3w for a total of four doses plus BCG at the assigned dose weekly for a total of three doses. During BCG maintenance courses 2-5 (each 24 weeks), participants were to receive atezolizumab 1200 mg IV infusion q3w for a total of eight doses per course plus BCG at the assigned dose weekly for a total of three doses per course.
Cohort 1B: Percentage of Participants With DLTs of BCG	16.7 Percentage of participants	—	—	—

PRIMARY outcome

Timeframe: Days 1-21

Maximum administered dose (MAD) of BCG.

Outcome measures

Outcome measures
Measure	Cohort 1A: Atezolizumab (BCG-unresponsive NMIBC) n=12 Participants Participants received atezolizumab 1200 mg IV infusion q3w, for a maximum of 32 doses or 96 weeks of therapy, whichever comes first.	Cohort 1B: Atezolizumab + BCG (BCG-unresponsive NMIBC) During BCG induction course (12 weeks), participants received atezolizumab 1200 mg IV infusion q3w for a total of four doses plus BCG at the assigned dose weekly for a total of six doses. During BCG maintenance course 1 (12 weeks), participants received atezolizumab 1200 mg IV infusion q3w for a total of four doses plus BCG at the assigned dose weekly for a total of three doses. Optional BCG maintenance courses 2-5 (each 24 weeks), participants received atezolizumab 1200 mg IV infusion q3w for a total of eight doses per course plus BCG at the assigned dose weekly for a total of three doses per course.	Cohort 2: Atezolizumab + BCG (BCG-relapsing NMIBC) During BCG induction course (12 weeks), participants were to receive atezolizumab 1200 mg IV infusion q3w for a total of four doses plus BCG at the assigned dose weekly for a total of six doses. During BCG maintenance course 1 (12 weeks), participants were to receive atezolizumab 1200 mg IV infusion q3w for a total of four doses plus BCG at the assigned dose weekly for a total of three doses. During BCG maintenance courses 2-5 (each 24 weeks), participants were to receive atezolizumab 1200 mg IV infusion q3w for a total of eight doses per course plus BCG at the assigned dose weekly for a total of three doses per course.	Cohort 3: Atezolizumab + BCG (BCG-naive NMIBC) During BCG induction course (12 weeks), participants were to receive atezolizumab 1200 mg IV infusion q3w for a total of four doses plus BCG at the assigned dose weekly for a total of six doses. During BCG maintenance course 1 (12 weeks), participants were to receive atezolizumab 1200 mg IV infusion q3w for a total of four doses plus BCG at the assigned dose weekly for a total of three doses. During BCG maintenance courses 2-5 (each 24 weeks), participants were to receive atezolizumab 1200 mg IV infusion q3w for a total of eight doses per course plus BCG at the assigned dose weekly for a total of three doses per course.
Cohort 1B: MAD of BCG	50 mg	—	—	—

PRIMARY outcome

Timeframe: 6 months

Population: Efficacy evaluable participants. The Sponsor decided not to enroll participants in Cohorts 2 and 3 after the enrollment of 24 patients in Cohort 1, as the study met its goals of providing preliminary safety and efficacy information for atezolizumab monotherapy alone and in combination with BCG in NMIBC.

CR at 6 months after the start of study treatment as assessed by the investigator on the basis of cystoscopic assessment and urine cytology.

Outcome measures

Outcome measures
Measure	Cohort 1A: Atezolizumab (BCG-unresponsive NMIBC) n=12 Participants Participants received atezolizumab 1200 mg IV infusion q3w, for a maximum of 32 doses or 96 weeks of therapy, whichever comes first.	Cohort 1B: Atezolizumab + BCG (BCG-unresponsive NMIBC) n=12 Participants During BCG induction course (12 weeks), participants received atezolizumab 1200 mg IV infusion q3w for a total of four doses plus BCG at the assigned dose weekly for a total of six doses. During BCG maintenance course 1 (12 weeks), participants received atezolizumab 1200 mg IV infusion q3w for a total of four doses plus BCG at the assigned dose weekly for a total of three doses. Optional BCG maintenance courses 2-5 (each 24 weeks), participants received atezolizumab 1200 mg IV infusion q3w for a total of eight doses per course plus BCG at the assigned dose weekly for a total of three doses per course.	Cohort 2: Atezolizumab + BCG (BCG-relapsing NMIBC) During BCG induction course (12 weeks), participants were to receive atezolizumab 1200 mg IV infusion q3w for a total of four doses plus BCG at the assigned dose weekly for a total of six doses. During BCG maintenance course 1 (12 weeks), participants were to receive atezolizumab 1200 mg IV infusion q3w for a total of four doses plus BCG at the assigned dose weekly for a total of three doses. During BCG maintenance courses 2-5 (each 24 weeks), participants were to receive atezolizumab 1200 mg IV infusion q3w for a total of eight doses per course plus BCG at the assigned dose weekly for a total of three doses per course.	Cohort 3: Atezolizumab + BCG (BCG-naive NMIBC) During BCG induction course (12 weeks), participants were to receive atezolizumab 1200 mg IV infusion q3w for a total of four doses plus BCG at the assigned dose weekly for a total of six doses. During BCG maintenance course 1 (12 weeks), participants were to receive atezolizumab 1200 mg IV infusion q3w for a total of four doses plus BCG at the assigned dose weekly for a total of three doses. During BCG maintenance courses 2-5 (each 24 weeks), participants were to receive atezolizumab 1200 mg IV infusion q3w for a total of eight doses per course plus BCG at the assigned dose weekly for a total of three doses per course.
Percentage of Participants With Complete Response (CR) as Assessed by the Investigator on the Basis of Cystoscopy and Urine Cytology at Month 6	33.3 Percentage of participants Interval 9.9 to 65.1	41.7 Percentage of participants Interval 15.2 to 72.3	—	—

SECONDARY outcome

Timeframe: 3 months

CR at the 3-month disease assessment, evaluated by both cystoscopy and cytology.

