Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

A Study of Enfortumab Vedotin for Patients With Locally Advanced or Metastatic Urothelial Bladder Cancer (EV-201)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03219333
Recruitment Status : Active, not recruiting
First Posted : July 17, 2017
Results First Posted : December 17, 2021
Last Update Posted : June 15, 2022
Sponsor:
Collaborator:
Seagen Inc.
Information provided by (Responsible Party):
Astellas Pharma Inc

Study Type Interventional
Study Design Allocation: N/A;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Carcinoma, Transitional Cell
Urinary Bladder Neoplasms
Urologic Neoplasms
Renal Pelvis Neoplasms
Urothelial Cancer
Ureteral Neoplasms
Urethral Neoplasms
Intervention Drug: Enfortumab vedotin
Enrollment 219
Recruitment Details  
Pre-assignment Details Eligible participants with locally advanced or metastatic urothelial cancer who have previously received systemic therapy with a PD-1/PD-L1 inhibitor and met inclusion criteria and none of the exclusion criteria were enrolled in the study.
Arm/Group Title Enfortumab Vedotin - Cohort 1 Enfortumab Vedotin - Cohort 2
Hide Arm/Group Description Participants in Cohort 1 had received prior treatment with platinum-containing chemotherapy. Enfortumab vedotin, at a dose of 1.25 mg/kg, was administered to participants as an IV infusion over approximately 30 minutes on Days 1, 8, and 15 of each 28-day cycle. Participants in Cohort 2 had received no platinum-containing chemotherapy were ineligible for treatment with cisplatin at the time of enrollment. Enfortumab vedotin, at a dose of 1.25 mg/kg, was administered to participants as an IV infusion over approximately 30 minutes on Days 1, 8, and 15 of each 28-day cycle.
Period Title: Overall Study
Started 128 91
Treated 125 89
Completed [1] 23 [2] 42 [3]
Not Completed 105 49
Reason Not Completed
Withdrawal by Subject             8             3
Lost to Follow-up             1             0
Death             94             44
Includes 4 participants who were enrolled and never received study treatment.             2             2
[1]
Participants still on treatment or in long term follow-up as of data cut-off date 08-Sep-2020.
[2]
Cohort 1 Completed includes 4 participants on treatment and 19 participants in follow-up.
[3]
Cohort 2 Completed includes 16 participants on treatment and 26 participants in follow-up.
Arm/Group Title Enfortumab Vedotin - Cohort 1 Enfortumab Vedotin - Cohort 2 Total
Hide Arm/Group Description Participants in Cohort 1 had received prior treatment with platinum-containing chemotherapy. Enfortumab vedotin, at a dose of 1.25 mg/kg, was administered to participants as an IV infusion over approximately 30 minutes on Days 1, 8, and 15 of each 28-day cycle. Participants in Cohort 2 had received no platinum-containing chemotherapy were ineligible for treatment with cisplatin at the time of enrollment. Enfortumab vedotin, at a dose of 1.25 mg/kg, was administered to participants as an IV infusion over approximately 30 minutes on Days 1, 8, and 15 of each 28-day cycle. Total of all reporting groups
Overall Number of Baseline Participants 125 89 214
Hide Baseline Analysis Population Description
Baseline population includes all enrolled participants who received a dose of enfortumab vedotin.
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 125 participants 89 participants 214 participants
69.0
(40 to 84)
75.0
(49 to 90)
72.0
(40 to 90)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 125 participants 89 participants 214 participants
Female
37
  29.6%
23
  25.8%
60
  28.0%
Male
88
  70.4%
66
  74.2%
154
  72.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 125 participants 89 participants 214 participants
Hispanic or Latino
5
   4.0%
1
   1.1%
6
   2.8%
Not Hispanic or Latino
118
  94.4%
83
  93.3%
201
  93.9%
Unknown or Not Reported
2
   1.6%
5
   5.6%
7
   3.3%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 125 participants 89 participants 214 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
11
   8.8%
20
  22.5%
31
  14.5%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
2
   1.6%
0
   0.0%
2
   0.9%
White
106
  84.8%
62
  69.7%
168
  78.5%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
6
   4.8%
7
   7.9%
13
   6.1%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 125 participants 89 participants 214 participants
North America
117
  93.6%
57
  64.0%
174
  81.3%
Europe
0
   0.0%
14
  15.7%
14
   6.5%
Asia
8
   6.4%
18
  20.2%
26
  12.1%
Eastern Cooperative Oncology Group (ECOG) Performance Status   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 125 participants 89 participants 214 participants
0
40
  32.0%
37
  41.6%
77
  36.0%
1
85
  68.0%
41
  46.1%
126
  58.9%
2
0
   0.0%
11
  12.4%
11
   5.1%
[1]
Measure Description: ECOG performance status was used to assess participants disease progression, and ability to carry out daily living activities. Measure Description: 0=Normal activity; 1=Symptoms but ambulatory; 2=In bed <50% of the time; 3= In bed >50% of the time; 4=100% bedridden; 5=Dead
1.Primary Outcome
Title Objective Response Rate (ORR) Per Blinded Independent Central Review (BICR)
Hide Description The percentage of participants with confirmed complete response (CR) or partial response (PR) according to Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1). CR is defined as disappearance of all target lesions and non-target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. PR is defined as a ≥30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters.
Time Frame Up to data cut-off date of 01 Mar 2019 for cohort 1 and 08 Sept 2020 for cohort 2 (Cohort 1 median follow-up time: 10.15 months [range 0.49, 16.46]. Cohort 2 median follow up time: 13.4 months [range 0.33 to 29.27]).
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set: includes all enrolled participants who received at least one dose of enfortumab vedotin.
Arm/Group Title Enfortumab Vedotin - Cohort 1 Enfortumab Vedotin - Cohort 2
Hide Arm/Group Description:
Participants in Cohort 1 had received prior treatment with platinum-containing chemotherapy. Enfortumab vedotin, at a dose of 1.25 mg/kg, was administered to participants as an IV infusion over approximately 30 minutes on Days 1, 8, and 15 of each 28-day cycle.
Participants in Cohort 2 had received no platinum-containing chemotherapy were ineligible for treatment with cisplatin at the time of enrollment. Enfortumab vedotin, at a dose of 1.25 mg/kg, was administered to participants as an IV infusion over approximately 30 minutes on Days 1, 8, and 15 of each 28-day cycle.
Overall Number of Participants Analyzed 125 89
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of Participants
44
(35.1 to 53.2)
51.7
(40.8 to 62.4)
2.Secondary Outcome
Title Duration of Objective Response (DOR) Per BICR
Hide Description The time from first documentation of objective response (CR or PR that is subsequently confirmed) to the first documentation of progressive disease (PD) or to death due to any cause, whichever comes first. CR and PR are defined in ORR per BICR endpoint. PD was defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 0.5 cm. The appearance of one or more new lesions is also considered progression. DOR was analyzed using Kaplan-Meier methodology.
Time Frame Up to data cut-off date of 01 Mar 2019 for cohort 1 and 08 Sept 2020 for cohort 2 (Cohort 1 median follow-up time: 10.15 months [range 0.49, 16.46]. Cohort 2 median follow up time: 13.4 months [range 0.33 to 29.27]).
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set: includes all enrolled participants who received at least one dose of enfortumab vedotin.
Arm/Group Title Enfortumab Vedotin - Cohort 1 Enfortumab Vedotin - Cohort 2
Hide Arm/Group Description:
Participants in Cohort 1 had received prior treatment with platinum-containing chemotherapy. Enfortumab vedotin, at a dose of 1.25 mg/kg, was administered to participants as an IV infusion over approximately 30 minutes on Days 1, 8, and 15 of each 28-day cycle.
Participants in Cohort 2 had received no platinum-containing chemotherapy were ineligible for treatment with cisplatin at the time of enrollment. Enfortumab vedotin, at a dose of 1.25 mg/kg, was administered to participants as an IV infusion over approximately 30 minutes on Days 1, 8, and 15 of each 28-day cycle.
Overall Number of Participants Analyzed 55 46
Median (95% Confidence Interval)
Unit of Measure: months
7.6 [1] 
(6.34 to NA)
10.9 [2] 
(5.78 to NA)
[1]
24 of the 55 responders (44%) had ongoing responses. Observed min, max: 0.95, 11.30+.
[2]
18 of the 46 responders (39%) had ongoing responses. Observed min, max: 0.99+, 20.80+
3.Secondary Outcome
Title Progression-Free Survival (PFS) Per BICR
Hide Description The time from start of study treatment to first documentation of objective tumor progression (PD per RECIST 1.1), or to death due to any cause, whichever comes first. PD is defined in the DOR per BICR endpoint.
Time Frame Up to data cut-off date of 01 Mar 2019 for cohort 1 and 08 Sept 2020 for cohort 2 (Cohort 1 median follow-up time: 10.15 months [range 0.49, 16.46]. Cohort 2 median follow up time: 13.4 months [range 0.33 to 29.27]).
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set: includes all enrolled participants who received at least one dose of enfortumab vedotin.
