Trial Outcomes & Findings for Avelumab and Radiation in Muscle-Invasive Bladder Cancer (NCT NCT03747419)
NCT ID: NCT03747419
Last Updated: 2025-10-31
Results Overview
Measured by the complete clinical response rate at 3 months following completion of radiation, followed by every 3 months until 2 years after registration, then every 6 months up to a maximum of 3 years after registration. Clinical response is assessed by cystoscopy, urine cytology, and CT Chest/Abdomen/Pelvis. No evidence of disease on these assessments at a given time point suggests a Complete Clinical Response at that time point.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
14 participants
Primary outcome timeframe
3 months following completion of radiation; then every 3 months until 2 years after registration; then every 6 months up to a maximum of 3 years after registration
Results posted on
2025-10-31
Participant Flow
14 patients were enrolled out of 17 that consented to the study. The target enrollment was 24 patients prior to study closure due to slow accrual.
Patients must have muscle invasive (T2-T4a) urothelial bladder carcinoma. They must also not be eligible for cisplatin-based chemotherapy.
Participant milestones
| Measure |
Avelumab and Bladder-Directed Radiation
* Avelumab will be administered every 2 weeks intravenously for 6 doses unless there is unacceptable toxicity
* Two radiation dose regimens are allowed, and the regimen selected is at the discretion of the treating radiation oncologist
|
|---|---|
|
Overall Study
STARTED
|
14
|
|
Overall Study
COMPLETED
|
14
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Avelumab and Radiation in Muscle-Invasive Bladder Cancer
Baseline characteristics by cohort
| Measure |
Avelumab and Bladder-Directed Radiation
n=14 Participants
* Avelumab will be administered every 2 weeks intravenously for 6 doses unless there is unacceptable toxicity
* Two radiation dose regimens are allowed, and the regimen selected is at the discretion of the treating radiation oncologist
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
14 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
10 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
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
14 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
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
14 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
ECOG Performance Status
ECOG = 0
|
5 Participants
n=5 Participants
|
|
ECOG Performance Status
ECOG = 1
|
5 Participants
n=5 Participants
|
|
ECOG Performance Status
ECOG = 2
|
4 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 3 months following completion of radiation; then every 3 months until 2 years after registration; then every 6 months up to a maximum of 3 years after registrationPopulation: 2 participants withdrew consent prior to completing protocol therapy and therefore could not be evaluated for the primary endpoint.
Measured by the complete clinical response rate at 3 months following completion of radiation, followed by every 3 months until 2 years after registration, then every 6 months up to a maximum of 3 years after registration. Clinical response is assessed by cystoscopy, urine cytology, and CT Chest/Abdomen/Pelvis. No evidence of disease on these assessments at a given time point suggests a Complete Clinical Response at that time point.
Outcome measures
| Measure |
Avelumab and Bladder-Directed Radiation
n=12 Participants
* Avelumab will be administered every 2 weeks intravenously for 6 doses unless there is unacceptable toxicity
* Two radiation dose regimens are allowed, and the regimen selected is at the discretion of the treating radiation oncologist
|
|---|---|
|
Complete Clinical Response Rate
Subjects that reached Complete CR at 3 months following completion of radiation
|
5 Participants
|
|
Complete Clinical Response Rate
Subjects that never reached Complete CR during FU
|
3 Participants
|
|
Complete Clinical Response Rate
Subjects that reached Complete CR during FU but after 3 months following completion of radiation
|
4 Participants
|
SECONDARY outcome
Timeframe: 3 yearsPopulation: 2 participants withdrew consent prior to completing protocol therapy.
Overall Survival (OS)
Outcome measures
| Measure |
Avelumab and Bladder-Directed Radiation
n=12 Participants
* Avelumab will be administered every 2 weeks intravenously for 6 doses unless there is unacceptable toxicity
* Two radiation dose regimens are allowed, and the regimen selected is at the discretion of the treating radiation oncologist
|
|---|---|
|
Overall Survival
Deaths due to progressive disease during FU
|
5 Participants
|
|
Overall Survival
Deaths due to unrelated condition during FU
|
2 Participants
|
|
Overall Survival
Subjects alive at time of study closure
|
4 Participants
|
|
Overall Survival
Subjects alive at time of study withdrawal during FU
|
1 Participants
|
SECONDARY outcome
Timeframe: 3 yearsPopulation: 2 participants withdrew consent prior to completing protocol therapy.
