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The study was terminated early 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.
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This Phase Ib/II study is designed to assess the safety, tolerability, pharmacokinetics, immunogenicity, patient reported outcomes (PROs), and preliminary anti-tumor activity of atezolizumab administered by intravenous (IV) infusion alone and in combination with intravesical BCG in high-risk NMIBC participants. The study will be conducted in following cohorts: Cohort 1A, Cohort 1B, Cohort 2, and Cohort 3. Atezolizumab will be administered at a fixed dose of 1200 milligrams (mg) every 3 weeks (q3w) for a maximum of 96 weeks. BCG will be administered to evaluate dose-limiting toxicities (DLTs), maximum tolerated dose (MTD), or maximum administered dose (MAD). De-escalation will be allowed for up to three dose levels of BCG (full dose [50 mg], 66 percent [%] of a full dose, and 33% of a full dose [Cohort 1B only]). After the MTD or MAD is determined for Cohort 1B, this dose will be used for all subsequent participants enrolled into Cohorts 1B, 2, and 3, unless the MTD is determined to be 33% of a full BCG dose. If MTD is determined to be 33% of a full BCG dose, then, no participants will be enrolled into Cohorts 2 and 3 until an assessment of the safety and activity of the combination of atezolizumab plus 33% of a full BCG dose is completed.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1A: Atezolizumab (BCG-unresponsive NMIBC) | Experimental | Participants will receive 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) | Experimental | During BCG induction course (12 weeks), participants will 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 will 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. Optional BCG maintenance courses 2-5 (each 24 weeks), participants will 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 2: Atezolizumab + BCG (BCG-relapsing NMIBC) | Experimental | During BCG induction course (12 weeks), participants will 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 will 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 will 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Atezolizumab | Drug | Atezolizumab will be administered as per the schedule specified in respective arm. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Adverse Events | Percentage of participants with at least one adverse event during the study. | From Baseline up to end of study (up to approximately 4.3 years) |
| Cohort 1B: Percentage of Participants With DLTs of BCG | Percentage of participants with dose-limiting toxicities (DLT) of BCG in Cohort 1B. | Days 1-21 |
| Cohort 1B: MAD of BCG | Maximum administered dose (MAD) of BCG. | Days 1-21 |
| Percentage of Participants With Complete Response (CR) as Assessed by the Investigator on the Basis of Cystoscopy and Urine Cytology at Month 6 | CR at 6 months after the start of study treatment as assessed by the investigator on the basis of cystoscopic assessment and urine cytology. | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With CR as Assessed by the Investigator on the Basis of Cystoscopy and Urine Cytology at Month 3 | CR at the 3-month disease assessment, evaluated by both cystoscopy and cytology. | 3 months |
| Duration of CR, as Assessed on the Basis of Cystoscopy and Urine Cytology |
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Inclusion Criteria:
BCG-unresponsive NMIBC:
Persistence of high-grade CIS at 6 months following an adequate course of BCG; or Stage/grade progression at 3 months after induction BCG; or Recurrence of high-grade CIS after achieving a disease-free state (i.e., CR) following induction of an adequate course of BCG that occurs less than (<) 6 months after the last exposure to BCG
BCG-relapsing NMIBC:
Recurrence of high-grade CIS after achieving a disease-free state following induction of an adequate course of BCG that occurs greater than or equal to (>/=) 6 months after the last exposure to BCG
Very high-risk (VHR) BCG-naïve NMIBC:
VHR NMIBC, defined as having at least 1 of the following: Multiple and/or large (greater than [>] 3 centimeters [cm]) T1, (HG/G3) tumors; T1, (HG/G3) tumor with concurrent CIS; T1, G3 with CIS in prostatic urethra; Micropapillary variant of non-muscle invasive urothelial carcinoma
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Hoffmann-La Roche | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Stanford Univ. | Stanford | California | 94305 | United States | ||
| University of Chicago Medical Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36803840 | Derived | Inman BA, Hahn NM, Stratton K, Kopp R, Sankin A, Skinner E, Pohar K, Gartrell BA, Pham S, Rishipathak D, Mariathasan S, Davarpanah N, Carter C, Steinberg GD. A Phase 1b/2 Study of Atezolizumab with or Without Bacille Calmette-Guerin in Patients with High-risk Non-muscle-invasive Bladder Cancer. Eur Urol Oncol. 2023 Jun;6(3):313-320. doi: 10.1016/j.euo.2023.01.013. Epub 2023 Feb 15. |