Arm/Group Title Enfortumab Vedotin - Cohort 1 Enfortumab Vedotin - Cohort 2
Hide Arm/Group Description:
Participants in Cohort 1 had received prior treatment with platinum-containing chemotherapy. Enfortumab vedotin, at a dose of 1.25 mg/kg, was administered to participants as an IV infusion over approximately 30 minutes on Days 1, 8, and 15 of each 28-day cycle.
Participants in Cohort 2 had received no platinum-containing chemotherapy were ineligible for treatment with cisplatin at the time of enrollment. Enfortumab vedotin, at a dose of 1.25 mg/kg, was administered to participants as an IV infusion over approximately 30 minutes on Days 1, 8, and 15 of each 28-day cycle.
Overall Number of Participants Analyzed 125 89
Median (95% Confidence Interval)
Unit of Measure: months
5.8
(4.93 to 7.46)
5.8
(5.03 to 8.28)
4.Secondary Outcome
Title ORR Per Investigator Assessment
Hide Description The percentage of participants with confirmed complete response (CR) or partial response (PR) according to Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1). CR and PR are defined in the ORR per BICR endpoint.
Time Frame Up to data cut-off date of 01 Mar 2019 for cohort 1 and 08 Sept 2020 for cohort 2 (Cohort 1 median follow-up time: 10.15 months [range 0.49, 16.46]. Cohort 2 median follow up time: 13.4 months [range 0.33 to 29.27]).
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set: includes all enrolled participants who received at least one dose of enfortumab vedotin.
Arm/Group Title Enfortumab Vedotin - Cohort 1 Enfortumab Vedotin - Cohort 2
Hide Arm/Group Description:
Participants in Cohort 1 had received prior treatment with platinum-containing chemotherapy. Enfortumab vedotin, at a dose of 1.25 mg/kg, was administered to participants as an IV infusion over approximately 30 minutes on Days 1, 8, and 15 of each 28-day cycle.
Participants in Cohort 2 had received no platinum-containing chemotherapy were ineligible for treatment with cisplatin at the time of enrollment. Enfortumab vedotin, at a dose of 1.25 mg/kg, was administered to participants as an IV infusion over approximately 30 minutes on Days 1, 8, and 15 of each 28-day cycle.
Overall Number of Participants Analyzed 125 89
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of Participants
39
(30.6 to 48.3)
50.6
(39.8 to 61.3)
5.Secondary Outcome
Title DOR Per Investigator Assessment
Hide Description The time from first documentation of objective response (CR or PR that is subsequently confirmed) to the first documentation of PD or to death due to any cause, whichever comes first. CR and PR are defined in ORR per BICR endpoint. PD is defined in the DOR per BICR endpoint.
Time Frame Up to data cut-off date of 01 Mar 2019 for cohort 1 and 08 Sept 2020 for cohort 2 (Cohort 1 median follow-up time: 10.15 months [range 0.49, 16.46]. Cohort 2 median follow up time: 13.4 months [range 0.33 to 29.27]).
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set: includes all enrolled participants who received at least one dose of enfortumab vedotin.
Arm/Group Title Enfortumab Vedotin - Cohort 1 Enfortumab Vedotin - Cohort 2
Hide Arm/Group Description:
Participants in Cohort 1 had received prior treatment with platinum-containing chemotherapy. Enfortumab vedotin, at a dose of 1.25 mg/kg, was administered to participants as an IV infusion over approximately 30 minutes on Days 1, 8, and 15 of each 28-day cycle.
Participants in Cohort 2 had received no platinum-containing chemotherapy were ineligible for treatment with cisplatin at the time of enrollment. Enfortumab vedotin, at a dose of 1.25 mg/kg, was administered to participants as an IV infusion over approximately 30 minutes on Days 1, 8, and 15 of each 28-day cycle.
Overall Number of Participants Analyzed 49 45
Median (95% Confidence Interval)
Unit of Measure: months
7.9 [1] 
(5.95 to NA)
10.7
(5.85 to 16.59)
[1]
26 of the 49 responders (53%) had ongoing responses. Observed min, max: 1.87, 12.91+.
6.Secondary Outcome
Title PFS Per Investigator Assessment
Hide Description The time from start of study treatment to first documentation of objective tumor progression (PD per RECIST 1.1), or to death due to any cause, whichever comes first. PD is defined in the DOR per BICR endpoint.
Time Frame Up to data cut-off date of 01 Mar 2019 for cohort 1 and 08 Sept 2020 for cohort 2 (Cohort 1 median follow-up time: 10.15 months [range 0.49, 16.46]. Cohort 2 median follow up time: 13.4 months [range 0.33 to 29.27]).
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set: includes all enrolled participants who received at least one dose of enfortumab vedotin.
Arm/Group Title Enfortumab Vedotin - Cohort 1 Enfortumab Vedotin - Cohort 2
Hide Arm/Group Description:
Participants in Cohort 1 had received prior treatment with platinum-containing chemotherapy. Enfortumab vedotin, at a dose of 1.25 mg/kg, was administered to participants as an IV infusion over approximately 30 minutes on Days 1, 8, and 15 of each 28-day cycle.
Participants in Cohort 2 had received no platinum-containing chemotherapy were ineligible for treatment with cisplatin at the time of enrollment. Enfortumab vedotin, at a dose of 1.25 mg/kg, was administered to participants as an IV infusion over approximately 30 minutes on Days 1, 8, and 15 of each 28-day cycle.
Overall Number of Participants Analyzed 125 89
Median (95% Confidence Interval)
Unit of Measure: months
5.8
(4.93 to 7.46)
7.2
(5.42 to 7.69)
7.Secondary Outcome
Title Number of Participants With Treatment-Emergent Laboratory Abnormalities (Hematology)
Hide Description A treatment-emergent laboratory abnormality is a value increases or decrease by 1 toxicity grade after the first study dose.
Time Frame Up to data cut-off date of 08 Sept 2020 (The median duration of treatment was 4.60 months for Cohort 1 [range: 0.5, 29.4 months] and 5.98 months for Cohort 2 [range: 0.3, 24.6 months]).
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Analysis Subset: Denominator for each laboratory parameter is based on the number of participants who received at least one dose of enfortumab vedotin and have a baseline and post-baseline laboratory value.
Arm/Group Title Enfortumab Vedotin - Cohort 1 Enfortumab Vedotin - Cohort 2
Hide Arm/Group Description:
Participants in Cohort 1 had received prior treatment with platinum-containing chemotherapy. Enfortumab vedotin, at a dose of 1.25 mg/kg, was administered to participants as an IV infusion over approximately 30 minutes on Days 1, 8, and 15 of each 28-day cycle.
Participants in Cohort 2 had received no platinum-containing chemotherapy were ineligible for treatment with cisplatin at the time of enrollment. Enfortumab vedotin, at a dose of 1.25 mg/kg, was administered to participants as an IV infusion over approximately 30 minutes on Days 1, 8, and 15 of each 28-day cycle.
Overall Number of Participants Analyzed 125 89
Measure Type: Count of Participants
Unit of Measure: Participants
Hemoglobin decreased (all grades) Number Analyzed 122 participants 88 participants
52
  42.6%
39
  44.3%
Hemoglobin decreased (grade 3-4) Number Analyzed 122 participants 88 participants
12
   9.8%
4
   4.5%
Leukocytes decreased (all grades) Number Analyzed 122 participants 88 participants
33
  27.0%
28
  31.8%
Leukocytes decreased (grade 3-4) Number Analyzed 122 participants 88 participants
5
   4.1%
4
   4.5%
Lymphocytes decreased (all grades) Number Analyzed 122 participants 88 participants
55
  45.1%
61
  69.3%
Lymphocytes decreased (grade 3-4) Number Analyzed 122 participants 88 participants
12
   9.8%
13
  14.8%
Lymphocytes increased (all grades) Number Analyzed 125 participants 88 participants
0
   0.0%
1
   1.1%
Lymphocytes increased (grade 3-4) Number Analyzed 125 participants 89 participants
0
   0.0%
0
   0.0%
Neutrophils decreased (all grades) Number Analyzed 122 participants 88 participants
28
  23.0%
27
  30.7%
Neutrophils decreased (grade 3-4) Number Analyzed 122 participants 88 participants
7
   5.7%
8
   9.1%
Platelets decreased (all grades) Number Analyzed 121 participants 88 participants
39
  32.2%
20
  22.7%
Platelets decreased (grade 3-4) Number Analyzed 125 participants 89 participants
0
   0.0%
0
   0.0%
8.Secondary Outcome
Title Number of Participants With Treatment-Emergent Laboratory Abnormalities (Serum Chemistry)
Hide Description A treatment-emergent laboratory abnormality is a value increases or decrease by 1 toxicity grade after the first study dose.
Time Frame Up to data cut-off date of 08 Sept 2020 (The median duration of treatment was 4.60 months for Cohort 1 [full range: 0.5, 29.4 months] and 5.98 months for Cohort 2 [full range: 0.3, 24.6 months]).
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Analysis Subset: Denominator for each laboratory parameter is based on the number of participants who received at least one dose of enfortumab vedotin and have a baseline and post-baseline laboratory value.
