NCT03617913 · STUDY IN CONTEXT
Avelumab in Combination With Fluorouracil and Mitomycin or Cisplatin and Radiation Therapy in Treating Participants With Muscle-Invasive Bladder Cancer
Draft scope assessment: narrower. Linked by condition-string match at the cancer-entity level. The study's eligibility - stage, biomarker, treatment line and prior therapy - has not been reconciled against this page's definition, so its population is narrower than this page in ways not yet recorded. The condition was transformed or resolved through the terminology hierarchy to reach this cancer type, so the link itself is a candidate a reviewer must confirm. Found by searching ClinicalTrials.gov for this cancer type, restricted to studies that have posted results to the registry. No FDA notice, FDA label or NCI summary held by this site cites this study. Because the search asked for posted results, studies without posted results were never looked for, so their absence from this page means nothing.
Read the full study record and all posted results →
Linked outcomes
Patients enrolled will have non-measurable disease based on imaging at baseline. Patients will be assessed for a response after 6 months of treatment using the results of a biopsy and cytology test. A complete response (CR) is defined as having a negative biopsy and negative urine cytology at 6 months from registration after finishing of concurrent RT and immunotherapy. Imaging of abdomen and pelvis confirming no systemic disease within 4 weeks of cystoscopy will be completed. The proportion of patients reporting a CR is reported here with confidence intervals for the true success proportion using the binomial distribution.
The maximum grade for each type of adverse event will be recorded for each patient, and frequency tables will be reviewed to determine patterns. The number of patients reporting a grade 3+ adverse event regardless of attribution is reported here.
EORTC QLQ-C30 is a 30-item patient-reported questionnaire. 28 of the 30 items are measured on a 1-4 scale (1=not at all; 4=very much) with the remaining two items (overall health and overall quality of life) scored on a 1-7 numeric analogue scale (1=very poor; 7=excellent). The recall period for the EORTC QLQ-C30 is one week. Changes from baseline will be statistically tested using paired t-tests, and standardized response means (mean of the change from baseline scores at a given cycle, divided by the standard deviation of the change scores) will be interpreted (after applying Middel's (2002) adjustment) using Cohen's (1988) cut-offs: \<0.20 = trivial; 0.20-\<0.50 = small; 0.50-\<0.80 = moderate; and \>=/0.80 = large. Correlation between outcomes will employ Pearson and/or Spearman correlations at individual time points.
EORTC QLQ-BLM30 is a 30-item questionnaire for patients with muscle invasive bladder cancer (T2, T3, T4a and T4b). The muscle-invasive bladder cancer module contains additional items assessing urostomy problems, problems associated with the use of a catheter, and body image. Changes from baseline will be statistically tested using paired t-tests, and standardized response means (mean of the change from baseline scores at a given cycle, divided by the standard deviation of the change scores) will be interpreted (after applying Middel's (2002) adjustment) using Cohen's (1988) cut-offs: \<0.20 = trivial; 0.20-\<0.50 = small; 0.50-\<0.80 = moderate; and \>=/0.80 = large. Correlation between outcomes will employ Pearson and/or Spearman correlations at individual time points.
Progression-free survival is defined as the time from registration to the time of progression or death. This study will not use RECIST criteria to evaluate response or progression. The patients enrolled will have non-measurable disease on imaging and response will be evaluated with biopsy or cytology. Progression is defined as progression in T stage, N stage or M stage both clinically or radiologically. Histological confirmation of metastatic disease is at the discretion of the treating provider. The median time will be estimated using the method of Kaplan-Meier.
Recurrence-free survival is defined as the time from registration to the time of recurrence or death. Recurrence is defined as having histologically proven first appearance of muscle invasive bladder cancer, clinical evidence of metastatic disease, or treatment with radical cystectomy or radiation to the bladder, or death due to any cause after they were confirmed remission at 6 month evaluation. The median time will be estimated using the method of Kaplan-Meier.
Reported safety
Quality of life and patient-reported measures
EORTC QLQ · Patient-reported Outcomes (European Organization for Research and Treatment of Cancer [EORTC] Quality of Life Questionnaire [QLQ]-30
Score direction: Not stated by the study. Direction is never inferred from an instrument name.