Progression Free Survival (PFS) as assessed by imaging, cystoscopy, and cytology.
Outcome measures
| Measure |
Avelumab and Bladder-Directed Radiation
n=12 Participants
* Avelumab will be administered every 2 weeks intravenously for 6 doses unless there is unacceptable toxicity
* Two radiation dose regimens are allowed, and the regimen selected is at the discretion of the treating radiation oncologist
|
|---|---|
|
Progression Free Survival
Disease progression after treatment
|
5 Participants
|
|
Progression Free Survival
No disease progression after treatment
|
7 Participants
|
SECONDARY outcome
Timeframe: 3 yearsPopulation: 2 participants withdrew consent prior to completing protocol therapy.
Metastases-free survival (MFS) as assessed by imaging.
Outcome measures
| Measure |
Avelumab and Bladder-Directed Radiation
n=12 Participants
* Avelumab will be administered every 2 weeks intravenously for 6 doses unless there is unacceptable toxicity
* Two radiation dose regimens are allowed, and the regimen selected is at the discretion of the treating radiation oncologist
|
|---|---|
|
Metastases-free Survival
Metastases after treatment
|
5 Participants
|
|
Metastases-free Survival
No metastases after treatment
|
7 Participants
|
SECONDARY outcome
Timeframe: 3 yearsPopulation: 2 participants withdrew consent prior to completing protocol therapy, and 1 participant withdrew consent during FU. Therefore, they could not be evaluated for overall survival.
Locoregional recurrence rate (LRR) as assessed by imaging.
Outcome measures
| Measure |
Avelumab and Bladder-Directed Radiation
n=12 Participants
* Avelumab will be administered every 2 weeks intravenously for 6 doses unless there is unacceptable toxicity
* Two radiation dose regimens are allowed, and the regimen selected is at the discretion of the treating radiation oncologist
|
|---|---|
|
Locoregional Recurrence Rate
No locoregional recurrence after treatment
|
11 Participants
|
|
Locoregional Recurrence Rate
Locoregional recurrence after treatment
|
1 Participants
|
SECONDARY outcome
Timeframe: Baseline; 3 months following completion of radiation; 2 years after treatmentPopulation: One participant declined to complete QoL forms during treatment and follow up.
Quality of Life Outcomes (QoL) as measured by patient report on questionnaires. Patients are given a statement and must assign a number to assess how the statement applies to them in the past 7 days. 0=Not at all; 1=A little bit; 2=Somewhat; 3=Quite a bit; 4=Very much. QoLs were collected at baseline, end of radiation, 3 months post-radiation completion, then every 3 months through year 2 after treatment. Median scores and interquartile ranges were calculated for baseline, 3 months post-radiation completion, and 2 years post-treatment. 3 months post-RT was selected to coincide with the primary outcome timeframe. Year 2 was selected due to the number of patients that reached this point during follow up; most patients did not surpass year 2. Higher score means worse outcome for questions regarding diarrhea, urinary frequency \& burning, and being bothered by treatment. Higher score means better outcome for questions regarding being content with quality of life and control over bowels.