Arm/Group Title Enfortumab Vedotin - Cohort 1 Enfortumab Vedotin - Cohort 2
Hide Arm/Group Description:
Participants in Cohort 1 had received prior treatment with platinum-containing chemotherapy. Enfortumab vedotin, at a dose of 1.25 mg/kg, was administered to participants as an IV infusion over approximately 30 minutes on Days 1, 8, and 15 of each 28-day cycle.
Participants in Cohort 2 had received no platinum-containing chemotherapy were ineligible for treatment with cisplatin at the time of enrollment. Enfortumab vedotin, at a dose of 1.25 mg/kg, was administered to participants as an IV infusion over approximately 30 minutes on Days 1, 8, and 15 of each 28-day cycle.
Overall Number of Participants Analyzed 125 89
Measure Type: Count of Participants
Unit of Measure: Participants
Alanine aminotransferase increased (all grades) Number Analyzed 122 participants 88 participants
34
  27.9%
26
  29.5%
Alanine aminotransferase increased (grade 3-4) Number Analyzed 122 participants 89 participants
1
   0.8%
0
   0.0%
Albumin decreased (all grades) Number Analyzed 122 participants 88 participants
38
  31.1%
16
  18.2%
Albumin decreased (grade 3-4) Number Analyzed 122 participants 89 participants
1
   0.8%
0
   0.0%
Alkaline phosphatase increased (all grades) Number Analyzed 122 participants 88 participants
21
  17.2%
12
  13.6%
Alkaline phosphatase increased (grade 3-4) Number Analyzed 122 participants 88 participants
1
   0.8%
0
   0.0%
Aspartate aminotransferase increased (all grades) Number Analyzed 121 participants 88 participants
79
  65.3%
52
  59.1%
Aspartate aminotransferase increased (grade 3-4) Number Analyzed 121 participants 88 participants
3
   2.5%
2
   2.3%
Bilirubin increased (all grades) Number Analyzed 122 participants 88 participants
13
  10.7%
5
   5.7%
Bilirubin increased (grade 3-4) Number Analyzed 122 participants 89 participants
1
   0.8%
0
   0.0%
Calcium decreased (all grades) Number Analyzed 122 participants 88 participants
15
  12.3%
7
   8.0%
Calcium decreased (grade 3-4) Number Analyzed 125 participants 89 participants
0
   0.0%
0
   0.0%
Calcium increased (all grades) Number Analyzed 122 participants 88 participants
1
   0.8%
7
   8.0%
Calcium increased (grade 3-4) Number Analyzed 125 participants 88 participants
0
   0.0%
3
   3.4%
Creatinine increased (all grades) Number Analyzed 122 participants 88 participants
73
  59.8%
46
  52.3%
Creatinine increased (grade 3-4) Number Analyzed 122 participants 88 participants
2
   1.6%
3
   3.4%
Glucose decreased (all grades) Number Analyzed 122 participants 88 participants
32
  26.2%
26
  29.5%
Glucose decreased (grade 3-4) Number Analyzed 125 participants 89 participants
0
   0.0%
0
   0.0%
Glucose increased (all grades) Number Analyzed 125 participants 89 participants
NA [1]  NA [1] 
Glucose increased (grade 3-4) Number Analyzed 122 participants 88 participants
10
   8.2%
11
  12.5%
Phosphate decreased (all grades) Number Analyzed 122 participants 88 participants
42
  34.4%
22
  25.0%
Phosphate decreased (grade 3-4) Number Analyzed 122 participants 88 participants
12
   9.8%
6
   6.8%
Potassium decreased (all grades) Number Analyzed 122 participants 88 participants
25
  20.5%
11
  12.5%
Potassium decreased (grade 3-4) Number Analyzed 122 participants 88 participants
2
   1.6%
1
   1.1%
Potassium increased (all grades) Number Analyzed 122 participants 88 participants
13
  10.7%
17
  19.3%
Potassium increased (grade 3-4) Number Analyzed 125 participants 88 participants
0
   0.0%
5
   5.7%
Sodium decreased (all grades) Number Analyzed 122 participants 88 participants
54
  44.3%
28
  31.8%
Sodium decreased (grade 3-4) Number Analyzed 122 participants 88 participants
10
   8.2%
6
   6.8%
Sodium increased (all grades) Number Analyzed 122 participants 88 participants
2
   1.6%
1
   1.1%
Sodium increased (grade 3-4) Number Analyzed 125 participants 89 participants
0
   0.0%
0
   0.0%
Urate increased (all grades) Number Analyzed 122 participants 88 participants
32
  26.2%
38
  43.2%
Urate increased (grade 3-4) Number Analyzed 122 participants 88 participants
8
   6.6%
8
   9.1%
Amylase increased (all grades) Number Analyzed 122 participants 88 participants
20
  16.4%
18
  20.5%
Amylase increased (grade 3-4) Number Analyzed 122 participants 88 participants
1
   0.8%
3
   3.4%
Lipase increased (all grades) Number Analyzed 122 participants 88 participants
37
  30.3%
32
  36.4%
Lipase increased (grade 3-4) Number Analyzed 122 participants 88 participants
12
   9.8%
10
  11.4%
[1]
Fasting glucose is required for CTCAE grading of hyperglycemia grade 1-2, not grade 3-4. Since fasting glucose was not required for this study, grade 1-2 (glucose-high) could not be determined. Only grade 3-4 was determined.
9.Secondary Outcome
Title Incidence of Antitherapeutic Antibody (ATA)
Hide Description Participants who were tested positive for ATA at any time post-baseline were considered to be transiently positive or persistently positive if >=2 consecutive samples were confirmed as positive.
Time Frame Up to data cut-off date of 08 Sept 2020 (The median duration of treatment was 4.60 months for Cohort 1 [full range: 0.5, 29.4 months] and 5.98 months for Cohort 2 [full range: 0.3, 24.6 months]).
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Analysis Set: Participants who received at least one dose of enfortumab vedotin. ATA subset (participants with a baseline and at least one post-baseline sample) - Cohort 1: 114 participants; Cohort 2: 81 participants.
Arm/Group Title Enfortumab Vedotin - Cohort 1 Enfortumab Vedotin - Cohort 2
Hide Arm/Group Description:
Participants in Cohort 1 had received prior treatment with platinum-containing chemotherapy. Enfortumab vedotin, at a dose of 1.25 mg/kg, was administered to participants as an IV infusion over approximately 30 minutes on Days 1, 8, and 15 of each 28-day cycle.
Participants in Cohort 2 had received no platinum-containing chemotherapy were ineligible for treatment with cisplatin at the time of enrollment. Enfortumab vedotin, at a dose of 1.25 mg/kg, was administered to participants as an IV infusion over approximately 30 minutes on Days 1, 8, and 15 of each 28-day cycle.
Overall Number of Participants Analyzed 114 81
Measure Type: Count of Participants
Unit of Measure: Participants
Baseline Negative Number Analyzed 112 participants 80 participants
Negative post-baseline
109
  97.3%
76
  95.0%
Transiently positive post-baseline
2
   1.8%
3
   3.8%
Persistently positive post-baseline
1
   0.9%
1
   1.3%
Baseline Positive Number Analyzed 2 participants 1 participants
Negative post-baseline
1
  50.0%
1
 100.0%
Transiently positive post-baseline
1
  50.0%
0
   0.0%
Persistently positive post-baseline
0
   0.0%
0
   0.0%
10.Secondary Outcome
Title Disease Control Rate at 16 Weeks (DCR16) Per BICR
Hide Description Percentage of participants with CR, PR, or stable disease (SD) at Week 16 visit. CR and PR are defined in ORR per BICR endpoint. SD was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study.
Time Frame Up to Week 16. Data cut-off date 01 Mar 2019 for cohort 1 and 08 Sept 2020 for cohort 2.
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set: includes all enrolled participants who received at least one dose of enfortumab vedotin.
Arm/Group Title Enfortumab Vedotin - Cohort 1 Enfortumab Vedotin - Cohort 2
Hide Arm/Group Description:
Participants in Cohort 1 had received prior treatment with platinum-containing chemotherapy. Enfortumab vedotin, at a dose of 1.25 mg/kg, was administered to participants as an IV infusion over approximately 30 minutes on Days 1, 8, and 15 of each 28-day cycle.
Participants in Cohort 2 had received no platinum-containing chemotherapy were ineligible for treatment with cisplatin at the time of enrollment. Enfortumab vedotin, at a dose of 1.25 mg/kg, was administered to participants as an IV infusion over approximately 30 minutes on Days 1, 8, and 15 of each 28-day cycle.
Overall Number of Participants Analyzed 125 89
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of Participants
50
(41.3 to 59.5)
58.4
(47.5 to 68.8)
11.Secondary Outcome
Title DCR16 Per Investigator Assessment
Hide Description Percentage of participants with CR, PR, or stable disease (SD) at Week 16 visit. CR and PR are defined in ORR per BICR endpoint. SD is defined in DCR16 per BICR endpoint.
