Trial Outcomes & Findings for Durvalumab and Vicineum in Subjects With High-Grade Non-Muscle-Invasive Bladder Cancer Previously Treated With Bacillus Calmette-Guerin (BCG) (NCT NCT03258593)

Last Updated: 2025-12-19

Results Overview

Adverse events were assessed by the Common Terminology Criteria for Adverse Events (CTCAE v5.0). A non-serious adverse event is any untoward medical occurrence. A serious adverse event is an adverse event or suspected adverse reaction that results in death, a life-threatening adverse drug experience, hospitalization, disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the previous outcomes mentioned. Grade 1 is mild, grade 2 is moderate, grade 3 is severe, grade 4 is life-threatening, and grade 5 is death related to adverse event.

Recruitment status

COMPLETED

Study phase

PHASE1

Target enrollment

15 participants

Primary outcome timeframe

Through study completion, an average of 315 days

Results posted on

2025-12-19

Participant Flow

No participants were enrolled in Level 1, Durvalumab 1500mg Intravenous (IV) Every 4 Weeks (Q4WK) + Vicineum 20 mg, and Arm 2, Durvalumab + Vicineum at the Maximum Tolerated Dose (MTD).

Participant milestones

Participant milestones
Measure	Run-In Cohort - Durvalumab 1500mg Intravenous (IV) Every 4 Weeks (Q4WK) + Vicineum 30 mg Durvalumab 1500 mg is administered intravenously (IV) once every 4 weeks for 12 months with an option to continue therapy for an additional 12 months (total of 24 months) provided that, participant is tolerating therapy and remains free of recurrent high grade non-muscle invasive bladder cancer (NMIBC) (see Treatment Period below). The dose of durvalumab is 1500 mg. If optional maintenance therapy continued in the second year, durvalumab 1500 mg will be administered intravenously once every 3 months to provide an immune boost. Vicineum is administered in a 12-week Induction Phase followed by a Maintenance Phase for at least one year with an option for a total of up to 2 years of treatment. During the Induction Phase, Vicineum is administered once weekly for 12 weeks. During the Maintenance Phase, Vicineum is administered every other week. The dose of Vicineum is 30 mg in 50 mL of saline.	Expansion Cohort - Durvalumab 1500mg Intravenous (IV) Every 4 Weeks (Q4WK) + Vicineum 30 mg Durvalumab + Vicineum, at the maximum tolerated dose (MTD). Durvalumab: an option to continue therapy for an additional 12 months (total of 24 months) provided that, participant is tolerating therapy and remains free of recurrent high grade NMIBC (see Treatment Period below). The dose of durvalumab is 1500 mg. If optional maintenance therapy continued in the second year, durvalumab 1500 mg will be administered intravenously once every 3 months to provide an immune boost. Vicineum is administered in a 12-week Induction Phase followed by a Maintenance Phase for at least one year with an option for a total of up to 2 years of treatment. During the Induction Phase, Vicineum is administered once weekly for 12 weeks. During the Maintenance Phase, Vicineum is administered every other week. The dose of Vicineum is 30 mg in 50 mL of saline.
Run-In Induction Phase STARTED	12	0
Run-In Induction Phase COMPLETED	12	0
Run-In Induction Phase NOT COMPLETED	0	0
Run-In Maintenance Phase STARTED	12	0
Run-In Maintenance Phase COMPLETED	5	0
Run-In Maintenance Phase NOT COMPLETED	7	0
Expansion Induction Phase STARTED	0	3
Expansion Induction Phase COMPLETED	0	3
Expansion Induction Phase NOT COMPLETED	0	0
Expansion Maintenance Phase STARTED	0	3
Expansion Maintenance Phase COMPLETED	0	1
Expansion Maintenance Phase NOT COMPLETED	0	2

Reasons for withdrawal

Reasons for withdrawal
Measure	Run-In Cohort - Durvalumab 1500mg Intravenous (IV) Every 4 Weeks (Q4WK) + Vicineum 30 mg Durvalumab 1500 mg is administered intravenously (IV) once every 4 weeks for 12 months with an option to continue therapy for an additional 12 months (total of 24 months) provided that, participant is tolerating therapy and remains free of recurrent high grade non-muscle invasive bladder cancer (NMIBC) (see Treatment Period below). The dose of durvalumab is 1500 mg. If optional maintenance therapy continued in the second year, durvalumab 1500 mg will be administered intravenously once every 3 months to provide an immune boost. Vicineum is administered in a 12-week Induction Phase followed by a Maintenance Phase for at least one year with an option for a total of up to 2 years of treatment. During the Induction Phase, Vicineum is administered once weekly for 12 weeks. During the Maintenance Phase, Vicineum is administered every other week. The dose of Vicineum is 30 mg in 50 mL of saline.	Expansion Cohort - Durvalumab 1500mg Intravenous (IV) Every 4 Weeks (Q4WK) + Vicineum 30 mg Durvalumab + Vicineum, at the maximum tolerated dose (MTD). Durvalumab: an option to continue therapy for an additional 12 months (total of 24 months) provided that, participant is tolerating therapy and remains free of recurrent high grade NMIBC (see Treatment Period below). The dose of durvalumab is 1500 mg. If optional maintenance therapy continued in the second year, durvalumab 1500 mg will be administered intravenously once every 3 months to provide an immune boost. Vicineum is administered in a 12-week Induction Phase followed by a Maintenance Phase for at least one year with an option for a total of up to 2 years of treatment. During the Induction Phase, Vicineum is administered once weekly for 12 weeks. During the Maintenance Phase, Vicineum is administered every other week. The dose of Vicineum is 30 mg in 50 mL of saline.
Run-In Maintenance Phase Disease recurrence	4	0
Run-In Maintenance Phase Disease progression	3	0
Expansion Maintenance Phase Withdrawal by Subject	0	1
Expansion Maintenance Phase Physician Decision	0	1

