Trial Outcomes & Findings for Study of Atezolizumab Combined With Split-dose Gemcitabine Plus Cisplatin in Urothelial Carcinoma (NCT NCT04602078)
NCT ID: NCT04602078
Last Updated: 2025-04-24
Results Overview
Percentage/proportion of patients with confirmed complete response (CR) or partial response (PR) as their overall best response throughout the study period according to RECIST 1.1 criteria. Evaluated by Computed tomography scans (CT scan).
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
82 participants
Primary outcome timeframe
Through study completion, average 2 years.
Results posted on
2025-04-24
Participant Flow
Patients screened
Participant milestones
| Measure |
AUREA Single-arm
Atezolizumab (1200 mg) intravenously administered every 21 days (one cycle) up to disease progression, unacceptable toxicity or absence of clinical benefit.
Gemcitabine 1000 mg/m2 IV on D1 and 1000 mg/m2 IV on D8 of each 21-day cycle plus Cisplatin 70 mg/m2 by IV on split-dose schedule of 35 mg/m2 on day 1 (D1) and 35 mg/m2 on day 8 (D8) for up to 6 cycles.
Atezolizumab 1200 mg/m2: Fixed dose of 1200 mg/m2 by intravenous (IV) infusion on D1 of each cycle up to disease progression, unacceptable toxicity or absence of clinical benefit.
Gemcitabine 1000 mg/m2: Gemcitabine 1000 mg/m2 IV on D1 and 1000 mg/m2 IV on D8 of each 21-day cycle for up to 6 cycles.
Cisplatin 70 mg/m2: Cisplatin 70 mg/m2 by IV on split-dose schedule of 35 mg/m2 on day 1 (D1) and 35 mg/m2 on day 8 (D8) for up to 6 cycles.
|
|---|---|
|
Overall Study
STARTED
|
66
|
|
Overall Study
COMPLETED
|
66
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
AUREA Single-arm
n=66 Participants
Atezolizumab (1200 mg) intravenously administered every 21 days (one cycle) up to disease progression, unacceptable toxicity or absence of clinical benefit.
Gemcitabine 1000 mg/m2 IV on D1 and 1000 mg/m2 IV on D8 of each 21-day cycle plus Cisplatin 70 mg/m2 by IV on split-dose schedule of 35 mg/m2 on day 1 (D1) and 35 mg/m2 on day 8 (D8) for up to 6 cycles.
Atezolizumab 1200 mg/m2: Fixed dose of 1200 mg/m2 by intravenous (IV) infusion on D1 of each cycle up to disease progression, unacceptable toxicity or absence of clinical benefit.
Gemcitabine 1000 mg/m2: Gemcitabine 1000 mg/m2 IV on D1 and 1000 mg/m2 IV on D8 of each 21-day cycle for up to 6 cycles.
Cisplatin 70 mg/m2: Cisplatin 70 mg/m2 by IV on split-dose schedule of 35 mg/m2 on day 1 (D1) and 35 mg/m2 on day 8 (D8) for up to 6 cycles.
|
|---|---|
|
Age, Continuous
|
71 years
n=66 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=66 Participants
|
|
Sex: Female, Male
Male
|
57 Participants
n=66 Participants
|
|
Region of Enrollment
Spain
|
66 participants
n=66 Participants
|
|
Eastern Cooperative Oncology Group performance status (ECOG-PS)
Score 0
|
17 Participants
n=66 Participants
|
|
Eastern Cooperative Oncology Group performance status (ECOG-PS)
Score 1
|
34 Participants
n=66 Participants
|
|
Eastern Cooperative Oncology Group performance status (ECOG-PS)
Score 2
|
15 Participants
n=66 Participants
|
|
Site of the primary tumor
Upper tract
|
11 Participants
n=66 Participants
|
|
Site of the primary tumor
Lower tract
|
55 Participants
n=66 Participants
|
|
Stage at inclusion
Locally advanced
|
8 Participants
n=66 Participants
|
|
Stage at inclusion
Metastatic
|
58 Participants
n=66 Participants
|
|
Metastatic locations
Lymph nodes · Affected
|
44 Participants
n=66 Participants
|
|
Metastatic locations
Lymph nodes · Not affected
|
22 Participants
n=66 Participants
|
|
Metastatic locations
Lung · Affected
|
36 Participants
n=66 Participants
|
|
Metastatic locations
Lung · Not affected
|
30 Participants
n=66 Participants
|
|
Metastatic locations
Bone · Affected
|
20 Participants
n=66 Participants
|
|
Metastatic locations
Bone · Not affected
|
46 Participants
n=66 Participants
|
|
Metastatic locations
Liver · Affected
|
12 Participants
n=66 Participants
|
|
Metastatic locations
Liver · Not affected
|
54 Participants
n=66 Participants
|
|
Reason unfit for full dose chemotherapy
ECOG 2 · Yes
|
15 Participants
n=66 Participants