Time Frame Up to Week 16. Data cut-off date 01 Mar 2019 for cohort 1 and 08 Sept 2020 for cohort 2.
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set: includes all enrolled participants who received at least one dose of enfortumab vedotin.
Arm/Group Title Enfortumab Vedotin - Cohort 1 Enfortumab Vedotin - Cohort 2
Hide Arm/Group Description:
Participants in Cohort 1 had received prior treatment with platinum-containing chemotherapy. Enfortumab vedotin, at a dose of 1.25 mg/kg, was administered to participants as an IV infusion over approximately 30 minutes on Days 1, 8, and 15 of each 28-day cycle.
Participants in Cohort 2 had received no platinum-containing chemotherapy were ineligible for treatment with cisplatin at the time of enrollment. Enfortumab vedotin, at a dose of 1.25 mg/kg, was administered to participants as an IV infusion over approximately 30 minutes on Days 1, 8, and 15 of each 28-day cycle.
Overall Number of Participants Analyzed 125 89
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of Participants
55
(46.0 to 64.1)
64.0
(53.2 to 73.9)
12.Secondary Outcome
Title Overall Survival (OS) at Time of Primary Analysis
Hide Description OS is defined as the time from first dose of enfortumab vedotin to death from any cause. This data is part of a pre-specified primary analysis. Updated data will be provided in a separate outcome measure upon study completion.
Time Frame Up to data cut-off date of 08 Sept 2020 (Cohort 1 median follow-up time: 28.4 months [range 0.49, 32.62]. Cohort 2 median follow up time: 13.4 months [range 0.33 to 29.27]).
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set: includes all enrolled participants who received at least one dose of enfortumab vedotin.
Arm/Group Title Enfortumab Vedotin - Cohort 1 Enfortumab Vedotin - Cohort 2
Hide Arm/Group Description:
Participants in Cohort 1 had received prior treatment with platinum-containing chemotherapy. Enfortumab vedotin, at a dose of 1.25 mg/kg, was administered to participants as an IV infusion over approximately 30 minutes on Days 1, 8, and 15 of each 28-day cycle.
Participants in Cohort 2 had received no platinum-containing chemotherapy were ineligible for treatment with cisplatin at the time of enrollment. Enfortumab vedotin, at a dose of 1.25 mg/kg, was administered to participants as an IV infusion over approximately 30 minutes on Days 1, 8, and 15 of each 28-day cycle.
Overall Number of Participants Analyzed 125 89
Median (95% Confidence Interval)
Unit of Measure: months
12.4
(9.46 to 15.57)
14.7
(10.51 to 18.20)
13.Secondary Outcome
Title Number of Participants With Adverse Events (AEs) at Time of Primary Analysis
Hide Description An AE is any untoward medical occurrence in a patient or clinical investigational participant administered a medicinal product and which does not necessarily have a causal relationship with this treatment. A treatment emergent adverse event (TEAE) was defined as a newly occurring or worsening AE after the first dose of study treatment and within 30 days after the last dose of study treatment. This data is part of a pre-specified primary analysis. Updated data will be provided in a separate outcome measure upon study completion.
Time Frame Up to data cut-off date of 08 Sept 2020 (The median duration of treatment was 4.60 months for Cohort 1 [range: 0.5, 29.4 months] and 5.98 months for Cohort 2 [range: 0.3, 24.6 months]).
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Analysis Set: includes all participants who received at least one dose of enfortumab vedotin.
Arm/Group Title Enfortumab Vedotin - Cohort 1 Enfortumab Vedotin - Cohort 2
Hide Arm/Group Description:
Participants in Cohort 1 had received prior treatment with platinum-containing chemotherapy. Enfortumab vedotin, at a dose of 1.25 mg/kg, was administered to participants as an IV infusion over approximately 30 minutes on Days 1, 8, and 15 of each 28-day cycle.
Participants in Cohort 2 had received no platinum-containing chemotherapy were ineligible for treatment with cisplatin at the time of enrollment. Enfortumab vedotin, at a dose of 1.25 mg/kg, was administered to participants as an IV infusion over approximately 30 minutes on Days 1, 8, and 15 of each 28-day cycle.
Overall Number of Participants Analyzed 125 89
Measure Type: Count of Participants
Unit of Measure: Participants
Any treatment-emergent AEs (TEAEs)
125
 100.0%
89
 100.0%
Treatment-related TEAEs
117
  93.6%
86
  96.6%
Any grade 3-5 TEAEs
93
  74.4%
62
  69.7%
Treatment-related grade 3-5 TEAEs
70
  56.0%
49
  55.1%
Any serious TEAEs
59
  47.2%
35
  39.3%
Treatment-related serious TEAEs
24
  19.2%
15
  16.9%
Any TEAEs leading to treatment discontinuation
21
  16.8%
18
  20.2%
Treatment-related TEAEs leading to treatment discontinuation
15
  12.0%
14
  15.7%
Any TEAEs leading to death
7
   5.6%
8
   9.0%
Treatment-related TEAEs leading to death
0
   0.0%
3
   3.4%
14.Secondary Outcome
Title Pharmacokinetics (PK) Parameter for Enfortumab Vedotin: Maximum Concentration (Cmax) (Serum)
Hide Description Cmax was derived from the PK blood samples collected. Day 1 data informed by samples collected on Day 1, Day 3, and Day 8. Day 15 data informed by samples collected on Day 15, Day 17, and Day 22.
Time Frame Up to data cut-off date of 08 Sept 2020. Collected during cycle 1 and 2 of treatment (approximately 2 months) at Day 1 pre-dose and end of infusion, Day 3, Day 8 pre-dose and end of infusion, Day 15 pre-dose and end of infusion, Day 17, and Day 22.
Hide Outcome Measure Data
Hide Analysis Population Description
PK Analysis Set: The PK of enfortumab vedotin Antibody-Drug Conjugate (ADC) was characterized in 207 participants overall; 120 participants in Cohort 1 and 87 participants in Cohort 2.
Arm/Group Title Enfortumab Vedotin - Cohort 1 Enfortumab Vedotin - Cohort 2
Hide Arm/Group Description:
Participants in Cohort 1 had received prior treatment with platinum-containing chemotherapy. Enfortumab vedotin, at a dose of 1.25 mg/kg, was administered to participants as an IV infusion over approximately 30 minutes on Days 1, 8, and 15 of each 28-day cycle.
Participants in Cohort 2 had received no platinum-containing chemotherapy were ineligible for treatment with cisplatin at the time of enrollment. Enfortumab vedotin, at a dose of 1.25 mg/kg, was administered to participants as an IV infusion over approximately 30 minutes on Days 1, 8, and 15 of each 28-day cycle.
Overall Number of Participants Analyzed 120 87
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: µg/mL
Cycle 1, Day 1 Number Analyzed 120 participants 87 participants
26.6
(28.5%)
23.9
(24.4%)
Cycle 1, Day 15 Number Analyzed 93 participants 64 participants
26.0
(28.3%)
21.7
(29.7%)
Cycle 2, Day 1 Number Analyzed 105 participants 73 participants
24.5
(31.4%)
22.0
(24.5%)
Cycle 2, Day 15 Number Analyzed 95 participants 62 participants
26.3
(25.2%)
20.7
(27.4%)
15.Secondary Outcome
Title PK Parameter for Enfortumab Vedotin: Time to Maximum Concentration (Tmax) (Serum)
Hide Description Tmax was derived from the PK blood samples collected. Time of maximum concentration corresponds to the end of infusion sample time. Day 1 data informed by samples collected on Day 1, Day 3, and Day 8. Day 15 data informed by samples collected on Day 15, Day 17, and Day 22.
Time Frame Up to data cut-off date of 08 Sept 2020. Collected during cycle 1 and 2 of treatment (approximately 2 months) at Day 1 pre-dose and end of infusion, Day 3, Day 8 pre-dose and end of infusion, Day 15 pre-dose and end of infusion, Day 17, and Day 22.
Hide Outcome Measure Data
Hide Analysis Population Description
PK Analysis Set: The PK of enfortumab vedotin ADC was characterized in 207 participants overall; 120 participants in Cohort 1 and 87 participants in Cohort 2.
Arm/Group Title Enfortumab Vedotin - Cohort 1 Enfortumab Vedotin - Cohort 2
Hide Arm/Group Description:
Participants in Cohort 1 had received prior treatment with platinum-containing chemotherapy. Enfortumab vedotin, at a dose of 1.25 mg/kg, was administered to participants as an IV infusion over approximately 30 minutes on Days 1, 8, and 15 of each 28-day cycle.
Participants in Cohort 2 had received no platinum-containing chemotherapy were ineligible for treatment with cisplatin at the time of enrollment. Enfortumab vedotin, at a dose of 1.25 mg/kg, was administered to participants as an IV infusion over approximately 30 minutes on Days 1, 8, and 15 of each 28-day cycle.
