Trial Outcomes & Findings for Neoadjuvant Atezolizumab in Localized Bladder Cancer (NCT NCT02451423)
NCT ID: NCT02451423
Last Updated: 2024-05-31
Results Overview
The immunologic effect MPDL3280A activity within bladder tissue will be measured by a change in the Cluster of differentiation 3 positive (CD3+) T cell count/µm2 between pretreatment biopsy and cystectomy tissue following MPDL3280A infusions. For each cohort, the mean of the log2 of ratio of post-treatment vs. pre-treatment counts with 95% confidence intervals will be reported.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
23 participants
Primary outcome timeframe
Up to 1 year
Results posted on
2024-05-31
Participant Flow
Cohort B was never opened to accrual
Participant milestones
| Measure |
Cohort A1: Atezolizumab Monotherapy (Single Dose)
Atezolizumab will be given as a neoadjuvant treatment Intravenously (IV) on Day 1 of each 21-day Cycle, for up to 1 cycle (1200mg x 1 dose)
|
Cohort A2: Atezolizumab Monotherapy (2 Doses)
Atezolizumab will be given as a neoadjuvant treatment Intravenously (IV) on Day 1 of each 21-day Cycle, for up to 2 cycles (1200 mg x 2 doses)
|
Cohort A3: Atezolizumab Monotherapy (3 Doses)
Atezolizumab will be given as a neoadjuvant treatment Intravenously (IV) on Day 1 of each 21-day Cycle, for up to 3 cycles (1200 mg x 3 doses)
|
|---|---|---|---|
|
Overall Study
STARTED
|
6
|
6
|
11
|
|
Overall Study
COMPLETED
|
6
|
6
|
11
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Neoadjuvant Atezolizumab in Localized Bladder Cancer
Baseline characteristics by cohort
| Measure |
Cohort A1: Atezolizumab Monotherapy (Single Dose)
n=6 Participants
Atezolizumab will be given as a neoadjuvant treatment Intravenously (IV) on Day 1 of each 21-day Cycle, for up to 1 cycle (1200mg x 1 dose)
|
Cohort A2: Atezolizumab Monotherapy (2 Doses)
n=6 Participants
Atezolizumab will be given as a neoadjuvant treatment Intravenously (IV) on Day 1 of each 21-day Cycle, for up to 2 cycles (1200 mg x 2 doses)
|
Cohort A3: Atezolizumab Monotherapy (3 Doses)
n=11 Participants
Atezolizumab will be given as a neoadjuvant treatment Intravenously (IV) on Day 1 of each 21-day Cycle, for up to 3 cycles (1200 mg x 3 doses)
|
Total
n=23 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Customized
60-69 years old
|
2 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
11 Participants
n=7 Participants
|
|
Age, Customized
70-79 years old
|
3 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
11 Participants
n=7 Participants
|
|
Age, Customized
80-89 years old
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
1 Participants
n=7 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
8 Participants
n=7 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
10 Participants
n=206 Participants
|
15 Participants
n=7 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
3 Participants
n=7 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
5 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
10 Participants
n=206 Participants
|
20 Participants
n=7 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
2 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
White
|
6 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
8 Participants
n=206 Participants
|
19 Participants
n=7 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
2 Participants
n=7 Participants
|
|
Region of Enrollment
United States
|
6 participants
n=99 Participants
|
6 participants
n=107 Participants
|
11 participants
n=206 Participants
|
23 participants
n=7 Participants
|
PRIMARY outcome
Timeframe: Up to 1 yearPopulation: Only 12 participants had evaluable pretreatment biopsy and cystectomy tissue following MPDL3280A infusions required for this protocol endpoint.
The immunologic effect MPDL3280A activity within bladder tissue will be measured by a change in the Cluster of differentiation 3 positive (CD3+) T cell count/µm2 between pretreatment biopsy and cystectomy tissue following MPDL3280A infusions. For each cohort, the mean of the log2 of ratio of post-treatment vs. pre-treatment counts with 95% confidence intervals will be reported.