Baseline Characteristics

Durvalumab and Vicineum in Subjects With High-Grade Non-Muscle-Invasive Bladder Cancer Previously Treated With Bacillus Calmette-Guerin (BCG)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Run-In Cohort - Durvalumab 1500mg Intravenous (IV) Every 4 Weeks (Q4WK) + Vicineum 30 mg n=12 Participants Durvalumab 1500 mg is administered intravenously (IV) once every 4 weeks for 12 months with an option to continue therapy for an additional 12 months (total of 24 months) provided that, participant is tolerating therapy and remains free of recurrent high grade non-muscle invasive bladder cancer (NMIBC) (see Treatment Period below). The dose of durvalumab is 1500 mg. If optional maintenance therapy continued in the second year, durvalumab 1500 mg will be administered intravenously once every 3 months to provide an immune boost. Vicineum is administered in a 12-week Induction Phase followed by a Maintenance Phase for at least one year with an option for a total of up to 2 years of treatment. During the Induction Phase, Vicineum is administered once weekly for 12 weeks. During the Maintenance Phase, Vicineum is administered every other week. The dose of Vicineum is 30 mg in 50 mL of saline.	Expansion Cohort - Durvalumab 1500mg Intravenous (IV) Every 4 Weeks (Q4WK) + Vicineum 30 mg n=3 Participants Durvalumab + Vicineum, at the maximum tolerated dose (MTD). Durvalumab: an option to continue therapy for an additional 12 months (total of 24 months) provided that, participant is tolerating therapy and remains free of recurrent high grade NMIBC (see Treatment Period below). The dose of durvalumab is 1500 mg. If optional maintenance therapy continued in the second year, durvalumab 1500 mg will be administered intravenously once every 3 months to provide an immune boost. Vicineum is administered in a 12-week Induction Phase followed by a Maintenance Phase for at least one year with an option for a total of up to 2 years of treatment. During the Induction Phase, Vicineum is administered once weekly for 12 weeks. During the Maintenance Phase, Vicineum is administered every other week. The dose of Vicineum is 30 mg in 50 mL of saline.	Total n=15 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=8 Participants	0 Participants n=6 Participants	0 Participants n=6 Participants
Age, Categorical Between 18 and 65 years	2 Participants n=8 Participants	1 Participants n=6 Participants	3 Participants n=6 Participants
Age, Categorical >=65 years	10 Participants n=8 Participants	2 Participants n=6 Participants	12 Participants n=6 Participants
Age, Continuous	72 years STANDARD_DEVIATION 8 • n=8 Participants	72 years STANDARD_DEVIATION 10 • n=6 Participants	72 years STANDARD_DEVIATION 8 • n=6 Participants
Sex: Female, Male Female	1 Participants n=8 Participants	0 Participants n=6 Participants	1 Participants n=6 Participants
Sex: Female, Male Male	11 Participants n=8 Participants	3 Participants n=6 Participants	14 Participants n=6 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=8 Participants	0 Participants n=6 Participants	0 Participants n=6 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	12 Participants n=8 Participants	3 Participants n=6 Participants	15 Participants n=6 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=8 Participants	0 Participants n=6 Participants	0 Participants n=6 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=8 Participants	0 Participants n=6 Participants	0 Participants n=6 Participants
Race (NIH/OMB) Asian	0 Participants n=8 Participants	1 Participants n=6 Participants	1 Participants n=6 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=8 Participants	0 Participants n=6 Participants	0 Participants n=6 Participants
Race (NIH/OMB) Black or African American	0 Participants n=8 Participants	0 Participants n=6 Participants	0 Participants n=6 Participants
Race (NIH/OMB) White	12 Participants n=8 Participants	2 Participants n=6 Participants	14 Participants n=6 Participants
Race (NIH/OMB) More than one race	0 Participants n=8 Participants	0 Participants n=6 Participants	0 Participants n=6 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=8 Participants	0 Participants n=6 Participants	0 Participants n=6 Participants
Region of Enrollment United States	12 participants n=8 Participants	3 participants n=6 Participants	15 participants n=6 Participants

PRIMARY outcome

Timeframe: Through study completion, an average of 315 days

Outcome measures

Outcome measures
Measure	Run-In Cohort - Durvalumab 1500mg Intravenous (IV) Every 4 Weeks (Q4WK) + Vicineum 30 mg n=12 Participants Durvalumab 1500 mg is administered intravenously (IV) once every 4 weeks for 12 months with an option to continue therapy for an additional 12 months (total of 24 months) provided that, participant is tolerating therapy and remains free of recurrent high grade non-muscle invasive bladder cancer (NMIBC) (see Treatment Period below). The dose of durvalumab is 1500 mg. If optional maintenance therapy continued in the second year, durvalumab 1500 mg will be administered intravenously once every 3 months to provide an immune boost. Vicineum is administered in a 12-week Induction Phase followed by a Maintenance Phase for at least one year with an option for a total of up to 2 years of treatment. During the Induction Phase, Vicineum is administered once weekly for 12 weeks. During the Maintenance Phase, Vicineum is administered every other week. The dose of Vicineum is 30 mg in 50 mL of saline.	Expansion Cohort - Durvalumab 1500mg Intravenous (IV) Every 4 Weeks (Q4WK) + Vicineum 30 mg n=3 Participants Durvalumab + Vicineum, at the maximum tolerated dose (MTD). Durvalumab: an option to continue therapy for an additional 12 months (total of 24 months) provided that, participant is tolerating therapy and remains free of recurrent high grade NMIBC (see Treatment Period below). The dose of durvalumab is 1500 mg. If optional maintenance therapy continued in the second year, durvalumab 1500 mg will be administered intravenously once every 3 months to provide an immune boost. Vicineum is administered in a 12-week Induction Phase followed by a Maintenance Phase for at least one year with an option for a total of up to 2 years of treatment. During the Induction Phase, Vicineum is administered once weekly for 12 weeks. During the Maintenance Phase, Vicineum is administered every other week. The dose of Vicineum is 30 mg in 50 mL of saline.	Total Cohort - Durvalumab 1500mg Intravenous (IV) Every 4 Weeks (Q4WK) + Vicineum 30 mg n=15 Participants Total Cohort - Durvalumab 1500mg Intravenous (IV) Every 4 Weeks (Q4WK) + Vicineum 30 mg
Number of Grades 1-5 Adverse Events Grade 1	12 adverse events	3 adverse events	15 adverse events
Number of Grades 1-5 Adverse Events Grade 2	9 adverse events	3 adverse events	12 adverse events
Number of Grades 1-5 Adverse Events Grade 3	4 adverse events	0 adverse events	4 adverse events
Number of Grades 1-5 Adverse Events Grade 4	0 adverse events	0 adverse events	0 adverse events
Number of Grades 1-5 Adverse Events Grade 5	0 adverse events	0 adverse events	0 adverse events

SECONDARY outcome

Timeframe: Baseline, week 1, weeks 2-5, week 6, week 10 and week 12

Urinary EpCAM will be measured and will be compared between participants who have a clinical response to therapy vs. those who do not respond. Although it is expected to have low power, a comparison of the EpCAM levels may be compared between the two response categories using a Wilcoxon rank sum test, with the resulting p-value intended to help describe the differences noted.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: From enrollment until event occurrence (recurrence, progression); twelve weeks.