Outcome measures

Outcome measures
Measure	Cohort 1A: Atezolizumab (BCG-unresponsive NMIBC) n=12 Participants Participants received atezolizumab 1200 mg IV infusion q3w, for a maximum of 32 doses or 96 weeks of therapy, whichever comes first.	Cohort 1B: Atezolizumab + BCG (BCG-unresponsive NMIBC) n=12 Participants During BCG induction course (12 weeks), participants received atezolizumab 1200 mg IV infusion q3w for a total of four doses plus BCG at the assigned dose weekly for a total of six doses. During BCG maintenance course 1 (12 weeks), participants received atezolizumab 1200 mg IV infusion q3w for a total of four doses plus BCG at the assigned dose weekly for a total of three doses. Optional BCG maintenance courses 2-5 (each 24 weeks), participants received atezolizumab 1200 mg IV infusion q3w for a total of eight doses per course plus BCG at the assigned dose weekly for a total of three doses per course.	Cohort 2: Atezolizumab + BCG (BCG-relapsing NMIBC) During BCG induction course (12 weeks), participants were to receive atezolizumab 1200 mg IV infusion q3w for a total of four doses plus BCG at the assigned dose weekly for a total of six doses. During BCG maintenance course 1 (12 weeks), participants were to receive atezolizumab 1200 mg IV infusion q3w for a total of four doses plus BCG at the assigned dose weekly for a total of three doses. During BCG maintenance courses 2-5 (each 24 weeks), participants were to receive atezolizumab 1200 mg IV infusion q3w for a total of eight doses per course plus BCG at the assigned dose weekly for a total of three doses per course.	Cohort 3: Atezolizumab + BCG (BCG-naive NMIBC) During BCG induction course (12 weeks), participants were to receive atezolizumab 1200 mg IV infusion q3w for a total of four doses plus BCG at the assigned dose weekly for a total of six doses. During BCG maintenance course 1 (12 weeks), participants were to receive atezolizumab 1200 mg IV infusion q3w for a total of four doses plus BCG at the assigned dose weekly for a total of three doses. During BCG maintenance courses 2-5 (each 24 weeks), participants were to receive atezolizumab 1200 mg IV infusion q3w for a total of eight doses per course plus BCG at the assigned dose weekly for a total of three doses per course.
Percentage of Participants With CR as Assessed by the Investigator on the Basis of Cystoscopy and Urine Cytology at Month 3	16.7 Percentage of participants Interval 2.1 to 48.4	41.7 Percentage of participants Interval 15.2 to 72.3	—	—

SECONDARY outcome

Timeframe: From first occurence of a documented CR until the time of recurrence of NMIBC or death from any cause (up to approximately 4.3 years)

Duration of CR will be defined for participants with a CR as the time from the first occurrence of a documented complete response to recurrence of high-grade NMIBC or death from any cause.

Outcome measures

Outcome measures
Measure	Cohort 1A: Atezolizumab (BCG-unresponsive NMIBC) n=4 Participants Participants received atezolizumab 1200 mg IV infusion q3w, for a maximum of 32 doses or 96 weeks of therapy, whichever comes first.	Cohort 1B: Atezolizumab + BCG (BCG-unresponsive NMIBC) n=5 Participants During BCG induction course (12 weeks), participants received atezolizumab 1200 mg IV infusion q3w for a total of four doses plus BCG at the assigned dose weekly for a total of six doses. During BCG maintenance course 1 (12 weeks), participants received atezolizumab 1200 mg IV infusion q3w for a total of four doses plus BCG at the assigned dose weekly for a total of three doses. Optional BCG maintenance courses 2-5 (each 24 weeks), participants received atezolizumab 1200 mg IV infusion q3w for a total of eight doses per course plus BCG at the assigned dose weekly for a total of three doses per course.	Cohort 2: Atezolizumab + BCG (BCG-relapsing NMIBC) During BCG induction course (12 weeks), participants were to receive atezolizumab 1200 mg IV infusion q3w for a total of four doses plus BCG at the assigned dose weekly for a total of six doses. During BCG maintenance course 1 (12 weeks), participants were to receive atezolizumab 1200 mg IV infusion q3w for a total of four doses plus BCG at the assigned dose weekly for a total of three doses. During BCG maintenance courses 2-5 (each 24 weeks), participants were to receive atezolizumab 1200 mg IV infusion q3w for a total of eight doses per course plus BCG at the assigned dose weekly for a total of three doses per course.	Cohort 3: Atezolizumab + BCG (BCG-naive NMIBC) During BCG induction course (12 weeks), participants were to receive atezolizumab 1200 mg IV infusion q3w for a total of four doses plus BCG at the assigned dose weekly for a total of six doses. During BCG maintenance course 1 (12 weeks), participants were to receive atezolizumab 1200 mg IV infusion q3w for a total of four doses plus BCG at the assigned dose weekly for a total of three doses. During BCG maintenance courses 2-5 (each 24 weeks), participants were to receive atezolizumab 1200 mg IV infusion q3w for a total of eight doses per course plus BCG at the assigned dose weekly for a total of three doses per course.
Duration of CR, as Assessed on the Basis of Cystoscopy and Urine Cytology Participants With CR at 6 Months	6.80 Months Interval 3.06 to Upper limit not estimable. Range: 3.06 to 22.3\* months. \* Indicating a censored observation for CR ongoing at last follow-up.	NA Months Median duration of CR was not reached. No participants had a recurrence event.	—	—
Duration of CR, as Assessed on the Basis of Cystoscopy and Urine Cytology Participants With CR at 3 Months	NA Months Median duration of CR was not reached. For these 2 patients, CR was ongoing with duration of CR 3.61\* and 22.3\* months.	NA Months Interval 3.71 to Median duration of CR was not reached. One patient had a recurrence event (duration of CR 3.71 months). For the remaining 4 patients, CR was ongoing with duration of CR ranging from 2.89\* to 24.5\* months.	—	—