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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.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | Cohort 1B: Atezolizumab + BCG (BCG-unresponsive NMIBC) |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Feb 10, 2020 |
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| Cohort 3: Atezolizumab + BCG (BCG-naive NMIBC) | Experimental | During BCG induction course (12 weeks), participants will 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 will 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 will 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. |
|
|
| Bacille Calmette-Guérin | Biological | For Cohort 1B, BCG will be administered (intravesically) at de-escalated doses. De-escalation will be allowed for up to three dose levels of BCG: full dose (50 mg), 66% of full dose, and 33% of full dose. After the MTD or MAD is determined for Cohort 1B, MTD/MAD will be used for all subsequent participants enrolled into Cohorts 1B, 2, and 3 (provided MAD or MTD is determined to be either full dose or 66% of a full BCG dose). |
|
|
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. |
| 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) |
| Percentage of Participants With Recurrence-Free Survival (RFS), as Assessed on the Basis of Cystoscopy and Urine Cytology | RFS rate at 6, 12, and 18 months, defined as the proportion of patients who are alive and free of persistent/recurrent high-grade NMIBC. | 6, 12 and 18 months |
| Bladder-Intact Disease-Free Survival (DFS), as Assessed on the Basis of Cystoscopy and Urine Cytology | Bladder-intact DFS was defined as the time from the first study treatment to earliest evidence of progression to muscle-invasive disease in the bladder, regional pelvic progression, distant metastasis, bladder cancer-related death, or cystectomy. | From first study treatment to earliest evidence of progression to muscle-invasive disease in the bladder, regional pelvic progression, distant metastasis, bladder cancer-related death, or cystectomy or death from any cause (up to approximately 4.3 years) |
| Progression-Free Survival (PFS), as Assessed on the Basis of Cystoscopy and Urine Cytology | PFS, defined as the time from the first study treatment to the first occurrence of progression to muscle-invasive disease based on cystoscopy and urine cytology or death from any cause. | Time from first study treatment to the first occurrence of progression to muscle-invasive disease or death from any cause (up to approximately 4.3 years) |
| Cystectomy-Free Survival (CFS), as Assessed on the Basis of Cystoscopy and Urine Cytology | Cystectomy-free survival, defined as from start of study treatment to bladder removal for any cause or death from any cause. | Time from first study treatment to cystectomy or death from any cause (up to approximately 4.3 years) |
| Overall Survival | Time from first study treatment to death from any cause (up to approximately 4.3 years) |
| Maximum Observed Serum Concentration of Atezolizumab (Cmax) | Maximum observed serum concentration of Atezolizumab (Cmax) | Cycle 1 Day 1 post-dose (Cycle length=21 days) |
| Minimum Observed Serum Concentration of Atezolizumab (Cmin) | Minimum observed serum concentration of atezolizumab (Cmin) | Pre-dose (0 hr) on Day 1 of Cycles 2, 3, 4 and 8 (Cycle length=21 days) |
| Percentage of Participants With Anti-Therapeutic Antibody (ADA) Response to Atezolizumab | Percentage of participants with anti-therapeutic antibody (ADA) response to atezolizumab. | 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) |
| Chicago |
| Illinois |
| 60637 |
| United States |
| Johns Hopkins Kimmel Cancer Center, Office of Research Administration | Baltimore | Maryland | 21205 | United States |
| The Montefiore Medical Center & The Albert Einstein College of Medicine; Department of Urology | The Bronx | New York | 10461 | United States |
| Duke University | Durham | North Carolina | 27705 | United States |
| Ohio State University | Columbus | Ohio | 43210 | United States |
| Oklahoma University Health Sciences Center | Oklahoma City | Oklahoma | 73104 | United States |
| VA Portland Healthcare System | Portland | Oregon | 97239 | United States |
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. |
| FG002 | 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. |
| FG003 | 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. |
| COMPLETED |
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| NOT COMPLETED |
|
|
Participants were enrolled only in Cohort 1 of this study. The Sponsor decided to stop further enrollment for Cohorts 2 and 3 after the enrollment of 24 participants 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.
