Trial Outcomes & Findings for Phase Ib Feasibility Trial of Neoadjuvant Nivolumab/Lirilumab in Cisplatin-Ineligible Muscle-Invasive Bladder Cancer (NCT NCT03532451)
NCT ID: NCT03532451
Last Updated: 2024-09-19
Results Overview
To assess safety of treatment according to Common Terminology Criteria for Adverse Events version 5.0 (CTCAE v5.0) manifested as the rate of Grade 3 or higher treatment related adverse events in patients treated with nivolumab (Cohort 1) or combination of nivolumab/lirilumab (Cohort 2). The NCI Common Terminology Criteria for Adverse Events is a descriptive terminology which can be utilized for Adverse Event (AE) reporting. Toxicity graded by CTCAE v5.0 scaling from 1-5 (mild to death). Grade 3 or higher events are those that are graded '3- severe or medically significant', 4- life-threatening consequences; urgent intervention indicated' or '5-Death related to AE'.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
43 participants
Primary outcome timeframe
16 months
Results posted on
2024-09-19
Participant Flow
Participant milestones
| Measure |
Cohort 1: Nivolumab
Nivolumab 480 mg IV on week 0 and week 4
Nivolumab: Nivolumab 480 mg intravenously (IV) over approximately 30 minutes every 4 weeks for 2 neo-adjuvant doses (week 0 and 4) followed by RC with bilateral (standard or extended) PLND as soon as possible but within 6 weeks after the last neoadjuvant infusion.
|
Cohort 2: Nivolumab/Lirilumab
Nivolumab 480 mg IV and Lirilumab 240 mg on week 0 and week 4
Nivolumab/Lirilumab: Nivolumab 480 mg IV over approximately 60 minutes every 4 weeks for 2 neo-adjuvant doses (week 0 and 4) with at least a 30 minute rest between infusions followed by lirilumab 240 mg IV over approximately 60 minutes every 4 weeks for 2 neo-adjuvant doses (week 0 and 4) followed by RC with bilateral (standard or extended) PLND as soon as possible but within 6 weeks after the last neoadjuvant infusion.
|
|---|---|---|
|
Overall Study
STARTED
|
13
|
30
|
|
Overall Study
COMPLETED
|
12
|
28
|
|
Overall Study
NOT COMPLETED
|
1
|
2
|
Reasons for withdrawal
| Measure |
Cohort 1: Nivolumab
Nivolumab 480 mg IV on week 0 and week 4
Nivolumab: Nivolumab 480 mg intravenously (IV) over approximately 30 minutes every 4 weeks for 2 neo-adjuvant doses (week 0 and 4) followed by RC with bilateral (standard or extended) PLND as soon as possible but within 6 weeks after the last neoadjuvant infusion.
|
Cohort 2: Nivolumab/Lirilumab
Nivolumab 480 mg IV and Lirilumab 240 mg on week 0 and week 4
Nivolumab/Lirilumab: Nivolumab 480 mg IV over approximately 60 minutes every 4 weeks for 2 neo-adjuvant doses (week 0 and 4) with at least a 30 minute rest between infusions followed by lirilumab 240 mg IV over approximately 60 minutes every 4 weeks for 2 neo-adjuvant doses (week 0 and 4) followed by RC with bilateral (standard or extended) PLND as soon as possible but within 6 weeks after the last neoadjuvant infusion.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
|
Overall Study
Did not undergo surgery
|
1
|
1
|
Baseline Characteristics
Phase Ib Feasibility Trial of Neoadjuvant Nivolumab/Lirilumab in Cisplatin-Ineligible Muscle-Invasive Bladder Cancer
Baseline characteristics by cohort
| Measure |
Cohort 1: Nivolumab
n=13 Participants
Nivolumab 480 mg IV on week 0 and week 4
Nivolumab: Nivolumab 480 mg intravenously (IV) over approximately 30 minutes every 4 weeks for 2 neo-adjuvant doses (week 0 and 4) followed by RC with bilateral (standard or extended) PLND as soon as possible but within 6 weeks after the last neoadjuvant infusion.
|
Cohort 2: Nivolumab/Lirilumab
n=29 Participants
Nivolumab 480 mg IV and Lirilumab 240 mg on week 0 and week 4
Nivolumab/Lirilumab: Nivolumab 480 mg IV over approximately 60 minutes every 4 weeks for 2 neo-adjuvant doses (week 0 and 4) with at least a 30 minute rest between infusions followed by lirilumab 240 mg IV over approximately 60 minutes every 4 weeks for 2 neo-adjuvant doses (week 0 and 4) followed by RC with bilateral (standard or extended) PLND as soon as possible but within 6 weeks after the last neoadjuvant infusion.
|
Total
n=42 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
76 years
n=5 Participants
|
75 years
n=7 Participants
|
75 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
28 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
11 Participants
n=5 Participants
|
27 Participants
n=7 Participants
|
38 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
13 Participants
n=5 Participants
|
27 Participants
n=7 Participants
|
40 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
ECOG Performance Status
0
|
10 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
28 Participants
n=5 Participants
|
|
ECOG Performance Status
1
|
2 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
ECOG Performance Status
2
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Prior Chemotherapy
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Clinical Stage
cT2 N0
|
10 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
33 Participants
n=5 Participants
|
|
Clinical Stage
cT3 N0
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Clinical Stage
cT4 N0
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Clinical Stage
cT2-4a N1
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Clinical Stage
cT2-4a Nx
|
0 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 16 monthsPopulation: Patients who received any treatment.
To assess safety of treatment according to Common Terminology Criteria for Adverse Events version 5.0 (CTCAE v5.0) manifested as the rate of Grade 3 or higher treatment related adverse events in patients treated with nivolumab (Cohort 1) or combination of nivolumab/lirilumab (Cohort 2). The NCI Common Terminology Criteria for Adverse Events is a descriptive terminology which can be utilized for Adverse Event (AE) reporting. Toxicity graded by CTCAE v5.0 scaling from 1-5 (mild to death). Grade 3 or higher events are those that are graded '3- severe or medically significant', 4- life-threatening consequences; urgent intervention indicated' or '5-Death related to AE'.