SECONDARY outcome

Timeframe: Cycle 1 Day 1 post-dose (Cycle length=21 days)

Population: PK evaluable participants. The Sponsor decided not to enroll participants in Cohorts 2 and 3 after the enrollment of 24 patients in Cohort 1, as the study met its goals of providing preliminary safety and efficacy information for atezolizumab monotherapy alone and in combination with BCG in NMIBC.

Maximum observed serum concentration of Atezolizumab (Cmax)

Outcome measures

Outcome measures
Measure	Cohort 1A: Atezolizumab (BCG-unresponsive NMIBC) n=12 Participants Participants received atezolizumab 1200 mg IV infusion q3w, for a maximum of 32 doses or 96 weeks of therapy, whichever comes first.	Cohort 1B: Atezolizumab + BCG (BCG-unresponsive NMIBC) n=11 Participants During BCG induction course (12 weeks), participants received atezolizumab 1200 mg IV infusion q3w for a total of four doses plus BCG at the assigned dose weekly for a total of six doses. During BCG maintenance course 1 (12 weeks), participants received atezolizumab 1200 mg IV infusion q3w for a total of four doses plus BCG at the assigned dose weekly for a total of three doses. Optional BCG maintenance courses 2-5 (each 24 weeks), participants received atezolizumab 1200 mg IV infusion q3w for a total of eight doses per course plus BCG at the assigned dose weekly for a total of three doses per course.	Cohort 2: Atezolizumab + BCG (BCG-relapsing NMIBC) During BCG induction course (12 weeks), participants were to receive atezolizumab 1200 mg IV infusion q3w for a total of four doses plus BCG at the assigned dose weekly for a total of six doses. During BCG maintenance course 1 (12 weeks), participants were to receive atezolizumab 1200 mg IV infusion q3w for a total of four doses plus BCG at the assigned dose weekly for a total of three doses. During BCG maintenance courses 2-5 (each 24 weeks), participants were to receive atezolizumab 1200 mg IV infusion q3w for a total of eight doses per course plus BCG at the assigned dose weekly for a total of three doses per course.	Cohort 3: Atezolizumab + BCG (BCG-naive NMIBC) During BCG induction course (12 weeks), participants were to receive atezolizumab 1200 mg IV infusion q3w for a total of four doses plus BCG at the assigned dose weekly for a total of six doses. During BCG maintenance course 1 (12 weeks), participants were to receive atezolizumab 1200 mg IV infusion q3w for a total of four doses plus BCG at the assigned dose weekly for a total of three doses. During BCG maintenance courses 2-5 (each 24 weeks), participants were to receive atezolizumab 1200 mg IV infusion q3w for a total of eight doses per course plus BCG at the assigned dose weekly for a total of three doses per course.
Maximum Observed Serum Concentration of Atezolizumab (Cmax)	413 μg/mL Standard Deviation 109	310 μg/mL Standard Deviation 63.7	—	—

SECONDARY outcome

Timeframe: Pre-dose (0 hr) on Day 1 of Cycles 2, 3, 4 and 8 (Cycle length=21 days)

Minimum observed serum concentration of atezolizumab (Cmin)

Outcome measures

Outcome measures
Measure	Cohort 1A: Atezolizumab (BCG-unresponsive NMIBC) n=12 Participants Participants received atezolizumab 1200 mg IV infusion q3w, for a maximum of 32 doses or 96 weeks of therapy, whichever comes first.	Cohort 1B: Atezolizumab + BCG (BCG-unresponsive NMIBC) n=12 Participants During BCG induction course (12 weeks), participants received atezolizumab 1200 mg IV infusion q3w for a total of four doses plus BCG at the assigned dose weekly for a total of six doses. During BCG maintenance course 1 (12 weeks), participants received atezolizumab 1200 mg IV infusion q3w for a total of four doses plus BCG at the assigned dose weekly for a total of three doses. Optional BCG maintenance courses 2-5 (each 24 weeks), participants received atezolizumab 1200 mg IV infusion q3w for a total of eight doses per course plus BCG at the assigned dose weekly for a total of three doses per course.	Cohort 2: Atezolizumab + BCG (BCG-relapsing NMIBC) During BCG induction course (12 weeks), participants were to receive atezolizumab 1200 mg IV infusion q3w for a total of four doses plus BCG at the assigned dose weekly for a total of six doses. During BCG maintenance course 1 (12 weeks), participants were to receive atezolizumab 1200 mg IV infusion q3w for a total of four doses plus BCG at the assigned dose weekly for a total of three doses. During BCG maintenance courses 2-5 (each 24 weeks), participants were to receive atezolizumab 1200 mg IV infusion q3w for a total of eight doses per course plus BCG at the assigned dose weekly for a total of three doses per course.	Cohort 3: Atezolizumab + BCG (BCG-naive NMIBC) During BCG induction course (12 weeks), participants were to receive atezolizumab 1200 mg IV infusion q3w for a total of four doses plus BCG at the assigned dose weekly for a total of six doses. During BCG maintenance course 1 (12 weeks), participants were to receive atezolizumab 1200 mg IV infusion q3w for a total of four doses plus BCG at the assigned dose weekly for a total of three doses. During BCG maintenance courses 2-5 (each 24 weeks), participants were to receive atezolizumab 1200 mg IV infusion q3w for a total of eight doses per course plus BCG at the assigned dose weekly for a total of three doses per course.
Minimum Observed Serum Concentration of Atezolizumab (Cmin) Cycle 2 Day 1	92.2 μg/mL Standard Deviation 14.9	90.5 μg/mL Standard Deviation 42.6	—	—
Minimum Observed Serum Concentration of Atezolizumab (Cmin) Cycle 3 Day 1	143 μg/mL Standard Deviation 26.1	133 μg/mL Standard Deviation 74.4	—	—
Minimum Observed Serum Concentration of Atezolizumab (Cmin) Cycle 4 Day 1	174 μg/mL Standard Deviation 38.4	162 μg/mL Standard Deviation 91.1	—	—
Minimum Observed Serum Concentration of Atezolizumab (Cmin) Cycle 8 Day 1	211 μg/mL Standard Deviation 59.4	192 μg/mL Standard Deviation 117	—	—