The response to treatment will be determined for evaluable participants who receive treatment and was measured as follows: Recurrence is suspected and/or determined by urine cytology and/or cystoscopic exam and then confirmed pathologically after a transurethral resection of bladder tumor (TURBT). Complete response rate for carcinoma in situ (CIS) is defined as the absence of CIS upon follow-up biopsies. Disease progression is defined as upstaging from a lower stage to a higher stage (e.g., Ta to T1-T4 or T1 to T2-4; CIS to T1 or CIS to T2-T4; or any N+ or M+ in these high-grade tumors).

Outcome measures

Outcome measures
Measure	Run-In Cohort - Durvalumab 1500mg Intravenous (IV) Every 4 Weeks (Q4WK) + Vicineum 30 mg n=12 Participants Durvalumab 1500 mg is administered intravenously (IV) once every 4 weeks for 12 months with an option to continue therapy for an additional 12 months (total of 24 months) provided that, participant is tolerating therapy and remains free of recurrent high grade non-muscle invasive bladder cancer (NMIBC) (see Treatment Period below). The dose of durvalumab is 1500 mg. If optional maintenance therapy continued in the second year, durvalumab 1500 mg will be administered intravenously once every 3 months to provide an immune boost. Vicineum is administered in a 12-week Induction Phase followed by a Maintenance Phase for at least one year with an option for a total of up to 2 years of treatment. During the Induction Phase, Vicineum is administered once weekly for 12 weeks. During the Maintenance Phase, Vicineum is administered every other week. The dose of Vicineum is 30 mg in 50 mL of saline.	Expansion Cohort - Durvalumab 1500mg Intravenous (IV) Every 4 Weeks (Q4WK) + Vicineum 30 mg n=3 Participants Durvalumab + Vicineum, at the maximum tolerated dose (MTD). Durvalumab: an option to continue therapy for an additional 12 months (total of 24 months) provided that, participant is tolerating therapy and remains free of recurrent high grade NMIBC (see Treatment Period below). The dose of durvalumab is 1500 mg. If optional maintenance therapy continued in the second year, durvalumab 1500 mg will be administered intravenously once every 3 months to provide an immune boost. Vicineum is administered in a 12-week Induction Phase followed by a Maintenance Phase for at least one year with an option for a total of up to 2 years of treatment. During the Induction Phase, Vicineum is administered once weekly for 12 weeks. During the Maintenance Phase, Vicineum is administered every other week. The dose of Vicineum is 30 mg in 50 mL of saline.	Total Cohort - Durvalumab 1500mg Intravenous (IV) Every 4 Weeks (Q4WK) + Vicineum 30 mg n=15 Participants Total Cohort - Durvalumab 1500mg Intravenous (IV) Every 4 Weeks (Q4WK) + Vicineum 30 mg
Response Rate Complete response	41.6 percentage of participants	66.6 percentage of participants	46.6 percentage of participants
Response Rate Recurrence	58.3 percentage of participants	33.3 percentage of participants	53.3 percentage of participants
Response Rate Disease progression	25 percentage of participants	33.3 percentage of participants	26.6 percentage of participants

SECONDARY outcome

Timeframe: Baseline, week 1, week 6, week 12

Evaluate the pharmacokinetic parameters of Vicineum obtained by urine samples. Urinary Vicineum (in ng/mL).

Outcome measures

Outcome measures
Measure	Run-In Cohort - Durvalumab 1500mg Intravenous (IV) Every 4 Weeks (Q4WK) + Vicineum 30 mg n=12 Participants Durvalumab 1500 mg is administered intravenously (IV) once every 4 weeks for 12 months with an option to continue therapy for an additional 12 months (total of 24 months) provided that, participant is tolerating therapy and remains free of recurrent high grade non-muscle invasive bladder cancer (NMIBC) (see Treatment Period below). The dose of durvalumab is 1500 mg. If optional maintenance therapy continued in the second year, durvalumab 1500 mg will be administered intravenously once every 3 months to provide an immune boost. Vicineum is administered in a 12-week Induction Phase followed by a Maintenance Phase for at least one year with an option for a total of up to 2 years of treatment. During the Induction Phase, Vicineum is administered once weekly for 12 weeks. During the Maintenance Phase, Vicineum is administered every other week. The dose of Vicineum is 30 mg in 50 mL of saline.	Expansion Cohort - Durvalumab 1500mg Intravenous (IV) Every 4 Weeks (Q4WK) + Vicineum 30 mg n=3 Participants Durvalumab + Vicineum, at the maximum tolerated dose (MTD). Durvalumab: an option to continue therapy for an additional 12 months (total of 24 months) provided that, participant is tolerating therapy and remains free of recurrent high grade NMIBC (see Treatment Period below). The dose of durvalumab is 1500 mg. If optional maintenance therapy continued in the second year, durvalumab 1500 mg will be administered intravenously once every 3 months to provide an immune boost. Vicineum is administered in a 12-week Induction Phase followed by a Maintenance Phase for at least one year with an option for a total of up to 2 years of treatment. During the Induction Phase, Vicineum is administered once weekly for 12 weeks. During the Maintenance Phase, Vicineum is administered every other week. The dose of Vicineum is 30 mg in 50 mL of saline.	Total Cohort - Durvalumab 1500mg Intravenous (IV) Every 4 Weeks (Q4WK) + Vicineum 30 mg n=15 Participants Total Cohort - Durvalumab 1500mg Intravenous (IV) Every 4 Weeks (Q4WK) + Vicineum 30 mg
Pharmacokinetic Parameters in Urine Maximum Concentration (Cmax) of Vicineum Week 1	2.6 ng/mL Interval 1.7 to 5.5	1.5 ng/mL Interval 1.5 to 1.5	4.7 ng/mL Interval 2.1 to 6.5
Pharmacokinetic Parameters in Urine Maximum Concentration (Cmax) of Vicineum Week 6	3.2 ng/mL Interval 1.5 to 4.7	1.5 ng/mL Interval 1.5 to 1.5	4.3 ng/mL Interval 2.4 to 7.5
Pharmacokinetic Parameters in Urine Maximum Concentration (Cmax) of Vicineum Week 1, Day 1	4320.0 ng/mL Interval 10.6 to 11965.5	305.4 ng/mL Interval 195.8 to 15231.8	3738.7 ng/mL Interval 49.9 to 14072.6
Pharmacokinetic Parameters in Urine Maximum Concentration (Cmax) of Vicineum Week 12	3.5 ng/mL Interval 1.8 to 5.5	7.5 ng/mL Interval 7.5 to 7.5	4.8 ng/mL Interval 2.1 to 7.5
Pharmacokinetic Parameters in Urine Maximum Concentration (Cmax) of Vicineum Baseline	2.5 ng/mL Interval 1.5 to 3.8	1.5 ng/mL Interval 1.5 to 1.5	3.2 ng/mL Interval 2.1 to 7.4

SECONDARY outcome

Timeframe: Baseline and after treatment with both agents, from enrollment up to 5 weeks

Population: Number of responders and non-responders in the rows below = overall number of participants analyzed for each group.