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 | 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. |
| BG002 | 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. |
| BG003 | 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. |
| BG004 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | Year |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percentage of Participants With Adverse Events | Percentage of participants with at least one adverse event during the study. | 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. | Posted | Number | Percentage of participants | From Baseline up to end of study (up to approximately 4.3 years) |
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| Primary | Cohort 1B: Percentage of Participants With DLTs of BCG | Percentage of participants with dose-limiting toxicities (DLT) of BCG in Cohort 1B. | 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. | Posted | Number | Percentage of participants | Days 1-21 |
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| Primary | Cohort 1B: MAD of BCG | Maximum administered dose (MAD) of BCG. | 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. | Posted | Number | mg | Days 1-21 |
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| Primary | Percentage of Participants With Complete Response (CR) as Assessed by the Investigator on the Basis of Cystoscopy and Urine Cytology at Month 6 | CR at 6 months after the start of study treatment as assessed by the investigator on the basis of cystoscopic assessment and urine cytology. | 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. | Posted | Number | 95% Confidence Interval | Percentage of participants | 6 months |
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| Secondary | Percentage of Participants With CR as Assessed by the Investigator on the Basis of Cystoscopy and Urine Cytology at Month 3 | CR at the 3-month disease assessment, evaluated by both cystoscopy and cytology. | 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. | Posted | Number | 95% Confidence Interval | Percentage of participants | 3 months |
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| Secondary | Duration of CR, as Assessed on the Basis of Cystoscopy and Urine Cytology | 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. | 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. | Posted | Median | 95% Confidence Interval | Months | 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) |
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| Secondary | Percentage of Participants With Recurrence-Free Survival (RFS), as Assessed on the Basis of Cystoscopy and Urine Cytology | RFS rate at 6, 12, and 18 months, defined as the proportion of patients who are alive and free of persistent/recurrent high-grade NMIBC. | 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. Data for RFS was not collected as the study was stopped early. | Posted | 6, 12 and 18 months |
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| Secondary | Bladder-Intact Disease-Free Survival (DFS), as Assessed on the Basis of Cystoscopy and Urine Cytology | Bladder-intact DFS was defined as the time from the first study treatment to earliest evidence of progression to muscle-invasive disease in the bladder, regional pelvic progression, distant metastasis, bladder cancer-related death, or cystectomy. | 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. Data for DFS was not collected as the study was stopped early. | Posted | From first study treatment to earliest evidence of progression to muscle-invasive disease in the bladder, regional pelvic progression, distant metastasis, bladder cancer-related death, or cystectomy or death from any cause (up to approximately 4.3 years) |
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| Secondary | Progression-Free Survival (PFS), as Assessed on the Basis of Cystoscopy and Urine Cytology | PFS, defined as the time from the first study treatment to the first occurrence of progression to muscle-invasive disease based on cystoscopy and urine cytology or death from any cause. | 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. Data for PFS was not collected as the study was stopped early. | Posted | Time from first study treatment to the first occurrence of progression to muscle-invasive disease or death from any cause (up to approximately 4.3 years) |
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| Secondary | Cystectomy-Free Survival (CFS), as Assessed on the Basis of Cystoscopy and Urine Cytology | Cystectomy-free survival, defined as from start of study treatment to bladder removal for any cause or death from any cause. | 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. Data for CFS was not collected as the study was stopped early. | Posted | Time from first study treatment to cystectomy or death from any cause (up to approximately 4.3 years) |