Outcome measures
| Measure |
Avelumab and Bladder-Directed Radiation
n=13 Participants
* Avelumab will be administered every 2 weeks intravenously for 6 doses unless there is unacceptable toxicity
* Two radiation dose regimens are allowed, and the regimen selected is at the discretion of the treating radiation oncologist
|
|---|---|
|
Change in Quality of Life Outcomes
3 months post-RT Median Score "I am bothered by side effects of treatment"
|
0 score on a scale
Interval 0.0 to 0.0
|
|
Change in Quality of Life Outcomes
3 months post-RT Median Score "It burns when I urinate"
|
0 score on a scale
Interval 0.0 to 0.0
|
|
Change in Quality of Life Outcomes
2 Year Median Score "I urinate more frequently than usual"
|
0 score on a scale
Interval 0.0 to 2.65625
|
|
Change in Quality of Life Outcomes
Baseline Median Score "I am bothered by side effects of treatment"
|
0 score on a scale
Interval 0.0 to 0.0
|
|
Change in Quality of Life Outcomes
Baseline Median Score "I am content with the quality of my life right now"
|
2 score on a scale
Interval 2.0 to 3.0
|
|
Change in Quality of Life Outcomes
Baseline Median Score "I have control of my bowels"
|
3 score on a scale
Interval 2.0 to 4.0
|
|
Change in Quality of Life Outcomes
Baseline Median Score "I urinate more frequently than usual"
|
2.5 score on a scale
Interval 1.75 to 3.25
|
|
Change in Quality of Life Outcomes
Basline Median Score "I have diarrhea"
|
0 score on a scale
Interval 0.0 to 0.0
|
|
Change in Quality of Life Outcomes
Baseline Median Score "It burns when I urinate"
|
0 score on a scale
Interval 0.0 to 1.0
|
|
Change in Quality of Life Outcomes
3 months post-RT "I am content with the quality of my life right now"
|
3 score on a scale
Interval 2.0 to 3.0
|
|
Change in Quality of Life Outcomes
3 months post-RT Median Score "I have control of my bowels"
|
1.5 score on a scale
Interval 1.25 to 3.0
|
|
Change in Quality of Life Outcomes
3 months post-RT Median Score "I urinate more frequently than usual"
|
2 score on a scale
Interval 1.8125 to 2.875
|
|
Change in Quality of Life Outcomes
3 months post-RT Median Score "I have diarrhea"
|
0.5 score on a scale
Interval 0.0 to 1.75
|
|
Change in Quality of Life Outcomes
2 Year Median Score "I am bothered by side effects of treatment"
|
0 score on a scale
Interval 0.0 to 0.0
|
|
Change in Quality of Life Outcomes
2 Year Median Score "I am content with the quality of my life right now"
|
3 score on a scale
Interval 3.0 to 4.0
|
|
Change in Quality of Life Outcomes
2 Year Median Score "I have control of my bowels"
|
3 score on a scale
Interval 1.3125 to 3.0
|
|
Change in Quality of Life Outcomes
2 Year Median Score "I have diarrhea"
|
0 score on a scale
Interval 0.0 to 1.4375
|
|
Change in Quality of Life Outcomes
2 Year Median Score "It burns when I urinate"
|
0 score on a scale
Interval 0.0 to 0.0
|
Adverse Events
Avelumab and Bladder-Directed Radiation
Serious events: 4 serious events
Other events: 14 other events
Deaths: 7 deaths
Serious adverse events
| Measure |
Avelumab and Bladder-Directed Radiation
n=14 participants at risk
* Avelumab will be administered every 2 weeks intravenously for 6 doses unless there is unacceptable toxicity
* Two radiation dose regimens are allowed, and the regimen selected is at the discretion of the treating radiation oncologist
|
|---|---|
|
Investigations
Aspartate aminotransferase increased
|
7.1%
1/14 • Number of events 1 • Baseline; every 2 weeks during Avelumab treatment; 30 post-completion of Avelumab treatment; 3 months post-completion of radiation; then every 3 months until 2 years post-treatment; then every 6 months during years 3-5 post-treatment
Assessed by research nurses, medical oncologists, physician assistants, nurse practitioners
|
|
Investigations
Alkaline phosphatase increased
|
7.1%
1/14 • Number of events 1 • Baseline; every 2 weeks during Avelumab treatment; 30 post-completion of Avelumab treatment; 3 months post-completion of radiation; then every 3 months until 2 years post-treatment; then every 6 months during years 3-5 post-treatment
Assessed by research nurses, medical oncologists, physician assistants, nurse practitioners
|
|
Investigations
Creatinine increased
|
7.1%
1/14 • Number of events 1 • Baseline; every 2 weeks during Avelumab treatment; 30 post-completion of Avelumab treatment; 3 months post-completion of radiation; then every 3 months until 2 years post-treatment; then every 6 months during years 3-5 post-treatment
Assessed by research nurses, medical oncologists, physician assistants, nurse practitioners
|
|
General disorders
Fatigue
|
7.1%