- release id
- clinical-indications-draft-1
- disease state id
- ds-urethral-cancer
- nct id
- NCT03617913
- qol key
- qol-0002
- source section id
- NCT03617913-om-0002
- source outcome index
- 2
- instrument
- EORTC QLQ
- instrument basis
- matched 'eortc' in the study's own wording
- scale title
- Patient-reported Outcomes (European Organization for Research and Treatment of Cancer [EORTC] Quality of Life Questionnaire [QLQ]-30
- measure definition
- EORTC QLQ-C30 is a 30-item patient-reported questionnaire. 28 of the 30 items are measured on a 1-4 scale (1=not at all; 4=very much) with the remaining two items (overall health and overall quality of life) scored on a 1-7 numeric analogue scale (1=very poor; 7=excellent). The recall period for the EORTC QLQ-C30 is one week. Changes from baseline will be statistically tested using paired t-tests, and standardized response means (mean of the change from baseline scores at a given cycle, divided by the standard deviation of the change scores) will be interpreted (after applying Middel's (2002) adjustment) using Cohen's (1988) cut-offs: \<0.20 = trivial; 0.20-\<0.50 = small; 0.50-\<0.80 = moderate; and \>=/0.80 = large. Correlation between outcomes will employ Pearson and/or Spearman correlations at individual time points.
- time frame
- Baseline to 12 months
- analysis role
- secondary
- reporting status
- POSTED
- higher is better
- Source null
- direction quote
- Source null
- population note
- All patients who were registered, treated, and completed the EORTC QLQ assessment at baseline and post-therapy were included in this analysis
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
EORTC QLQ · Patient-reported Outcomes (European Organization for Research and Treatment of Cancer [EORTC] EORTCQOL-Muscle-Invasive Bladder Cancer Module [BLM]30
Score direction: Not stated by the study. Direction is never inferred from an instrument name.
- release id
- clinical-indications-draft-1
- disease state id
- ds-urethral-cancer
- nct id
- NCT03617913
- qol key
- qol-0003
- source section id
- NCT03617913-om-0003
- source outcome index
- 3
- instrument
- EORTC QLQ
- instrument basis
- matched 'eortc' in the study's own wording
- scale title
- Patient-reported Outcomes (European Organization for Research and Treatment of Cancer [EORTC] EORTCQOL-Muscle-Invasive Bladder Cancer Module [BLM]30
- measure definition
- EORTC QLQ-BLM30 is a 30-item questionnaire for patients with muscle invasive bladder cancer (T2, T3, T4a and T4b). The muscle-invasive bladder cancer module contains additional items assessing urostomy problems, problems associated with the use of a catheter, and body image. Changes from baseline will be statistically tested using paired t-tests, and standardized response means (mean of the change from baseline scores at a given cycle, divided by the standard deviation of the change scores) will be interpreted (after applying Middel's (2002) adjustment) using Cohen's (1988) cut-offs: \<0.20 = trivial; 0.20-\<0.50 = small; 0.50-\<0.80 = moderate; and \>=/0.80 = large. Correlation between outcomes will employ Pearson and/or Spearman correlations at individual time points.
- time frame
- Baseline to 12 months
- analysis role
- secondary
- reporting status
- POSTED
- higher is better
- Source null
- direction quote
- Source null
- population note
- All patients who were registered, treated, and completed the EORTC QLQ assessment at baseline and post-therapy were included in this analysis.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
Full draft applicability and source-link record
- trial
- release id
- clinical-indications-draft-1
- disease state id
- ds-urethral-cancer
- nct id
- NCT03617913
- trial label
- Avelumab in Combination With Fluorouracil and Mitomycin or Cisplatin and Radiation Therapy in Treating Participants With Muscle-Invasive Bladder Cancer
- applicability
- narrower
- applicability note
- Linked by condition-string match at the cancer-entity level. The study's eligibility - stage, biomarker, treatment line and prior therapy - has not been reconciled against this page's definition, so its population is narrower than this page in ways not yet recorded. The condition was transformed or resolved through the terminology hierarchy to reach this cancer type, so the link itself is a candidate a reviewer must confirm.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- provenance class
- registry-condition-search
- discovery note
- Found by searching ClinicalTrials.gov for this cancer type, restricted to studies that have posted results to the registry. No FDA notice, FDA label or NCI summary held by this site cites this study. Because the search asked for posted results, studies without posted results were never looked for, so their absence from this page means nothing.