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| Secondary | Overall Survival | 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. Data for OS was not collected as the study was stopped early. | Posted | Time from first study treatment to death from any cause (up to approximately 4.3 years) |
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| Secondary | Maximum Observed Serum Concentration of Atezolizumab (Cmax) | Maximum observed serum concentration of Atezolizumab (Cmax) | 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. | Posted | Mean | Standard Deviation | μg/mL | Cycle 1 Day 1 post-dose (Cycle length=21 days) |
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| Secondary | Minimum Observed Serum Concentration of Atezolizumab (Cmin) | Minimum observed serum concentration of atezolizumab (Cmin) | 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. | Posted | Mean | Standard Deviation | μg/mL | Pre-dose (0 hr) on Day 1 of Cycles 2, 3, 4 and 8 (Cycle length=21 days) |
| ||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Anti-Therapeutic Antibody (ADA) Response to Atezolizumab | Percentage of participants with anti-therapeutic antibody (ADA) response to atezolizumab. | 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. | Posted | Number | Percentage of participants | 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) |
|
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.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. | 1 | 12 | 3 | 12 | 11 | 12 |
| EG001 | 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. | 0 | 12 | 3 | 12 | 12 | 12 |
| EG002 | 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. | 0 | 0 | 0 | 0 | 0 | 0 |
| EG003 | 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. | 0 | 0 | 0 | 0 | 0 | 0 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Blood loss anaemia | Blood and lymphatic system disorders | MedDRA version 23.1 | Systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | MedDRA version 23.1 | Systematic Assessment |
| |
| Complication associated with device | General disorders | MedDRA version 23.1 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA version 23.1 | Systematic Assessment |
| |
| Coronavirus infection | Infections and infestations | MedDRA version 23.1 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA version 23.1 | Systematic Assessment |
| |
| Pyelonephritis | Infections and infestations | MedDRA version 23.1 | Systematic Assessment |
| |
| Haematuria | Renal and urinary disorders | MedDRA version 23.1 | Systematic Assessment |
| |
| Urinary retention | Renal and urinary disorders | MedDRA version 23.1 | Systematic Assessment |
| |
| Aspiration | Respiratory, thoracic and mediastinal disorders | MedDRA version 23.1 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA version 23.1 | Systematic Assessment |
| |
| Lymphadenopathy | Blood and lymphatic system disorders | MedDRA version 23.1 | Systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | MedDRA version 23.1 | Systematic Assessment |
| |
| Hypothyroidism | Endocrine disorders | MedDRA version 23.1 | Systematic Assessment |
| |
| Dry eye | Eye disorders | MedDRA version 23.1 | Systematic Assessment |
| |
| Eye irritation | Eye disorders | MedDRA version 23.1 | Systematic Assessment |
| |
| Abdominal distension | Gastrointestinal disorders | MedDRA version 23.1 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA version 23.1 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA version 23.1 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA version 23.1 | Systematic Assessment |
| |
| Dry mouth | Gastrointestinal disorders | MedDRA version 23.1 | Systematic Assessment |
| |
| Dysphagia | Gastrointestinal disorders | MedDRA version 23.1 | Systematic Assessment |
| |
| Lip oedema | Gastrointestinal disorders | MedDRA version 23.1 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA version 23.1 | Systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | MedDRA version 23.1 | Systematic Assessment |
| |
| Chills | General disorders | MedDRA version 23.1 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA version 23.1 | Systematic Assessment |
| |
| Influenza like illness | General disorders | MedDRA version 23.1 | Systematic Assessment |
| |
| Injury associated with device | General disorders | MedDRA version 23.1 | Systematic Assessment |
| |
| Mucosal inflammation | General disorders | MedDRA version 23.1 | Systematic Assessment |
| |
| Oedema | General disorders | MedDRA version 23.1 | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA version 23.1 | Systematic Assessment |