PD-L1 levels will be obtained at baseline and after treatment with both agents. The change in levels will be determined between the two measurements, and these changes will be compared between responders and non-responders. Although it is expected to have low power, in each case the comparisons between the two response categories will be made using a Wilcoxon rank sum test, with the resulting p-value intended to help describe the differences noted.

Outcome measures

Outcome measures
Measure	Run-In Cohort - Durvalumab 1500mg Intravenous (IV) Every 4 Weeks (Q4WK) + Vicineum 30 mg n=12 Participants Durvalumab 1500 mg is administered intravenously (IV) once every 4 weeks for 12 months with an option to continue therapy for an additional 12 months (total of 24 months) provided that, participant is tolerating therapy and remains free of recurrent high grade non-muscle invasive bladder cancer (NMIBC) (see Treatment Period below). The dose of durvalumab is 1500 mg. If optional maintenance therapy continued in the second year, durvalumab 1500 mg will be administered intravenously once every 3 months to provide an immune boost. Vicineum is administered in a 12-week Induction Phase followed by a Maintenance Phase for at least one year with an option for a total of up to 2 years of treatment. During the Induction Phase, Vicineum is administered once weekly for 12 weeks. During the Maintenance Phase, Vicineum is administered every other week. The dose of Vicineum is 30 mg in 50 mL of saline.	Expansion Cohort - Durvalumab 1500mg Intravenous (IV) Every 4 Weeks (Q4WK) + Vicineum 30 mg n=3 Participants Durvalumab + Vicineum, at the maximum tolerated dose (MTD). Durvalumab: an option to continue therapy for an additional 12 months (total of 24 months) provided that, participant is tolerating therapy and remains free of recurrent high grade NMIBC (see Treatment Period below). The dose of durvalumab is 1500 mg. If optional maintenance therapy continued in the second year, durvalumab 1500 mg will be administered intravenously once every 3 months to provide an immune boost. Vicineum is administered in a 12-week Induction Phase followed by a Maintenance Phase for at least one year with an option for a total of up to 2 years of treatment. During the Induction Phase, Vicineum is administered once weekly for 12 weeks. During the Maintenance Phase, Vicineum is administered every other week. The dose of Vicineum is 30 mg in 50 mL of saline.	Total Cohort - Durvalumab 1500mg Intravenous (IV) Every 4 Weeks (Q4WK) + Vicineum 30 mg n=15 Participants Total Cohort - Durvalumab 1500mg Intravenous (IV) Every 4 Weeks (Q4WK) + Vicineum 30 mg
Change in Programmed Death-ligand 1 (PD-L1) Levels Between Responders and Non-Responders Non-responders PDL1 levels after treatment (vs baseline)	505.9 pg/mL Interval 421.3 to 532.4	228.4 pg/mL Interval 228.4 to 228.4	489.7 pg/mL Interval 368.6 to 524.2
Change in Programmed Death-ligand 1 (PD-L1) Levels Between Responders and Non-Responders Responders PDL1 levels after treatment (vs baseline	573.4 pg/mL Interval 533.8 to 670.3	342.5 pg/mL Interval 319.4 to 365.6	533.8 pg/mL Interval 443.5 to 621.8

SECONDARY outcome

Timeframe: baseline and after treatment with both agents

PD-1 levels will be obtained at baseline and after treatment with both agents. The change in levels will be determined between the two measurements, and these changes will be compared between responders and non-responders. Although it is expected to have low power, in each case the comparisons between the two response categories will be made using a Wilcoxon rank sum test, with the resulting p-value intended to help describe the differences noted.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline and after treatment, from enrollment up to 5 weeks

Population: Number of participants with SD and participants with PD in the rows below = overall number of participants analyzed for each group.

PD-L1 levels will be obtained at baseline and after treatment with both agents. The change will be compared between those who respond or have stable disease (SD (clinical benefit=Complete Response (CR)+Partial Response (PR)+SD) and those with progressive disease (PD). Although it is expected to have low power, in each case the comparisons between the two response categories will be made using a Wilcoxon rank sum test, with the resulting p-value intended to help describe the differences noted.