|
|
Reason unfit for full dose chemotherapy
ECOG 2 · No
|
51 Participants
n=66 Participants
|
|
Reason unfit for full dose chemotherapy
Age > 70 years · Yes
|
36 Participants
n=66 Participants
|
|
Reason unfit for full dose chemotherapy
Age > 70 years · No
|
30 Participants
n=66 Participants
|
|
Reason unfit for full dose chemotherapy
creatinine clearance 30-60 μmol/L · Yes
|
33 Participants
n=66 Participants
|
|
Reason unfit for full dose chemotherapy
creatinine clearance 30-60 μmol/L · No
|
33 Participants
n=66 Participants
|
|
Prior local therapy
Surgery · Yes
|
58 Participants
n=66 Participants
|
|
Prior local therapy
Surgery · No
|
8 Participants
n=66 Participants
|
|
Prior local therapy
Radiotherapy · Yes
|
9 Participants
n=66 Participants
|
|
Prior local therapy
Radiotherapy · No
|
57 Participants
n=66 Participants
|
|
PD-L1 status
Positive
|
14 Participants
n=66 Participants
|
|
PD-L1 status
Negative
|
26 Participants
n=66 Participants
|
|
PD-L1 status
Unknown
|
26 Participants
n=66 Participants
|
PRIMARY outcome
Timeframe: Through study completion, average 2 years.Percentage/proportion of patients with confirmed complete response (CR) or partial response (PR) as their overall best response throughout the study period according to RECIST 1.1 criteria. Evaluated by Computed tomography scans (CT scan).
Outcome measures
| Measure |
AUREA Single-arm
n=66 Participants
Atezolizumab (1200 mg) intravenously administered every 21 days (one cycle) up to disease progression, unacceptable toxicity or absence of clinical benefit.
Gemcitabine 1000 mg/m2 IV on D1 and 1000 mg/m2 IV on D8 of each 21-day cycle plus Cisplatin 70 mg/m2 by IV on split-dose schedule of 35 mg/m2 on day 1 (D1) and 35 mg/m2 on day 8 (D8) for up to 6 cycles.
Atezolizumab 1200 mg/m2: Fixed dose of 1200 mg/m2 by intravenous (IV) infusion on D1 of each cycle up to disease progression, unacceptable toxicity or absence of clinical benefit.
Gemcitabine 1000 mg/m2: Gemcitabine 1000 mg/m2 IV on D1 and 1000 mg/m2 IV on D8 of each 21-day cycle for up to 6 cycles.
Cisplatin 70 mg/m2: Cisplatin 70 mg/m2 by IV on split-dose schedule of 35 mg/m2 on day 1 (D1) and 35 mg/m2 on day 8 (D8) for up to 6 cycles.
|
|---|---|
|
Overall Response Rate (ORR)
|
48.5 Percentage of patients with response
Interval 36.0 to 61.1
|
SECONDARY outcome
Timeframe: Through study completion, average 2 years. CT scans for evaluation will be performed at baseline, on week 9, week 18 and then every 12 weeks (q12w) ± 1w until objective disease progressionPopulation: Patients with CR or PR
Time from first confirmed response (CR or PR) to the date of the documented PD as determined using RECIST 1.1 criteria or death due to any cause, whichever occurs first.
Outcome measures
| Measure |
AUREA Single-arm
n=32 Participants
Atezolizumab (1200 mg) intravenously administered every 21 days (one cycle) up to disease progression, unacceptable toxicity or absence of clinical benefit.
Gemcitabine 1000 mg/m2 IV on D1 and 1000 mg/m2 IV on D8 of each 21-day cycle plus Cisplatin 70 mg/m2 by IV on split-dose schedule of 35 mg/m2 on day 1 (D1) and 35 mg/m2 on day 8 (D8) for up to 6 cycles.
Atezolizumab 1200 mg/m2: Fixed dose of 1200 mg/m2 by intravenous (IV) infusion on D1 of each cycle up to disease progression, unacceptable toxicity or absence of clinical benefit.
Gemcitabine 1000 mg/m2: Gemcitabine 1000 mg/m2 IV on D1 and 1000 mg/m2 IV on D8 of each 21-day cycle for up to 6 cycles.
Cisplatin 70 mg/m2: Cisplatin 70 mg/m2 by IV on split-dose schedule of 35 mg/m2 on day 1 (D1) and 35 mg/m2 on day 8 (D8) for up to 6 cycles.
|
|---|---|
|
Duration of Response (DoR)
|
9.2 months
Interval 5.5 to 16.8
|
SECONDARY outcome
Timeframe: Through study completion, average 2 years. CT scans for evaluation will be performed at baseline, on week 9, week 18 and then every 12 weeks (q12w) ± 1w until objective disease progression as per PI's criteria or death (whichever comes first).Population: Patients with CR or PR
Time from first dosing date to the date of the documented ORR as determined using RECIST 1.1 criteria.