1/14 • Number of events 1 • Baseline; every 2 weeks during Avelumab treatment; 30 post-completion of Avelumab treatment; 3 months post-completion of radiation; then every 3 months until 2 years post-treatment; then every 6 months during years 3-5 post-treatment
Assessed by research nurses, medical oncologists, physician assistants, nurse practitioners
|
|
Cardiac disorders
Atrial Fibrillation
|
7.1%
1/14 • Number of events 1 • Baseline; every 2 weeks during Avelumab treatment; 30 post-completion of Avelumab treatment; 3 months post-completion of radiation; then every 3 months until 2 years post-treatment; then every 6 months during years 3-5 post-treatment
Assessed by research nurses, medical oncologists, physician assistants, nurse practitioners
|
|
Vascular disorders
Hypotension
|
7.1%
1/14 • Number of events 1 • Baseline; every 2 weeks during Avelumab treatment; 30 post-completion of Avelumab treatment; 3 months post-completion of radiation; then every 3 months until 2 years post-treatment; then every 6 months during years 3-5 post-treatment
Assessed by research nurses, medical oncologists, physician assistants, nurse practitioners
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
7.1%
1/14 • Number of events 1 • Baseline; every 2 weeks during Avelumab treatment; 30 post-completion of Avelumab treatment; 3 months post-completion of radiation; then every 3 months until 2 years post-treatment; then every 6 months during years 3-5 post-treatment
Assessed by research nurses, medical oncologists, physician assistants, nurse practitioners
|
|
Metabolism and nutrition disorders
Hyponatremia
|
7.1%
1/14 • Number of events 1 • Baseline; every 2 weeks during Avelumab treatment; 30 post-completion of Avelumab treatment; 3 months post-completion of radiation; then every 3 months until 2 years post-treatment; then every 6 months during years 3-5 post-treatment
Assessed by research nurses, medical oncologists, physician assistants, nurse practitioners
|
|
Infections and infestations
Lung infection
|
7.1%
1/14 • Number of events 1 • Baseline; every 2 weeks during Avelumab treatment; 30 post-completion of Avelumab treatment; 3 months post-completion of radiation; then every 3 months until 2 years post-treatment; then every 6 months during years 3-5 post-treatment
Assessed by research nurses, medical oncologists, physician assistants, nurse practitioners
|
Other adverse events
| Measure |
Avelumab and Bladder-Directed Radiation
n=14 participants at risk
* Avelumab will be administered every 2 weeks intravenously for 6 doses unless there is unacceptable toxicity
* Two radiation dose regimens are allowed, and the regimen selected is at the discretion of the treating radiation oncologist
|
|---|---|
|
Blood and lymphatic system disorders
Anemia
|
14.3%
2/14 • Number of events 2 • Baseline; every 2 weeks during Avelumab treatment; 30 post-completion of Avelumab treatment; 3 months post-completion of radiation; then every 3 months until 2 years post-treatment; then every 6 months during years 3-5 post-treatment
Assessed by research nurses, medical oncologists, physician assistants, nurse practitioners
|
|
Blood and lymphatic system disorders
Leukocytosis
|
7.1%
1/14 • Number of events 1 • Baseline; every 2 weeks during Avelumab treatment; 30 post-completion of Avelumab treatment; 3 months post-completion of radiation; then every 3 months until 2 years post-treatment; then every 6 months during years 3-5 post-treatment
Assessed by research nurses, medical oncologists, physician assistants, nurse practitioners
|
|
Blood and lymphatic system disorders
Thrombotic thrombocytopenic purpura
|
7.1%
1/14 • Number of events 1 • Baseline; every 2 weeks during Avelumab treatment; 30 post-completion of Avelumab treatment; 3 months post-completion of radiation; then every 3 months until 2 years post-treatment; then every 6 months during years 3-5 post-treatment
Assessed by research nurses, medical oncologists, physician assistants, nurse practitioners
|
|
Endocrine disorders
Hyperthyroidism
|
7.1%
1/14 • Number of events 1 • Baseline; every 2 weeks during Avelumab treatment; 30 post-completion of Avelumab treatment; 3 months post-completion of radiation; then every 3 months until 2 years post-treatment; then every 6 months during years 3-5 post-treatment
Assessed by research nurses, medical oncologists, physician assistants, nurse practitioners
|
|
Endocrine disorders
Hypothyroidism
|
21.4%
3/14 • Number of events 3 • Baseline; every 2 weeks during Avelumab treatment; 30 post-completion of Avelumab treatment; 3 months post-completion of radiation; then every 3 months until 2 years post-treatment; then every 6 months during years 3-5 post-treatment