Outcome measures
| Measure |
Cohort 1: Nivolumab
n=13 Participants
Nivolumab 480 mg IV on week 0 and week 4
Nivolumab: Nivolumab 480 mg intravenously (IV) over approximately 30 minutes every 4 weeks for 2 neo-adjuvant doses (week 0 and 4) followed by RC with bilateral (standard or extended) PLND as soon as possible but within 6 weeks after the last neoadjuvant infusion.
|
Cohort 2: Nivolumab/Lirilumab
n=29 Participants
Nivolumab 480 mg IV and Lirilumab 240 mg on week 0 and week 4
Nivolumab/Lirilumab: Nivolumab 480 mg IV over approximately 60 minutes every 4 weeks for 2 neo-adjuvant doses (week 0 and 4) with at least a 30 minute rest between infusions followed by lirilumab 240 mg IV over approximately 60 minutes every 4 weeks for 2 neo-adjuvant doses (week 0 and 4) followed by RC with bilateral (standard or extended) PLND as soon as possible but within 6 weeks after the last neoadjuvant infusion.
|
|---|---|---|
|
Grade 3 or Higher Treatment Related Adverse Events as Assessed by CTCAE V5.0
|
0 proportion of participants
Interval 0.0 to 0.21
|
0.07 proportion of participants
Interval 0.01 to 0.2
|
SECONDARY outcome
Timeframe: Responses was assessed at baseline and time of radical cystectomy (within 6 weeks after the last treatment), up to 6 months.Measured by pathologic complete (pT0N0) and partial (\<pT2N0) response rate at time of RC in the two cohorts
Outcome measures
| Measure |
Cohort 1: Nivolumab
n=12 Participants
Nivolumab 480 mg IV on week 0 and week 4
Nivolumab: Nivolumab 480 mg intravenously (IV) over approximately 30 minutes every 4 weeks for 2 neo-adjuvant doses (week 0 and 4) followed by RC with bilateral (standard or extended) PLND as soon as possible but within 6 weeks after the last neoadjuvant infusion.
|
Cohort 2: Nivolumab/Lirilumab
n=28 Participants
Nivolumab 480 mg IV and Lirilumab 240 mg on week 0 and week 4
Nivolumab/Lirilumab: Nivolumab 480 mg IV over approximately 60 minutes every 4 weeks for 2 neo-adjuvant doses (week 0 and 4) with at least a 30 minute rest between infusions followed by lirilumab 240 mg IV over approximately 60 minutes every 4 weeks for 2 neo-adjuvant doses (week 0 and 4) followed by RC with bilateral (standard or extended) PLND as soon as possible but within 6 weeks after the last neoadjuvant infusion.
|
|---|---|---|
|
Percentage of Participants With Pathologic Complete and Partial Response
ypT0N0
|
16.7 percentage of participants
Interval 3.0 to 43.8
|
21.4 percentage of participants
Interval 9.8 to 38.0
|
|
Percentage of Participants With Pathologic Complete and Partial Response
<ypT2N0
|
25.0 percentage of participants
Interval 7.2 to 52.7
|
32.1 percentage of participants
Interval 17.9 to 49.4
|
SECONDARY outcome
Timeframe: 24 monthsMeasured by recurrence rate after 2 years following the RC in the two cohorts.
Outcome measures
| Measure |
Cohort 1: Nivolumab
n=12 Participants
Nivolumab 480 mg IV on week 0 and week 4
Nivolumab: Nivolumab 480 mg intravenously (IV) over approximately 30 minutes every 4 weeks for 2 neo-adjuvant doses (week 0 and 4) followed by RC with bilateral (standard or extended) PLND as soon as possible but within 6 weeks after the last neoadjuvant infusion.
|
Cohort 2: Nivolumab/Lirilumab
n=28 Participants
Nivolumab 480 mg IV and Lirilumab 240 mg on week 0 and week 4
Nivolumab/Lirilumab: Nivolumab 480 mg IV over approximately 60 minutes every 4 weeks for 2 neo-adjuvant doses (week 0 and 4) with at least a 30 minute rest between infusions followed by lirilumab 240 mg IV over approximately 60 minutes every 4 weeks for 2 neo-adjuvant doses (week 0 and 4) followed by RC with bilateral (standard or extended) PLND as soon as possible but within 6 weeks after the last neoadjuvant infusion.
|
|---|---|---|
|
Two Year Recurrence-free Survival
|
82 percentage of RFS patients
Interval 61.9 to 100.0
|
89 percentage of RFS patients
Interval 78.5 to 100.0
|
SECONDARY outcome
Timeframe: from completion of neoadjuvant treatment to 6 weeks afterthe rate of patients in each cohort who do not get RC within 6 weeks after completion of neoadjuvant treatment specifically and directly related to treatment-related adverse events (AEs)
Outcome measures
| Measure |
Cohort 1: Nivolumab
n=12 Participants
Nivolumab 480 mg IV on week 0 and week 4
Nivolumab: Nivolumab 480 mg intravenously (IV) over approximately 30 minutes every 4 weeks for 2 neo-adjuvant doses (week 0 and 4) followed by RC with bilateral (standard or extended) PLND as soon as possible but within 6 weeks after the last neoadjuvant infusion.
|
Cohort 2: Nivolumab/Lirilumab
n=28 Participants
Nivolumab 480 mg IV and Lirilumab 240 mg on week 0 and week 4
Nivolumab/Lirilumab: Nivolumab 480 mg IV over approximately 60 minutes every 4 weeks for 2 neo-adjuvant doses (week 0 and 4) with at least a 30 minute rest between infusions followed by lirilumab 240 mg IV over approximately 60 minutes every 4 weeks for 2 neo-adjuvant doses (week 0 and 4) followed by RC with bilateral (standard or extended) PLND as soon as possible but within 6 weeks after the last neoadjuvant infusion.
|
|---|---|---|
|
Rate of no RC Due to TRAEs
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: From pre-treatment Transurethral Resection of Bladder Tumor (TURBT) which happens 10 weeks (at most) before treatment to post-treatment Radical Cystectomy (RC), up to 6 months. RC was scheduled within 6 weeks after the last neoadjuvant infusionCD8+ TIL density was measured at baseline(TURBT) and radical cystectomy after treatment. Change in CD8+ TIL density from pre-treatment Transurethral Resection of Bladder Tumor (TURBT) to post-treatment Radical Cystectomy (RC) tissues separately in patients treated with nivolumab or combination of nivolumab/lirilumab. Each individual patient's CD8+ TIL density change was defined as number of CD8+ cells / the annotated tissue area in mm2
Outcome measures
| Measure |
Cohort 1: Nivolumab
n=12 Participants
Nivolumab 480 mg IV on week 0 and week 4
Nivolumab: Nivolumab 480 mg intravenously (IV) over approximately 30 minutes every 4 weeks for 2 neo-adjuvant doses (week 0 and 4) followed by RC with bilateral (standard or extended) PLND as soon as possible but within 6 weeks after the last neoadjuvant infusion.
|
Cohort 2: Nivolumab/Lirilumab
n=28 Participants
Nivolumab 480 mg IV and Lirilumab 240 mg on week 0 and week 4
Nivolumab/Lirilumab: Nivolumab 480 mg IV over approximately 60 minutes every 4 weeks for 2 neo-adjuvant doses (week 0 and 4) with at least a 30 minute rest between infusions followed by lirilumab 240 mg IV over approximately 60 minutes every 4 weeks for 2 neo-adjuvant doses (week 0 and 4) followed by RC with bilateral (standard or extended) PLND as soon as possible but within 6 weeks after the last neoadjuvant infusion.