SECONDARY outcome

Timeframe: Pre-dose (0 hr) on Day 1 of Cycles 1, 2, 3, 4, 8, 16, 24 (Cycle length=21 days), end of atezolizumab treatment (up to 96 weeks), 120 days after end of atezolizumab treatment (up to 113 weeks)

Population: ADA evaluable participants. The Sponsor decided not to enroll participants in Cohorts 2 and 3 after the enrollment of 24 patients in Cohort 1, as the study met its goals of providing preliminary safety and efficacy information for atezolizumab monotherapy alone and in combination with BCG in NMIBC.

Percentage of participants with anti-therapeutic antibody (ADA) response to atezolizumab.

Outcome measures

Outcome measures
Measure	Cohort 1A: Atezolizumab (BCG-unresponsive NMIBC) n=12 Participants Participants received atezolizumab 1200 mg IV infusion q3w, for a maximum of 32 doses or 96 weeks of therapy, whichever comes first.	Cohort 1B: Atezolizumab + BCG (BCG-unresponsive NMIBC) n=12 Participants During BCG induction course (12 weeks), participants received atezolizumab 1200 mg IV infusion q3w for a total of four doses plus BCG at the assigned dose weekly for a total of six doses. During BCG maintenance course 1 (12 weeks), participants received atezolizumab 1200 mg IV infusion q3w for a total of four doses plus BCG at the assigned dose weekly for a total of three doses. Optional BCG maintenance courses 2-5 (each 24 weeks), participants received atezolizumab 1200 mg IV infusion q3w for a total of eight doses per course plus BCG at the assigned dose weekly for a total of three doses per course.	Cohort 2: Atezolizumab + BCG (BCG-relapsing NMIBC) During BCG induction course (12 weeks), participants were to receive atezolizumab 1200 mg IV infusion q3w for a total of four doses plus BCG at the assigned dose weekly for a total of six doses. During BCG maintenance course 1 (12 weeks), participants were to receive atezolizumab 1200 mg IV infusion q3w for a total of four doses plus BCG at the assigned dose weekly for a total of three doses. During BCG maintenance courses 2-5 (each 24 weeks), participants were to receive atezolizumab 1200 mg IV infusion q3w for a total of eight doses per course plus BCG at the assigned dose weekly for a total of three doses per course.	Cohort 3: Atezolizumab + BCG (BCG-naive NMIBC) During BCG induction course (12 weeks), participants were to receive atezolizumab 1200 mg IV infusion q3w for a total of four doses plus BCG at the assigned dose weekly for a total of six doses. During BCG maintenance course 1 (12 weeks), participants were to receive atezolizumab 1200 mg IV infusion q3w for a total of four doses plus BCG at the assigned dose weekly for a total of three doses. During BCG maintenance courses 2-5 (each 24 weeks), participants were to receive atezolizumab 1200 mg IV infusion q3w for a total of eight doses per course plus BCG at the assigned dose weekly for a total of three doses per course.
Percentage of Participants With Anti-Therapeutic Antibody (ADA) Response to Atezolizumab Baseline prevalence	9.1 Percentage of participants	0 Percentage of participants	—	—
Percentage of Participants With Anti-Therapeutic Antibody (ADA) Response to Atezolizumab Post-Baseline Treatment-Emergent	8.3 Percentage of participants	41.7 Percentage of participants	—	—

Adverse Events

Cohort 1A: Atezolizumab (BCG-unresponsive NMIBC)

Serious events: 3 serious events

Other events: 11 other events

Deaths: 1 deaths

Cohort 1B: Atezolizumab + BCG (BCG-unresponsive NMIBC)