- outcome Count
- 6
- harms Count
- 1
- qol Count
- 2
- outcomes
- release id
- clinical-indications-draft-1
- disease state id
- ds-urethral-cancer
- nct id
- NCT03617913
- outcome key
- om-0000
- source section id
- NCT03617913-om-0000
- source outcome index
- 0
- endpoint
- Proportion of Participants With Complete Response (At 6 Months)
- endpoint definition
- Patients enrolled will have non-measurable disease based on imaging at baseline. Patients will be assessed for a response after 6 months of treatment using the results of a biopsy and cytology test. A complete response (CR) is defined as having a negative biopsy and negative urine cytology at 6 months from registration after finishing of concurrent RT and immunotherapy. Imaging of abdomen and pelvis confirming no systemic disease within 4 weeks of cystoscopy will be completed. The proportion of patients reporting a CR is reported here with confidence intervals for the true success proportion using the binomial distribution.
- time origin
- At 6 months from registration
- analysis role
- primary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- All patients who registered and began protocol treatment are included in this analysis.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-urethral-cancer
- nct id
- NCT03617913
- outcome key
- om-0001
- source section id
- NCT03617913-om-0001
- source outcome index
- 1
- endpoint
- Adverse Events Per National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE v5.0)
- endpoint definition
- The maximum grade for each type of adverse event will be recorded for each patient, and frequency tables will be reviewed to determine patterns. The number of patients reporting a grade 3+ adverse event regardless of attribution is reported here.
- time origin
- Up to 12 months
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- All patients who were registered, received protocol treatment, and were assessed for adverse events were included in this analysis.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-urethral-cancer
- nct id
- NCT03617913
- outcome key
- om-0002
- source section id
- NCT03617913-om-0002
- source outcome index
- 2
- endpoint
- Patient-reported Outcomes (European Organization for Research and Treatment of Cancer [EORTC] Quality of Life Questionnaire [QLQ]-30
- endpoint definition
- EORTC QLQ-C30 is a 30-item patient-reported questionnaire. 28 of the 30 items are measured on a 1-4 scale (1=not at all; 4=very much) with the remaining two items (overall health and overall quality of life) scored on a 1-7 numeric analogue scale (1=very poor; 7=excellent). The recall period for the EORTC QLQ-C30 is one week. Changes from baseline will be statistically tested using paired t-tests, and standardized response means (mean of the change from baseline scores at a given cycle, divided by the standard deviation of the change scores) will be interpreted (after applying Middel's (2002) adjustment) using Cohen's (1988) cut-offs: \<0.20 = trivial; 0.20-\<0.50 = small; 0.50-\<0.80 = moderate; and \>=/0.80 = large. Correlation between outcomes will employ Pearson and/or Spearman correlations at individual time points.
- time origin
- Baseline to 12 months
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- All patients who were registered, treated, and completed the EORTC QLQ assessment at baseline and post-therapy were included in this analysis
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-urethral-cancer
- nct id
- NCT03617913
- outcome key
- om-0003
- source section id
- NCT03617913-om-0003
- source outcome index
- 3
- endpoint
- Patient-reported Outcomes (European Organization for Research and Treatment of Cancer [EORTC] EORTCQOL-Muscle-Invasive Bladder Cancer Module [BLM]30
- endpoint definition
- EORTC QLQ-BLM30 is a 30-item questionnaire for patients with muscle invasive bladder cancer (T2, T3, T4a and T4b). The muscle-invasive bladder cancer module contains additional items assessing urostomy problems, problems associated with the use of a catheter, and body image. Changes from baseline will be statistically tested using paired t-tests, and standardized response means (mean of the change from baseline scores at a given cycle, divided by the standard deviation of the change scores) will be interpreted (after applying Middel's (2002) adjustment) using Cohen's (1988) cut-offs: \<0.20 = trivial; 0.20-\<0.50 = small; 0.50-\<0.80 = moderate; and \>=/0.80 = large. Correlation between outcomes will employ Pearson and/or Spearman correlations at individual time points.
- time origin
- Baseline to 12 months
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- All patients who were registered, treated, and completed the EORTC QLQ assessment at baseline and post-therapy were included in this analysis.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-urethral-cancer
- nct id
- NCT03617913
- outcome key
- om-0004
- source section id
- NCT03617913-om-0004
- source outcome index
- 4
- endpoint
- Progression-free Survival
- endpoint definition
- Progression-free survival is defined as the time from registration to the time of progression or death. This study will not use RECIST criteria to evaluate response or progression. The patients enrolled will have non-measurable disease on imaging and response will be evaluated with biopsy or cytology. Progression is defined as progression in T stage, N stage or M stage both clinically or radiologically. Histological confirmation of metastatic disease is at the discretion of the treating provider. The median time will be estimated using the method of Kaplan-Meier.