Assessed by research nurses, medical oncologists, physician assistants, nurse practitioners
|
|
Gastrointestinal disorders
Abdominal pain
|
7.1%
1/14 • Number of events 1 • Baseline; every 2 weeks during Avelumab treatment; 30 post-completion of Avelumab treatment; 3 months post-completion of radiation; then every 3 months until 2 years post-treatment; then every 6 months during years 3-5 post-treatment
Assessed by research nurses, medical oncologists, physician assistants, nurse practitioners
|
|
Gastrointestinal disorders
Diarrhea
|
50.0%
7/14 • Number of events 7 • Baseline; every 2 weeks during Avelumab treatment; 30 post-completion of Avelumab treatment; 3 months post-completion of radiation; then every 3 months until 2 years post-treatment; then every 6 months during years 3-5 post-treatment
Assessed by research nurses, medical oncologists, physician assistants, nurse practitioners
|
|
Gastrointestinal disorders
Nausea
|
7.1%
1/14 • Number of events 1 • Baseline; every 2 weeks during Avelumab treatment; 30 post-completion of Avelumab treatment; 3 months post-completion of radiation; then every 3 months until 2 years post-treatment; then every 6 months during years 3-5 post-treatment
Assessed by research nurses, medical oncologists, physician assistants, nurse practitioners
|
|
Gastrointestinal disorders
Rectal hemorrhage
|
7.1%
1/14 • Number of events 1 • Baseline; every 2 weeks during Avelumab treatment; 30 post-completion of Avelumab treatment; 3 months post-completion of radiation; then every 3 months until 2 years post-treatment; then every 6 months during years 3-5 post-treatment
Assessed by research nurses, medical oncologists, physician assistants, nurse practitioners
|
|
Gastrointestinal disorders
Vomiting
|
7.1%
1/14 • Number of events 1 • Baseline; every 2 weeks during Avelumab treatment; 30 post-completion of Avelumab treatment; 3 months post-completion of radiation; then every 3 months until 2 years post-treatment; then every 6 months during years 3-5 post-treatment
Assessed by research nurses, medical oncologists, physician assistants, nurse practitioners
|
|
General disorders
Edema limbs
|
14.3%
2/14 • Number of events 2 • Baseline; every 2 weeks during Avelumab treatment; 30 post-completion of Avelumab treatment; 3 months post-completion of radiation; then every 3 months until 2 years post-treatment; then every 6 months during years 3-5 post-treatment
Assessed by research nurses, medical oncologists, physician assistants, nurse practitioners
|
|
General disorders
Fatigue
|
42.9%
6/14 • Number of events 6 • Baseline; every 2 weeks during Avelumab treatment; 30 post-completion of Avelumab treatment; 3 months post-completion of radiation; then every 3 months until 2 years post-treatment; then every 6 months during years 3-5 post-treatment
Assessed by research nurses, medical oncologists, physician assistants, nurse practitioners
|
|
General disorders
Fever
|
7.1%
1/14 • Number of events 1 • Baseline; every 2 weeks during Avelumab treatment; 30 post-completion of Avelumab treatment; 3 months post-completion of radiation; then every 3 months until 2 years post-treatment; then every 6 months during years 3-5 post-treatment
Assessed by research nurses, medical oncologists, physician assistants, nurse practitioners
|
|
General disorders
Infusion related reaction
|
21.4%
3/14 • Number of events 3 • Baseline; every 2 weeks during Avelumab treatment; 30 post-completion of Avelumab treatment; 3 months post-completion of radiation; then every 3 months until 2 years post-treatment; then every 6 months during years 3-5 post-treatment
Assessed by research nurses, medical oncologists, physician assistants, nurse practitioners
|
|
Infections and infestations
Urinary tract infection
|
21.4%
3/14 • Number of events 3 • Baseline; every 2 weeks during Avelumab treatment; 30 post-completion of Avelumab treatment; 3 months post-completion of radiation; then every 3 months until 2 years post-treatment; then every 6 months during years 3-5 post-treatment
Assessed by research nurses, medical oncologists, physician assistants, nurse practitioners
|
|
Investigations
Alanine aminotransferase increased
|
14.3%
2/14 • Number of events 2 • Baseline; every 2 weeks during Avelumab treatment; 30 post-completion of Avelumab treatment; 3 months post-completion of radiation; then every 3 months until 2 years post-treatment; then every 6 months during years 3-5 post-treatment
Assessed by research nurses, medical oncologists, physician assistants, nurse practitioners
|
|
Investigations
Alkaline phosphatase increased
|
14.3%