|
|---|---|---|
|
Change in CD8+ TIL Density
|
120.5 percent of CD8+ cells
Interval -508.9 to 809.8
|
126.9 percent of CD8+ cells
Interval -235.6 to 939.6
|
SECONDARY outcome
Timeframe: The outcome was measured from pre-treatment Transurethral Resection of Bladder Tumor (TURBT) to Radical Cystectomy (RC), up to 6 months.TURBT was scheduled 10 weeks at most before the treatment. RC was scheduled within 6 weeks after the last treatment.CD8+ TIL density was measured at baseline(TURBT) and radical cystectomy after treatment. The change in CD8+ TIL density from pre-treatment Transurethral Resection of Bladder Tumor (TURBT) to post-treatment Radical Cystectomy (RC) tissues separately in patients treated with nivolumab or combination of nivolumab/liriluma. Each individual patient's percent change was defined as \[(Cystectomy TIL Density)-(TURBT TIL Density)\] / (TURBT TIL Density) x 100
Outcome measures
| Measure |
Cohort 1: Nivolumab
n=12 Participants
Nivolumab 480 mg IV on week 0 and week 4
Nivolumab: Nivolumab 480 mg intravenously (IV) over approximately 30 minutes every 4 weeks for 2 neo-adjuvant doses (week 0 and 4) followed by RC with bilateral (standard or extended) PLND as soon as possible but within 6 weeks after the last neoadjuvant infusion.
|
Cohort 2: Nivolumab/Lirilumab
n=28 Participants
Nivolumab 480 mg IV and Lirilumab 240 mg on week 0 and week 4
Nivolumab/Lirilumab: Nivolumab 480 mg IV over approximately 60 minutes every 4 weeks for 2 neo-adjuvant doses (week 0 and 4) with at least a 30 minute rest between infusions followed by lirilumab 240 mg IV over approximately 60 minutes every 4 weeks for 2 neo-adjuvant doses (week 0 and 4) followed by RC with bilateral (standard or extended) PLND as soon as possible but within 6 weeks after the last neoadjuvant infusion.
|
|---|---|---|
|
Percentage Change in CD8+ TIL Density
|
0.8 percentage of change
Interval -0.7 to 49.2
|
1.1 percentage of change
Interval -0.8 to 12.1
|
Adverse Events
Cohort 1: Nivolumab
Serious events: 3 serious events
Other events: 12 other events
Deaths: 3 deaths
Cohort 2: Nivolumab/Lirilumab
Serious events: 6 serious events
Other events: 28 other events
Deaths: 6 deaths
Serious adverse events
| Measure |
Cohort 1: Nivolumab
n=13 participants at risk
Nivolumab 480 mg IV on week 0 and week 4
Nivolumab: Nivolumab 480 mg intravenously (IV) over approximately 30 minutes every 4 weeks for 2 neo-adjuvant doses (week 0 and 4) followed by RC with bilateral (standard or extended) PLND as soon as possible but within 6 weeks after the last neoadjuvant infusion.
|
Cohort 2: Nivolumab/Lirilumab
n=29 participants at risk
Nivolumab 480 mg IV and Lirilumab 240 mg on week 0 and week 4
Nivolumab/Lirilumab: Nivolumab 480 mg IV over approximately 60 minutes every 4 weeks for 2 neo-adjuvant doses (week 0 and 4) with at least a 30 minute rest between infusions followed by lirilumab 240 mg IV over approximately 60 minutes every 4 weeks for 2 neo-adjuvant doses (week 0 and 4) followed by RC with bilateral (standard or extended) PLND as soon as possible but within 6 weeks after the last neoadjuvant infusion.
|
|---|---|---|
|
Cardiac disorders
Myocardial ischaemia
|
7.7%
1/13 • Participants were followed for AE from the first treatment to 100 days after their last dose of neoadjuvant therapy.
The AEs removed are those do not meet the AE definition. The change of data reported is due to the fact that the AE data have undergone further data cleaning/data management. The result we provide at this time is after the data cleaning.
|
0.00%
0/29 • Participants were followed for AE from the first treatment to 100 days after their last dose of neoadjuvant therapy.
The AEs removed are those do not meet the AE definition. The change of data reported is due to the fact that the AE data have undergone further data cleaning/data management. The result we provide at this time is after the data cleaning.
|
|
Infections and infestations
Urinary tract infection
|
7.7%
1/13 • Participants were followed for AE from the first treatment to 100 days after their last dose of neoadjuvant therapy.
The AEs removed are those do not meet the AE definition. The change of data reported is due to the fact that the AE data have undergone further data cleaning/data management. The result we provide at this time is after the data cleaning.
|
3.4%
1/29 • Participants were followed for AE from the first treatment to 100 days after their last dose of neoadjuvant therapy.
The AEs removed are those do not meet the AE definition. The change of data reported is due to the fact that the AE data have undergone further data cleaning/data management. The result we provide at this time is after the data cleaning.
|
|
Injury, poisoning and procedural complications
Postoperative ileus
|
7.7%
1/13 • Participants were followed for AE from the first treatment to 100 days after their last dose of neoadjuvant therapy.
The AEs removed are those do not meet the AE definition. The change of data reported is due to the fact that the AE data have undergone further data cleaning/data management. The result we provide at this time is after the data cleaning.
|
0.00%
0/29 • Participants were followed for AE from the first treatment to 100 days after their last dose of neoadjuvant therapy.
The AEs removed are those do not meet the AE definition. The change of data reported is due to the fact that the AE data have undergone further data cleaning/data management. The result we provide at this time is after the data cleaning.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer
|
7.7%
1/13 • Participants were followed for AE from the first treatment to 100 days after their last dose of neoadjuvant therapy.
The AEs removed are those do not meet the AE definition. The change of data reported is due to the fact that the AE data have undergone further data cleaning/data management. The result we provide at this time is after the data cleaning.
|
3.4%
1/29 • Participants were followed for AE from the first treatment to 100 days after their last dose of neoadjuvant therapy.
The AEs removed are those do not meet the AE definition. The change of data reported is due to the fact that the AE data have undergone further data cleaning/data management. The result we provide at this time is after the data cleaning.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory distress syndrome
|
7.7%
1/13 • Participants were followed for AE from the first treatment to 100 days after their last dose of neoadjuvant therapy.
The AEs removed are those do not meet the AE definition. The change of data reported is due to the fact that the AE data have undergone further data cleaning/data management. The result we provide at this time is after the data cleaning.
|
0.00%
0/29 • Participants were followed for AE from the first treatment to 100 days after their last dose of neoadjuvant therapy.
The AEs removed are those do not meet the AE definition. The change of data reported is due to the fact that the AE data have undergone further data cleaning/data management. The result we provide at this time is after the data cleaning.
|
|
Infections and infestations
Clostridium difficile colitis
|
0.00%
0/13 • Participants were followed for AE from the first treatment to 100 days after their last dose of neoadjuvant therapy.
The AEs removed are those do not meet the AE definition. The change of data reported is due to the fact that the AE data have undergone further data cleaning/data management. The result we provide at this time is after the data cleaning.
|
3.4%
1/29 • Participants were followed for AE from the first treatment to 100 days after their last dose of neoadjuvant therapy.