Overall Number of Participants Analyzed 120 87
Median (Full Range)
Unit of Measure: days
Cycle 1, Day 1 Number Analyzed 119 participants 87 participants
0.0278
(0.010 to 0.052)
0.0264
(0.021 to 0.088)
Cycle 1, Day 15 Number Analyzed 92 participants 63 participants
0.0285
(0.014 to 0.054)
0.0264
(0.014 to 0.084)
Cycle 2, Day 1 Number Analyzed 104 participants 73 participants
0.0264
(0.011 to 0.042)
0.0264
(0.015 to 0.074)
Cycle 2, Day 15 Number Analyzed 94 participants 62 participants
0.0285
(0.020 to 0.115)
0.0257
(0.010 to 0.047)
16.Secondary Outcome
Title PK Parameter for Enfortumab Vedotin: Area Under Concentration-Time Curve (AUC) (Serum)
Hide Description AUC was derived from the PK blood samples collected.
Time Frame Up to data cut-off date of 08 Sept 2020. AUC0-7 was assessed (in cycles 1 and 2) based on concentration data from Day 1 to Day 8 (pre dose) and AUC0-14 was assessed based on data from D15 (pre dose) to D29 (pre-dose).
Hide Outcome Measure Data
Hide Analysis Population Description
PK Analysis Set: The PK of enfortumab vedotin ADC was characterized in 207 participants overall; 120 participants in Cohort 1 and 87 participants in Cohort 2.
Arm/Group Title Enfortumab Vedotin - Cohort 1 Enfortumab Vedotin - Cohort 2
Hide Arm/Group Description:
Participants in Cohort 1 had received prior treatment with platinum-containing chemotherapy. Enfortumab vedotin, at a dose of 1.25 mg/kg, was administered to participants as an IV infusion over approximately 30 minutes on Days 1, 8, and 15 of each 28-day cycle.
Participants in Cohort 2 had received no platinum-containing chemotherapy were ineligible for treatment with cisplatin at the time of enrollment. Enfortumab vedotin, at a dose of 1.25 mg/kg, was administered to participants as an IV infusion over approximately 30 minutes on Days 1, 8, and 15 of each 28-day cycle.
Overall Number of Participants Analyzed 120 87
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: day*µg/mL
7-day post-infusion AUC (AUC(d0-7)) - Cycle 1, Day 1 Number Analyzed 115 participants 85 participants
34.6
(34.0%)
33.5
(41.4%)
AUC(d0-7) - Cycle 1, Day 15 Number Analyzed 88 participants 63 participants
31.3
(43.8%)
26.3
(46.0%)
AUC(d0-7) - Cycle 2, Day 1 Number Analyzed 104 participants 72 participants
36.4
(36.7%)
32.0
(30.0%)
AUC(d0-7) - Cycle 2, Day 15 Number Analyzed 88 participants 56 participants
35.9
(41.2%)
27.8
(35.8%)
14-day post-infusion AUC (AUC(d0-14)) - Cycle 1, Day 15 Number Analyzed 85 participants 59 participants
34.7
(44.7%)
30.9
(47.5%)
AUC(d0-14) - Cycle 2, Day 15 Number Analyzed 82 participants 60 participants
41.2
(40.4%)
33.1
(36.6%)
17.Secondary Outcome
Title PK Parameter for Free Monomethyl Auristatin E (MMAE): Cmax (Plasma)
Hide Description Cmax was derived from the PK blood samples collected. Day 1 data informed by samples collected on Day 1, Day 3, and Day 8. Day 15 data informed by samples collected on Day 15, Day 17, and Day 22.
Time Frame Up to data cut-off date of 08 Sept 2020. Collected during cycle 1 and 2 of treatment (approximately 2 months) at Day 1 pre-dose and end of infusion, Day 3, Day 8 pre-dose and end of infusion, Day 15 pre-dose and end of infusion, Day 17, and Day 22.
Hide Outcome Measure Data
Hide Analysis Population Description
PK Analysis Set: The PK of Free MMAE was characterized in 201 participants overall; 117 participants in Cohort 1 and 84 participants in Cohort 2.
Arm/Group Title Enfortumab Vedotin - Cohort 1 Enfortumab Vedotin - Cohort 2
Hide Arm/Group Description:
Participants in Cohort 1 had received prior treatment with platinum-containing chemotherapy. Enfortumab vedotin, at a dose of 1.25 mg/kg, was administered to participants as an IV infusion over approximately 30 minutes on Days 1, 8, and 15 of each 28-day cycle.
Participants in Cohort 2 had received no platinum-containing chemotherapy were ineligible for treatment with cisplatin at the time of enrollment. Enfortumab vedotin, at a dose of 1.25 mg/kg, was administered to participants as an IV infusion over approximately 30 minutes on Days 1, 8, and 15 of each 28-day cycle.
Overall Number of Participants Analyzed 117 84
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: ng/mL
Cycle 1, Day 1 Number Analyzed 117 participants 84 participants
3.1
(67.0%)
2.6
(57.8%)
Cycle 1, Day 15 Number Analyzed 93 participants 64 participants
3.9
(64.8%)
3.5
(51.8%)
Cycle 2, Day 1 Number Analyzed 106 participants 72 participants
2.4
(57.4%)
2.2
(60.8%)
Cycle 2, Day 15 Number Analyzed 90 participants 62 participants
3.0
(64.8%)
2.9
(59.9%)
18.Secondary Outcome
Title PK Parameter for Free MMAE: Tmax (Plasma)
Hide Description Tmax was derived from the PK blood samples collected. Day 1 data informed by samples collected on Day 1, Day 3, and Day 8. Day 15 data informed by samples collected on Day 15, Day 17, and Day 22.
Time Frame Up to data cut-off date of 08 Sept 2020. Collected during cycle 1 and 2 of treatment (approximately 2 months) at Day 1 pre-dose and end of infusion, Day 3, Day 8 pre-dose and end of infusion, Day 15 pre-dose and end of infusion, Day 17, and Day 22.
Hide Outcome Measure Data
Hide Analysis Population Description
PK Analysis Set: The PK of Free MMAE was characterized in 201 participants overall; 117 participants in Cohort 1 and 84 participants in Cohort 2.
Arm/Group Title Enfortumab Vedotin - Cohort 1 Enfortumab Vedotin - Cohort 2
Hide Arm/Group Description:
Participants in Cohort 1 had received prior treatment with platinum-containing chemotherapy. Enfortumab vedotin, at a dose of 1.25 mg/kg, was administered to participants as an IV infusion over approximately 30 minutes on Days 1, 8, and 15 of each 28-day cycle.
Participants in Cohort 2 had received no platinum-containing chemotherapy were ineligible for treatment with cisplatin at the time of enrollment. Enfortumab vedotin, at a dose of 1.25 mg/kg, was administered to participants as an IV infusion over approximately 30 minutes on Days 1, 8, and 15 of each 28-day cycle.
Overall Number of Participants Analyzed 117 84
Median (Full Range)
Unit of Measure: days
Cycle 1, Day 1 Number Analyzed 117 participants 84 participants
1.9
(1 to 5)
1.9
(1 to 4)
Cycle 1, Day 15 Number Analyzed 93 participants 64 participants
2.0
(1 to 11)
1.9
(1 to 9)
Cycle 2, Day 1 Number Analyzed 106 participants 72 participants
2.0
(1 to 5)
1.8
(1 to 5)
Cycle 2, Day 15 Number Analyzed 90 participants 62 participants
1.9
(1 to 9)
1.9
(1 to 10)
19.Secondary Outcome
Title PK Parameter for Free MMAE: AUC (Plasma)
Hide Description AUC was derived from the PK blood samples collected.
Time Frame Up to data cut-off date of 08 Sept 2020. AUC0-7 was assessed (in cycles 1 and 2) based on concentration data from Day 1 to Day 8 (pre dose) and AUC0-14 was assessed based on data from D15 (pre dose) to D29 (pre-dose).
Hide Outcome Measure Data
Hide Analysis Population Description
PK Analysis Set: The PK of Free MMAE was characterized in 201 participants overall; 117 participants in Cohort 1 and 84 participants in Cohort 2.
Arm/Group Title Enfortumab Vedotin - Cohort 1 Enfortumab Vedotin - Cohort 2
Hide Arm/Group Description:
Participants in Cohort 1 had received prior treatment with platinum-containing chemotherapy. Enfortumab vedotin, at a dose of 1.25 mg/kg, was administered to participants as an IV infusion over approximately 30 minutes on Days 1, 8, and 15 of each 28-day cycle.
Participants in Cohort 2 had received no platinum-containing chemotherapy were ineligible for treatment with cisplatin at the time of enrollment. Enfortumab vedotin, at a dose of 1.25 mg/kg, was administered to participants as an IV infusion over approximately 30 minutes on Days 1, 8, and 15 of each 28-day cycle.