Outcome measures

Outcome measures
Measure	Run-In Cohort - Durvalumab 1500mg Intravenous (IV) Every 4 Weeks (Q4WK) + Vicineum 30 mg n=12 Participants Durvalumab 1500 mg is administered intravenously (IV) once every 4 weeks for 12 months with an option to continue therapy for an additional 12 months (total of 24 months) provided that, participant is tolerating therapy and remains free of recurrent high grade non-muscle invasive bladder cancer (NMIBC) (see Treatment Period below). The dose of durvalumab is 1500 mg. If optional maintenance therapy continued in the second year, durvalumab 1500 mg will be administered intravenously once every 3 months to provide an immune boost. Vicineum is administered in a 12-week Induction Phase followed by a Maintenance Phase for at least one year with an option for a total of up to 2 years of treatment. During the Induction Phase, Vicineum is administered once weekly for 12 weeks. During the Maintenance Phase, Vicineum is administered every other week. The dose of Vicineum is 30 mg in 50 mL of saline.	Expansion Cohort - Durvalumab 1500mg Intravenous (IV) Every 4 Weeks (Q4WK) + Vicineum 30 mg n=3 Participants Durvalumab + Vicineum, at the maximum tolerated dose (MTD). Durvalumab: an option to continue therapy for an additional 12 months (total of 24 months) provided that, participant is tolerating therapy and remains free of recurrent high grade NMIBC (see Treatment Period below). The dose of durvalumab is 1500 mg. If optional maintenance therapy continued in the second year, durvalumab 1500 mg will be administered intravenously once every 3 months to provide an immune boost. Vicineum is administered in a 12-week Induction Phase followed by a Maintenance Phase for at least one year with an option for a total of up to 2 years of treatment. During the Induction Phase, Vicineum is administered once weekly for 12 weeks. During the Maintenance Phase, Vicineum is administered every other week. The dose of Vicineum is 30 mg in 50 mL of saline.	Total Cohort - Durvalumab 1500mg Intravenous (IV) Every 4 Weeks (Q4WK) + Vicineum 30 mg n=15 Participants Total Cohort - Durvalumab 1500mg Intravenous (IV) Every 4 Weeks (Q4WK) + Vicineum 30 mg
Change in Programmed Death-ligand 1 (PD-L1) Levels Between Participants Who Respond and Have Stable Disease (SD), and Those With Progressive Disease (PD) PDL1 level changes in participants with SD (treatment vs baseline)	533.8 pg/mL Interval 498.3 to 573.4	342.5 pg/mL Interval 319.4 to 365.6	505.9 pg/mL Interval 378.9 to 561.0
Change in Programmed Death-ligand 1 (PD-L1) Levels Between Participants Who Respond and Have Stable Disease (SD), and Those With Progressive Disease (PD) PDL1 level changes in participants with PD (treatment vs baseline	516 pg/mL Interval 494.8 to 612.9	228.4 pg/mL Interval 228.4 to 228.4	494.8 pg/mL Interval 412.2 to 564.6

SECONDARY outcome

Timeframe: baseline and after treatment

PD-1 levels will be obtained at baseline and after treatment with both agents. The change will be compared between those who respond or have stable disease (SD (clinical benefit=Complete Response (CR)+Partial Response (PR)+SD) and those with progressive disease (PD). Although it is expected to have low power, in each case the comparisons between the two response categories will be made using a Wilcoxon rank sum test, with the resulting p-value intended to help describe the differences noted.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: baseline, 3 weeks, and 5 weeks

All evaluable participants will have determinations of many immune parameters at baseline, 3 months, and 6 months. The changes in the parameters obtained from blood samples will be determined at baseline vs. 3 months, and baseline vs. 6 months. Comparisons of the paired values will be performed using a Wilcoxon signed rank test, and a Hochberg adjustment may be used.

Outcome measures

Outcome measures
Measure	Run-In Cohort - Durvalumab 1500mg Intravenous (IV) Every 4 Weeks (Q4WK) + Vicineum 30 mg n=12 Participants Durvalumab 1500 mg is administered intravenously (IV) once every 4 weeks for 12 months with an option to continue therapy for an additional 12 months (total of 24 months) provided that, participant is tolerating therapy and remains free of recurrent high grade non-muscle invasive bladder cancer (NMIBC) (see Treatment Period below). The dose of durvalumab is 1500 mg. If optional maintenance therapy continued in the second year, durvalumab 1500 mg will be administered intravenously once every 3 months to provide an immune boost. Vicineum is administered in a 12-week Induction Phase followed by a Maintenance Phase for at least one year with an option for a total of up to 2 years of treatment. During the Induction Phase, Vicineum is administered once weekly for 12 weeks. During the Maintenance Phase, Vicineum is administered every other week. The dose of Vicineum is 30 mg in 50 mL of saline.	Expansion Cohort - Durvalumab 1500mg Intravenous (IV) Every 4 Weeks (Q4WK) + Vicineum 30 mg n=3 Participants Durvalumab + Vicineum, at the maximum tolerated dose (MTD). Durvalumab: an option to continue therapy for an additional 12 months (total of 24 months) provided that, participant is tolerating therapy and remains free of recurrent high grade NMIBC (see Treatment Period below). The dose of durvalumab is 1500 mg. If optional maintenance therapy continued in the second year, durvalumab 1500 mg will be administered intravenously once every 3 months to provide an immune boost. Vicineum is administered in a 12-week Induction Phase followed by a Maintenance Phase for at least one year with an option for a total of up to 2 years of treatment. During the Induction Phase, Vicineum is administered once weekly for 12 weeks. During the Maintenance Phase, Vicineum is administered every other week. The dose of Vicineum is 30 mg in 50 mL of saline.	Total Cohort - Durvalumab 1500mg Intravenous (IV) Every 4 Weeks (Q4WK) + Vicineum 30 mg n=15 Participants Total Cohort - Durvalumab 1500mg Intravenous (IV) Every 4 Weeks (Q4WK) + Vicineum 30 mg
Changes in the Immune Parameters Obtained From Blood Samples 3 weeks Interleukin 10 (IL-10) vs Baseline	0.120 pg/mL Interval 0.047 to 0.202	0.07 pg/mL Interval -0.04 to 0.15	0.120 pg/mL Interval 0.045 to 0.205
Changes in the Immune Parameters Obtained From Blood Samples 3 weeks Interferon Gamma (IFN-γ) vs Baseline	4.340 pg/mL Interval 0.95 to 9.315	0.640 pg/mL Interval -0.035 to 2.225	3.850 pg/mL Interval 0.72 to 6.525
Changes in the Immune Parameters Obtained From Blood Samples 5 weeks Interferon Gamma (IFN-γ) vs Baseline	3.290 pg/mL Interval 1.375 to 8.312	1.750 pg/mL Interval 0.985 to 12.265	3.120 pg/mL Interval 1.37 to 10.825
Changes in the Immune Parameters Obtained From Blood Samples 3 weeks Interleukin 6 (IL-6) vs Baseline	0.395 pg/mL Interval 0.037 to 0.802	0.180 pg/mL Interval 0.115 to 0.32	0.280 pg/mL Interval 0.05 to 0.59
Changes in the Immune Parameters Obtained From Blood Samples 5 weeks Interleukin 6 (IL-6) vs Baseline	0.540 pg/mL Interval -0.07 to 0.87	0.220 pg/mL Interval 0.145 to 0.52	0.400 pg/mL Interval 0.005 to 0.77
Changes in the Immune Parameters Obtained From Blood Samples 3 weeks Interleukin 8 (IL-8) vs Baseline	0.730 pg/mL Interval -0.482 to 1.37	0.880 pg/mL Interval -0.795 to 10.295	0.860 pg/mL Interval -0.895 to 1.61
Changes in the Immune Parameters Obtained From Blood Samples 5 weeks Interleukin 8 (IL-8) vs Baseline	-0.395 pg/mL Interval -0.647 to 0.597	-0.160 pg/mL Interval -0.455 to 10.145	-0.180 pg/mL Interval -0.665 to 0.715
Changes in the Immune Parameters Obtained From Blood Samples 5 weeks Interleukin 10 (IL-10) vs Baseline	0.105 pg/mL Interval 0.047 to 0.365	0.120 pg/mL Interval 0.075 to 0.305	0.120 pg/mL Interval 0.045 to 0.38
Changes in the Immune Parameters Obtained From Blood Samples 3 weeks Tumor Necrosis Factor Alpha (TNF-α) vs Baseline	0.400 pg/mL Interval 0.207 to 0.56	0.260 pg/mL Interval 0.1 to 0.525	0.350 pg/mL Interval 0.165 to 0.59
Changes in the Immune Parameters Obtained From Blood Samples 5 weeks Tumor Necrosis Factor Alpha (TNF-α) vs Baseline	0.240 pg/mL Interval 0.122 to 1.207	0.270 pg/mL Interval 0.175 to 0.32	0.270 pg/mL Interval 0.11 to 0.93