Outcome measures
| Measure |
AUREA Single-arm
n=32 Participants
Atezolizumab (1200 mg) intravenously administered every 21 days (one cycle) up to disease progression, unacceptable toxicity or absence of clinical benefit.
Gemcitabine 1000 mg/m2 IV on D1 and 1000 mg/m2 IV on D8 of each 21-day cycle plus Cisplatin 70 mg/m2 by IV on split-dose schedule of 35 mg/m2 on day 1 (D1) and 35 mg/m2 on day 8 (D8) for up to 6 cycles.
Atezolizumab 1200 mg/m2: Fixed dose of 1200 mg/m2 by intravenous (IV) infusion on D1 of each cycle up to disease progression, unacceptable toxicity or absence of clinical benefit.
Gemcitabine 1000 mg/m2: Gemcitabine 1000 mg/m2 IV on D1 and 1000 mg/m2 IV on D8 of each 21-day cycle for up to 6 cycles.
Cisplatin 70 mg/m2: Cisplatin 70 mg/m2 by IV on split-dose schedule of 35 mg/m2 on day 1 (D1) and 35 mg/m2 on day 8 (D8) for up to 6 cycles.
|
|---|---|
|
Time to Response (TtR)
|
2.1 months
Interval 2.0 to 2.2
|
SECONDARY outcome
Timeframe: Through study completion, average 2 years. CT scans for evaluation will be performed at baseline, on week 9, week 18 and then every 12 weeks (q12w) ± 1w until objective disease progression as per PI's criteria or death (whichever comes first).Percentage/proportion of patients with confirmed complete response (CR) or partial response (PR), or stable disease (SD) as their overall best response throughout the study period.
Outcome measures
| Measure |
AUREA Single-arm
n=66 Participants
Atezolizumab (1200 mg) intravenously administered every 21 days (one cycle) up to disease progression, unacceptable toxicity or absence of clinical benefit.
Gemcitabine 1000 mg/m2 IV on D1 and 1000 mg/m2 IV on D8 of each 21-day cycle plus Cisplatin 70 mg/m2 by IV on split-dose schedule of 35 mg/m2 on day 1 (D1) and 35 mg/m2 on day 8 (D8) for up to 6 cycles.
Atezolizumab 1200 mg/m2: Fixed dose of 1200 mg/m2 by intravenous (IV) infusion on D1 of each cycle up to disease progression, unacceptable toxicity or absence of clinical benefit.
Gemcitabine 1000 mg/m2: Gemcitabine 1000 mg/m2 IV on D1 and 1000 mg/m2 IV on D8 of each 21-day cycle for up to 6 cycles.
Cisplatin 70 mg/m2: Cisplatin 70 mg/m2 by IV on split-dose schedule of 35 mg/m2 on day 1 (D1) and 35 mg/m2 on day 8 (D8) for up to 6 cycles.
|
|---|---|
|
Clinical Benefit Rate (CBR)
|
66.7 Percentage of patients with response
Interval 54.0 to 77.8
|
SECONDARY outcome
Timeframe: Through study completion, average 2 years.Time from first dosing date to the date of death. A subject who has not died will be censored at the last known date alive.
Outcome measures
| Measure |
AUREA Single-arm
n=66 Participants
Atezolizumab (1200 mg) intravenously administered every 21 days (one cycle) up to disease progression, unacceptable toxicity or absence of clinical benefit.
Gemcitabine 1000 mg/m2 IV on D1 and 1000 mg/m2 IV on D8 of each 21-day cycle plus Cisplatin 70 mg/m2 by IV on split-dose schedule of 35 mg/m2 on day 1 (D1) and 35 mg/m2 on day 8 (D8) for up to 6 cycles.
Atezolizumab 1200 mg/m2: Fixed dose of 1200 mg/m2 by intravenous (IV) infusion on D1 of each cycle up to disease progression, unacceptable toxicity or absence of clinical benefit.
Gemcitabine 1000 mg/m2: Gemcitabine 1000 mg/m2 IV on D1 and 1000 mg/m2 IV on D8 of each 21-day cycle for up to 6 cycles.
Cisplatin 70 mg/m2: Cisplatin 70 mg/m2 by IV on split-dose schedule of 35 mg/m2 on day 1 (D1) and 35 mg/m2 on day 8 (D8) for up to 6 cycles.
|
|---|---|
|
Overall Survival (OS)
|
12.9 months
Interval 10.2 to 20.2
|
SECONDARY outcome
Timeframe: Through study completion, average 2 years. CT scans for evaluation will be performed at baseline, on week 9, week 18 and then every 12 weeks (q12w) ± 1w until objective disease progression as per PI's criteria or death (whichever comes first).Time from first dosing date to the date of confirmed PD. A subject who has not died will be censored at the last known date alive.