2/14 • Number of events 2 • Baseline; every 2 weeks during Avelumab treatment; 30 post-completion of Avelumab treatment; 3 months post-completion of radiation; then every 3 months until 2 years post-treatment; then every 6 months during years 3-5 post-treatment
Assessed by research nurses, medical oncologists, physician assistants, nurse practitioners
|
|
Investigations
Aspartate aminotransferase increased
|
7.1%
1/14 • Number of events 1 • Baseline; every 2 weeks during Avelumab treatment; 30 post-completion of Avelumab treatment; 3 months post-completion of radiation; then every 3 months until 2 years post-treatment; then every 6 months during years 3-5 post-treatment
Assessed by research nurses, medical oncologists, physician assistants, nurse practitioners
|
|
Investigations
Blood bilirubin increased
|
7.1%
1/14 • Number of events 1 • Baseline; every 2 weeks during Avelumab treatment; 30 post-completion of Avelumab treatment; 3 months post-completion of radiation; then every 3 months until 2 years post-treatment; then every 6 months during years 3-5 post-treatment
Assessed by research nurses, medical oncologists, physician assistants, nurse practitioners
|
|
Investigations
Creatinine increased
|
14.3%
2/14 • Number of events 2 • Baseline; every 2 weeks during Avelumab treatment; 30 post-completion of Avelumab treatment; 3 months post-completion of radiation; then every 3 months until 2 years post-treatment; then every 6 months during years 3-5 post-treatment
Assessed by research nurses, medical oncologists, physician assistants, nurse practitioners
|
|
Investigations
Lymphocyte count decreased
|
28.6%
4/14 • Number of events 4 • Baseline; every 2 weeks during Avelumab treatment; 30 post-completion of Avelumab treatment; 3 months post-completion of radiation; then every 3 months until 2 years post-treatment; then every 6 months during years 3-5 post-treatment
Assessed by research nurses, medical oncologists, physician assistants, nurse practitioners
|
|
Investigations
Neutrophil count decreased
|
7.1%
1/14 • Number of events 1 • Baseline; every 2 weeks during Avelumab treatment; 30 post-completion of Avelumab treatment; 3 months post-completion of radiation; then every 3 months until 2 years post-treatment; then every 6 months during years 3-5 post-treatment
Assessed by research nurses, medical oncologists, physician assistants, nurse practitioners
|
|
Investigations
Platelet count decreased
|
14.3%
2/14 • Number of events 2 • Baseline; every 2 weeks during Avelumab treatment; 30 post-completion of Avelumab treatment; 3 months post-completion of radiation; then every 3 months until 2 years post-treatment; then every 6 months during years 3-5 post-treatment
Assessed by research nurses, medical oncologists, physician assistants, nurse practitioners
|
|
Investigations
Weight loss
|
14.3%
2/14 • Number of events 2 • Baseline; every 2 weeks during Avelumab treatment; 30 post-completion of Avelumab treatment; 3 months post-completion of radiation; then every 3 months until 2 years post-treatment; then every 6 months during years 3-5 post-treatment
Assessed by research nurses, medical oncologists, physician assistants, nurse practitioners
|
|
Investigations
White blood cell decreased
|
7.1%
1/14 • Number of events 1 • Baseline; every 2 weeks during Avelumab treatment; 30 post-completion of Avelumab treatment; 3 months post-completion of radiation; then every 3 months until 2 years post-treatment; then every 6 months during years 3-5 post-treatment
Assessed by research nurses, medical oncologists, physician assistants, nurse practitioners
|
|
Metabolism and nutrition disorders
Anorexia
|
14.3%
2/14 • Number of events 2 • Baseline; every 2 weeks during Avelumab treatment; 30 post-completion of Avelumab treatment; 3 months post-completion of radiation; then every 3 months until 2 years post-treatment; then every 6 months during years 3-5 post-treatment
Assessed by research nurses, medical oncologists, physician assistants, nurse practitioners
|
|
Metabolism and nutrition disorders
Dehydration
|
7.1%
1/14 • Number of events 1 • Baseline; every 2 weeks during Avelumab treatment; 30 post-completion of Avelumab treatment; 3 months post-completion of radiation; then every 3 months until 2 years post-treatment; then every 6 months during years 3-5 post-treatment
Assessed by research nurses, medical oncologists, physician assistants, nurse practitioners
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
7.1%
1/14 • Number of events 1 • Baseline; every 2 weeks during Avelumab treatment; 30 post-completion of Avelumab treatment; 3 months post-completion of radiation; then every 3 months until 2 years post-treatment; then every 6 months during years 3-5 post-treatment