Serious events: 3 serious events

Other events: 12 other events

Deaths: 0 deaths

Cohort 2: Atezolizumab + BCG (BCG-relapsing NMIBC)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Cohort 3: Atezolizumab + BCG (BCG-naive NMIBC)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Cohort 1A: Atezolizumab (BCG-unresponsive NMIBC) n=12 participants at risk Participants received atezolizumab 1200 mg IV infusion q3w, for a maximum of 32 doses or 96 weeks of therapy, whichever comes first.	Cohort 1B: Atezolizumab + BCG (BCG-unresponsive NMIBC) n=12 participants at risk During BCG induction course (12 weeks), participants received atezolizumab 1200 mg IV infusion q3w for a total of four doses plus BCG at the assigned dose weekly for a total of six doses. During BCG maintenance course 1 (12 weeks), participants received atezolizumab 1200 mg IV infusion q3w for a total of four doses plus BCG at the assigned dose weekly for a total of three doses. Optional BCG maintenance courses 2-5 (each 24 weeks), participants received atezolizumab 1200 mg IV infusion q3w for a total of eight doses per course plus BCG at the assigned dose weekly for a total of three doses per course.	Cohort 2: Atezolizumab + BCG (BCG-relapsing NMIBC) During BCG induction course (12 weeks), participants were to receive atezolizumab 1200 mg IV infusion q3w for a total of four doses plus BCG at the assigned dose weekly for a total of six doses. During BCG maintenance course 1 (12 weeks), participants were to receive atezolizumab 1200 mg IV infusion q3w for a total of four doses plus BCG at the assigned dose weekly for a total of three doses. During BCG maintenance courses 2-5 (each 24 weeks), participants were to receive atezolizumab 1200 mg IV infusion q3w for a total of eight doses per course plus BCG at the assigned dose weekly for a total of three doses per course.	Cohort 3: Atezolizumab + BCG (BCG-naive NMIBC) During BCG induction course (12 weeks), participants were to receive atezolizumab 1200 mg IV infusion q3w for a total of four doses plus BCG at the assigned dose weekly for a total of six doses. During BCG maintenance course 1 (12 weeks), participants were to receive atezolizumab 1200 mg IV infusion q3w for a total of four doses plus BCG at the assigned dose weekly for a total of three doses. During BCG maintenance courses 2-5 (each 24 weeks), participants were to receive atezolizumab 1200 mg IV infusion q3w for a total of eight doses per course plus BCG at the assigned dose weekly for a total of three doses per course.
Blood and lymphatic system disorders Blood loss anaemia	0.00% 0/12 • From the first study drug to the data cutoff date: 29 September 2020 (up to 4.3 years) The Safety Evaluable Population includes all participants treated with any amount of study drug (atezolizumab or BCG). Participants were enrolled only in Cohort 1 of this study. The Sponsor decided not to enroll participants in Cohorts 2 and 3 after the enrollment of 24 patients in Cohort 1, as the study met its goals of providing preliminary safety and efficacy information for atezolizumab monotherapy alone and in combination with BCG in NMIBC.	8.3% 1/12 • Number of events 1 • From the first study drug to the data cutoff date: 29 September 2020 (up to 4.3 years) The Safety Evaluable Population includes all participants treated with any amount of study drug (atezolizumab or BCG). Participants were enrolled only in Cohort 1 of this study. The Sponsor decided not to enroll participants in Cohorts 2 and 3 after the enrollment of 24 patients in Cohort 1, as the study met its goals of providing preliminary safety and efficacy information for atezolizumab monotherapy alone and in combination with BCG in NMIBC.	— 0/0 • From the first study drug to the data cutoff date: 29 September 2020 (up to 4.3 years) The Safety Evaluable Population includes all participants treated with any amount of study drug (atezolizumab or BCG). Participants were enrolled only in Cohort 1 of this study. The Sponsor decided not to enroll participants in Cohorts 2 and 3 after the enrollment of 24 patients in Cohort 1, as the study met its goals of providing preliminary safety and efficacy information for atezolizumab monotherapy alone and in combination with BCG in NMIBC.	— 0/0 • From the first study drug to the data cutoff date: 29 September 2020 (up to 4.3 years) The Safety Evaluable Population includes all participants treated with any amount of study drug (atezolizumab or BCG). Participants were enrolled only in Cohort 1 of this study. The Sponsor decided not to enroll participants in Cohorts 2 and 3 after the enrollment of 24 patients in Cohort 1, as the study met its goals of providing preliminary safety and efficacy information for atezolizumab monotherapy alone and in combination with BCG in NMIBC.
Cardiac disorders Atrial fibrillation	8.3% 1/12 • Number of events 1 • From the first study drug to the data cutoff date: 29 September 2020 (up to 4.3 years) The Safety Evaluable Population includes all participants treated with any amount of study drug (atezolizumab or BCG). Participants were enrolled only in Cohort 1 of this study. The Sponsor decided not to enroll participants in Cohorts 2 and 3 after the enrollment of 24 patients in Cohort 1, as the study met its goals of providing preliminary safety and efficacy information for atezolizumab monotherapy alone and in combination with BCG in NMIBC.	0.00% 0/12 • From the first study drug to the data cutoff date: 29 September 2020 (up to 4.3 years) The Safety Evaluable Population includes all participants treated with any amount of study drug (atezolizumab or BCG). Participants were enrolled only in Cohort 1 of this study. The Sponsor decided not to enroll participants in Cohorts 2 and 3 after the enrollment of 24 patients in Cohort 1, as the study met its goals of providing preliminary safety and efficacy information for atezolizumab monotherapy alone and in combination with BCG in NMIBC.	— 0/0 • From the first study drug to the data cutoff date: 29 September 2020 (up to 4.3 years) The Safety Evaluable Population includes all participants treated with any amount of study drug (atezolizumab or BCG). Participants were enrolled only in Cohort 1 of this study. The Sponsor decided not to enroll participants in Cohorts 2 and 3 after the enrollment of 24 patients in Cohort 1, as the study met its goals of providing preliminary safety and efficacy information for atezolizumab monotherapy alone and in combination with BCG in NMIBC.	— 0/0 • From the first study drug to the data cutoff date: 29 September 2020 (up to 4.3 years) The Safety Evaluable Population includes all participants treated with any amount of study drug (atezolizumab or BCG). Participants were enrolled only in Cohort 1 of this study. The Sponsor decided not to enroll participants in Cohorts 2 and 3 after the enrollment of 24 patients in Cohort 1, as the study met its goals of providing preliminary safety and efficacy information for atezolizumab monotherapy alone and in combination with BCG in NMIBC.