Outcome measures
| Measure |
AUREA Single-arm
n=66 Participants
Atezolizumab (1200 mg) intravenously administered every 21 days (one cycle) up to disease progression, unacceptable toxicity or absence of clinical benefit.
Gemcitabine 1000 mg/m2 IV on D1 and 1000 mg/m2 IV on D8 of each 21-day cycle plus Cisplatin 70 mg/m2 by IV on split-dose schedule of 35 mg/m2 on day 1 (D1) and 35 mg/m2 on day 8 (D8) for up to 6 cycles.
Atezolizumab 1200 mg/m2: Fixed dose of 1200 mg/m2 by intravenous (IV) infusion on D1 of each cycle up to disease progression, unacceptable toxicity or absence of clinical benefit.
Gemcitabine 1000 mg/m2: Gemcitabine 1000 mg/m2 IV on D1 and 1000 mg/m2 IV on D8 of each 21-day cycle for up to 6 cycles.
Cisplatin 70 mg/m2: Cisplatin 70 mg/m2 by IV on split-dose schedule of 35 mg/m2 on day 1 (D1) and 35 mg/m2 on day 8 (D8) for up to 6 cycles.
|
|---|---|
|
Progression-Free Survival (PFS)
|
6.9 months
Interval 6.7 to 9.4
|
SECONDARY outcome
Timeframe: 6 months from the first dose administration. CT scans for evaluation will be performed at baseline, on week 9, week 18 and then every 12 weeksProportion of patients free of PD at 6 months since start of treatment. A subject who has not died will be censored at the last known date alive.
Outcome measures
| Measure |
AUREA Single-arm
n=66 Participants
Atezolizumab (1200 mg) intravenously administered every 21 days (one cycle) up to disease progression, unacceptable toxicity or absence of clinical benefit.
Gemcitabine 1000 mg/m2 IV on D1 and 1000 mg/m2 IV on D8 of each 21-day cycle plus Cisplatin 70 mg/m2 by IV on split-dose schedule of 35 mg/m2 on day 1 (D1) and 35 mg/m2 on day 8 (D8) for up to 6 cycles.
Atezolizumab 1200 mg/m2: Fixed dose of 1200 mg/m2 by intravenous (IV) infusion on D1 of each cycle up to disease progression, unacceptable toxicity or absence of clinical benefit.
Gemcitabine 1000 mg/m2: Gemcitabine 1000 mg/m2 IV on D1 and 1000 mg/m2 IV on D8 of each 21-day cycle for up to 6 cycles.
Cisplatin 70 mg/m2: Cisplatin 70 mg/m2 by IV on split-dose schedule of 35 mg/m2 on day 1 (D1) and 35 mg/m2 on day 8 (D8) for up to 6 cycles.
|
|---|---|
|
6 Months Progression-Free Survival (PFS)
|
67.6 Percentage of patients
Interval 57.1 to 80.0
|
SECONDARY outcome
Timeframe: Through study completion, average 2 yearsFrequency of adverse events (AEs) reported classified by type and severity.
Outcome measures
| Measure |
AUREA Single-arm
n=66 Participants
Atezolizumab (1200 mg) intravenously administered every 21 days (one cycle) up to disease progression, unacceptable toxicity or absence of clinical benefit.
Gemcitabine 1000 mg/m2 IV on D1 and 1000 mg/m2 IV on D8 of each 21-day cycle plus Cisplatin 70 mg/m2 by IV on split-dose schedule of 35 mg/m2 on day 1 (D1) and 35 mg/m2 on day 8 (D8) for up to 6 cycles.
Atezolizumab 1200 mg/m2: Fixed dose of 1200 mg/m2 by intravenous (IV) infusion on D1 of each cycle up to disease progression, unacceptable toxicity or absence of clinical benefit.
Gemcitabine 1000 mg/m2: Gemcitabine 1000 mg/m2 IV on D1 and 1000 mg/m2 IV on D8 of each 21-day cycle for up to 6 cycles.
Cisplatin 70 mg/m2: Cisplatin 70 mg/m2 by IV on split-dose schedule of 35 mg/m2 on day 1 (D1) and 35 mg/m2 on day 8 (D8) for up to 6 cycles.
|
|---|---|
|
Adverse Events Frequency (Safety)
Any grade AE · Experienced AEs
|
66 Participants
|
|
Adverse Events Frequency (Safety)
Any grade AE · Did not experience AEs
|
0 Participants
|
|
Adverse Events Frequency (Safety)
AE Grade >=3 · Experienced AEs
|
62 Participants
|
|
Adverse Events Frequency (Safety)
AE Grade >=3 · Did not experience AEs
|
4 Participants
|
SECONDARY outcome
Timeframe: Through study completion, average 2 yearsFrequency of treatment-related adverse events reported classified by type and severity.