Overall Number of Participants Analyzed 117 84
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: day*ng/mL
7-day post-infusion AUC (AUC(d0-7)) - Cycle 1, Day 1 Number Analyzed 115 participants 84 participants
14.1
(81.7%)
13.0
(64.1%)
AUC(d0-7) - Cycle 1, Day 15 Number Analyzed 88 participants 66 participants
19.1
(79.1%)
18.1
(65.0%)
AUC(d0-7) - Cycle 2, Day 1 Number Analyzed 104 participants 72 participants
11.3
(58.0%)
10.6
(65.0%)
AUC(d0-7) - Cycle 2, Day 15 Number Analyzed 88 participants 57 participants
14.9
(64.7%)
15.3
(60.2%)
14-day post-infusion AUC (AUC(d0-14)) - Cycle 1, Day 15 Number Analyzed 91 participants 62 participants
25.9
(74.7%)
22.6
(76.4%)
AUC(d0-14) - Cycle 2, Day 15 Number Analyzed 84 participants 63 participants
19.1
(61.2%)
21.3
(65.0%)
20.Secondary Outcome
Title PK Parameter for Total Antibody (TAb): Cmax (Serum)
Hide Description Cmax was derived from the PK blood samples collected. Day 1 data informed by samples collected on Day 1, Day 3, and Day 8. Day 15 data informed by samples collected on Day 15, Day 17, and Day 22.
Time Frame Up to data cut-off date of 08 Sept 2020. Collected during cycle 1 and 2 of treatment (approximately 2 months) at Day 1 pre-dose and end of infusion, Day 3, Day 8 pre-dose and end of infusion, Day 15 pre-dose and end of infusion, Day 17, and Day 22.
Hide Outcome Measure Data
Hide Analysis Population Description
PK Analysis Set: The PK of TAb was characterized in 207 participants overall; 120 participants in Cohort 1 and 87 participants in Cohort 2.
Arm/Group Title Enfortumab Vedotin - Cohort 1 Enfortumab Vedotin - Cohort 2
Hide Arm/Group Description:
Participants in Cohort 1 had received prior treatment with platinum-containing chemotherapy. Enfortumab vedotin, at a dose of 1.25 mg/kg, was administered to participants as an IV infusion over approximately 30 minutes on Days 1, 8, and 15 of each 28-day cycle.
Participants in Cohort 2 had received no platinum-containing chemotherapy were ineligible for treatment with cisplatin at the time of enrollment. Enfortumab vedotin, at a dose of 1.25 mg/kg, was administered to participants as an IV infusion over approximately 30 minutes on Days 1, 8, and 15 of each 28-day cycle.
Overall Number of Participants Analyzed 120 87
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: µg/mL
Cycle 1, Day 1 Number Analyzed 120 participants 87 participants
26.6
(30.4%)
26.4
(23.4%)
Cycle 1, Day 15 Number Analyzed 93 participants 64 participants
30.9
(22.9%)
27.3
(25.7%)
Cycle 2, Day 1 Number Analyzed 105 participants 74 participants
26.2
(30.5%)
26.3
(23.8%)
Cycle 2, Day 15 Number Analyzed 95 participants 62 participants
30.2
(22.7%)
27.1
(28.2%)
21.Secondary Outcome
Title PK Parameter for TAb: Tmax (Serum)
Hide Description Tmax was derived from the PK blood samples collected. Time of maximum concentration corresponds to the end of infusion sample time. Day 1 data informed by samples collected on Day 1, Day 3, and Day 8. Day 15 data informed by samples collected on Day 15, Day 17, and Day 22.
Time Frame Up to data cut-off date of 08 Sept 2020. Collected during cycle 1 and 2 of treatment (approximately 2 months) at Day 1 pre-dose and end of infusion, Day 3, Day 8 pre-dose and end of infusion, Day 15 pre-dose and end of infusion, Day 17, and Day 22.
Hide Outcome Measure Data
Hide Analysis Population Description
PK Analysis Set: The PK of TAb was characterized in 207 participants overall; 120 participants in Cohort 1 and 87 participants in Cohort 2.
Arm/Group Title Enfortumab Vedotin - Cohort 1 Enfortumab Vedotin - Cohort 2
Hide Arm/Group Description:
Participants in Cohort 1 had received prior treatment with platinum-containing chemotherapy. Enfortumab vedotin, at a dose of 1.25 mg/kg, was administered to participants as an IV infusion over approximately 30 minutes on Days 1, 8, and 15 of each 28-day cycle.
Participants in Cohort 2 had received no platinum-containing chemotherapy were ineligible for treatment with cisplatin at the time of enrollment. Enfortumab vedotin, at a dose of 1.25 mg/kg, was administered to participants as an IV infusion over approximately 30 minutes on Days 1, 8, and 15 of each 28-day cycle.
Overall Number of Participants Analyzed 120 87
Median (Full Range)
Unit of Measure: days
Cycle 1, Day 1 Number Analyzed 119 participants 87 participants
0.0278
(0.010 to 0.052)
0.0264
(0.021 to 0.088)
Cycle 1, Day 15 Number Analyzed 92 participants 63 participants
0.0285
(0.014 to 0.054)
0.0264
(0.014 to 0.084)
Cycle 2, Day 1 Number Analyzed 104 participants 74 participants
0.0264
(0.011 to 0.042)
0.0264
(0.015 to 0.074)
Cycle 2, Day 15 Number Analyzed 94 participants 62 participants
0.0285
(0.020 to 0.115)
0.0257
(0.010 to 0.047)
22.Secondary Outcome
Title PK Parameter for TAb: AUC (Serum)
Hide Description AUC was derived from the PK blood samples collected.
Time Frame Up to data cut-off date of 08 Sept 2020. AUC0-7 was assessed (in cycles 1 and 2) based on concentration data from Day 1 to Day 8 (pre dose) and AUC0-14 was assessed based on data from D15 (pre dose) to D29 (pre-dose).
Hide Outcome Measure Data
Hide Analysis Population Description
PK Analysis Set: The PK of TAb was characterized in 207 participants overall; 120 participants in Cohort 1 and 87 participants in Cohort 2.
Arm/Group Title Enfortumab Vedotin - Cohort 1 Enfortumab Vedotin - Cohort 2
Hide Arm/Group Description:
Participants in Cohort 1 had received prior treatment with platinum-containing chemotherapy. Enfortumab vedotin, at a dose of 1.25 mg/kg, was administered to participants as an IV infusion over approximately 30 minutes on Days 1, 8, and 15 of each 28-day cycle.
Participants in Cohort 2 had received no platinum-containing chemotherapy were ineligible for treatment with cisplatin at the time of enrollment. Enfortumab vedotin, at a dose of 1.25 mg/kg, was administered to participants as an IV infusion over approximately 30 minutes on Days 1, 8, and 15 of each 28-day cycle.
Overall Number of Participants Analyzed 120 87
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: day*µg/mL
7-day post-infusion AUC (AUC(d0-7)) - Cycle 1, Day 1 Number Analyzed 115 participants 85 participants
63.4
(33.6%)
66.8
(34.3%)
AUC(d0-7) - Cycle 1, Day 15 Number Analyzed 88 participants 63 participants
77.6
(35.2%)
72.3
(37.9%)
AUC(d0-7) - Cycle 2, Day 1 Number Analyzed 104 participants 72 participants
73.2
(33.5%)
72.9
(26.4%)
AUC(d0-7) - Cycle 2, Day 15 Number Analyzed 88 participants 56 participants
87.9
(30.6%)
81.0
(30.9%)
14-day post-infusion AUC (AUC(d0-14)) - Cycle 1, Day 15 Number Analyzed 93 participants 62 participants
98.1
(38.8%)
91.1
(40.3%)
AUC(d0-14) - Cycle 2, Day 15 Number Analyzed 84 participants 62 participants
113.0
(33.8%)
109.7
(41.5%)
23.Secondary Outcome
Title Overall Survival (OS)
Hide Description [Not Specified]
Time Frame Updated Time Frame description will be provided at study completion.
Outcome Measure Data Not Reported
24.Secondary Outcome
Title Number of Participants With Adverse Events (AEs)
Hide Description An AE is any untoward medical occurrence in a patient or clinical investigational participant administered a medicinal product and which does not necessarily have a causal relationship with this treatment. A treatment emergent adverse event (TEAE) was defined as a newly occurring or worsening AE after the first dose of study treatment and within 30 days after the last dose of study treatment.
Time Frame Updated Time Frame description will be provided at study completion.
Outcome Measure Data Not Reported
Time Frame Non-serious Adverse events were assessed for the duration of treatment. The median duration of treatment was 4.60 months for Cohort 1 (full range: 0.5, 29.4 months) and 5.98 months for Cohort 2 (full range: 0.3, 24.6 months). Serious AEs and All-Cause Mortality was from first dose until death. Cohort 1 median follow-up time: 28.4 months [range 0.49, 32.62]. Cohort 2 median follow up time: 13.4 months [range 0.33 to 29.27]).
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Enfortumab Vedotin - Cohort 1 Enfortumab Vedotin - Cohort 2
Hide Arm/Group Description Participants in Cohort 1 had received prior treatment with platinum-containing chemotherapy. Enfortumab vedotin, at a dose of 1.25 mg/kg, was administered to participants as an IV infusion over approximately 30 minutes on Days 1, 8, and 15 of each 28-day cycle. Participants in Cohort 2 had received no platinum-containing chemotherapy were ineligible for treatment with cisplatin at the time of enrollment. Enfortumab vedotin, at a dose of 1.25 mg/kg, was administered to participants as an IV infusion over approximately 30 minutes on Days 1, 8, and 15 of each 28-day cycle.