Outcome measures
| Measure |
Cohort A1: Atezolizumab Monotherapy (Single Dose)
n=2 Participants
Atezolizumab will be given as a neoadjuvant treatment Intravenously (IV) on Day 1 of each 21-day Cycle, for up to 1 cycle (1200mg x 1 dose)
|
Cohort A2: Atezolizumab Monotherapy (2 Doses)
n=2 Participants
Atezolizumab will be given as a neoadjuvant treatment Intravenously (IV) on Day 1 of each 21-day Cycle, for up to 2 cycles (1200 mg x 2 doses)
|
Cohort A3: Atezolizumab Monotherapy (3 Doses)
n=8 Participants
Atezolizumab will be given as a neoadjuvant treatment Intravenously (IV) on Day 1 of each 21-day Cycle, for up to 3 cycles (1200 mg x 3 doses)
|
|---|---|---|---|
|
Mean log2 (Fold Change of CD3+ T-Cell Count/µm2) Over Time
|
-0.036 log2(fold change)
Interval -3.326 to 3.253
|
-0.041 log2(fold change)
Interval -2.184 to 2.103
|
1.516 log2(fold change)
Interval 0.653 to 2.379
|
PRIMARY outcome
Timeframe: Up to 1 yearPopulation: CD3+ Ki67+ proliferative T cell count/µm2 data was not collected.
The immunologic effect MPDL3280A activity within bladder tissue will be measured by a change in the CD3+ Ki67+ proliferative T cell count/µm2 between pretreatment biopsy and cystectomy tissue following MPDL3280A infusions. For each cohort, the mean of the log2 of ratio of post-treatment vs. pre-treatment counts with 95% confidence intervals will be reported.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: Up to 1 yearPopulation: Only 12 participants had evaluable pretreatment biopsy and cystectomy tissue following MPDL3280A infusions required for this protocol endpoint.
The immunologic effect MPDL3280A activity within bladder tissue will be measured by a change in the cluster of differentiation 4 positive (CD4+) FoxP3- helper T cells count/µm2 between pretreatment biopsy and cystectomy tissue following MPDL3280A infusions. For each cohort, the mean of the log2 of ratio of post-treatment vs. pre-treatment counts with 95% confidence intervals will be reported.
Outcome measures
| Measure |
Cohort A1: Atezolizumab Monotherapy (Single Dose)
n=2 Participants
Atezolizumab will be given as a neoadjuvant treatment Intravenously (IV) on Day 1 of each 21-day Cycle, for up to 1 cycle (1200mg x 1 dose)
|
Cohort A2: Atezolizumab Monotherapy (2 Doses)
n=2 Participants
Atezolizumab will be given as a neoadjuvant treatment Intravenously (IV) on Day 1 of each 21-day Cycle, for up to 2 cycles (1200 mg x 2 doses)
|
Cohort A3: Atezolizumab Monotherapy (3 Doses)
n=8 Participants
Atezolizumab will be given as a neoadjuvant treatment Intravenously (IV) on Day 1 of each 21-day Cycle, for up to 3 cycles (1200 mg x 3 doses)
|
|---|---|---|---|
|
Mean log2 (Fold Change of CD4+ FoxP3- Helper T Cell Count/µm2) Over Time
|
0.829 log2(fold change)
Interval -1.818 to 3.477
|
0.831 log2(fold change)
Interval -1.105 to 2.768
|
0.66 log2(fold change)
Interval -0.637 to 1.958
|
PRIMARY outcome
Timeframe: Up to 1 yearPopulation: Only 12 participants had evaluable pretreatment biopsy and cystectomy tissue following MPDL3280A infusions required for this protocol endpoint.
The immunologic effect MPDL3280A activity within bladder tissue will be measured by a change in the CD4+ FoxP3+ regulatory T cell count/µm2 between pretreatment biopsy and cystectomy tissue following MPDL3280A infusions. For each cohort, the mean of the log2 of ratio of post-treatment vs. pre-treatment counts with 95% confidence intervals will be reported.