General disorders Complication associated with device	0.00% 0/12 • From the first study drug to the data cutoff date: 29 September 2020 (up to 4.3 years) The Safety Evaluable Population includes all participants treated with any amount of study drug (atezolizumab or BCG). Participants were enrolled only in Cohort 1 of this study. The Sponsor decided not to enroll participants in Cohorts 2 and 3 after the enrollment of 24 patients in Cohort 1, as the study met its goals of providing preliminary safety and efficacy information for atezolizumab monotherapy alone and in combination with BCG in NMIBC.	8.3% 1/12 • Number of events 1 • From the first study drug to the data cutoff date: 29 September 2020 (up to 4.3 years) The Safety Evaluable Population includes all participants treated with any amount of study drug (atezolizumab or BCG). Participants were enrolled only in Cohort 1 of this study. The Sponsor decided not to enroll participants in Cohorts 2 and 3 after the enrollment of 24 patients in Cohort 1, as the study met its goals of providing preliminary safety and efficacy information for atezolizumab monotherapy alone and in combination with BCG in NMIBC.	— 0/0 • From the first study drug to the data cutoff date: 29 September 2020 (up to 4.3 years) The Safety Evaluable Population includes all participants treated with any amount of study drug (atezolizumab or BCG). Participants were enrolled only in Cohort 1 of this study. The Sponsor decided not to enroll participants in Cohorts 2 and 3 after the enrollment of 24 patients in Cohort 1, as the study met its goals of providing preliminary safety and efficacy information for atezolizumab monotherapy alone and in combination with BCG in NMIBC.	— 0/0 • From the first study drug to the data cutoff date: 29 September 2020 (up to 4.3 years) The Safety Evaluable Population includes all participants treated with any amount of study drug (atezolizumab or BCG). Participants were enrolled only in Cohort 1 of this study. The Sponsor decided not to enroll participants in Cohorts 2 and 3 after the enrollment of 24 patients in Cohort 1, as the study met its goals of providing preliminary safety and efficacy information for atezolizumab monotherapy alone and in combination with BCG in NMIBC.
General disorders Pyrexia	8.3% 1/12 • Number of events 1 • From the first study drug to the data cutoff date: 29 September 2020 (up to 4.3 years) The Safety Evaluable Population includes all participants treated with any amount of study drug (atezolizumab or BCG). Participants were enrolled only in Cohort 1 of this study. The Sponsor decided not to enroll participants in Cohorts 2 and 3 after the enrollment of 24 patients in Cohort 1, as the study met its goals of providing preliminary safety and efficacy information for atezolizumab monotherapy alone and in combination with BCG in NMIBC.	0.00% 0/12 • From the first study drug to the data cutoff date: 29 September 2020 (up to 4.3 years) The Safety Evaluable Population includes all participants treated with any amount of study drug (atezolizumab or BCG). Participants were enrolled only in Cohort 1 of this study. The Sponsor decided not to enroll participants in Cohorts 2 and 3 after the enrollment of 24 patients in Cohort 1, as the study met its goals of providing preliminary safety and efficacy information for atezolizumab monotherapy alone and in combination with BCG in NMIBC.	— 0/0 • From the first study drug to the data cutoff date: 29 September 2020 (up to 4.3 years) The Safety Evaluable Population includes all participants treated with any amount of study drug (atezolizumab or BCG). Participants were enrolled only in Cohort 1 of this study. The Sponsor decided not to enroll participants in Cohorts 2 and 3 after the enrollment of 24 patients in Cohort 1, as the study met its goals of providing preliminary safety and efficacy information for atezolizumab monotherapy alone and in combination with BCG in NMIBC.	— 0/0 • From the first study drug to the data cutoff date: 29 September 2020 (up to 4.3 years) The Safety Evaluable Population includes all participants treated with any amount of study drug (atezolizumab or BCG). Participants were enrolled only in Cohort 1 of this study. The Sponsor decided not to enroll participants in Cohorts 2 and 3 after the enrollment of 24 patients in Cohort 1, as the study met its goals of providing preliminary safety and efficacy information for atezolizumab monotherapy alone and in combination with BCG in NMIBC.
Infections and infestations Coronavirus infection	0.00% 0/12 • From the first study drug to the data cutoff date: 29 September 2020 (up to 4.3 years) The Safety Evaluable Population includes all participants treated with any amount of study drug (atezolizumab or BCG). Participants were enrolled only in Cohort 1 of this study. The Sponsor decided not to enroll participants in Cohorts 2 and 3 after the enrollment of 24 patients in Cohort 1, as the study met its goals of providing preliminary safety and efficacy information for atezolizumab monotherapy alone and in combination with BCG in NMIBC.	8.3% 1/12 • Number of events 1 • From the first study drug to the data cutoff date: 29 September 2020 (up to 4.3 years) The Safety Evaluable Population includes all participants treated with any amount of study drug (atezolizumab or BCG). Participants were enrolled only in Cohort 1 of this study. The Sponsor decided not to enroll participants in Cohorts 2 and 3 after the enrollment of 24 patients in Cohort 1, as the study met its goals of providing preliminary safety and efficacy information for atezolizumab monotherapy alone and in combination with BCG in NMIBC.	