The AEs removed are those do not meet the AE definition. The change of data reported is due to the fact that the AE data have undergone further data cleaning/data management. The result we provide at this time is after the data cleaning.
|
|
Injury, poisoning and procedural complications
Post procedural haemorrhage
|
0.00%
0/13 • Participants were followed for AE from the first treatment to 100 days after their last dose of neoadjuvant therapy.
The AEs removed are those do not meet the AE definition. The change of data reported is due to the fact that the AE data have undergone further data cleaning/data management. The result we provide at this time is after the data cleaning.
|
3.4%
1/29 • Participants were followed for AE from the first treatment to 100 days after their last dose of neoadjuvant therapy.
The AEs removed are those do not meet the AE definition. The change of data reported is due to the fact that the AE data have undergone further data cleaning/data management. The result we provide at this time is after the data cleaning.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder cancer
|
0.00%
0/13 • Participants were followed for AE from the first treatment to 100 days after their last dose of neoadjuvant therapy.
The AEs removed are those do not meet the AE definition. The change of data reported is due to the fact that the AE data have undergone further data cleaning/data management. The result we provide at this time is after the data cleaning.
|
3.4%
1/29 • Participants were followed for AE from the first treatment to 100 days after their last dose of neoadjuvant therapy.
The AEs removed are those do not meet the AE definition. The change of data reported is due to the fact that the AE data have undergone further data cleaning/data management. The result we provide at this time is after the data cleaning.
|
|
Nervous system disorders
Haemorrhage intracranial
|
0.00%
0/13 • Participants were followed for AE from the first treatment to 100 days after their last dose of neoadjuvant therapy.
The AEs removed are those do not meet the AE definition. The change of data reported is due to the fact that the AE data have undergone further data cleaning/data management. The result we provide at this time is after the data cleaning.
|
3.4%
1/29 • Participants were followed for AE from the first treatment to 100 days after their last dose of neoadjuvant therapy.
The AEs removed are those do not meet the AE definition. The change of data reported is due to the fact that the AE data have undergone further data cleaning/data management. The result we provide at this time is after the data cleaning.
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/13 • Participants were followed for AE from the first treatment to 100 days after their last dose of neoadjuvant therapy.
The AEs removed are those do not meet the AE definition. The change of data reported is due to the fact that the AE data have undergone further data cleaning/data management. The result we provide at this time is after the data cleaning.
|
3.4%
1/29 • Participants were followed for AE from the first treatment to 100 days after their last dose of neoadjuvant therapy.
The AEs removed are those do not meet the AE definition. The change of data reported is due to the fact that the AE data have undergone further data cleaning/data management. The result we provide at this time is after the data cleaning.
|
|
Respiratory, thoracic and mediastinal disorders
Aspiration
|
0.00%
0/13 • Participants were followed for AE from the first treatment to 100 days after their last dose of neoadjuvant therapy.
The AEs removed are those do not meet the AE definition. The change of data reported is due to the fact that the AE data have undergone further data cleaning/data management. The result we provide at this time is after the data cleaning.
|
3.4%
1/29 • Participants were followed for AE from the first treatment to 100 days after their last dose of neoadjuvant therapy.
The AEs removed are those do not meet the AE definition. The change of data reported is due to the fact that the AE data have undergone further data cleaning/data management. The result we provide at this time is after the data cleaning.
|
Other adverse events
| Measure |
Cohort 1: Nivolumab
n=13 participants at risk
Nivolumab 480 mg IV on week 0 and week 4
Nivolumab: Nivolumab 480 mg intravenously (IV) over approximately 30 minutes every 4 weeks for 2 neo-adjuvant doses (week 0 and 4) followed by RC with bilateral (standard or extended) PLND as soon as possible but within 6 weeks after the last neoadjuvant infusion.
|
Cohort 2: Nivolumab/Lirilumab
n=29 participants at risk
Nivolumab 480 mg IV and Lirilumab 240 mg on week 0 and week 4
Nivolumab/Lirilumab: Nivolumab 480 mg IV over approximately 60 minutes every 4 weeks for 2 neo-adjuvant doses (week 0 and 4) with at least a 30 minute rest between infusions followed by lirilumab 240 mg IV over approximately 60 minutes every 4 weeks for 2 neo-adjuvant doses (week 0 and 4) followed by RC with bilateral (standard or extended) PLND as soon as possible but within 6 weeks after the last neoadjuvant infusion.
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
7.7%
1/13 • Participants were followed for AE from the first treatment to 100 days after their last dose of neoadjuvant therapy.
The AEs removed are those do not meet the AE definition. The change of data reported is due to the fact that the AE data have undergone further data cleaning/data management. The result we provide at this time is after the data cleaning.
|
6.9%
2/29 • Participants were followed for AE from the first treatment to 100 days after their last dose of neoadjuvant therapy.
The AEs removed are those do not meet the AE definition. The change of data reported is due to the fact that the AE data have undergone further data cleaning/data management. The result we provide at this time is after the data cleaning.
|
|
Gastrointestinal disorders
Abdominal pain
|
7.7%
1/13 • Participants were followed for AE from the first treatment to 100 days after their last dose of neoadjuvant therapy.
The AEs removed are those do not meet the AE definition. The change of data reported is due to the fact that the AE data have undergone further data cleaning/data management. The result we provide at this time is after the data cleaning.
|
0.00%
0/29 • Participants were followed for AE from the first treatment to 100 days after their last dose of neoadjuvant therapy.
The AEs removed are those do not meet the AE definition. The change of data reported is due to the fact that the AE data have undergone further data cleaning/data management. The result we provide at this time is after the data cleaning.
|
|
Gastrointestinal disorders
Ascites
|
7.7%
1/13 • Participants were followed for AE from the first treatment to 100 days after their last dose of neoadjuvant therapy.
The AEs removed are those do not meet the AE definition. The change of data reported is due to the fact that the AE data have undergone further data cleaning/data management. The result we provide at this time is after the data cleaning.
|
0.00%
0/29 • Participants were followed for AE from the first treatment to 100 days after their last dose of neoadjuvant therapy.
The AEs removed are those do not meet the AE definition. The change of data reported is due to the fact that the AE data have undergone further data cleaning/data management. The result we provide at this time is after the data cleaning.
|
|
Gastrointestinal disorders
Constipation
|
7.7%
1/13 • Participants were followed for AE from the first treatment to 100 days after their last dose of neoadjuvant therapy.
The AEs removed are those do not meet the AE definition. The change of data reported is due to the fact that the AE data have undergone further data cleaning/data management. The result we provide at this time is after the data cleaning.
|
17.2%
5/29 • Participants were followed for AE from the first treatment to 100 days after their last dose of neoadjuvant therapy.
The AEs removed are those do not meet the AE definition. The change of data reported is due to the fact that the AE data have undergone further data cleaning/data management. The result we provide at this time is after the data cleaning.
|
|
Gastrointestinal disorders
Diarrhoea
|
7.7%
1/13 • Participants were followed for AE from the first treatment to 100 days after their last dose of neoadjuvant therapy.