Outcome measures
| Measure |
Cohort A1: Atezolizumab Monotherapy (Single Dose)
n=2 Participants
Atezolizumab will be given as a neoadjuvant treatment Intravenously (IV) on Day 1 of each 21-day Cycle, for up to 1 cycle (1200mg x 1 dose)
|
Cohort A2: Atezolizumab Monotherapy (2 Doses)
n=2 Participants
Atezolizumab will be given as a neoadjuvant treatment Intravenously (IV) on Day 1 of each 21-day Cycle, for up to 2 cycles (1200 mg x 2 doses)
|
Cohort A3: Atezolizumab Monotherapy (3 Doses)
n=8 Participants
Atezolizumab will be given as a neoadjuvant treatment Intravenously (IV) on Day 1 of each 21-day Cycle, for up to 3 cycles (1200 mg x 3 doses)
|
|---|---|---|---|
|
Mean log2 (Fold Change of CD4+ FoxP3+ Regulatory T Cell Count/µm2) Over Time
|
1.556 log2(fold change)
Interval 0.664 to 2.447
|
2.903 log2(fold change)
Interval 2.686 to 3.12
|
0.238 log2(fold change)
Interval -1.215 to 1.692
|
PRIMARY outcome
Timeframe: Up to 1 yearPopulation: Only 12 participants had evaluable pretreatment biopsy and cystectomy tissue following MPDL3280A infusions required for this protocol endpoint.
The immunologic effect MPDL3280A activity within bladder tissue will be measured by a change in the cluster of differentiation 8 positive (CD8+) cytotoxic T cell count/µm2 between pretreatment biopsy and cystectomy tissue following MPDL3280A infusions. For each cohort, the mean of the log2 of ratio of post-treatment vs. pre-treatment counts with 95% confidence intervals will be reported.
Outcome measures
| Measure |
Cohort A1: Atezolizumab Monotherapy (Single Dose)
n=2 Participants
Atezolizumab will be given as a neoadjuvant treatment Intravenously (IV) on Day 1 of each 21-day Cycle, for up to 1 cycle (1200mg x 1 dose)
|
Cohort A2: Atezolizumab Monotherapy (2 Doses)
n=2 Participants
Atezolizumab will be given as a neoadjuvant treatment Intravenously (IV) on Day 1 of each 21-day Cycle, for up to 2 cycles (1200 mg x 2 doses)
|
Cohort A3: Atezolizumab Monotherapy (3 Doses)
n=8 Participants
Atezolizumab will be given as a neoadjuvant treatment Intravenously (IV) on Day 1 of each 21-day Cycle, for up to 3 cycles (1200 mg x 3 doses)
|
|---|---|---|---|
|
Mean log2 (Fold Change of CD8+ Cytotoxic T Cell Count/µm2) Over Time
|
0.937 log2(fold change)
Interval -0.496 to 2.369
|
0.666 log2(fold change)
Interval -0.992 to 2.324
|
2.017 log2(fold change)
Interval 0.384 to 3.65
|
PRIMARY outcome
Timeframe: Up to 2 yearsThe percentage of participants requiring a treatment-related delay in surgery beyond 12 weeks from study start will be summarized using descriptive statistics.
Outcome measures
| Measure |
Cohort A1: Atezolizumab Monotherapy (Single Dose)
n=6 Participants
Atezolizumab will be given as a neoadjuvant treatment Intravenously (IV) on Day 1 of each 21-day Cycle, for up to 1 cycle (1200mg x 1 dose)
|
Cohort A2: Atezolizumab Monotherapy (2 Doses)
n=6 Participants
Atezolizumab will be given as a neoadjuvant treatment Intravenously (IV) on Day 1 of each 21-day Cycle, for up to 2 cycles (1200 mg x 2 doses)
|
Cohort A3: Atezolizumab Monotherapy (3 Doses)
n=11 Participants
Atezolizumab will be given as a neoadjuvant treatment Intravenously (IV) on Day 1 of each 21-day Cycle, for up to 3 cycles (1200 mg x 3 doses)
|
|---|---|---|---|
|
Percentage of Participants With a Treatment-related Delay
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
PRIMARY outcome
Timeframe: Up to 2 yearsTreatment-related adverse events occurring prior to surgery will be summarized by maximum toxicity grade for all participants treated with a particular regimen. The grade of toxicity will be calculated using NCI CTCAE version 4.0.