Assessed by research nurses, medical oncologists, physician assistants, nurse practitioners
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
7.1%
1/14 • Number of events 1 • Baseline; every 2 weeks during Avelumab treatment; 30 post-completion of Avelumab treatment; 3 months post-completion of radiation; then every 3 months until 2 years post-treatment; then every 6 months during years 3-5 post-treatment
Assessed by research nurses, medical oncologists, physician assistants, nurse practitioners
|
|
Metabolism and nutrition disorders
Hypokalemia
|
14.3%
2/14 • Number of events 2 • Baseline; every 2 weeks during Avelumab treatment; 30 post-completion of Avelumab treatment; 3 months post-completion of radiation; then every 3 months until 2 years post-treatment; then every 6 months during years 3-5 post-treatment
Assessed by research nurses, medical oncologists, physician assistants, nurse practitioners
|
|
Metabolism and nutrition disorders
Hyponatremia
|
7.1%
1/14 • Number of events 1 • Baseline; every 2 weeks during Avelumab treatment; 30 post-completion of Avelumab treatment; 3 months post-completion of radiation; then every 3 months until 2 years post-treatment; then every 6 months during years 3-5 post-treatment
Assessed by research nurses, medical oncologists, physician assistants, nurse practitioners
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
7.1%
1/14 • Number of events 1 • Baseline; every 2 weeks during Avelumab treatment; 30 post-completion of Avelumab treatment; 3 months post-completion of radiation; then every 3 months until 2 years post-treatment; then every 6 months during years 3-5 post-treatment
Assessed by research nurses, medical oncologists, physician assistants, nurse practitioners
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
7.1%
1/14 • Number of events 1 • Baseline; every 2 weeks during Avelumab treatment; 30 post-completion of Avelumab treatment; 3 months post-completion of radiation; then every 3 months until 2 years post-treatment; then every 6 months during years 3-5 post-treatment
Assessed by research nurses, medical oncologists, physician assistants, nurse practitioners
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
7.1%
1/14 • Number of events 1 • Baseline; every 2 weeks during Avelumab treatment; 30 post-completion of Avelumab treatment; 3 months post-completion of radiation; then every 3 months until 2 years post-treatment; then every 6 months during years 3-5 post-treatment
Assessed by research nurses, medical oncologists, physician assistants, nurse practitioners
|
|
Nervous system disorders
Dizziness
|
7.1%
1/14 • Number of events 1 • Baseline; every 2 weeks during Avelumab treatment; 30 post-completion of Avelumab treatment; 3 months post-completion of radiation; then every 3 months until 2 years post-treatment; then every 6 months during years 3-5 post-treatment
Assessed by research nurses, medical oncologists, physician assistants, nurse practitioners
|
|
Nervous system disorders
Dysgeusia
|
7.1%
1/14 • Number of events 1 • Baseline; every 2 weeks during Avelumab treatment; 30 post-completion of Avelumab treatment; 3 months post-completion of radiation; then every 3 months until 2 years post-treatment; then every 6 months during years 3-5 post-treatment
Assessed by research nurses, medical oncologists, physician assistants, nurse practitioners
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
7.1%
1/14 • Number of events 1 • Baseline; every 2 weeks during Avelumab treatment; 30 post-completion of Avelumab treatment; 3 months post-completion of radiation; then every 3 months until 2 years post-treatment; then every 6 months during years 3-5 post-treatment
Assessed by research nurses, medical oncologists, physician assistants, nurse practitioners
|
|
Psychiatric disorders
Confusion
|
14.3%
2/14 • Number of events 2 • Baseline; every 2 weeks during Avelumab treatment; 30 post-completion of Avelumab treatment; 3 months post-completion of radiation; then every 3 months until 2 years post-treatment; then every 6 months during years 3-5 post-treatment
Assessed by research nurses, medical oncologists, physician assistants, nurse practitioners
|
|
Renal and urinary disorders
Acute kidney injury
|
7.1%
1/14 • Number of events 1 • Baseline; every 2 weeks during Avelumab treatment; 30 post-completion of Avelumab treatment; 3 months post-completion of radiation; then every 3 months until 2 years post-treatment; then every 6 months during years 3-5 post-treatment