Outcome measures
| Measure |
AUREA Single-arm
n=66 Participants
Atezolizumab (1200 mg) intravenously administered every 21 days (one cycle) up to disease progression, unacceptable toxicity or absence of clinical benefit.
Gemcitabine 1000 mg/m2 IV on D1 and 1000 mg/m2 IV on D8 of each 21-day cycle plus Cisplatin 70 mg/m2 by IV on split-dose schedule of 35 mg/m2 on day 1 (D1) and 35 mg/m2 on day 8 (D8) for up to 6 cycles.
Atezolizumab 1200 mg/m2: Fixed dose of 1200 mg/m2 by intravenous (IV) infusion on D1 of each cycle up to disease progression, unacceptable toxicity or absence of clinical benefit.
Gemcitabine 1000 mg/m2: Gemcitabine 1000 mg/m2 IV on D1 and 1000 mg/m2 IV on D8 of each 21-day cycle for up to 6 cycles.
Cisplatin 70 mg/m2: Cisplatin 70 mg/m2 by IV on split-dose schedule of 35 mg/m2 on day 1 (D1) and 35 mg/m2 on day 8 (D8) for up to 6 cycles.
|
|---|---|
|
Treatment-related Adverse Events Frequency (Safety)
Treatment-related AEs any grade · Experienced AEs
|
62 Participants
|
|
Treatment-related Adverse Events Frequency (Safety)
Treatment-related AEs any grade · Did not experience AEs
|
4 Participants
|
|
Treatment-related Adverse Events Frequency (Safety)
Treatment-related AEs grade >=3 · Experienced AEs
|
44 Participants
|
|
Treatment-related Adverse Events Frequency (Safety)
Treatment-related AEs grade >=3 · Did not experience AEs
|
22 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: PD-L1 expression measured at the end of the trial. PFS assessed Through study completion, average 2 yearsPopulation: 26 patients had no PD-L1 determined
Correlation between the expression of PD-L1 with PFS during experimental treatment. Patients will be grouped based on the PD-L1 expression levels in PD-L1 positive or negative patients. Progression free survival will be assessed in both groups of patients and compared to identify potential statistically significant differences between groups.
Outcome measures
| Measure |
AUREA Single-arm
n=40 Participants
Atezolizumab (1200 mg) intravenously administered every 21 days (one cycle) up to disease progression, unacceptable toxicity or absence of clinical benefit.
Gemcitabine 1000 mg/m2 IV on D1 and 1000 mg/m2 IV on D8 of each 21-day cycle plus Cisplatin 70 mg/m2 by IV on split-dose schedule of 35 mg/m2 on day 1 (D1) and 35 mg/m2 on day 8 (D8) for up to 6 cycles.
Atezolizumab 1200 mg/m2: Fixed dose of 1200 mg/m2 by intravenous (IV) infusion on D1 of each cycle up to disease progression, unacceptable toxicity or absence of clinical benefit.
Gemcitabine 1000 mg/m2: Gemcitabine 1000 mg/m2 IV on D1 and 1000 mg/m2 IV on D8 of each 21-day cycle for up to 6 cycles.
Cisplatin 70 mg/m2: Cisplatin 70 mg/m2 by IV on split-dose schedule of 35 mg/m2 on day 1 (D1) and 35 mg/m2 on day 8 (D8) for up to 6 cycles.
|
|---|---|
|
Progression Free Survival Measured by RECIST 1.1 in Patients Grouped According to Their PD-L1 Expression
PD-L1 positive
|
6.9 months
Interval 6.4 to 17.0
|
|
Progression Free Survival Measured by RECIST 1.1 in Patients Grouped According to Their PD-L1 Expression
PD-L1 negative
|
6.9 months
Interval 6.0 to 9.7
|
OTHER_PRE_SPECIFIED outcome
Timeframe: PD-L1 expression measured at the end of the trial. ORR assessed Through study completion, average 2 yearsPopulation: 26 patients had no PD-L1 determined
Correlation between the expression of PD-L1 with ORR during experimental treatment. Patients will be grouped based on the PD-L1 expression levels in PD-L1 positive or negative patients. ORR will be assessed in both groups of patients and compared to identify potential statistically significant differences between groups.
Outcome measures
| Measure |
AUREA Single-arm
n=40 Participants
Atezolizumab (1200 mg) intravenously administered every 21 days (one cycle) up to disease progression, unacceptable toxicity or absence of clinical benefit.
Gemcitabine 1000 mg/m2 IV on D1 and 1000 mg/m2 IV on D8 of each 21-day cycle plus Cisplatin 70 mg/m2 by IV on split-dose schedule of 35 mg/m2 on day 1 (D1) and 35 mg/m2 on day 8 (D8) for up to 6 cycles.