SECONDARY outcome

Timeframe: baseline, 3 months, and 6 months

All evaluable participants will have determinations of many immune parameters at baseline, 3 months, and 6 months. The changes in the parameters obtained from biopsies will be obtained from baseline vs. a single second biopsy at 6 months. Comparisons of the paired values will be performed using a Wilcoxon signed rank test, and a Hochberg adjustment may be used.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Assessed from start of therapy to disease recurrence or last follow up; up to 1 year.

A DFS curve will be created using the Kaplan-Meier method based on all participants considered to be evaluable based on having received protocol treatment. DFS survival is defined as the time from the start of treatment until disease recurrence or death. Recurrence is suspected and/or determined by urine cytology and/or cystoscopic exam and then confirmed pathologically after a bladder biopsy or transurethral resection of bladder tumor (TURBT).

Outcome measures

Outcome measures
Measure	Run-In Cohort - Durvalumab 1500mg Intravenous (IV) Every 4 Weeks (Q4WK) + Vicineum 30 mg n=12 Participants Durvalumab 1500 mg is administered intravenously (IV) once every 4 weeks for 12 months with an option to continue therapy for an additional 12 months (total of 24 months) provided that, participant is tolerating therapy and remains free of recurrent high grade non-muscle invasive bladder cancer (NMIBC) (see Treatment Period below). The dose of durvalumab is 1500 mg. If optional maintenance therapy continued in the second year, durvalumab 1500 mg will be administered intravenously once every 3 months to provide an immune boost. Vicineum is administered in a 12-week Induction Phase followed by a Maintenance Phase for at least one year with an option for a total of up to 2 years of treatment. During the Induction Phase, Vicineum is administered once weekly for 12 weeks. During the Maintenance Phase, Vicineum is administered every other week. The dose of Vicineum is 30 mg in 50 mL of saline.	Expansion Cohort - Durvalumab 1500mg Intravenous (IV) Every 4 Weeks (Q4WK) + Vicineum 30 mg n=3 Participants Durvalumab + Vicineum, at the maximum tolerated dose (MTD). Durvalumab: an option to continue therapy for an additional 12 months (total of 24 months) provided that, participant is tolerating therapy and remains free of recurrent high grade NMIBC (see Treatment Period below). The dose of durvalumab is 1500 mg. If optional maintenance therapy continued in the second year, durvalumab 1500 mg will be administered intravenously once every 3 months to provide an immune boost. Vicineum is administered in a 12-week Induction Phase followed by a Maintenance Phase for at least one year with an option for a total of up to 2 years of treatment. During the Induction Phase, Vicineum is administered once weekly for 12 weeks. During the Maintenance Phase, Vicineum is administered every other week. The dose of Vicineum is 30 mg in 50 mL of saline.	Total Cohort - Durvalumab 1500mg Intravenous (IV) Every 4 Weeks (Q4WK) + Vicineum 30 mg n=15 Participants Total Cohort - Durvalumab 1500mg Intravenous (IV) Every 4 Weeks (Q4WK) + Vicineum 30 mg
Disease Free Survival (DFS)	12.8 Weeks Interval 12.3 to The upper Confidence Interval limit was NOT ACHIEVED/NEVER ATTAINED, i.e., CANNOT be calculated. There were not enough events for it to be determined.	50.1 Weeks Interval 12.3 to The upper Confidence Interval limit was NOT ACHIEVED/NEVER ATTAINED, i.e., CANNOT be calculated. There were not enough events for it to be determined.	13.2 Weeks Interval 12.28 to The upper Confidence Interval limit was NOT ACHIEVED/NEVER ATTAINED, i.e., CANNOT be calculated. There were not enough events for it to be determined.

OTHER_PRE_SPECIFIED outcome

Timeframe: Through study completion, an average of 315 days.

Here is the number of participants with serious and/or non-serious adverse events assessed by the Common Terminology Criteria for Adverse Events (CTCAE v5.0). A non-serious adverse event is any untoward medical occurrence. A serious adverse event is an adverse event or suspected adverse reaction that results in death, a life-threatening adverse drug experience, hospitalization, disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the previous outcomes mentioned.

Outcome measures

Outcome measures
Measure	Run-In Cohort - Durvalumab 1500mg Intravenous (IV) Every 4 Weeks (Q4WK) + Vicineum 30 mg n=12 Participants Durvalumab 1500 mg is administered intravenously (IV) once every 4 weeks for 12 months with an option to continue therapy for an additional 12 months (total of 24 months) provided that, participant is tolerating therapy and remains free of recurrent high grade non-muscle invasive bladder cancer (NMIBC) (see Treatment Period below). The dose of durvalumab is 1500 mg. If optional maintenance therapy continued in the second year, durvalumab 1500 mg will be administered intravenously once every 3 months to provide an immune boost. Vicineum is administered in a 12-week Induction Phase followed by a Maintenance Phase for at least one year with an option for a total of up to 2 years of treatment. During the Induction Phase, Vicineum is administered once weekly for 12 weeks. During the Maintenance Phase, Vicineum is administered every other week. The dose of Vicineum is 30 mg in 50 mL of saline.	Expansion Cohort - Durvalumab 1500mg Intravenous (IV) Every 4 Weeks (Q4WK) + Vicineum 30 mg n=3 Participants Durvalumab + Vicineum, at the maximum tolerated dose (MTD). Durvalumab: an option to continue therapy for an additional 12 months (total of 24 months) provided that, participant is tolerating therapy and remains free of recurrent high grade NMIBC (see Treatment Period below). The dose of durvalumab is 1500 mg. If optional maintenance therapy continued in the second year, durvalumab 1500 mg will be administered intravenously once every 3 months to provide an immune boost. Vicineum is administered in a 12-week Induction Phase followed by a Maintenance Phase for at least one year with an option for a total of up to 2 years of treatment. During the Induction Phase, Vicineum is administered once weekly for 12 weeks. During the Maintenance Phase, Vicineum is administered every other week. The dose of Vicineum is 30 mg in 50 mL of saline.	Total Cohort - Durvalumab 1500mg Intravenous (IV) Every 4 Weeks (Q4WK) + Vicineum 30 mg Total Cohort - Durvalumab 1500mg Intravenous (IV) Every 4 Weeks (Q4WK) + Vicineum 30 mg
Number of Participants With Serious and/or Non-serious Adverse Events Assessed by the Common Terminology Criteria for Adverse Events (CTCAE v5.0)	12 Participants	3 Participants	—