The AEs removed are those do not meet the AE definition. The change of data reported is due to the fact that the AE data have undergone further data cleaning/data management. The result we provide at this time is after the data cleaning.
|
6.9%
2/29 • Participants were followed for AE from the first treatment to 100 days after their last dose of neoadjuvant therapy.
The AEs removed are those do not meet the AE definition. The change of data reported is due to the fact that the AE data have undergone further data cleaning/data management. The result we provide at this time is after the data cleaning.
|
|
Gastrointestinal disorders
Dry mouth
|
7.7%
1/13 • Participants were followed for AE from the first treatment to 100 days after their last dose of neoadjuvant therapy.
The AEs removed are those do not meet the AE definition. The change of data reported is due to the fact that the AE data have undergone further data cleaning/data management. The result we provide at this time is after the data cleaning.
|
0.00%
0/29 • Participants were followed for AE from the first treatment to 100 days after their last dose of neoadjuvant therapy.
The AEs removed are those do not meet the AE definition. The change of data reported is due to the fact that the AE data have undergone further data cleaning/data management. The result we provide at this time is after the data cleaning.
|
|
Gastrointestinal disorders
Haematochezia
|
7.7%
1/13 • Participants were followed for AE from the first treatment to 100 days after their last dose of neoadjuvant therapy.
The AEs removed are those do not meet the AE definition. The change of data reported is due to the fact that the AE data have undergone further data cleaning/data management. The result we provide at this time is after the data cleaning.
|
0.00%
0/29 • Participants were followed for AE from the first treatment to 100 days after their last dose of neoadjuvant therapy.
The AEs removed are those do not meet the AE definition. The change of data reported is due to the fact that the AE data have undergone further data cleaning/data management. The result we provide at this time is after the data cleaning.
|
|
Gastrointestinal disorders
Nausea
|
23.1%
3/13 • Participants were followed for AE from the first treatment to 100 days after their last dose of neoadjuvant therapy.
The AEs removed are those do not meet the AE definition. The change of data reported is due to the fact that the AE data have undergone further data cleaning/data management. The result we provide at this time is after the data cleaning.
|
13.8%
4/29 • Participants were followed for AE from the first treatment to 100 days after their last dose of neoadjuvant therapy.
The AEs removed are those do not meet the AE definition. The change of data reported is due to the fact that the AE data have undergone further data cleaning/data management. The result we provide at this time is after the data cleaning.
|
|
Gastrointestinal disorders
Proctalgia
|
7.7%
1/13 • Participants were followed for AE from the first treatment to 100 days after their last dose of neoadjuvant therapy.
The AEs removed are those do not meet the AE definition. The change of data reported is due to the fact that the AE data have undergone further data cleaning/data management. The result we provide at this time is after the data cleaning.
|
0.00%
0/29 • Participants were followed for AE from the first treatment to 100 days after their last dose of neoadjuvant therapy.
The AEs removed are those do not meet the AE definition. The change of data reported is due to the fact that the AE data have undergone further data cleaning/data management. The result we provide at this time is after the data cleaning.
|
|
General disorders
Fatigue
|
23.1%
3/13 • Participants were followed for AE from the first treatment to 100 days after their last dose of neoadjuvant therapy.
The AEs removed are those do not meet the AE definition. The change of data reported is due to the fact that the AE data have undergone further data cleaning/data management. The result we provide at this time is after the data cleaning.
|
13.8%
4/29 • Participants were followed for AE from the first treatment to 100 days after their last dose of neoadjuvant therapy.
The AEs removed are those do not meet the AE definition. The change of data reported is due to the fact that the AE data have undergone further data cleaning/data management. The result we provide at this time is after the data cleaning.
|
|
General disorders
Localised oedema
|
7.7%
1/13 • Participants were followed for AE from the first treatment to 100 days after their last dose of neoadjuvant therapy.
The AEs removed are those do not meet the AE definition. The change of data reported is due to the fact that the AE data have undergone further data cleaning/data management. The result we provide at this time is after the data cleaning.
|
0.00%
0/29 • Participants were followed for AE from the first treatment to 100 days after their last dose of neoadjuvant therapy.
The AEs removed are those do not meet the AE definition. The change of data reported is due to the fact that the AE data have undergone further data cleaning/data management. The result we provide at this time is after the data cleaning.
|
|
General disorders
Swelling
|
7.7%
1/13 • Participants were followed for AE from the first treatment to 100 days after their last dose of neoadjuvant therapy.
The AEs removed are those do not meet the AE definition. The change of data reported is due to the fact that the AE data have undergone further data cleaning/data management. The result we provide at this time is after the data cleaning.
|
0.00%
0/29 • Participants were followed for AE from the first treatment to 100 days after their last dose of neoadjuvant therapy.
The AEs removed are those do not meet the AE definition. The change of data reported is due to the fact that the AE data have undergone further data cleaning/data management. The result we provide at this time is after the data cleaning.
|
|
Infections and infestations
Candida infection
|
7.7%
1/13 • Participants were followed for AE from the first treatment to 100 days after their last dose of neoadjuvant therapy.
The AEs removed are those do not meet the AE definition. The change of data reported is due to the fact that the AE data have undergone further data cleaning/data management. The result we provide at this time is after the data cleaning.
|
0.00%
0/29 • Participants were followed for AE from the first treatment to 100 days after their last dose of neoadjuvant therapy.
The AEs removed are those do not meet the AE definition. The change of data reported is due to the fact that the AE data have undergone further data cleaning/data management. The result we provide at this time is after the data cleaning.
|
|
Infections and infestations
Urinary tract infection
|
7.7%
1/13 • Participants were followed for AE from the first treatment to 100 days after their last dose of neoadjuvant therapy.
The AEs removed are those do not meet the AE definition. The change of data reported is due to the fact that the AE data have undergone further data cleaning/data management. The result we provide at this time is after the data cleaning.
|
13.8%
4/29 • Participants were followed for AE from the first treatment to 100 days after their last dose of neoadjuvant therapy.
The AEs removed are those do not meet the AE definition. The change of data reported is due to the fact that the AE data have undergone further data cleaning/data management. The result we provide at this time is after the data cleaning.
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
7.7%
1/13 • Participants were followed for AE from the first treatment to 100 days after their last dose of neoadjuvant therapy.
The AEs removed are those do not meet the AE definition. The change of data reported is due to the fact that the AE data have undergone further data cleaning/data management. The result we provide at this time is after the data cleaning.
|
10.3%
3/29 • Participants were followed for AE from the first treatment to 100 days after their last dose of neoadjuvant therapy.
The AEs removed are those do not meet the AE definition. The change of data reported is due to the fact that the AE data have undergone further data cleaning/data management. The result we provide at this time is after the data cleaning.
|
|
Injury, poisoning and procedural complications
Stoma site pain
|
7.7%
1/13 • Participants were followed for AE from the first treatment to 100 days after their last dose of neoadjuvant therapy.
The AEs removed are those do not meet the AE definition. The change of data reported is due to the fact that the AE data have undergone further data cleaning/data management. The result we provide at this time is after the data cleaning.
|
0.00%
0/29 • Participants were followed for AE from the first treatment to 100 days after their last dose of neoadjuvant therapy.