Atezolizumab 1200 mg/m2: Fixed dose of 1200 mg/m2 by intravenous (IV) infusion on D1 of each cycle up to disease progression, unacceptable toxicity or absence of clinical benefit.
Gemcitabine 1000 mg/m2: Gemcitabine 1000 mg/m2 IV on D1 and 1000 mg/m2 IV on D8 of each 21-day cycle for up to 6 cycles.
Cisplatin 70 mg/m2: Cisplatin 70 mg/m2 by IV on split-dose schedule of 35 mg/m2 on day 1 (D1) and 35 mg/m2 on day 8 (D8) for up to 6 cycles.
|
|---|---|
|
ORR Measured by RECIST 1.1. in Patients Grouped According to Their PD-L1 Expression
PD-L1 positive · Tumor objective response
|
8 Participants
|
|
ORR Measured by RECIST 1.1. in Patients Grouped According to Their PD-L1 Expression
PD-L1 positive · No response
|
6 Participants
|
|
ORR Measured by RECIST 1.1. in Patients Grouped According to Their PD-L1 Expression
PD-L1 negative · Tumor objective response
|
10 Participants
|
|
ORR Measured by RECIST 1.1. in Patients Grouped According to Their PD-L1 Expression
PD-L1 negative · No response
|
16 Participants
|
Adverse Events
AUREA Single-arm
Serious events: 48 serious events
Other events: 66 other events
Deaths: 47 deaths
Serious adverse events
| Measure |
AUREA Single-arm
n=66 participants at risk
Atezolizumab (1200 mg) intravenously administered every 21 days (one cycle) up to disease progression, unacceptable toxicity or absence of clinical benefit.
Gemcitabine 1000 mg/m2 IV on D1 and 1000 mg/m2 IV on D8 of each 21-day cycle plus Cisplatin 70 mg/m2 by IV on split-dose schedule of 35 mg/m2 on day 1 (D1) and 35 mg/m2 on day 8 (D8) for up to 6 cycles.
Atezolizumab 1200 mg/m2: Fixed dose of 1200 mg/m2 by intravenous (IV) infusion on D1 of each cycle up to disease progression, unacceptable toxicity or absence of clinical benefit.
Gemcitabine 1000 mg/m2: Gemcitabine 1000 mg/m2 IV on D1 and 1000 mg/m2 IV on D8 of each 21-day cycle for up to 6 cycles.
Cisplatin 70 mg/m2: Cisplatin 70 mg/m2 by IV on split-dose schedule of 35 mg/m2 on day 1 (D1) and 35 mg/m2 on day 8 (D8) for up to 6 cycles.
|
|---|---|
|
General disorders
Abdominal pain
|
1.5%
1/66 • Number of events 1 • Through study completion, average 2 years.
|
|
Renal and urinary disorders
Acute kidney injury
|
7.6%
5/66 • Number of events 6 • Through study completion, average 2 years.
|
|
Gastrointestinal disorders
Anal hemorrhage
|
1.5%
1/66 • Number of events 1 • Through study completion, average 2 years.
|
|
Blood and lymphatic system disorders
Anemia
|
1.5%
1/66 • Number of events 1 • Through study completion, average 2 years.
|
|
General disorders
Back pain
|
1.5%
1/66 • Number of events 1 • Through study completion, average 2 years.
|
|
Blood and lymphatic system disorders
Pancitopenia
|
1.5%
1/66 • Number of events 1 • Through study completion, average 2 years.
|
|
Investigations
Blood bilirubin increased
|
1.5%
1/66 • Number of events 1 • Through study completion, average 2 years.
|
|
Cardiac disorders
Cardiac arrest
|
1.5%
1/66 • Number of events 1 • Through study completion, average 2 years.
|
|
Gastrointestinal disorders
Colitis
|
1.5%
1/66 • Number of events 1 • Through study completion, average 2 years.
|
|
Psychiatric disorders
Confusion
|
1.5%
1/66 • Number of events 1 • Through study completion, average 2 years.
|
|
Investigations
Creatinine increased
|
1.5%
1/66 • Number of events 1 • Through study completion, average 2 years.
|
|
General disorders
Death NOS
|
1.5%
1/66 • Number of events 1 • Through study completion, average 2 years.
|
|
General disorders
Disease progression
|
27.3%
18/66 • Number of events 18 • Through study completion, average 2 years.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
3.0%
2/66 • Number of events 4 • Through study completion, average 2 years.
|
|
Gastrointestinal disorders
Esophagitis
|
1.5%
1/66 • Number of events 1 • Through study completion, average 2 years.
|
|
General disorders
Fatigue
|
3.0%
2/66 • Number of events 2 • Through study completion, average 2 years.
|
|
General disorders
Fever
|
4.5%
3/66 • Number of events 3 • Through study completion, average 2 years.