OTHER_PRE_SPECIFIED outcome

Timeframe: 6 weeks

The MTD will be identified based on being the dose level at which 0 or 1 participants in 6 has a dose-limiting toxicity (DLT). A DLT will be defined as any Grade 3 or higher toxicity that occurs during the initial 6-week period the subject is on treatment (i.e., the DLT evaluation period). Grade 3 is severe, grade 4 is life-threatening and grade 5 is death related to adverse event.

Outcome measures

Outcome measures
Measure	Run-In Cohort - Durvalumab 1500mg Intravenous (IV) Every 4 Weeks (Q4WK) + Vicineum 30 mg n=15 Participants Durvalumab 1500 mg is administered intravenously (IV) once every 4 weeks for 12 months with an option to continue therapy for an additional 12 months (total of 24 months) provided that, participant is tolerating therapy and remains free of recurrent high grade non-muscle invasive bladder cancer (NMIBC) (see Treatment Period below). The dose of durvalumab is 1500 mg. If optional maintenance therapy continued in the second year, durvalumab 1500 mg will be administered intravenously once every 3 months to provide an immune boost. Vicineum is administered in a 12-week Induction Phase followed by a Maintenance Phase for at least one year with an option for a total of up to 2 years of treatment. During the Induction Phase, Vicineum is administered once weekly for 12 weeks. During the Maintenance Phase, Vicineum is administered every other week. The dose of Vicineum is 30 mg in 50 mL of saline.	Expansion Cohort - Durvalumab 1500mg Intravenous (IV) Every 4 Weeks (Q4WK) + Vicineum 30 mg Durvalumab + Vicineum, at the maximum tolerated dose (MTD). Durvalumab: an option to continue therapy for an additional 12 months (total of 24 months) provided that, participant is tolerating therapy and remains free of recurrent high grade NMIBC (see Treatment Period below). The dose of durvalumab is 1500 mg. If optional maintenance therapy continued in the second year, durvalumab 1500 mg will be administered intravenously once every 3 months to provide an immune boost. Vicineum is administered in a 12-week Induction Phase followed by a Maintenance Phase for at least one year with an option for a total of up to 2 years of treatment. During the Induction Phase, Vicineum is administered once weekly for 12 weeks. During the Maintenance Phase, Vicineum is administered every other week. The dose of Vicineum is 30 mg in 50 mL of saline.	Total Cohort - Durvalumab 1500mg Intravenous (IV) Every 4 Weeks (Q4WK) + Vicineum 30 mg Total Cohort - Durvalumab 1500mg Intravenous (IV) Every 4 Weeks (Q4WK) + Vicineum 30 mg
Maximum Tolerated Dose (MTD) of Durvalumab	1500 Mg	—	—

OTHER_PRE_SPECIFIED outcome

Timeframe: 6 weeks

Outcome measures

Outcome measures
Measure	Run-In Cohort - Durvalumab 1500mg Intravenous (IV) Every 4 Weeks (Q4WK) + Vicineum 30 mg n=15 Participants Durvalumab 1500 mg is administered intravenously (IV) once every 4 weeks for 12 months with an option to continue therapy for an additional 12 months (total of 24 months) provided that, participant is tolerating therapy and remains free of recurrent high grade non-muscle invasive bladder cancer (NMIBC) (see Treatment Period below). The dose of durvalumab is 1500 mg. If optional maintenance therapy continued in the second year, durvalumab 1500 mg will be administered intravenously once every 3 months to provide an immune boost. Vicineum is administered in a 12-week Induction Phase followed by a Maintenance Phase for at least one year with an option for a total of up to 2 years of treatment. During the Induction Phase, Vicineum is administered once weekly for 12 weeks. During the Maintenance Phase, Vicineum is administered every other week. The dose of Vicineum is 30 mg in 50 mL of saline.	Expansion Cohort - Durvalumab 1500mg Intravenous (IV) Every 4 Weeks (Q4WK) + Vicineum 30 mg Durvalumab + Vicineum, at the maximum tolerated dose (MTD). Durvalumab: an option to continue therapy for an additional 12 months (total of 24 months) provided that, participant is tolerating therapy and remains free of recurrent high grade NMIBC (see Treatment Period below). The dose of durvalumab is 1500 mg. If optional maintenance therapy continued in the second year, durvalumab 1500 mg will be administered intravenously once every 3 months to provide an immune boost. Vicineum is administered in a 12-week Induction Phase followed by a Maintenance Phase for at least one year with an option for a total of up to 2 years of treatment. During the Induction Phase, Vicineum is administered once weekly for 12 weeks. During the Maintenance Phase, Vicineum is administered every other week. The dose of Vicineum is 30 mg in 50 mL of saline.	Total Cohort - Durvalumab 1500mg Intravenous (IV) Every 4 Weeks (Q4WK) + Vicineum 30 mg Total Cohort - Durvalumab 1500mg Intravenous (IV) Every 4 Weeks (Q4WK) + Vicineum 30 mg
Maximum Tolerated Dose (MTD) of Vicineum	30 Mg	—	—

OTHER_PRE_SPECIFIED outcome

Timeframe: 6 weeks

A DLT will be defined as any Grade 3 or higher toxicity that occurs during the initial 6-week period the subject is on treatment (i.e., the DLT evaluation period). Grade 3 is severe, grade 4 is life-threatening and grade 5 is death related to adverse event.

