Trial Outcomes & Findings for A Window of Opportunity Trial: Avelumab in Non-metastatic Muscle Invasive Bladder Cancer (NCT NCT03498196)

Last Updated: 2020-08-24

Results Overview

The change in T cell subpopulations (CD8, CD4 and/or CD3) in tumor samples will be collected from FFPE tissue. FFPE tissue from the pre-study time point refers to tissue from the TURBT. FFPE tissue from the 2-3 week post-op time point refers to FFPE tissue from the RC

Recruitment status

TERMINATED

Study phase

PHASE1/PHASE2

Target enrollment

1 participants

Primary outcome timeframe

pre-study time and 2-3 week post-operation

Results posted on

2020-08-24

Participant Flow

Participant milestones

Participant milestones
Measure	Avelumab Avelumab 10 mg/kg intravenously, over 60 minutes every 2 weeks for 3 cycles or 42 days. Avelumab: avelumab 10 mg/kg intravenously every 2 weeks for 3 cycles or 42 days.
Overall Study STARTED	1
Overall Study COMPLETED	1
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

A Window of Opportunity Trial: Avelumab in Non-metastatic Muscle Invasive Bladder Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Avelumab n=1 Participants Avelumab 10 mg/kg intravenously, over 60 minutes every 2 weeks for 3 cycles or 42 days. Avelumab: avelumab 10 mg/kg intravenously every 2 weeks for 3 cycles or 42 days.
Age, Continuous	58 years STANDARD_DEVIATION NA • n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants
Sex: Female, Male Male	1 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	1 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	1 Participants n=5 Participants
Race (NIH/OMB) White	0 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	1 participants n=5 Participants
Current Smoking	1 Participants n=5 Participants

PRIMARY outcome

Timeframe: pre-study time and 2-3 week post-operation

Population: The assay for the outcome measure was planned to do after enrolling several patients and collecting specimen but only one patient was enrolled for this study. No assay was done.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: pre-study time and 2-3 week post-operation

Number of patient with pathological response will be counted

Outcome measures

Outcome measures
Measure	Avelumab n=1 Participants Avelumab 10 mg/kg intravenously, over 60 minutes every 2 weeks for 3 cycles or 42 days. Avelumab: avelumab 10 mg/kg intravenously every 2 weeks for 3 cycles or 42 days.
Pathological Response Rate	0 Participants

SECONDARY outcome

Timeframe: 2 years after radical cystectomy

Population: since one patient was available for this study analysis, the time of recurrence or death was reported.

A patient will be followed for recurrence and survival for up to 2 years after radical cystectomy.

Outcome measures

Outcome measures
Measure	Avelumab n=1 Participants Avelumab 10 mg/kg intravenously, over 60 minutes every 2 weeks for 3 cycles or 42 days. Avelumab: avelumab 10 mg/kg intravenously every 2 weeks for 3 cycles or 42 days.
2 Year Disease Free Survival (DFS)	5.48 months

SECONDARY outcome

Timeframe: 90 days post operation

High grade adverse events are defined as grade of 3-4 on the CTCAE (Common terminology criteria for adverse events) grading scale.

Outcome measures

Outcome measures
Measure	Avelumab n=1 Participants Avelumab 10 mg/kg intravenously, over 60 minutes every 2 weeks for 3 cycles or 42 days. Avelumab: avelumab 10 mg/kg intravenously every 2 weeks for 3 cycles or 42 days.
Rate of High Grade(Grade 3-4) Adverse Event	1 Participants

Adverse Events

Avelumab

Serious events: 1 serious events

Other events: 1 other events

Deaths: 1 deaths

Serious adverse events

Serious adverse events
Measure	Avelumab n=1 participants at risk Avelumab 10 mg/kg intravenously, over 60 minutes every 2 weeks for 3 cycles or 42 days. Avelumab: avelumab 10 mg/kg intravenously every 2 weeks for 3 cycles or 42 days.
Infections and infestations Sepsis	100.0% 1/1 • Number of events 1 • 90 days after radical cystectomy (RC) or end of the last cycle of Avelumab for those not receiving RC.
Renal and urinary disorders Urinary tract obstruction	100.0% 1/1 • Number of events 1 • 90 days after radical cystectomy (RC) or end of the last cycle of Avelumab for those not receiving RC.

Other adverse events

Other adverse events
Measure	Avelumab n=1 participants at risk Avelumab 10 mg/kg intravenously, over 60 minutes every 2 weeks for 3 cycles or 42 days. Avelumab: avelumab 10 mg/kg intravenously every 2 weeks for 3 cycles or 42 days.
Blood and lymphatic system disorders Anemia	100.0% 1/1 • Number of events 3 • 90 days after radical cystectomy (RC) or end of the last cycle of Avelumab for those not receiving RC.
Investigations Creatinine increased	100.0% 1/1 • Number of events 1 • 90 days after radical cystectomy (RC) or end of the last cycle of Avelumab for those not receiving RC.
Renal and urinary disorders Renal and urinary disorders - Other, specify	100.0% 1/1 • Number of events 1 • 90 days after radical cystectomy (RC) or end of the last cycle of Avelumab for those not receiving RC.

Additional Information

Jennifer M. Taylor, MD, MPH

Baylor College of Medicine

Phone: 713-797-7670

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place