Outcome measures
| Measure |
Cohort A1: Atezolizumab Monotherapy (Single Dose)
n=6 Participants
Atezolizumab will be given as a neoadjuvant treatment Intravenously (IV) on Day 1 of each 21-day Cycle, for up to 1 cycle (1200mg x 1 dose)
|
Cohort A2: Atezolizumab Monotherapy (2 Doses)
n=6 Participants
Atezolizumab will be given as a neoadjuvant treatment Intravenously (IV) on Day 1 of each 21-day Cycle, for up to 2 cycles (1200 mg x 2 doses)
|
Cohort A3: Atezolizumab Monotherapy (3 Doses)
n=11 Participants
Atezolizumab will be given as a neoadjuvant treatment Intravenously (IV) on Day 1 of each 21-day Cycle, for up to 3 cycles (1200 mg x 3 doses)
|
|---|---|---|---|
|
Number of Participants With Maximum Grade Treatment-related Toxicities Prior to Surgery
Diarrhea
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Maximum Grade Treatment-related Toxicities Prior to Surgery
Abdominal Pain
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Maximum Grade Treatment-related Toxicities Prior to Surgery
Rash maculo-papular
|
0 Participants
|
1 Participants
|
2 Participants
|
|
Number of Participants With Maximum Grade Treatment-related Toxicities Prior to Surgery
Musculoskeletal and connective tissue disorder - Other (Joint Ache)
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Maximum Grade Treatment-related Toxicities Prior to Surgery
Fatigue
|
0 Participants
|
2 Participants
|
3 Participants
|
|
Number of Participants With Maximum Grade Treatment-related Toxicities Prior to Surgery
Hematuria
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Maximum Grade Treatment-related Toxicities Prior to Surgery
Headache
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Maximum Grade Treatment-related Toxicities Prior to Surgery
Alopecia
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Maximum Grade Treatment-related Toxicities Prior to Surgery
Skin and Subcutaneous disorders, Other (Scrotal skin disruption)
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Maximum Grade Treatment-related Toxicities Prior to Surgery
Alanine aminotransferase increased
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Maximum Grade Treatment-related Toxicities Prior to Surgery
Aspartate aminotransferase increased
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Maximum Grade Treatment-related Toxicities Prior to Surgery
Chills
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Maximum Grade Treatment-related Toxicities Prior to Surgery
Creatinine increased
|
0 Participants
|
0 Participants
|
2 Participants
|
|
Number of Participants With Maximum Grade Treatment-related Toxicities Prior to Surgery
Weight loss
|
0 Participants
|
0 Participants
|
2 Participants
|
|
Number of Participants With Maximum Grade Treatment-related Toxicities Prior to Surgery
Pain
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Maximum Grade Treatment-related Toxicities Prior to Surgery
Hyponatremia
|
0 Participants
|
0 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Up to 2 yearsPopulation: One participant in Cohort A2 had T1 disease at baseline and did not meet the T2 or greater criteria for inclusion in this analysis.
Point estimates and 95% confidence intervals of the near complete pathologic response rate, defined as the presence of only pTa or pTis in patients with T2 or greater disease at baseline.
Outcome measures
| Measure |
Cohort A1: Atezolizumab Monotherapy (Single Dose)
n=6 Participants
Atezolizumab will be given as a neoadjuvant treatment Intravenously (IV) on Day 1 of each 21-day Cycle, for up to 1 cycle (1200mg x 1 dose)
|
Cohort A2: Atezolizumab Monotherapy (2 Doses)
n=5 Participants
Atezolizumab will be given as a neoadjuvant treatment Intravenously (IV) on Day 1 of each 21-day Cycle, for up to 2 cycles (1200 mg x 2 doses)
|
Cohort A3: Atezolizumab Monotherapy (3 Doses)
n=11 Participants
Atezolizumab will be given as a neoadjuvant treatment Intravenously (IV) on Day 1 of each 21-day Cycle, for up to 3 cycles (1200 mg x 3 doses)
|
|---|---|---|---|
|
Near Complete Pathologic Response Rate
|
0.2967 proportion of participants
Interval 0.03005 to 0.5635
|
0 proportion of participants
insufficient number of participants with events
|
0 proportion of participants
insufficient number of participants with events
|
SECONDARY outcome
Timeframe: Up to 2 yearsThe percentage of participants with a two- year RFS defined from study start until recurrence of disease or death from any cause, will be obtained using the Kaplan Meier method for the ITT population.