Assessed by research nurses, medical oncologists, physician assistants, nurse practitioners
|
|
Renal and urinary disorders
Chronic kidney disease
|
7.1%
1/14 • Number of events 1 • Baseline; every 2 weeks during Avelumab treatment; 30 post-completion of Avelumab treatment; 3 months post-completion of radiation; then every 3 months until 2 years post-treatment; then every 6 months during years 3-5 post-treatment
Assessed by research nurses, medical oncologists, physician assistants, nurse practitioners
|
|
Renal and urinary disorders
Cystitis noninfective
|
14.3%
2/14 • Number of events 2 • Baseline; every 2 weeks during Avelumab treatment; 30 post-completion of Avelumab treatment; 3 months post-completion of radiation; then every 3 months until 2 years post-treatment; then every 6 months during years 3-5 post-treatment
Assessed by research nurses, medical oncologists, physician assistants, nurse practitioners
|
|
Renal and urinary disorders
Hematuria
|
42.9%
6/14 • Number of events 6 • Baseline; every 2 weeks during Avelumab treatment; 30 post-completion of Avelumab treatment; 3 months post-completion of radiation; then every 3 months until 2 years post-treatment; then every 6 months during years 3-5 post-treatment
Assessed by research nurses, medical oncologists, physician assistants, nurse practitioners
|
|
Renal and urinary disorders
Dysuria
|
7.1%
1/14 • Number of events 1 • Baseline; every 2 weeks during Avelumab treatment; 30 post-completion of Avelumab treatment; 3 months post-completion of radiation; then every 3 months until 2 years post-treatment; then every 6 months during years 3-5 post-treatment
Assessed by research nurses, medical oncologists, physician assistants, nurse practitioners
|
|
Renal and urinary disorders
Urinary frequency
|
14.3%
2/14 • Number of events 2 • Baseline; every 2 weeks during Avelumab treatment; 30 post-completion of Avelumab treatment; 3 months post-completion of radiation; then every 3 months until 2 years post-treatment; then every 6 months during years 3-5 post-treatment
Assessed by research nurses, medical oncologists, physician assistants, nurse practitioners
|
|
Renal and urinary disorders
Urinary incontinence
|
7.1%
1/14 • Number of events 1 • Baseline; every 2 weeks during Avelumab treatment; 30 post-completion of Avelumab treatment; 3 months post-completion of radiation; then every 3 months until 2 years post-treatment; then every 6 months during years 3-5 post-treatment
Assessed by research nurses, medical oncologists, physician assistants, nurse practitioners
|
|
Renal and urinary disorders
Urinary urgency
|
7.1%
1/14 • Number of events 1 • Baseline; every 2 weeks during Avelumab treatment; 30 post-completion of Avelumab treatment; 3 months post-completion of radiation; then every 3 months until 2 years post-treatment; then every 6 months during years 3-5 post-treatment
Assessed by research nurses, medical oncologists, physician assistants, nurse practitioners
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
14.3%
2/14 • Number of events 2 • Baseline; every 2 weeks during Avelumab treatment; 30 post-completion of Avelumab treatment; 3 months post-completion of radiation; then every 3 months until 2 years post-treatment; then every 6 months during years 3-5 post-treatment
Assessed by research nurses, medical oncologists, physician assistants, nurse practitioners
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
7.1%
1/14 • Number of events 1 • Baseline; every 2 weeks during Avelumab treatment; 30 post-completion of Avelumab treatment; 3 months post-completion of radiation; then every 3 months until 2 years post-treatment; then every 6 months during years 3-5 post-treatment
Assessed by research nurses, medical oncologists, physician assistants, nurse practitioners
|
|
Skin and subcutaneous tissue disorders
Actinic Keratosis
|
7.1%
1/14 • Number of events 1 • Baseline; every 2 weeks during Avelumab treatment; 30 post-completion of Avelumab treatment; 3 months post-completion of radiation; then every 3 months until 2 years post-treatment; then every 6 months during years 3-5 post-treatment
Assessed by research nurses, medical oncologists, physician assistants, nurse practitioners
|
|
Vascular disorders
Thromboembolic event
|
7.1%
1/14 • Number of events 1 • Baseline; every 2 weeks during Avelumab treatment; 30 post-completion of Avelumab treatment; 3 months post-completion of radiation; then every 3 months until 2 years post-treatment; then every 6 months during years 3-5 post-treatment
Assessed by research nurses, medical oncologists, physician assistants, nurse practitioners
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place