- time origin
- From registration to time of first documentation of progression or death from any cause, assessed up to 12 months
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- All patients who registered and were treated are included in this analysis.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-urethral-cancer
- nct id
- NCT03617913
- outcome key
- om-0005
- source section id
- NCT03617913-om-0005
- source outcome index
- 5
- endpoint
- Recurrence-free Survival
- endpoint definition
- Recurrence-free survival is defined as the time from registration to the time of recurrence or death. Recurrence is defined as having histologically proven first appearance of muscle invasive bladder cancer, clinical evidence of metastatic disease, or treatment with radical cystectomy or radiation to the bladder, or death due to any cause after they were confirmed remission at 6 month evaluation. The median time will be estimated using the method of Kaplan-Meier.
- time origin
- From documented complete response to the first documentation of recurrence, assessed up to 12 months
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- All patients who were registered, treated, and were assessed as having a Complete Response (CR) are eligible for this analysis. This endpoint can only be analyzed if more than one patient is eligible.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- arms
- release id
- clinical-indications-draft-1
- disease state id
- ds-urethral-cancer
- nct id
- NCT03617913
- outcome key
- om-0000
- arm key
- OG000
- arm label
- Avelumab and Cisplatin IV
- regimen
- Participants received avelumab IV over 60 minutes every 14 days for a total of 10 courses in the absence of disease progression or unacceptable toxicity. Beginning 29 days after the first dose of avelumab, participants received 35 mg/m\^2/day cisplatin IV starting on day 1 of courses 3-5 for up to 6 weeks in the absence of disease progression or unacceptable toxicity.
- analyzed count
- 2
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT03617913-om-0000#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-urethral-cancer
- nct id
- NCT03617913
- outcome key
- om-0001
- arm key
- OG000
- arm label
- Avelumab and Cisplatin IV
- regimen
- Participants received avelumab IV over 60 minutes every 14 days for a total of 10 courses in the absence of disease progression or unacceptable toxicity. Beginning 29 days after the first dose of avelumab, participants received 35 mg/m\^2/day cisplatin IV starting on day 1 of courses 3-5 for up to 6 weeks in the absence of disease progression or unacceptable toxicity.
- analyzed count
- 2
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT03617913-om-0001#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-urethral-cancer
- nct id
- NCT03617913
- outcome key
- om-0002
- arm key
- OG000
- arm label
- Avelumab and Cisplatin IV
- regimen
- Participants received avelumab IV over 60 minutes every 14 days for a total of 10 courses in the absence of disease progression or unacceptable toxicity. Beginning 29 days after the first dose of avelumab, participants received 35 mg/m\^2/day cisplatin IV starting on day 1 of courses 3-5 for up to 6 weeks in the absence of disease progression or unacceptable toxicity.
- analyzed count
- 0
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT03617913-om-0002#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-urethral-cancer
- nct id
- NCT03617913
- outcome key
- om-0003
- arm key
- OG000
- arm label
- Avelumab and Cisplatin IV
- regimen
- Participants received avelumab IV over 60 minutes every 14 days for a total of 10 courses in the absence of disease progression or unacceptable toxicity. Beginning 29 days after the first dose of avelumab, participants received 35 mg/m\^2/day cisplatin IV starting on day 1 of courses 3-5 for up to 6 weeks in the absence of disease progression or unacceptable toxicity.
- analyzed count
- 0
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT03617913-om-0003#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-urethral-cancer
- nct id
- NCT03617913
- outcome key
- om-0004
- arm key
- OG000
- arm label
- Avelumab and Cisplatin IV
- regimen
- Participants received avelumab IV over 60 minutes every 14 days for a total of 10 courses in the absence of disease progression or unacceptable toxicity. Beginning 29 days after the first dose of avelumab, participants received 35 mg/m\^2/day cisplatin IV starting on day 1 of courses 3-5 for up to 6 weeks in the absence of disease progression or unacceptable toxicity.