| |
| Peripheral swelling | General disorders | MedDRA version 23.1 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA version 23.1 | Systematic Assessment |
| |
| Hepatic steatosis | Hepatobiliary disorders | MedDRA version 23.1 | Systematic Assessment |
| |
| Seasonal allergy | Immune system disorders | MedDRA version 23.1 | Systematic Assessment |
| |
| Atypical mycobacterial pneumonia | Infections and infestations | MedDRA version 23.1 | Systematic Assessment |
| |
| Candida infection | Infections and infestations | MedDRA version 23.1 | Systematic Assessment |
| |
| Cystitis | Infections and infestations | MedDRA version 23.1 | Systematic Assessment |
| |
| Ear infection | Infections and infestations | MedDRA version 23.1 | Systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA version 23.1 | Systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA version 23.1 | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA version 23.1 | Systematic Assessment |
| |
| Pustule | Infections and infestations | MedDRA version 23.1 | Systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA version 23.1 | Systematic Assessment |
| |
| Tooth infection | Infections and infestations | MedDRA version 23.1 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA version 23.1 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA version 23.1 | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA version 23.1 | Systematic Assessment |
| |
| Amylase increased | Investigations | MedDRA version 23.1 | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA version 23.1 | Systematic Assessment |
| |
| Blood alkaline phosphatase increased | Investigations | MedDRA version 23.1 | Systematic Assessment |
| |
| Blood creatinine increased | Investigations | MedDRA version 23.1 | Systematic Assessment |
| |
| Lymphocyte count decreased | Investigations | MedDRA version 23.1 | Systematic Assessment |
| |
| Platelet count decreased | Investigations | MedDRA version 23.1 | Systematic Assessment |
| |
| Weight decreased | Investigations | MedDRA version 23.1 | Systematic Assessment |
| |
| Weight increased | Investigations | MedDRA version 23.1 | Systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA version 23.1 | Systematic Assessment |
| |
| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA version 23.1 | Systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA version 23.1 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA version 23.1 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA version 23.1 | Systematic Assessment |
| |
| Bone pain | Musculoskeletal and connective tissue disorders | MedDRA version 23.1 | Systematic Assessment |
| |
| Flank pain | Musculoskeletal and connective tissue disorders | MedDRA version 23.1 | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA version 23.1 | Systematic Assessment |
| |
| Anosmia | Nervous system disorders | MedDRA version 23.1 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA version 23.1 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA version 23.1 | Systematic Assessment |
| |
| Hypoaesthesia | Nervous system disorders | MedDRA version 23.1 | Systematic Assessment |
| |
| Neuropathy peripheral | Nervous system disorders | MedDRA version 23.1 | Systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA version 23.1 | Systematic Assessment |
| |
| Tremor | Nervous system disorders | MedDRA version 23.1 | Systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA version 23.1 | Systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA version 23.1 | Systematic Assessment |
| |
| Bladder pain | Renal and urinary disorders | MedDRA version 23.1 | Systematic Assessment |
| |
| Bladder spasm | Renal and urinary disorders | MedDRA version 23.1 | Systematic Assessment |
| |
| Chronic kidney disease | Renal and urinary disorders | MedDRA version 23.1 | Systematic Assessment |
| |
| Cystitis noninfective | Renal and urinary disorders | MedDRA version 23.1 | Systematic Assessment |
| |
| Dysuria | Renal and urinary disorders | MedDRA version 23.1 | Systematic Assessment |
| |
| Haematuria | Renal and urinary disorders | MedDRA version 23.1 | Systematic Assessment |
| |
| Micturition urgency | Renal and urinary disorders | MedDRA version 23.1 | Systematic Assessment |
| |
| Nocturia | Renal and urinary disorders | MedDRA version 23.1 | Systematic Assessment |
| |
| Pollakiuria | Renal and urinary disorders | MedDRA version 23.1 | Systematic Assessment |
| |
| Urge incontinence | Renal and urinary disorders | MedDRA version 23.1 | Systematic Assessment |
| |
| Urinary incontinence | Renal and urinary disorders | MedDRA version 23.1 | Systematic Assessment |
| |