Outcome measures

Outcome measures
Measure	Run-In Cohort - Durvalumab 1500mg Intravenous (IV) Every 4 Weeks (Q4WK) + Vicineum 30 mg n=12 Participants Durvalumab 1500 mg is administered intravenously (IV) once every 4 weeks for 12 months with an option to continue therapy for an additional 12 months (total of 24 months) provided that, participant is tolerating therapy and remains free of recurrent high grade non-muscle invasive bladder cancer (NMIBC) (see Treatment Period below). The dose of durvalumab is 1500 mg. If optional maintenance therapy continued in the second year, durvalumab 1500 mg will be administered intravenously once every 3 months to provide an immune boost. Vicineum is administered in a 12-week Induction Phase followed by a Maintenance Phase for at least one year with an option for a total of up to 2 years of treatment. During the Induction Phase, Vicineum is administered once weekly for 12 weeks. During the Maintenance Phase, Vicineum is administered every other week. The dose of Vicineum is 30 mg in 50 mL of saline.	Expansion Cohort - Durvalumab 1500mg Intravenous (IV) Every 4 Weeks (Q4WK) + Vicineum 30 mg n=3 Participants Durvalumab + Vicineum, at the maximum tolerated dose (MTD). Durvalumab: an option to continue therapy for an additional 12 months (total of 24 months) provided that, participant is tolerating therapy and remains free of recurrent high grade NMIBC (see Treatment Period below). The dose of durvalumab is 1500 mg. If optional maintenance therapy continued in the second year, durvalumab 1500 mg will be administered intravenously once every 3 months to provide an immune boost. Vicineum is administered in a 12-week Induction Phase followed by a Maintenance Phase for at least one year with an option for a total of up to 2 years of treatment. During the Induction Phase, Vicineum is administered once weekly for 12 weeks. During the Maintenance Phase, Vicineum is administered every other week. The dose of Vicineum is 30 mg in 50 mL of saline.	Total Cohort - Durvalumab 1500mg Intravenous (IV) Every 4 Weeks (Q4WK) + Vicineum 30 mg Total Cohort - Durvalumab 1500mg Intravenous (IV) Every 4 Weeks (Q4WK) + Vicineum 30 mg
Dose-Limiting Toxicity (DLT) Grade 3	33.3 percentage of participants	0 percentage of participants	—
Dose-Limiting Toxicity (DLT) Grade 4	0 percentage of participants	0 percentage of participants	—
Dose-Limiting Toxicity (DLT) Grade 5	0 percentage of participants	0 percentage of participants	—

Adverse Events

Run-In Cohort - Durvalumab 1500mg Intravenous (IV) Every 4 Weeks (Q4WK) + Vicineum 30 mg

Serious events: 4 serious events

Other events: 12 other events

Deaths: 0 deaths

Expansion Cohort - Durvalumab 1500mg Intravenous (IV) Every 4 Weeks (Q4WK) + Vicineum 30 mg

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Total Cohort - Durvalumab 1500mg Intravenous (IV) Every 4 Weeks (Q4WK) + Vicineum 30 mg

Serious events: 4 serious events

Other events: 15 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Run-In Cohort - Durvalumab 1500mg Intravenous (IV) Every 4 Weeks (Q4WK) + Vicineum 30 mg n=12 participants at risk Durvalumab 1500 mg is administered intravenously (IV) once every 4 weeks for 12 months with an option to continue therapy for an additional 12 months (total of 24 months) provided that, participant is tolerating therapy and remains free of recurrent high grade non-muscle invasive bladder cancer (NMIBC) (see Treatment Period below). The dose of durvalumab is 1500 mg. If optional maintenance therapy continued in the second year, durvalumab 1500 mg will be administered intravenously once every 3 months to provide an immune boost. Vicineum is administered in a 12-week Induction Phase followed by a Maintenance Phase for at least one year with an option for a total of up to 2 years of treatment. During the Induction Phase, Vicineum is administered once weekly for 12 weeks. During the Maintenance Phase, Vicineum is administered every other week. The dose of Vicineum is 30 mg in 50 mL of saline.	Expansion Cohort - Durvalumab 1500mg Intravenous (IV) Every 4 Weeks (Q4WK) + Vicineum 30 mg n=3 participants at risk Durvalumab + Vicineum, at the maximum tolerated dose (MTD). Durvalumab: an option to continue therapy for an additional 12 months (total of 24 months) provided that, participant is tolerating therapy and remains free of recurrent high grade NMIBC (see Treatment Period below). The dose of durvalumab is 1500 mg. If optional maintenance therapy continued in the second year, durvalumab 1500 mg will be administered intravenously once every 3 months to provide an immune boost. Vicineum is administered in a 12-week Induction Phase followed by a Maintenance Phase for at least one year with an option for a total of up to 2 years of treatment. During the Induction Phase, Vicineum is administered once weekly for 12 weeks. During the Maintenance Phase, Vicineum is administered every other week. The dose of Vicineum is 30 mg in 50 mL of saline.	Total Cohort - Durvalumab 1500mg Intravenous (IV) Every 4 Weeks (Q4WK) + Vicineum 30 mg n=15 participants at risk Total Cohort - Durvalumab 1500mg Intravenous (IV) Every 4 Weeks (Q4WK) + Vicineum 30 mg
Infections and infestations Bladder infection	8.3% 1/12 • Number of events 1 • Through study completion, an average of 315 days	0.00% 0/3 • Through study completion, an average of 315 days	6.7% 1/15 • Number of events 1 • Through study completion, an average of 315 days
Renal and urinary disorders Hematuria	8.3% 1/12 • Number of events 1 • Through study completion, an average of 315 days	0.00% 0/3 • Through study completion, an average of 315 days	6.7% 1/15 • Number of events 1 • Through study completion, an average of 315 days
Metabolism and nutrition disorders Hyponatremia	8.3% 1/12 • Number of events 1 • Through study completion, an average of 315 days	0.00% 0/3 • Through study completion, an average of 315 days	6.7% 1/15 • Number of events 1 • Through study completion, an average of 315 days
Vascular disorders Thromboembolic event	8.3% 1/12 • Number of events 1 • Through study completion, an average of 315 days	0.00% 0/3 • Through study completion, an average of 315 days	6.7% 1/15 • Number of events 1 • Through study completion, an average of 315 days

Other adverse events

Additional Information

Dr. Raju Chelluri

National Cancer Institute

Phone: 240-858-3700

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place