All-Cause Mortality
Enfortumab Vedotin - Cohort 1 Enfortumab Vedotin - Cohort 2
Affected / at Risk (%) Affected / at Risk (%)
Total   94/125 (75.20%)   44/89 (49.44%) 
Hide Serious Adverse Events
Enfortumab Vedotin - Cohort 1 Enfortumab Vedotin - Cohort 2
Affected / at Risk (%) Affected / at Risk (%)
Total   59/125 (47.20%)   35/89 (39.33%) 
Blood and lymphatic system disorders     
Febrile neutropenia  1  5/125 (4.00%)  1/89 (1.12%) 
Neutropenia  1  2/125 (1.60%)  2/89 (2.25%) 
Cardiac disorders     
Atrial fibrillation  1  0/125 (0.00%)  2/89 (2.25%) 
Acute myocardial infarction  1  0/125 (0.00%)  1/89 (1.12%) 
Atrial thrombosis  1  0/125 (0.00%)  1/89 (1.12%) 
Cardiac disorder  1  1/125 (0.80%)  0/89 (0.00%) 
Cardiac failure  1  0/125 (0.00%)  1/89 (1.12%) 
Myocardial infarction  1  0/125 (0.00%)  1/89 (1.12%) 
Endocrine disorders     
Adrenal insufficiency  1  0/125 (0.00%)  1/89 (1.12%) 
Eye disorders     
Cataract  1  0/125 (0.00%)  1/89 (1.12%) 
Gastrointestinal disorders     
Diarrhoea  1  3/125 (2.40%)  3/89 (3.37%) 
Nausea  1  3/125 (2.40%)  2/89 (2.25%) 
Abdominal pain  1  3/125 (2.40%)  1/89 (1.12%) 
Vomiting  1  3/125 (2.40%)  1/89 (1.12%) 
Colitis  1  2/125 (1.60%)  1/89 (1.12%) 
Enterocolitis  1  1/125 (0.80%)  0/89 (0.00%) 
Gastrointestinal haemorrhage  1  1/125 (0.80%)  0/89 (0.00%) 
Large intestinal obstruction  1  1/125 (0.80%)  0/89 (0.00%) 
Odynophagia  1  1/125 (0.80%)  0/89 (0.00%) 
Small intestinal obstruction  1  1/125 (0.80%)  0/89 (0.00%) 
Stomatitis  1  0/125 (0.00%)  1/89 (1.12%) 
Upper gastrointestinal haemorrhage  1  0/125 (0.00%)  1/89 (1.12%) 
General disorders     
Fatigue  1  3/125 (2.40%)  0/89 (0.00%) 
Pyrexia  1  2/125 (1.60%)  1/89 (1.12%) 
Chills  1  1/125 (0.80%)  1/89 (1.12%) 
Infusion site extravasation  1  2/125 (1.60%)  0/89 (0.00%) 
Asthenia  1  0/125 (0.00%)  1/89 (1.12%) 
Incarcerated hernia  1  1/125 (0.80%)  0/89 (0.00%) 
Multiple organ dysfunction syndrome  1  0/125 (0.00%)  1/89 (1.12%) 
Non-cardiac chest pain  1  0/125 (0.00%)  1/89 (1.12%) 
Hepatobiliary disorders     
Bile duct stone  1  1/125 (0.80%)  0/89 (0.00%) 
Infections and infestations     
Urinary tract infection  1  6/125 (4.80%)  3/89 (3.37%) 
Sepsis  1  4/125 (3.20%)  4/89 (4.49%) 
Cellulitis  1  6/125 (4.80%)  0/89 (0.00%) 
Pneumonia  1  3/125 (2.40%)  3/89 (3.37%) 
Bacteraemia  1  0/125 (0.00%)  1/89 (1.12%) 
Device related infection  1  1/125 (0.80%)  0/89 (0.00%) 
Infection  1  1/125 (0.80%)  0/89 (0.00%) 
Joint abscess  1  0/125 (0.00%)  1/89 (1.12%) 
Kidney infection  1  0/125 (0.00%)  1/89 (1.12%) 
Pneumonia bacterial  1  0/125 (0.00%)  1/89 (1.12%) 
Urinary tract infection staphylococcal  1  1/125 (0.80%)  0/89 (0.00%) 
Urosepsis  1  0/125 (0.00%)  1/89 (1.12%) 
Injury, poisoning and procedural complications     
Fall  1  2/125 (1.60%)  0/89 (0.00%) 
Compression fracture  1  1/125 (0.80%)  0/89 (0.00%) 
Wound  1  1/125 (0.80%)  0/89 (0.00%) 
Investigations     
Amylase increased  1  0/125 (0.00%)  1/89 (1.12%) 
Hepatic enzyme increased  1  0/125 (0.00%)  1/89 (1.12%) 
Lipase increased  1  0/125 (0.00%)  1/89 (1.12%) 
Neutrophil count decreased  1  1/125 (0.80%)  0/89 (0.00%) 
Urine output decreased  1  0/125 (0.00%)  1/89 (1.12%) 
White blood cell count decreased  1  1/125 (0.80%)  0/89 (0.00%) 
Metabolism and nutrition disorders     
Hyperglycaemia  1  2/125 (1.60%)  2/89 (2.25%) 
Hyponatraemia  1  3/125 (2.40%)  1/89 (1.12%) 
Decreased appetite  1  1/125 (0.80%)  2/89 (2.25%) 
Dehydration  1  1/125 (0.80%)  2/89 (2.25%) 
Hyperkalaemia  1  0/125 (0.00%)  1/89 (1.12%) 
Hyperuricaemia  1  1/125 (0.80%)  0/89 (0.00%) 
Hypoglycaemia  1  1/125 (0.80%)  0/89 (0.00%) 
Hypomagnesaemia  1  1/125 (0.80%)  0/89 (0.00%) 
Metabolic acidosis  1  0/125 (0.00%)  1/89 (1.12%) 
Musculoskeletal and connective tissue disorders     
Back pain  1  1/125 (0.80%)  0/89 (0.00%) 
Bone pain  1  0/125 (0.00%)  1/89 (1.12%) 
Muscular weakness  1  1/125 (0.80%)  0/89 (0.00%) 
Myositis  1  0/125 (0.00%)  1/89 (1.12%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Transitional cell carcinoma metastatic  1  2/125 (1.60%)  3/89 (3.37%) 
Cancer pain  1  1/125 (0.80%)  0/89 (0.00%) 
Colon cancer  1  1/125 (0.80%)  0/89 (0.00%) 
Squamous cell carcinoma of skin  1  0/125 (0.00%)  1/89 (1.12%) 
Transitional cell carcinoma  1  1/125 (0.80%)  0/89 (0.00%) 
Nervous system disorders     
Spinal cord compression  1  2/125 (1.60%)  0/89 (0.00%) 
Demyelinating polyneuropathy  1  0/125 (0.00%)  1/89 (1.12%) 
Encephalopathy  1  1/125 (0.80%)  0/89 (0.00%) 
Paraplegia  1  0/125 (0.00%)  1/89 (1.12%) 
Peripheral motor neuropathy  1  0/125 (0.00%)  1/89 (1.12%) 
Psychiatric disorders     
Delirium  1  1/125 (0.80%)  1/89 (1.12%) 
Confusional state  1  1/125 (0.80%)  0/89 (0.00%) 
Renal and urinary disorders     
Acute kidney injury  1  4/125 (3.20%)  9/89 (10.11%) 
Haematuria  1  3/125 (2.40%)  1/89 (1.12%) 
Urinary tract obstruction  1  2/125 (1.60%)  0/89 (0.00%) 
Renal impairment  1  0/125 (0.00%)  1/89 (1.12%) 
Ureterolithiasis  1  0/125 (0.00%)  1/89 (1.12%) 
Respiratory, thoracic and mediastinal disorders     
Dyspnoea  1  4/125 (3.20%)  0/89 (0.00%) 
Hypoxia  1  3/125 (2.40%)  0/89 (0.00%) 
Acute respiratory failure  1  2/125 (1.60%)  0/89 (0.00%) 
Cough  1  2/125 (1.60%)  0/89 (0.00%) 
Pneumonia aspiration  1  2/125 (1.60%)  0/89 (0.00%) 
Pulmonary embolism  1  2/125 (1.60%)  0/89 (0.00%) 
Aspiration  1  0/125 (0.00%)  1/89 (1.12%) 
Chronic obstructive pulmonary disease  1  0/125 (0.00%)  1/89 (1.12%) 
Interstitial lung disease  1  1/125 (0.80%)  0/89 (0.00%) 
Pleural effusion  1  1/125 (0.80%)  0/89 (0.00%) 
Pneumonitis  1  0/125 (0.00%)  1/89 (1.12%) 
Skin and subcutaneous tissue disorders     
Rash vesicular  1  2/125 (1.60%)  0/89 (0.00%) 
Dermatitis bullous  1  0/125 (0.00%)  1/89 (1.12%) 
Drug eruption  1  1/125 (0.80%)  0/89 (0.00%) 
Rash  1  0/125 (0.00%)  1/89 (1.12%) 
Rash maculo-papular  1  0/125 (0.00%)  1/89 (1.12%) 
Stevens-Johnson syndrome  1  1/125 (0.80%)  0/89 (0.00%) 
Vascular disorders     
Deep vein thrombosis  1  2/125 (1.60%)  0/89 (0.00%) 