Outcome measures
| Measure |
Cohort A1: Atezolizumab Monotherapy (Single Dose)
n=6 Participants
Atezolizumab will be given as a neoadjuvant treatment Intravenously (IV) on Day 1 of each 21-day Cycle, for up to 1 cycle (1200mg x 1 dose)
|
Cohort A2: Atezolizumab Monotherapy (2 Doses)
n=6 Participants
Atezolizumab will be given as a neoadjuvant treatment Intravenously (IV) on Day 1 of each 21-day Cycle, for up to 2 cycles (1200 mg x 2 doses)
|
Cohort A3: Atezolizumab Monotherapy (3 Doses)
n=11 Participants
Atezolizumab will be given as a neoadjuvant treatment Intravenously (IV) on Day 1 of each 21-day Cycle, for up to 3 cycles (1200 mg x 3 doses)
|
|---|---|---|---|
|
Relapse-free Survival (RFS) Rate Intention-To-Treat (ITT) Population
|
67 percentage of participants
Interval 38.0 to 100.0
|
83 percentage of participants
Interval 58.0 to 100.0
|
82 percentage of participants
Interval 62.0 to 100.0
|
SECONDARY outcome
Timeframe: Up to 2 yearsOverall survival rate will be reported as the percentage of participants from study start until death from any cause obtained by Kaplan Meier method for the ITT population.
Outcome measures
| Measure |
Cohort A1: Atezolizumab Monotherapy (Single Dose)
n=6 Participants
Atezolizumab will be given as a neoadjuvant treatment Intravenously (IV) on Day 1 of each 21-day Cycle, for up to 1 cycle (1200mg x 1 dose)
|
Cohort A2: Atezolizumab Monotherapy (2 Doses)
n=6 Participants
Atezolizumab will be given as a neoadjuvant treatment Intravenously (IV) on Day 1 of each 21-day Cycle, for up to 2 cycles (1200 mg x 2 doses)
|
Cohort A3: Atezolizumab Monotherapy (3 Doses)
n=11 Participants
Atezolizumab will be given as a neoadjuvant treatment Intravenously (IV) on Day 1 of each 21-day Cycle, for up to 3 cycles (1200 mg x 3 doses)
|
|---|---|---|---|
|
Overall Survival Rate
|
80 percentage of participants
Interval 52.0 to 100.0
|
83 percentage of participants
Interval 59.0 to 100.0
|
100 percentage of participants
Interval 100.0 to 100.0
|
SECONDARY outcome
Timeframe: Up to 2 yearsPopulation: Tumor and T-cell PD-L1/PD-1 immunohistochemical expression data was not collected.
Fisher's exact test will be used to test the association of baseline tumor and T-cell programmed death-ligand 1 (PD-L1)/programmed cell death protein 1 (PD-1) immunohistochemical expression with disease response.
Outcome measures
Outcome data not reported
Adverse Events
Cohort A1: Atezolizumab Monotherapy (Single Dose)
Serious events: 1 serious events
Other events: 6 other events
Deaths: 1 deaths
Cohort A2: Atezolizumab Monotherapy (2 Doses)
Serious events: 0 serious events
Other events: 5 other events
Deaths: 1 deaths
Cohort A3: Atezolizumab Monotherapy (3 Doses)
Serious events: 0 serious events
Other events: 11 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Cohort A1: Atezolizumab Monotherapy (Single Dose)
n=6 participants at risk
Atezolizumab will be given as a neoadjuvant treatment Intravenously (IV) on Day 1 of each 21-day Cycle, for up to 1 cycle (1200mg x 1 dose)
|
Cohort A2: Atezolizumab Monotherapy (2 Doses)
n=6 participants at risk
Atezolizumab will be given as a neoadjuvant treatment Intravenously (IV) on Day 1 of each 21-day Cycle, for up to 2 cycles (1200 mg x 2 doses)
|