|
|
Injury, poisoning and procedural complications
Fracture
|
3.0%
2/66 • Number of events 2 • Through study completion, average 2 years.
|
|
General disorders
Incarcerated hernia
|
1.5%
1/66 • Number of events 1 • Through study completion, average 2 years.
|
|
Nervous system disorders
Headache
|
1.5%
1/66 • Number of events 1 • Through study completion, average 2 years.
|
|
Cardiac disorders
Heart failure
|
3.0%
2/66 • Number of events 2 • Through study completion, average 2 years.
|
|
Renal and urinary disorders
Hematuria
|
4.5%
3/66 • Number of events 5 • Through study completion, average 2 years.
|
|
Injury, poisoning and procedural complications
Hip fracture
|
1.5%
1/66 • Number of events 1 • Through study completion, average 2 years.
|
|
Injury, poisoning and procedural complications
traumatic head injury
|
3.0%
2/66 • Number of events 2 • Through study completion, average 2 years.
|
|
Respiratory, thoracic and mediastinal disorders
Lung infection
|
1.5%
1/66 • Number of events 1 • Through study completion, average 2 years.
|
|
Musculoskeletal and connective tissue disorders
Inmune-mediated myopathy
|
1.5%
1/66 • Number of events 1 • Through study completion, average 2 years.
|
|
Cardiac disorders
Myocardial infarction
|
1.5%
1/66 • Number of events 1 • Through study completion, average 2 years.
|
|
Nervous system disorders
Traumatic brain injury
|
1.5%
1/66 • Number of events 1 • Through study completion, average 2 years.
|
|
Blood and lymphatic system disorders
Neutrophil count decreased
|
3.0%
2/66 • Number of events 2 • Through study completion, average 2 years.
|
|
General disorders
Pain
|
1.5%
1/66 • Number of events 1 • Through study completion, average 2 years.
|
|
Blood and lymphatic system disorders
Platelet count decreased
|
4.5%
3/66 • Number of events 3 • Through study completion, average 2 years.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
1.5%
1/66 • Number of events 1 • Through study completion, average 2 years.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
1.5%
1/66 • Number of events 1 • Through study completion, average 2 years.
|
|
Psychiatric disorders
Drug abuse
|
1.5%
1/66 • Number of events 2 • Through study completion, average 2 years.
|
|
Renal and urinary disorders
Acute nephritis
|
1.5%
1/66 • Number of events 2 • Through study completion, average 2 years.
|
|
Renal and urinary disorders
Nephritis
|
1.5%
1/66 • Number of events 1 • Through study completion, average 2 years.
|
|
Renal and urinary disorders
Acute pyelonephritis
|
1.5%
1/66 • Number of events 1 • Through study completion, average 2 years.
|
|
Renal and urinary disorders
Impaired renal function
|
1.5%
1/66 • Number of events 1 • Through study completion, average 2 years.
|
|
Infections and infestations
COVID 19
|
4.5%
3/66 • Number of events 3 • Through study completion, average 2 years.
|
|
Infections and infestations
Sepsis
|
6.1%
4/66 • Number of events 4 • Through study completion, average 2 years.
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
3.0%
2/66 • Number of events 2 • Through study completion, average 2 years.
|
|
Nervous system disorders
Stroke
|
1.5%
1/66 • Number of events 1 • Through study completion, average 2 years.
|
|
General disorders
Sudden death NOS
|
1.5%
1/66 • Number of events 1 • Through study completion, average 2 years.
|
|
Surgical and medical procedures
left percutaneous nephrostomy non-permeable
|
1.5%
1/66 • Number of events 1 • Through study completion, average 2 years.
|
|
Surgical and medical procedures
Bladder TUR
|
1.5%
1/66 • Number of events 1 • Through study completion, average 2 years.
|
|
Surgical and medical procedures
Urethral TUR
|
1.5%
1/66 • Number of events 1 • Through study completion, average 2 years.
|
|
Surgical and medical procedures
Prostate TUR
|
1.5%
1/66 • Number of events 1 • Through study completion, average 2 years.
|
|
Nervous system disorders
Syncope
|
1.5%
1/66 • Number of events 1 • Through study completion, average 2 years.
|
|
Respiratory, thoracic and mediastinal disorders
Upper respiratory infection
|
1.5%
1/66 • Number of events 1 • Through study completion, average 2 years.
|
|
Renal and urinary disorders
Urinary tract infection
|
15.2%
10/66 • Number of events 12 • Through study completion, average 2 years.
|
|
Renal and urinary disorders
Urinary tract obstruction
|
1.5%
1/66 • Number of events 1 • Through study completion, average 2 years.
|
|
Gastrointestinal disorders
Vomiting
|
3.0%
2/66 • Number of events 2 • Through study completion, average 2 years.
|
|
Vascular disorders
Bilateral Pulmonary Embolism
|
1.5%
1/66 • Number of events 1 • Through study completion, average 2 years.
|
|
Vascular disorders
Hemorragic hipovolemic shock
|
1.5%
1/66 • Number of events 1 • Through study completion, average 2 years.
|
Other adverse events
| Measure |
AUREA Single-arm
n=66 participants at risk
Atezolizumab (1200 mg) intravenously administered every 21 days (one cycle) up to disease progression, unacceptable toxicity or absence of clinical benefit.