- analyzed count
- 2
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT03617913-om-0004#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-urethral-cancer
- nct id
- NCT03617913
- outcome key
- om-0005
- arm key
- OG000
- arm label
- Avelumab and Cisplatin IV
- regimen
- Participants received avelumab IV over 60 minutes every 14 days for a total of 10 courses in the absence of disease progression or unacceptable toxicity. Beginning 29 days after the first dose of avelumab, participants received 35 mg/m\^2/day cisplatin IV starting on day 1 of courses 3-5 for up to 6 weeks in the absence of disease progression or unacceptable toxicity.
- analyzed count
- 0
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT03617913-om-0005#groups/OG000
- harms
- release id
- clinical-indications-draft-1
- disease state id
- ds-urethral-cancer
- nct id
- NCT03617913
- harm key
- EG000
- source section id
- NCT03617913-ae
- event group key
- EG000
- event group label
- Avelumab and Cisplatin IV
- serious affected
- 1
- serious at risk
- 2
- other affected
- 2
- other at risk
- 2
- frequency threshold
- 0
- collection period
- Adverse Events were assessed at the end of every 14 day cycle during treatment, up to 12 cycles.
- event definition
- Adverse Events were assessed at the end of every 14 day cycle during treatment, up to 12 cycles.
- undenominated note
- Source null
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- quality of life
- release id
- clinical-indications-draft-1
- disease state id
- ds-urethral-cancer
- nct id
- NCT03617913
- qol key
- qol-0002
- source section id
- NCT03617913-om-0002
- source outcome index
- 2
- instrument
- EORTC QLQ
- instrument basis
- matched 'eortc' in the study's own wording
- scale title
- Patient-reported Outcomes (European Organization for Research and Treatment of Cancer [EORTC] Quality of Life Questionnaire [QLQ]-30
- measure definition
- EORTC QLQ-C30 is a 30-item patient-reported questionnaire. 28 of the 30 items are measured on a 1-4 scale (1=not at all; 4=very much) with the remaining two items (overall health and overall quality of life) scored on a 1-7 numeric analogue scale (1=very poor; 7=excellent). The recall period for the EORTC QLQ-C30 is one week. Changes from baseline will be statistically tested using paired t-tests, and standardized response means (mean of the change from baseline scores at a given cycle, divided by the standard deviation of the change scores) will be interpreted (after applying Middel's (2002) adjustment) using Cohen's (1988) cut-offs: \<0.20 = trivial; 0.20-\<0.50 = small; 0.50-\<0.80 = moderate; and \>=/0.80 = large. Correlation between outcomes will employ Pearson and/or Spearman correlations at individual time points.
- time frame
- Baseline to 12 months
- analysis role
- secondary
- reporting status
- POSTED
- higher is better
- Source null
- direction quote
- Source null
- population note
- All patients who were registered, treated, and completed the EORTC QLQ assessment at baseline and post-therapy were included in this analysis
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-urethral-cancer
- nct id
- NCT03617913
- qol key
- qol-0003
- source section id
- NCT03617913-om-0003
- source outcome index
- 3
- instrument
- EORTC QLQ
- instrument basis
- matched 'eortc' in the study's own wording
- scale title
- Patient-reported Outcomes (European Organization for Research and Treatment of Cancer [EORTC] EORTCQOL-Muscle-Invasive Bladder Cancer Module [BLM]30
- measure definition
- EORTC QLQ-BLM30 is a 30-item questionnaire for patients with muscle invasive bladder cancer (T2, T3, T4a and T4b). The muscle-invasive bladder cancer module contains additional items assessing urostomy problems, problems associated with the use of a catheter, and body image. Changes from baseline will be statistically tested using paired t-tests, and standardized response means (mean of the change from baseline scores at a given cycle, divided by the standard deviation of the change scores) will be interpreted (after applying Middel's (2002) adjustment) using Cohen's (1988) cut-offs: \<0.20 = trivial; 0.20-\<0.50 = small; 0.50-\<0.80 = moderate; and \>=/0.80 = large. Correlation between outcomes will employ Pearson and/or Spearman correlations at individual time points.
- time frame
- Baseline to 12 months
- analysis role
- secondary
- reporting status
- POSTED
- higher is better
- Source null
- direction quote
- Source null
- population note
- All patients who were registered, treated, and completed the EORTC QLQ assessment at baseline and post-therapy were included in this analysis.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- setting source links
Preserved source evidence · Not medical advice
Triangle