Cohort A3: Atezolizumab Monotherapy (3 Doses)
n=11 participants at risk
Atezolizumab will be given as a neoadjuvant treatment Intravenously (IV) on Day 1 of each 21-day Cycle, for up to 3 cycles (1200 mg x 3 doses)
|
|---|---|---|---|
|
Infections and infestations
Kidney infection
|
16.7%
1/6 • Number of events 1 • Up to 2 years
|
0.00%
0/6 • Up to 2 years
|
0.00%
0/11 • Up to 2 years
|
Other adverse events
| Measure |
Cohort A1: Atezolizumab Monotherapy (Single Dose)
n=6 participants at risk
Atezolizumab will be given as a neoadjuvant treatment Intravenously (IV) on Day 1 of each 21-day Cycle, for up to 1 cycle (1200mg x 1 dose)
|
Cohort A2: Atezolizumab Monotherapy (2 Doses)
n=6 participants at risk
Atezolizumab will be given as a neoadjuvant treatment Intravenously (IV) on Day 1 of each 21-day Cycle, for up to 2 cycles (1200 mg x 2 doses)
|
Cohort A3: Atezolizumab Monotherapy (3 Doses)
n=11 participants at risk
Atezolizumab will be given as a neoadjuvant treatment Intravenously (IV) on Day 1 of each 21-day Cycle, for up to 3 cycles (1200 mg x 3 doses)
|
|---|---|---|---|
|
General disorders
Fatigue
|
33.3%
2/6 • Number of events 2 • Up to 2 years
|
60.0%
3/5 • Number of events 3 • Up to 2 years
|
27.3%
3/11 • Number of events 3 • Up to 2 years
|
|
General disorders
Fever
|
16.7%
1/6 • Number of events 1 • Up to 2 years
|
0.00%
0/5 • Up to 2 years
|
9.1%
1/11 • Number of events 1 • Up to 2 years
|
|
General disorders
Localized edema
|
16.7%
1/6 • Number of events 1 • Up to 2 years
|
0.00%
0/5 • Up to 2 years
|
9.1%
1/11 • Number of events 1 • Up to 2 years
|
|
General disorders
Pain
|
0.00%
0/6 • Up to 2 years
|
20.0%
1/5 • Number of events 1 • Up to 2 years
|
9.1%
1/11 • Number of events 1 • Up to 2 years
|
|
General disorders
Chills
|
0.00%
0/6 • Up to 2 years
|
0.00%
0/5 • Up to 2 years
|
9.1%
1/11 • Number of events 1 • Up to 2 years
|
|
Gastrointestinal disorders
Constipation
|
16.7%
1/6 • Number of events 1 • Up to 2 years
|
20.0%
1/5 • Number of events 1 • Up to 2 years
|
18.2%
2/11 • Number of events 2 • Up to 2 years
|
|
Gastrointestinal disorders
Diarrhea
|
50.0%
3/6 • Number of events 12 • Up to 2 years
|
0.00%
0/5 • Up to 2 years
|
9.1%
1/11 • Number of events 3 • Up to 2 years
|
|
Gastrointestinal disorders
Abdominal pain
|
16.7%
1/6 • Number of events 1 • Up to 2 years
|
0.00%
0/5 • Up to 2 years
|
9.1%
1/11 • Number of events 1 • Up to 2 years
|
|
Gastrointestinal disorders
Nausea
|
16.7%
1/6 • Number of events 1 • Up to 2 years
|
20.0%
1/5 • Number of events 1 • Up to 2 years
|
0.00%
0/11 • Up to 2 years
|
|
Gastrointestinal disorders
Fecal incontinence
|
16.7%
1/6 • Number of events 1 • Up to 2 years
|
0.00%
0/5 • Up to 2 years
|
0.00%
0/11 • Up to 2 years
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
0.00%
0/6 • Up to 2 years
|
20.0%
1/5 • Number of events 1 • Up to 2 years
|
0.00%
0/11 • Up to 2 years
|
|
Gastrointestinal disorders
Gastrointestinal disorders - Other, specify
|
0.00%
0/6 • Up to 2 years
|
0.00%
0/5 • Up to 2 years
|
9.1%
1/11 • Number of events 1 • Up to 2 years
|
|
Gastrointestinal disorders
Malabsorption
|
16.7%
1/6 • Number of events 1 • Up to 2 years
|
0.00%
0/5 • Up to 2 years
|
0.00%
0/11 • Up to 2 years
|
|
Infections and infestations
Urinary tract infection