Hypertension  1  1/125 (0.80%)  1/89 (1.12%) 
Hypotension  1  0/125 (0.00%)  2/89 (2.25%) 
Aortic stenosis  1  1/125 (0.80%)  0/89 (0.00%) 
Embolism  1  1/125 (0.80%)  0/89 (0.00%) 
Shock  1  0/125 (0.00%)  1/89 (1.12%) 
1
Term from vocabulary, MedDRA v23.0
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Enfortumab Vedotin - Cohort 1 Enfortumab Vedotin - Cohort 2
Affected / at Risk (%) Affected / at Risk (%)
Total   125/125 (100.00%)   89/89 (100.00%) 
Blood and lymphatic system disorders     
Anaemia  1  44/125 (35.20%)  34/89 (38.20%) 
Neutropenia  1  14/125 (11.20%)  12/89 (13.48%) 
Cardiac disorders     
Tachycardia  1  9/125 (7.20%)  1/89 (1.12%) 
Palpitations  1  1/125 (0.80%)  5/89 (5.62%) 
Eye disorders     
Dry eye  1  30/125 (24.00%)  17/89 (19.10%) 
Lacrimation increased  1  21/125 (16.80%)  12/89 (13.48%) 
Vision blurred  1  20/125 (16.00%)  9/89 (10.11%) 
Punctate keratitis  1  9/125 (7.20%)  3/89 (3.37%) 
Blepharitis  1  8/125 (6.40%)  3/89 (3.37%) 
Gastrointestinal disorders     
Diarrhoea  1  53/125 (42.40%)  31/89 (34.83%) 
Nausea  1  57/125 (45.60%)  27/89 (30.34%) 
Constipation  1  35/125 (28.00%)  18/89 (20.22%) 
Vomiting  1  25/125 (20.00%)  12/89 (13.48%) 
Abdominal pain  1  26/125 (20.80%)  6/89 (6.74%) 
Dry mouth  1  11/125 (8.80%)  8/89 (8.99%) 
Stomatitis  1  10/125 (8.00%)  7/89 (7.87%) 
Gastrooesophageal reflux disease  1  9/125 (7.20%)  5/89 (5.62%) 
Abdominal distension  1  4/125 (3.20%)  7/89 (7.87%) 
Abdominal pain upper  1  6/125 (4.80%)  5/89 (5.62%) 
Dysphagia  1  7/125 (5.60%)  2/89 (2.25%) 
General disorders     
Fatigue  1  69/125 (55.20%)  40/89 (44.94%) 
Oedema peripheral  1  31/125 (24.80%)  20/89 (22.47%) 
Pyrexia  1  17/125 (13.60%)  15/89 (16.85%) 
Gait disturbance  1  7/125 (5.60%)  9/89 (10.11%) 
Asthenia  1  7/125 (5.60%)  8/89 (8.99%) 
Chills  1  6/125 (4.80%)  6/89 (6.74%) 
Malaise  1  10/125 (8.00%)  2/89 (2.25%) 
Infections and infestations     
Urinary tract infection  1  24/125 (19.20%)  13/89 (14.61%) 
Pneumonia  1  8/125 (6.40%)  5/89 (5.62%) 
Oral candidiasis  1  7/125 (5.60%)  5/89 (5.62%) 
Cellulitis  1  7/125 (5.60%)  0/89 (0.00%) 
Injury, poisoning and procedural complications     
Fall  1  15/125 (12.00%)  8/89 (8.99%) 
Infusion related reaction  1  4/125 (3.20%)  5/89 (5.62%) 
Investigations     
Weight decreased  1  40/125 (32.00%)  31/89 (34.83%) 
Aspartate aminotransferase increased  1  19/125 (15.20%)  11/89 (12.36%) 
Amylase increased  1  12/125 (9.60%)  15/89 (16.85%) 
Lipase increased  1  16/125 (12.80%)  10/89 (11.24%) 
Alanine aminotransferase increased  1  15/125 (12.00%)  9/89 (10.11%) 
Blood creatinine increased  1  10/125 (8.00%)  5/89 (5.62%) 
White blood cell count decreased  1  7/125 (5.60%)  4/89 (4.49%) 
Lymphocyte count decreased  1  8/125 (6.40%)  1/89 (1.12%) 
Blood alkaline phosphatase increased  1  7/125 (5.60%)  1/89 (1.12%) 
Metabolism and nutrition disorders     
Decreased appetite  1  65/125 (52.00%)  36/89 (40.45%) 
Hyperglycaemia  1  19/125 (15.20%)  14/89 (15.73%) 
Hyponatraemia  1  18/125 (14.40%)  9/89 (10.11%) 
Dehydration  1  12/125 (9.60%)  12/89 (13.48%) 
Hypokalaemia  1  16/125 (12.80%)  6/89 (6.74%) 
Hyperuricaemia  1  9/125 (7.20%)  4/89 (4.49%) 
Hypophosphataemia  1  8/125 (6.40%)  5/89 (5.62%) 
Hypoalbuminaemia  1  4/125 (3.20%)  5/89 (5.62%) 
Hypercalcaemia  1  2/125 (1.60%)  6/89 (6.74%) 
Hyperkalaemia  1  2/125 (1.60%)  6/89 (6.74%) 
Musculoskeletal and connective tissue disorders     
Back pain  1  20/125 (16.00%)  4/89 (4.49%) 
Pain in extremity  1  14/125 (11.20%)  10/89 (11.24%) 
Muscular weakness  1  10/125 (8.00%)  8/89 (8.99%) 
Arthralgia  1  10/125 (8.00%)  7/89 (7.87%) 
Myalgia  1  10/125 (8.00%)  6/89 (6.74%) 
Musculoskeletal pain  1  7/125 (5.60%)  1/89 (1.12%) 
Nervous system disorders     
Peripheral sensory neuropathy  1  54/125 (43.20%)  44/89 (49.44%) 
Dysgeusia  1  49/125 (39.20%)  26/89 (29.21%) 
Dizziness  1  20/125 (16.00%)  10/89 (11.24%) 
Peripheral motor neuropathy  1  13/125 (10.40%)  8/89 (8.99%) 
Headache  1  6/125 (4.80%)  5/89 (5.62%) 
Paraesthesia  1  4/125 (3.20%)  6/89 (6.74%) 
Psychiatric disorders     
Insomnia  1  18/125 (14.40%)  13/89 (14.61%) 
Anxiety  1  4/125 (3.20%)  5/89 (5.62%) 
Renal and urinary disorders     
Acute kidney injury  1  8/125 (6.40%)  15/89 (16.85%) 
Haematuria  1  12/125 (9.60%)  10/89 (11.24%) 
Pollakiuria  1  4/125 (3.20%)  5/89 (5.62%) 
Respiratory, thoracic and mediastinal disorders     
Cough  1  22/125 (17.60%)  12/89 (13.48%) 
Dyspnoea  1  20/125 (16.00%)  14/89 (15.73%) 
Rhinorrhoea  1  7/125 (5.60%)  9/89 (10.11%) 
Dysphonia  1  7/125 (5.60%)  4/89 (4.49%) 
Skin and subcutaneous tissue disorders     
Alopecia  1  64/125 (51.20%)  47/89 (52.81%) 
Pruritus  1  34/125 (27.20%)  31/89 (34.83%) 
Rash maculo-papular  1  29/125 (23.20%)  29/89 (32.58%) 
Dry skin  1  35/125 (28.00%)  17/89 (19.10%) 
Rash erythematous  1  15/125 (12.00%)  6/89 (6.74%) 
Skin hyperpigmentation  1  13/125 (10.40%)  4/89 (4.49%) 
Rash macular  1  6/125 (4.80%)  6/89 (6.74%) 
Skin exfoliation  1  7/125 (5.60%)  3/89 (3.37%) 
Vascular disorders     
Hypotension  1  9/125 (7.20%)  5/89 (5.62%) 
Hypertension  1  7/125 (5.60%)  4/89 (4.49%) 
1
Term from vocabulary, MedDRA v23.0
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Institute and/or Principal Investigator may publish trial data generated at their specific study site after Sponsor publication of the multi-center data. Sponsor must receive a site's manuscript prior to publication for review and comment as specified in the Investigator Agreement.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Chief Medical Officer
Organization: Seagen Inc
Phone: 855-473-2436
EMail: medinfo@seagen.com
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Astellas Pharma Inc
ClinicalTrials.gov Identifier: NCT03219333    
Other Study ID Numbers: SGN22E-001
First Submitted: July 13, 2017
First Posted: July 17, 2017
Results First Submitted: October 26, 2021
Results First Posted: December 17, 2021
Last Update Posted: June 15, 2022