The AEs removed are those do not meet the AE definition. The change of data reported is due to the fact that the AE data have undergone further data cleaning/data management. The result we provide at this time is after the data cleaning.
|
|
Investigations
Blood creatinine increased
|
7.7%
1/13 • Participants were followed for AE from the first treatment to 100 days after their last dose of neoadjuvant therapy.
The AEs removed are those do not meet the AE definition. The change of data reported is due to the fact that the AE data have undergone further data cleaning/data management. The result we provide at this time is after the data cleaning.
|
0.00%
0/29 • Participants were followed for AE from the first treatment to 100 days after their last dose of neoadjuvant therapy.
The AEs removed are those do not meet the AE definition. The change of data reported is due to the fact that the AE data have undergone further data cleaning/data management. The result we provide at this time is after the data cleaning.
|
|
Investigations
Red blood cell count decreased
|
7.7%
1/13 • Participants were followed for AE from the first treatment to 100 days after their last dose of neoadjuvant therapy.
The AEs removed are those do not meet the AE definition. The change of data reported is due to the fact that the AE data have undergone further data cleaning/data management. The result we provide at this time is after the data cleaning.
|
0.00%
0/29 • Participants were followed for AE from the first treatment to 100 days after their last dose of neoadjuvant therapy.
The AEs removed are those do not meet the AE definition. The change of data reported is due to the fact that the AE data have undergone further data cleaning/data management. The result we provide at this time is after the data cleaning.
|
|
Investigations
Urine output decreased
|
7.7%
1/13 • Participants were followed for AE from the first treatment to 100 days after their last dose of neoadjuvant therapy.
The AEs removed are those do not meet the AE definition. The change of data reported is due to the fact that the AE data have undergone further data cleaning/data management. The result we provide at this time is after the data cleaning.
|
0.00%
0/29 • Participants were followed for AE from the first treatment to 100 days after their last dose of neoadjuvant therapy.
The AEs removed are those do not meet the AE definition. The change of data reported is due to the fact that the AE data have undergone further data cleaning/data management. The result we provide at this time is after the data cleaning.
|
|
Investigations
Weight decreased
|
7.7%
1/13 • Participants were followed for AE from the first treatment to 100 days after their last dose of neoadjuvant therapy.
The AEs removed are those do not meet the AE definition. The change of data reported is due to the fact that the AE data have undergone further data cleaning/data management. The result we provide at this time is after the data cleaning.
|
0.00%
0/29 • Participants were followed for AE from the first treatment to 100 days after their last dose of neoadjuvant therapy.
The AEs removed are those do not meet the AE definition. The change of data reported is due to the fact that the AE data have undergone further data cleaning/data management. The result we provide at this time is after the data cleaning.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
15.4%
2/13 • Participants were followed for AE from the first treatment to 100 days after their last dose of neoadjuvant therapy.
The AEs removed are those do not meet the AE definition. The change of data reported is due to the fact that the AE data have undergone further data cleaning/data management. The result we provide at this time is after the data cleaning.
|
6.9%
2/29 • Participants were followed for AE from the first treatment to 100 days after their last dose of neoadjuvant therapy.
The AEs removed are those do not meet the AE definition. The change of data reported is due to the fact that the AE data have undergone further data cleaning/data management. The result we provide at this time is after the data cleaning.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
15.4%
2/13 • Participants were followed for AE from the first treatment to 100 days after their last dose of neoadjuvant therapy.
The AEs removed are those do not meet the AE definition. The change of data reported is due to the fact that the AE data have undergone further data cleaning/data management. The result we provide at this time is after the data cleaning.
|
13.8%
4/29 • Participants were followed for AE from the first treatment to 100 days after their last dose of neoadjuvant therapy.
The AEs removed are those do not meet the AE definition. The change of data reported is due to the fact that the AE data have undergone further data cleaning/data management. The result we provide at this time is after the data cleaning.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
7.7%
1/13 • Participants were followed for AE from the first treatment to 100 days after their last dose of neoadjuvant therapy.
The AEs removed are those do not meet the AE definition. The change of data reported is due to the fact that the AE data have undergone further data cleaning/data management. The result we provide at this time is after the data cleaning.
|
0.00%
0/29 • Participants were followed for AE from the first treatment to 100 days after their last dose of neoadjuvant therapy.
The AEs removed are those do not meet the AE definition. The change of data reported is due to the fact that the AE data have undergone further data cleaning/data management. The result we provide at this time is after the data cleaning.
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
7.7%
1/13 • Participants were followed for AE from the first treatment to 100 days after their last dose of neoadjuvant therapy.
The AEs removed are those do not meet the AE definition. The change of data reported is due to the fact that the AE data have undergone further data cleaning/data management. The result we provide at this time is after the data cleaning.
|
0.00%
0/29 • Participants were followed for AE from the first treatment to 100 days after their last dose of neoadjuvant therapy.
The AEs removed are those do not meet the AE definition. The change of data reported is due to the fact that the AE data have undergone further data cleaning/data management. The result we provide at this time is after the data cleaning.
|
|
Musculoskeletal and connective tissue disorders
Joint swelling
|
7.7%
1/13 • Participants were followed for AE from the first treatment to 100 days after their last dose of neoadjuvant therapy.
The AEs removed are those do not meet the AE definition. The change of data reported is due to the fact that the AE data have undergone further data cleaning/data management. The result we provide at this time is after the data cleaning.
|
0.00%
0/29 • Participants were followed for AE from the first treatment to 100 days after their last dose of neoadjuvant therapy.
The AEs removed are those do not meet the AE definition. The change of data reported is due to the fact that the AE data have undergone further data cleaning/data management. The result we provide at this time is after the data cleaning.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
7.7%
1/13 • Participants were followed for AE from the first treatment to 100 days after their last dose of neoadjuvant therapy.
The AEs removed are those do not meet the AE definition. The change of data reported is due to the fact that the AE data have undergone further data cleaning/data management. The result we provide at this time is after the data cleaning.
|
10.3%
3/29 • Participants were followed for AE from the first treatment to 100 days after their last dose of neoadjuvant therapy.
The AEs removed are those do not meet the AE definition. The change of data reported is due to the fact that the AE data have undergone further data cleaning/data management. The result we provide at this time is after the data cleaning.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
7.7%
1/13 • Participants were followed for AE from the first treatment to 100 days after their last dose of neoadjuvant therapy.
The AEs removed are those do not meet the AE definition. The change of data reported is due to the fact that the AE data have undergone further data cleaning/data management. The result we provide at this time is after the data cleaning.
|
0.00%
0/29 • Participants were followed for AE from the first treatment to 100 days after their last dose of neoadjuvant therapy.
The AEs removed are those do not meet the AE definition. The change of data reported is due to the fact that the AE data have undergone further data cleaning/data management. The result we provide at this time is after the data cleaning.
|
|
Nervous system disorders
Headache
|
7.7%
1/13 • Participants were followed for AE from the first treatment to 100 days after their last dose of neoadjuvant therapy.