— 0/0 • From the first study drug to the data cutoff date: 29 September 2020 (up to 4.3 years) The Safety Evaluable Population includes all participants treated with any amount of study drug (atezolizumab or BCG). Participants were enrolled only in Cohort 1 of this study. The Sponsor decided not to enroll participants in Cohorts 2 and 3 after the enrollment of 24 patients in Cohort 1, as the study met its goals of providing preliminary safety and efficacy information for atezolizumab monotherapy alone and in combination with BCG in NMIBC.	— 0/0 • From the first study drug to the data cutoff date: 29 September 2020 (up to 4.3 years) The Safety Evaluable Population includes all participants treated with any amount of study drug (atezolizumab or BCG). Participants were enrolled only in Cohort 1 of this study. The Sponsor decided not to enroll participants in Cohorts 2 and 3 after the enrollment of 24 patients in Cohort 1, as the study met its goals of providing preliminary safety and efficacy information for atezolizumab monotherapy alone and in combination with BCG in NMIBC.
Infections and infestations Pneumonia	0.00% 0/12 • From the first study drug to the data cutoff date: 29 September 2020 (up to 4.3 years) The Safety Evaluable Population includes all participants treated with any amount of study drug (atezolizumab or BCG). Participants were enrolled only in Cohort 1 of this study. The Sponsor decided not to enroll participants in Cohorts 2 and 3 after the enrollment of 24 patients in Cohort 1, as the study met its goals of providing preliminary safety and efficacy information for atezolizumab monotherapy alone and in combination with BCG in NMIBC.	8.3% 1/12 • Number of events 1 • From the first study drug to the data cutoff date: 29 September 2020 (up to 4.3 years) The Safety Evaluable Population includes all participants treated with any amount of study drug (atezolizumab or BCG). Participants were enrolled only in Cohort 1 of this study. The Sponsor decided not to enroll participants in Cohorts 2 and 3 after the enrollment of 24 patients in Cohort 1, as the study met its goals of providing preliminary safety and efficacy information for atezolizumab monotherapy alone and in combination with BCG in NMIBC.	— 0/0 • From the first study drug to the data cutoff date: 29 September 2020 (up to 4.3 years) The Safety Evaluable Population includes all participants treated with any amount of study drug (atezolizumab or BCG). Participants were enrolled only in Cohort 1 of this study. The Sponsor decided not to enroll participants in Cohorts 2 and 3 after the enrollment of 24 patients in Cohort 1, as the study met its goals of providing preliminary safety and efficacy information for atezolizumab monotherapy alone and in combination with BCG in NMIBC.	— 0/0 • From the first study drug to the data cutoff date: 29 September 2020 (up to 4.3 years) The Safety Evaluable Population includes all participants treated with any amount of study drug (atezolizumab or BCG). Participants were enrolled only in Cohort 1 of this study. The Sponsor decided not to enroll participants in Cohorts 2 and 3 after the enrollment of 24 patients in Cohort 1, as the study met its goals of providing preliminary safety and efficacy information for atezolizumab monotherapy alone and in combination with BCG in NMIBC.
Infections and infestations Pyelonephritis	8.3% 1/12 • Number of events 1 • From the first study drug to the data cutoff date: 29 September 2020 (up to 4.3 years) The Safety Evaluable Population includes all participants treated with any amount of study drug (atezolizumab or BCG). Participants were enrolled only in Cohort 1 of this study. The Sponsor decided not to enroll participants in Cohorts 2 and 3 after the enrollment of 24 patients in Cohort 1, as the study met its goals of providing preliminary safety and efficacy information for atezolizumab monotherapy alone and in combination with BCG in NMIBC.	0.00% 0/12 • From the first study drug to the data cutoff date: 29 September 2020 (up to 4.3 years) The Safety Evaluable Population includes all participants treated with any amount of study drug (atezolizumab or BCG). Participants were enrolled only in Cohort 1 of this study. The Sponsor decided not to enroll participants in Cohorts 2 and 3 after the enrollment of 24 patients in Cohort 1, as the study met its goals of providing preliminary safety and efficacy information for atezolizumab monotherapy alone and in combination with BCG in NMIBC.	— 0/0 • From the first study drug to the data cutoff date: 29 September 2020 (up to 4.3 years) The Safety Evaluable Population includes all participants treated with any amount of study drug (atezolizumab or BCG). Participants were enrolled only in Cohort 1 of this study. The Sponsor decided not to enroll participants in Cohorts 2 and 3 after the enrollment of 24 patients in Cohort 1, as the study met its goals of providing preliminary safety and efficacy information for atezolizumab monotherapy alone and in combination with BCG in NMIBC.	— 0/0 • From the first study drug to the data cutoff date: 29 September 2020 (up to 4.3 years) The Safety Evaluable Population includes all participants treated with any amount of study drug (atezolizumab or BCG). Participants were enrolled only in Cohort 1 of this study. The Sponsor decided not to enroll participants in Cohorts 2 and 3 after the enrollment of 24 patients in Cohort 1, as the study met its goals of providing preliminary safety and efficacy information for atezolizumab monotherapy alone and in combination with BCG in NMIBC.