| Aspiration | Respiratory, thoracic and mediastinal disorders | MedDRA version 23.1 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA version 23.1 | Systematic Assessment |
| |
| Dysphonia | Respiratory, thoracic and mediastinal disorders | MedDRA version 23.1 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA version 23.1 | Systematic Assessment |
| |
| Hypoxia | Respiratory, thoracic and mediastinal disorders | MedDRA version 23.1 | Systematic Assessment |
| |
| Laryngeal haemorrhage | Respiratory, thoracic and mediastinal disorders | MedDRA version 23.1 | Systematic Assessment |
| |
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA version 23.1 | Systematic Assessment |
| |
| Paranasal sinus hypersecretion | Respiratory, thoracic and mediastinal disorders | MedDRA version 23.1 | Systematic Assessment |
| |
| Productive cough | Respiratory, thoracic and mediastinal disorders | MedDRA version 23.1 | Systematic Assessment |
| |
| Actinic keratosis | Skin and subcutaneous tissue disorders | MedDRA version 23.1 | Systematic Assessment |
| |
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA version 23.1 | Systematic Assessment |
| |
| Dermatitis | Skin and subcutaneous tissue disorders | MedDRA version 23.1 | Systematic Assessment |
| |
| Erythema | Skin and subcutaneous tissue disorders | MedDRA version 23.1 | Systematic Assessment |
| |
| Hyperhidrosis | Skin and subcutaneous tissue disorders | MedDRA version 23.1 | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA version 23.1 | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA version 23.1 | Systematic Assessment |
| |
| Rash macular | Skin and subcutaneous tissue disorders | MedDRA version 23.1 | Systematic Assessment |
| |
| Rash maculo-papular | Skin and subcutaneous tissue disorders | MedDRA version 23.1 | Systematic Assessment |
| |
| Skin lesion | Skin and subcutaneous tissue disorders | MedDRA version 23.1 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA version 23.1 | Systematic Assessment |
| |
| Phlebitis | Vascular disorders | MedDRA version 23.1 | Systematic Assessment |
|
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.
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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Medical Communications | Hoffmann-La Roche | 800-821-8590 | genentech@druginfo.com |
| Aug 23, 2021 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D001749 | Urinary Bladder Neoplasms |
| ID | Term |
|---|---|
| D014571 | Urologic Neoplasms |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D001745 | Urinary Bladder Diseases |
| D014570 | Urologic Diseases |
| D052801 | Male Urogenital Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C000594389 | atezolizumab |
| D001500 | BCG Vaccine |
| ID | Term |
|---|---|
| D032581 | Tuberculosis Vaccines |
| D001428 | Bacterial Vaccines |
| D014612 | Vaccines |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
Not provided
Not provided
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
|
|
| OG002 | 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. |
| OG003 | 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. |
|
|
| OG002 | 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. |
| OG003 | 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. |
|
|
| OG002 | 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. |
| OG003 | 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. |
|
|
| OG002 | 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. |
| OG003 | 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. |
|
| OG002 | 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. |
| OG003 | 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. |
|
| OG002 | 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. |
| OG003 | 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. |
|
| OG002 | 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. |
| OG003 | 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. |
|
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. |
| OG003 | 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. |
|
| OG002 |
| 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. |
| OG003 | 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. |
|
|
| OG002 | 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. |
| OG003 | 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. |
|
|
| OG002 | 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. |
| OG003 | 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. |
|
|
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| Title | Measurements |
|---|---|
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| Title | Measurements |
|---|---|
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| Title | Measurements |
|---|---|
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