|
33.3%
2/6 • Number of events 4 • Up to 2 years
|
20.0%
1/5 • Number of events 2 • Up to 2 years
|
9.1%
1/11 • Number of events 1 • Up to 2 years
|
|
Infections and infestations
Kidney infection
|
0.00%
0/6 • Up to 2 years
|
0.00%
0/5 • Up to 2 years
|
9.1%
1/11 • Number of events 1 • Up to 2 years
|
|
Infections and infestations
Upper respiratory infection
|
0.00%
0/6 • Up to 2 years
|
0.00%
0/5 • Up to 2 years
|
9.1%
1/11 • Number of events 1 • Up to 2 years
|
|
Investigations
Creatinine increased
|
33.3%
2/6 • Number of events 4 • Up to 2 years
|
0.00%
0/5 • Up to 2 years
|
27.3%
3/11 • Number of events 4 • Up to 2 years
|
|
Investigations
Weight loss
|
0.00%
0/6 • Up to 2 years
|
20.0%
1/5 • Number of events 1 • Up to 2 years
|
18.2%
2/11 • Number of events 2 • Up to 2 years
|
|
Investigations
Blood bilirubin increased
|
16.7%
1/6 • Number of events 2 • Up to 2 years
|
0.00%
0/5 • Up to 2 years
|
0.00%
0/11 • Up to 2 years
|
|
Injury, poisoning and procedural complications
Aortic injury
|
0.00%
0/6 • Up to 2 years
|
0.00%
0/5 • Up to 2 years
|
9.1%
1/11 • Number of events 1 • Up to 2 years
|
|
Injury, poisoning and procedural complications
Fracture
|
16.7%
1/6 • Number of events 1 • Up to 2 years
|
0.00%
0/5 • Up to 2 years
|
0.00%
0/11 • Up to 2 years
|
|
Injury, poisoning and procedural complications
Injury, poisoning and procedural complications - Other, specify
|
0.00%
0/6 • Up to 2 years
|
0.00%
0/5 • Up to 2 years
|
9.1%
1/11 • Number of events 1 • Up to 2 years
|
|
Injury, poisoning and procedural complications
Intestinal stoma site bleeding
|
0.00%
0/6 • Up to 2 years
|
0.00%
0/5 • Up to 2 years
|
9.1%
1/11 • Number of events 1 • Up to 2 years
|
|
Injury, poisoning and procedural complications
Seroma
|
16.7%
1/6 • Number of events 1 • Up to 2 years
|
0.00%
0/5 • Up to 2 years
|
0.00%
0/11 • Up to 2 years
|
|
Injury, poisoning and procedural complications
Wound dehiscence
|
0.00%
0/6 • Up to 2 years
|
0.00%
0/5 • Up to 2 years
|
9.1%
1/11 • Number of events 1 • Up to 2 years
|
|
Renal and urinary disorders
Hematuria
|
0.00%
0/6 • Up to 2 years
|
40.0%
2/5 • Number of events 2 • Up to 2 years
|
0.00%
0/11 • Up to 2 years
|
|
Renal and urinary disorders
Urinary incontinence
|
0.00%
0/6 • Up to 2 years
|
20.0%
1/5 • Number of events 1 • Up to 2 years
|
9.1%
1/11 • Number of events 1 • Up to 2 years
|
|
Renal and urinary disorders
Chronic kidney disease
|
0.00%
0/6 • Up to 2 years
|
0.00%
0/5 • Up to 2 years
|
9.1%
1/11 • Number of events 1 • Up to 2 years
|
|
Renal and urinary disorders
Renal and urinary disorders - Other, specify
|
0.00%
0/6 • Up to 2 years
|
0.00%
0/5 • Up to 2 years
|
9.1%
1/11 • Number of events 1 • Up to 2 years
|
|
Metabolism and nutrition disorders
Anorexia
|
33.3%
2/6 • Number of events 2 • Up to 2 years
|
0.00%
0/5 • Up to 2 years
|
0.00%
0/11 • Up to 2 years
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
0.00%
0/6 • Up to 2 years
|
0.00%
0/5 • Up to 2 years
|
18.2%
2/11 • Number of events 2 • Up to 2 years
|
|
Metabolism and nutrition disorders
Hyponatremia
|
0.00%
0/6 • Up to 2 years
|
0.00%
0/5 • Up to 2 years
|
18.2%
2/11 • Number of events 4 • Up to 2 years
|
|
Metabolism and nutrition disorders
Dehydration
|
16.7%
1/6 • Number of events 1 • Up to 2 years