The AEs removed are those do not meet the AE definition. The change of data reported is due to the fact that the AE data have undergone further data cleaning/data management. The result we provide at this time is after the data cleaning.
|
0.00%
0/29 • Participants were followed for AE from the first treatment to 100 days after their last dose of neoadjuvant therapy.
The AEs removed are those do not meet the AE definition. The change of data reported is due to the fact that the AE data have undergone further data cleaning/data management. The result we provide at this time is after the data cleaning.
|
|
Renal and urinary disorders
Urinary incontinence
|
15.4%
2/13 • Participants were followed for AE from the first treatment to 100 days after their last dose of neoadjuvant therapy.
The AEs removed are those do not meet the AE definition. The change of data reported is due to the fact that the AE data have undergone further data cleaning/data management. The result we provide at this time is after the data cleaning.
|
0.00%
0/29 • Participants were followed for AE from the first treatment to 100 days after their last dose of neoadjuvant therapy.
The AEs removed are those do not meet the AE definition. The change of data reported is due to the fact that the AE data have undergone further data cleaning/data management. The result we provide at this time is after the data cleaning.
|
|
Renal and urinary disorders
Urinary retention
|
7.7%
1/13 • Participants were followed for AE from the first treatment to 100 days after their last dose of neoadjuvant therapy.
The AEs removed are those do not meet the AE definition. The change of data reported is due to the fact that the AE data have undergone further data cleaning/data management. The result we provide at this time is after the data cleaning.
|
0.00%
0/29 • Participants were followed for AE from the first treatment to 100 days after their last dose of neoadjuvant therapy.
The AEs removed are those do not meet the AE definition. The change of data reported is due to the fact that the AE data have undergone further data cleaning/data management. The result we provide at this time is after the data cleaning.
|
|
Reproductive system and breast disorders
Pelvic pain
|
7.7%
1/13 • Participants were followed for AE from the first treatment to 100 days after their last dose of neoadjuvant therapy.
The AEs removed are those do not meet the AE definition. The change of data reported is due to the fact that the AE data have undergone further data cleaning/data management. The result we provide at this time is after the data cleaning.
|
0.00%
0/29 • Participants were followed for AE from the first treatment to 100 days after their last dose of neoadjuvant therapy.
The AEs removed are those do not meet the AE definition. The change of data reported is due to the fact that the AE data have undergone further data cleaning/data management. The result we provide at this time is after the data cleaning.
|
|
Reproductive system and breast disorders
Testicular swelling
|
7.7%
1/13 • Participants were followed for AE from the first treatment to 100 days after their last dose of neoadjuvant therapy.
The AEs removed are those do not meet the AE definition. The change of data reported is due to the fact that the AE data have undergone further data cleaning/data management. The result we provide at this time is after the data cleaning.
|
0.00%
0/29 • Participants were followed for AE from the first treatment to 100 days after their last dose of neoadjuvant therapy.
The AEs removed are those do not meet the AE definition. The change of data reported is due to the fact that the AE data have undergone further data cleaning/data management. The result we provide at this time is after the data cleaning.
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
7.7%
1/13 • Participants were followed for AE from the first treatment to 100 days after their last dose of neoadjuvant therapy.
The AEs removed are those do not meet the AE definition. The change of data reported is due to the fact that the AE data have undergone further data cleaning/data management. The result we provide at this time is after the data cleaning.
|
0.00%
0/29 • Participants were followed for AE from the first treatment to 100 days after their last dose of neoadjuvant therapy.
The AEs removed are those do not meet the AE definition. The change of data reported is due to the fact that the AE data have undergone further data cleaning/data management. The result we provide at this time is after the data cleaning.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
7.7%
1/13 • Participants were followed for AE from the first treatment to 100 days after their last dose of neoadjuvant therapy.
The AEs removed are those do not meet the AE definition. The change of data reported is due to the fact that the AE data have undergone further data cleaning/data management. The result we provide at this time is after the data cleaning.
|
0.00%
0/29 • Participants were followed for AE from the first treatment to 100 days after their last dose of neoadjuvant therapy.
The AEs removed are those do not meet the AE definition. The change of data reported is due to the fact that the AE data have undergone further data cleaning/data management. The result we provide at this time is after the data cleaning.
|
|
Skin and subcutaneous tissue disorders
Decubitus ulcer
|
7.7%
1/13 • Participants were followed for AE from the first treatment to 100 days after their last dose of neoadjuvant therapy.
The AEs removed are those do not meet the AE definition. The change of data reported is due to the fact that the AE data have undergone further data cleaning/data management. The result we provide at this time is after the data cleaning.
|
0.00%
0/29 • Participants were followed for AE from the first treatment to 100 days after their last dose of neoadjuvant therapy.
The AEs removed are those do not meet the AE definition. The change of data reported is due to the fact that the AE data have undergone further data cleaning/data management. The result we provide at this time is after the data cleaning.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
7.7%
1/13 • Participants were followed for AE from the first treatment to 100 days after their last dose of neoadjuvant therapy.
The AEs removed are those do not meet the AE definition. The change of data reported is due to the fact that the AE data have undergone further data cleaning/data management. The result we provide at this time is after the data cleaning.
|
20.7%
6/29 • Participants were followed for AE from the first treatment to 100 days after their last dose of neoadjuvant therapy.
The AEs removed are those do not meet the AE definition. The change of data reported is due to the fact that the AE data have undergone further data cleaning/data management. The result we provide at this time is after the data cleaning.
|
|
Skin and subcutaneous tissue disorders
Rash
|
7.7%
1/13 • Participants were followed for AE from the first treatment to 100 days after their last dose of neoadjuvant therapy.
The AEs removed are those do not meet the AE definition. The change of data reported is due to the fact that the AE data have undergone further data cleaning/data management. The result we provide at this time is after the data cleaning.
|
6.9%
2/29 • Participants were followed for AE from the first treatment to 100 days after their last dose of neoadjuvant therapy.
The AEs removed are those do not meet the AE definition. The change of data reported is due to the fact that the AE data have undergone further data cleaning/data management. The result we provide at this time is after the data cleaning.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
15.4%
2/13 • Participants were followed for AE from the first treatment to 100 days after their last dose of neoadjuvant therapy.
The AEs removed are those do not meet the AE definition. The change of data reported is due to the fact that the AE data have undergone further data cleaning/data management. The result we provide at this time is after the data cleaning.
|
0.00%
0/29 • Participants were followed for AE from the first treatment to 100 days after their last dose of neoadjuvant therapy.
The AEs removed are those do not meet the AE definition. The change of data reported is due to the fact that the AE data have undergone further data cleaning/data management. The result we provide at this time is after the data cleaning.
|
|
Vascular disorders
Hypotension
|
7.7%
1/13 • Participants were followed for AE from the first treatment to 100 days after their last dose of neoadjuvant therapy.
The AEs removed are those do not meet the AE definition. The change of data reported is due to the fact that the AE data have undergone further data cleaning/data management. The result we provide at this time is after the data cleaning.
|
0.00%
0/29 • Participants were followed for AE from the first treatment to 100 days after their last dose of neoadjuvant therapy.