Renal and urinary disorders Haematuria	0.00% 0/12 • From the first study drug to the data cutoff date: 29 September 2020 (up to 4.3 years) The Safety Evaluable Population includes all participants treated with any amount of study drug (atezolizumab or BCG). Participants were enrolled only in Cohort 1 of this study. The Sponsor decided not to enroll participants in Cohorts 2 and 3 after the enrollment of 24 patients in Cohort 1, as the study met its goals of providing preliminary safety and efficacy information for atezolizumab monotherapy alone and in combination with BCG in NMIBC.	16.7% 2/12 • Number of events 2 • From the first study drug to the data cutoff date: 29 September 2020 (up to 4.3 years) The Safety Evaluable Population includes all participants treated with any amount of study drug (atezolizumab or BCG). Participants were enrolled only in Cohort 1 of this study. The Sponsor decided not to enroll participants in Cohorts 2 and 3 after the enrollment of 24 patients in Cohort 1, as the study met its goals of providing preliminary safety and efficacy information for atezolizumab monotherapy alone and in combination with BCG in NMIBC.	— 0/0 • From the first study drug to the data cutoff date: 29 September 2020 (up to 4.3 years) The Safety Evaluable Population includes all participants treated with any amount of study drug (atezolizumab or BCG). Participants were enrolled only in Cohort 1 of this study. The Sponsor decided not to enroll participants in Cohorts 2 and 3 after the enrollment of 24 patients in Cohort 1, as the study met its goals of providing preliminary safety and efficacy information for atezolizumab monotherapy alone and in combination with BCG in NMIBC.	— 0/0 • From the first study drug to the data cutoff date: 29 September 2020 (up to 4.3 years) The Safety Evaluable Population includes all participants treated with any amount of study drug (atezolizumab or BCG). Participants were enrolled only in Cohort 1 of this study. The Sponsor decided not to enroll participants in Cohorts 2 and 3 after the enrollment of 24 patients in Cohort 1, as the study met its goals of providing preliminary safety and efficacy information for atezolizumab monotherapy alone and in combination with BCG in NMIBC.
Renal and urinary disorders Urinary retention	0.00% 0/12 • From the first study drug to the data cutoff date: 29 September 2020 (up to 4.3 years) The Safety Evaluable Population includes all participants treated with any amount of study drug (atezolizumab or BCG). Participants were enrolled only in Cohort 1 of this study. The Sponsor decided not to enroll participants in Cohorts 2 and 3 after the enrollment of 24 patients in Cohort 1, as the study met its goals of providing preliminary safety and efficacy information for atezolizumab monotherapy alone and in combination with BCG in NMIBC.	0.00% 0/12 • From the first study drug to the data cutoff date: 29 September 2020 (up to 4.3 years) The Safety Evaluable Population includes all participants treated with any amount of study drug (atezolizumab or BCG). Participants were enrolled only in Cohort 1 of this study. The Sponsor decided not to enroll participants in Cohorts 2 and 3 after the enrollment of 24 patients in Cohort 1, as the study met its goals of providing preliminary safety and efficacy information for atezolizumab monotherapy alone and in combination with BCG in NMIBC.	— 0/0 • From the first study drug to the data cutoff date: 29 September 2020 (up to 4.3 years) The Safety Evaluable Population includes all participants treated with any amount of study drug (atezolizumab or BCG). Participants were enrolled only in Cohort 1 of this study. The Sponsor decided not to enroll participants in Cohorts 2 and 3 after the enrollment of 24 patients in Cohort 1, as the study met its goals of providing preliminary safety and efficacy information for atezolizumab monotherapy alone and in combination with BCG in NMIBC.	— 0/0 • From the first study drug to the data cutoff date: 29 September 2020 (up to 4.3 years) The Safety Evaluable Population includes all participants treated with any amount of study drug (atezolizumab or BCG). Participants were enrolled only in Cohort 1 of this study. The Sponsor decided not to enroll participants in Cohorts 2 and 3 after the enrollment of 24 patients in Cohort 1, as the study met its goals of providing preliminary safety and efficacy information for atezolizumab monotherapy alone and in combination with BCG in NMIBC.
Respiratory, thoracic and mediastinal disorders Aspiration	8.3% 1/12 • Number of events 1 • From the first study drug to the data cutoff date: 29 September 2020 (up to 4.3 years) The Safety Evaluable Population includes all participants treated with any amount of study drug (atezolizumab or BCG). Participants were enrolled only in Cohort 1 of this study. The Sponsor decided not to enroll participants in Cohorts 2 and 3 after the enrollment of 24 patients in Cohort 1, as the study met its goals of providing preliminary safety and efficacy information for atezolizumab monotherapy alone and in combination with BCG in NMIBC.	0.00% 0/12 • From the first study drug to the data cutoff date: 29 September 2020 (up to 4.3 years) The Safety Evaluable Population includes all participants treated with any amount of study drug (atezolizumab or BCG). Participants were enrolled only in Cohort 1 of this study. The Sponsor decided not to enroll participants in Cohorts 2 and 3 after the enrollment of 24 patients in Cohort 1, as the study met its goals of providing preliminary safety and efficacy information for atezolizumab monotherapy alone and in combination with BCG in NMIBC.	— 0/0 • From the first study drug to the data cutoff date: 29 September 2020 (up to 4.3 years) The Safety Evaluable Population includes all participants treated with any amount of study drug (atezolizumab or BCG). Participants were enrolled only in Cohort 1 of this study. The Sponsor decided not to enroll participants in Cohorts 2 and 3 after the enrollment of 24 patients in Cohort 1, as the study met its goals of providing preliminary safety and efficacy information for atezolizumab monotherapy alone and in combination with BCG in NMIBC.	— 0/0 • From the first study drug to the data cutoff date: 29 September 2020 (up to 4.3 years) The Safety Evaluable Population includes all participants treated with any amount of study drug (atezolizumab or BCG). Participants were enrolled only in Cohort 1 of this study. The Sponsor decided not to enroll participants in Cohorts 2 and 3 after the enrollment of 24 patients in Cohort 1, as the study met its goals of providing preliminary safety and efficacy information for atezolizumab monotherapy alone and in combination with BCG in NMIBC.

Other adverse events

Additional Information

Medical Communications

Hoffmann-La Roche

Phone: 800-821-8590

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee 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.
Publication restrictions are in place

Restriction type: OTHER