|
0.00%
0/5 • Up to 2 years
|
0.00%
0/11 • Up to 2 years
|
|
Metabolism and nutrition disorders
Hypokalemia
|
16.7%
1/6 • Number of events 7 • Up to 2 years
|
0.00%
0/5 • Up to 2 years
|
0.00%
0/11 • Up to 2 years
|
|
Blood and lymphatic system disorders
Anemia
|
0.00%
0/6 • Up to 2 years
|
0.00%
0/5 • Up to 2 years
|
27.3%
3/11 • Number of events 9 • Up to 2 years
|
|
Investigations
White blood cell decreased
|
0.00%
0/6 • Up to 2 years
|
0.00%
0/5 • Up to 2 years
|
9.1%
1/11 • Number of events 1 • Up to 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/6 • Up to 2 years
|
0.00%
0/5 • Up to 2 years
|
9.1%
1/11 • Number of events 1 • Up to 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
16.7%
1/6 • Number of events 1 • Up to 2 years
|
0.00%
0/5 • Up to 2 years
|
0.00%
0/11 • Up to 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/6 • Up to 2 years
|
0.00%
0/5 • Up to 2 years
|
9.1%
1/11 • Number of events 1 • Up to 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Sore throat
|
0.00%
0/6 • Up to 2 years
|
0.00%
0/5 • Up to 2 years
|
9.1%
1/11 • Number of events 1 • Up to 2 years
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
16.7%
1/6 • Number of events 1 • Up to 2 years
|
0.00%
0/5 • Up to 2 years
|
9.1%
1/11 • Number of events 1 • Up to 2 years
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
0.00%
0/6 • Up to 2 years
|
20.0%
1/5 • Number of events 1 • Up to 2 years
|
18.2%
2/11 • Number of events 2 • Up to 2 years
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/6 • Up to 2 years
|
0.00%
0/5 • Up to 2 years
|
18.2%
2/11 • Number of events 2 • Up to 2 years
|
|
Nervous system disorders
Dizziness
|
0.00%
0/6 • Up to 2 years
|
0.00%
0/5 • Up to 2 years
|
9.1%
1/11 • Number of events 1 • Up to 2 years
|
|
Nervous system disorders
Dysgeusia
|
16.7%
1/6 • Number of events 1 • Up to 2 years
|
0.00%
0/5 • Up to 2 years
|
0.00%
0/11 • Up to 2 years
|
|
Reproductive system and breast disorders
Erectile dysfunction
|
16.7%
1/6 • Number of events 1 • Up to 2 years
|
20.0%
1/5 • Number of events 1 • Up to 2 years
|
0.00%
0/11 • Up to 2 years
|
|
Vascular disorders
Hypertension
|
16.7%
1/6 • Number of events 1 • Up to 2 years
|
0.00%
0/5 • Up to 2 years
|
0.00%
0/11 • Up to 2 years
|
|
Vascular disorders
Hypotension
|
16.7%
1/6 • Number of events 1 • Up to 2 years
|
0.00%
0/5 • Up to 2 years
|
0.00%
0/11 • Up to 2 years
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders, Other
|
0.00%
0/6 • Up to 2 years
|
0.00%
0/6 • Up to 2 years
|
9.1%
1/11 • Number of events 1 • Up to 2 years
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal and connective tissue disorder - Other, specify
|
0.00%
0/6 • Up to 2 years
|
16.7%
1/6 • Number of events 1 • Up to 2 years
|
0.00%
0/11 • Up to 2 years
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/6 • Up to 2 years
|
0.00%
0/6 • Up to 2 years
|
9.1%
1/11 • Number of events 1 • Up to 2 years
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/6 • Up to 2 years
|
0.00%
0/6 • Up to 2 years
|
9.1%
1/11 • Number of events 1 • Up to 2 years
|
Additional Information
Dr. Lawrence Fong, MD
University of California, San Francsico
Phone: (415) 514-3160
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place