Gemcitabine 1000 mg/m2 IV on D1 and 1000 mg/m2 IV on D8 of each 21-day cycle plus Cisplatin 70 mg/m2 by IV on split-dose schedule of 35 mg/m2 on day 1 (D1) and 35 mg/m2 on day 8 (D8) for up to 6 cycles.
Atezolizumab 1200 mg/m2: Fixed dose of 1200 mg/m2 by intravenous (IV) infusion on D1 of each cycle up to disease progression, unacceptable toxicity or absence of clinical benefit.
Gemcitabine 1000 mg/m2: Gemcitabine 1000 mg/m2 IV on D1 and 1000 mg/m2 IV on D8 of each 21-day cycle for up to 6 cycles.
Cisplatin 70 mg/m2: Cisplatin 70 mg/m2 by IV on split-dose schedule of 35 mg/m2 on day 1 (D1) and 35 mg/m2 on day 8 (D8) for up to 6 cycles.
|
|---|---|
|
Blood and lymphatic system disorders
Anemia
|
65.2%
43/66 • Through study completion, average 2 years.
|
|
Metabolism and nutrition disorders
Anorexia
|
21.2%
14/66 • Through study completion, average 2 years.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
10.6%
7/66 • Through study completion, average 2 years.
|
|
General disorders
Back pain
|
13.6%
9/66 • Through study completion, average 2 years.
|
|
Gastrointestinal disorders
Constipation
|
39.4%
26/66 • Through study completion, average 2 years.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
6.1%
4/66 • Through study completion, average 2 years.
|
|
Investigations
Creatinine increased
|
10.6%
7/66 • Through study completion, average 2 years.
|
|
Gastrointestinal disorders
Diarrhea
|
15.2%
10/66 • Through study completion, average 2 years.
|
|
Nervous system disorders
Dizziness
|
7.6%
5/66 • Through study completion, average 2 years.
|
|
Nervous system disorders
Dysgeusia
|
6.1%
4/66 • Through study completion, average 2 years.
|
|
Respiratory, thoracic and mediastinal disorders
Edema limbs
|
9.1%
6/66 • Through study completion, average 2 years.
|
|
General disorders
Fatigue
|
62.1%
41/66 • Through study completion, average 2 years.
|
|
General disorders
Fever
|
13.6%
9/66 • Through study completion, average 2 years.
|
|
Renal and urinary disorders
Hematuria
|
19.7%
13/66 • Through study completion, average 2 years.
|
|
Investigations
Hyperglycemia
|
9.1%
6/66 • Through study completion, average 2 years.
|
|
Investigations
Hypomagnesemia
|
12.1%
8/66 • Through study completion, average 2 years.
|
|
Endocrine disorders
Hypothyroidism
|
13.6%
9/66 • Through study completion, average 2 years.
|
|
Psychiatric disorders
Insomnia
|
9.1%
6/66 • Through study completion, average 2 years.
|
|
Gastrointestinal disorders
Mucositis oral
|
6.1%
4/66 • Through study completion, average 2 years.
|
|
Gastrointestinal disorders
Nausea
|
36.4%
24/66 • Through study completion, average 2 years.
|
|
Blood and lymphatic system disorders
Neutrophil count decreased
|
50.0%
33/66 • Through study completion, average 2 years.
|
|
General disorders
Pain in extremity
|
15.2%
10/66 • Through study completion, average 2 years.
|
|
Blood and lymphatic system disorders
Platelet count decreased
|
39.4%
26/66 • Through study completion, average 2 years.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
9.1%
6/66 • Through study completion, average 2 years.
|
|
Infections and infestations
COVID-19
|
9.1%
6/66 • Through study completion, average 2 years.
|
|
Investigations
Serum amylase increased
|
9.1%
6/66 • Through study completion, average 2 years.
|
|
Ear and labyrinth disorders
Tinnitus
|
10.6%
7/66 • Through study completion, average 2 years.
|
|
Renal and urinary disorders
Urinary tract infection
|
25.8%
17/66 • Through study completion, average 2 years.
|
|
Gastrointestinal disorders
Vomiting
|
18.2%
12/66 • Through study completion, average 2 years.
|
|
Gastrointestinal disorders
Abdominal pain
|
9.1%
6/66 • Through study completion, average 2 years.
|
Additional Information
A responsible person designated by the Sponsor
Spanish Oncology GenitoUrinary Group (SOGUG)
Phone: 0034934344412
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place