The AEs removed are those do not meet the AE definition. The change of data reported is due to the fact that the AE data have undergone further data cleaning/data management. The result we provide at this time is after the data cleaning.
|
|
Vascular disorders
Lymphocele
|
7.7%
1/13 • Participants were followed for AE from the first treatment to 100 days after their last dose of neoadjuvant therapy.
The AEs removed are those do not meet the AE definition. The change of data reported is due to the fact that the AE data have undergone further data cleaning/data management. The result we provide at this time is after the data cleaning.
|
0.00%
0/29 • Participants were followed for AE from the first treatment to 100 days after their last dose of neoadjuvant therapy.
The AEs removed are those do not meet the AE definition. The change of data reported is due to the fact that the AE data have undergone further data cleaning/data management. The result we provide at this time is after the data cleaning.
|
|
Endocrine disorders
Hyperthyroidism
|
0.00%
0/13 • Participants were followed for AE from the first treatment to 100 days after their last dose of neoadjuvant therapy.
The AEs removed are those do not meet the AE definition. The change of data reported is due to the fact that the AE data have undergone further data cleaning/data management. The result we provide at this time is after the data cleaning.
|
6.9%
2/29 • Participants were followed for AE from the first treatment to 100 days after their last dose of neoadjuvant therapy.
The AEs removed are those do not meet the AE definition. The change of data reported is due to the fact that the AE data have undergone further data cleaning/data management. The result we provide at this time is after the data cleaning.
|
|
Endocrine disorders
Hypothyroidism
|
0.00%
0/13 • Participants were followed for AE from the first treatment to 100 days after their last dose of neoadjuvant therapy.
The AEs removed are those do not meet the AE definition. The change of data reported is due to the fact that the AE data have undergone further data cleaning/data management. The result we provide at this time is after the data cleaning.
|
6.9%
2/29 • Participants were followed for AE from the first treatment to 100 days after their last dose of neoadjuvant therapy.
The AEs removed are those do not meet the AE definition. The change of data reported is due to the fact that the AE data have undergone further data cleaning/data management. The result we provide at this time is after the data cleaning.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/13 • Participants were followed for AE from the first treatment to 100 days after their last dose of neoadjuvant therapy.
The AEs removed are those do not meet the AE definition. The change of data reported is due to the fact that the AE data have undergone further data cleaning/data management. The result we provide at this time is after the data cleaning.
|
13.8%
4/29 • Participants were followed for AE from the first treatment to 100 days after their last dose of neoadjuvant therapy.
The AEs removed are those do not meet the AE definition. The change of data reported is due to the fact that the AE data have undergone further data cleaning/data management. The result we provide at this time is after the data cleaning.
|
|
General disorders
Chills
|
0.00%
0/13 • Participants were followed for AE from the first treatment to 100 days after their last dose of neoadjuvant therapy.
The AEs removed are those do not meet the AE definition. The change of data reported is due to the fact that the AE data have undergone further data cleaning/data management. The result we provide at this time is after the data cleaning.
|
31.0%
9/29 • Participants were followed for AE from the first treatment to 100 days after their last dose of neoadjuvant therapy.
The AEs removed are those do not meet the AE definition. The change of data reported is due to the fact that the AE data have undergone further data cleaning/data management. The result we provide at this time is after the data cleaning.
|
|
General disorders
Pyrexia
|
0.00%
0/13 • Participants were followed for AE from the first treatment to 100 days after their last dose of neoadjuvant therapy.
The AEs removed are those do not meet the AE definition. The change of data reported is due to the fact that the AE data have undergone further data cleaning/data management. The result we provide at this time is after the data cleaning.
|
13.8%
4/29 • Participants were followed for AE from the first treatment to 100 days after their last dose of neoadjuvant therapy.
The AEs removed are those do not meet the AE definition. The change of data reported is due to the fact that the AE data have undergone further data cleaning/data management. The result we provide at this time is after the data cleaning.
|
|
Injury, poisoning and procedural complications
Procedural pain
|
0.00%
0/13 • Participants were followed for AE from the first treatment to 100 days after their last dose of neoadjuvant therapy.
The AEs removed are those do not meet the AE definition. The change of data reported is due to the fact that the AE data have undergone further data cleaning/data management. The result we provide at this time is after the data cleaning.
|
6.9%
2/29 • Participants were followed for AE from the first treatment to 100 days after their last dose of neoadjuvant therapy.
The AEs removed are those do not meet the AE definition. The change of data reported is due to the fact that the AE data have undergone further data cleaning/data management. The result we provide at this time is after the data cleaning.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/13 • Participants were followed for AE from the first treatment to 100 days after their last dose of neoadjuvant therapy.
The AEs removed are those do not meet the AE definition. The change of data reported is due to the fact that the AE data have undergone further data cleaning/data management. The result we provide at this time is after the data cleaning.
|
6.9%
2/29 • Participants were followed for AE from the first treatment to 100 days after their last dose of neoadjuvant therapy.
The AEs removed are those do not meet the AE definition. The change of data reported is due to the fact that the AE data have undergone further data cleaning/data management. The result we provide at this time is after the data cleaning.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/13 • Participants were followed for AE from the first treatment to 100 days after their last dose of neoadjuvant therapy.
The AEs removed are those do not meet the AE definition. The change of data reported is due to the fact that the AE data have undergone further data cleaning/data management. The result we provide at this time is after the data cleaning.
|
6.9%
2/29 • Participants were followed for AE from the first treatment to 100 days after their last dose of neoadjuvant therapy.
The AEs removed are those do not meet the AE definition. The change of data reported is due to the fact that the AE data have undergone further data cleaning/data management. The result we provide at this time is after the data cleaning.
|
|
Reproductive system and breast disorders
Vaginal discharge
|
0.00%
0/13 • Participants were followed for AE from the first treatment to 100 days after their last dose of neoadjuvant therapy.
The AEs removed are those do not meet the AE definition. The change of data reported is due to the fact that the AE data have undergone further data cleaning/data management. The result we provide at this time is after the data cleaning.
|
6.9%
2/29 • Participants were followed for AE from the first treatment to 100 days after their last dose of neoadjuvant therapy.
The AEs removed are those do not meet the AE definition. The change of data reported is due to the fact that the AE data have undergone further data cleaning/data management. The result we provide at this time is after the data cleaning.
|
|
Vascular disorders
Hypertension
|
0.00%
0/13 • Participants were followed for AE from the first treatment to 100 days after their last dose of neoadjuvant therapy.
The AEs removed are those do not meet the AE definition. The change of data reported is due to the fact that the AE data have undergone further data cleaning/data management. The result we provide at this time is after the data cleaning.
|
13.8%
4/29 • Participants were followed for AE from the first treatment to 100 days after their last dose of neoadjuvant therapy.
The AEs removed are those do not meet the AE definition. The change of data reported is due to the fact that the AE data have undergone further data cleaning/data management. The result we provide at this time is after the data cleaning.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place