Trial · NCT02603432
A Study Of Avelumab In Patients With Locally Advanced Or Metastatic Urothelial Cancer (JAVELIN Bladder 100)
NCT02603432, Phase 3, Completed, Pfizer; results first posted 2020-12-17
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Study Of Avelumab In Patients With Locally Advanced Or Metastatic Urothelial Cancer (JAVELIN Bladder 100). Trials, record NCT02603432. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02603432
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study Of Avelumab In Patients With Locally Advanced Or Metastatic Urothelial Cancer (JAVELIN Bladder 100)
- NCT number
- NCT02603432
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 700 participants, actual
- Lead sponsor
- Pfizer
- Conditions
- Urothelial Cancer
- Interventions
- Avelumab, Best Supportive Care, Following the planned interim analysis for this study: Avelumab
- First posted
- 2015-11-11
- Last updated
- 2024-03-27
- Other registries' IDs
- eudract:2015-003262-86
- Results first posted
- 2020-12-17
Source ClinicalTrials.gov
Registered outcomes26
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Overall Survival (OS) | From randomization to discontinuation from the study, death or date of censoring, whichever occurred first (for a maximum duration of 41 months) | Overall survival was defined as the time (in months) from the date of randomization to the date of death due to any cause. Participants last known to be alive were censored at date of last contact. Analysis was performed using Kaplan-Meier method. |
| Secondary | Progression-Free Survival (PFS) as Assessed by Blinded Independent Central Review (BICR) | From randomization to date of progression of disease, discontinuation from the study, death or date of censoring, whichever occurred first (for a maximum duration of 41 months) | BICR assessed PFS: Duration from randomization until disease progression (PD) or death. PD as per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 was defined for target disease as at least a 20% increase in sum of diameters of target lesions, taking as reference smallest sum on study (included baseline sum if that was smallest on study). In addition to relative increase of 20%, sum must have also demonstrated an absolute increase of at least 5 millimeters. For non-target disease: PD was defined as unequivocal progression of pre-existing lesions and if overall tumor burden increased sufficiently to merit discontinuation of therapy. Appearance of any new unequivocal malignant lesion was also considered PD. Analysis was performed using Kaplan-Meier. PFS data was censored on date of last adequate tumor assessment for participants with no event (PD or death), who started new anti-cancer therapy prior to an event or with an event after 2 or more missing tumor assessments. |
| Secondary | Progression-Free Survival (PFS) as Assessed by Investigator | From randomization to date of progression of disease, discontinuation from the study, death or date of censoring, whichever occurred first (for a maximum duration of 41 months) | Investigator assessed PFS: Duration from randomization to first documentation of PD or death, whichever occurred first. PD as per RECIST version 1.1 was defined for target disease as at least a 20% increase in sum of diameters of target lesions, taking as reference smallest sum on study (this included baseline sum if that was smallest on study). In addition to relative increase of 20%, sum must have also demonstrated an absolute increase of at least 5 mm. For non-target disease: PD was defined as unequivocal progression of pre-existing lesions and if overall tumor burden increased sufficiently to merit discontinuation of therapy. Appearance of any new unequivocal malignant lesion was also considered PD. Analysis was performed using Kaplan-Meier. PFS data was censored on date of last adequate tumor assessment for participants with no event (PD or death), who started a new anti-cancer therapy prior to an event or with an event after 2 or more missing tumor assessments. |
| Secondary | Percentage of Participants With Objective Response (OR) as Assessed by Blinded Independent Central Review (BICR) | From randomization to progression of disease, start of new anti-cancer therapy or discontinuation from study or death, whichever occurred first (for a maximum duration of 41 months) | BICR assessed objective response according to RECIST version 1.1, was defined as participants with confirmed best overall response of complete response (CR) or partial response (PR). CR was defined as complete disappearance of all target and non-target lesions, with the exception of nodal disease and sustained for at least 4 weeks. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to less than (\<) 10 mm. PR was defined as at least 30% decrease in the sum of the longest dimensions of target lesions taking as reference the baseline sum longest dimensions. |
| Secondary | Percentage of Participants With Objective Response as Assessed by Investigator | From randomization to progression of disease, start of new anti-cancer therapy or discontinuation from study or death, whichever occurred first (for a maximum duration of 41 months) | Investigator assessed objective response according to RECIST version 1.1, was defined as participants with confirmed best overall response of CR or PR. CR was defined as complete disappearance of all target and non-target lesions, with the exception of nodal disease and sustained for at least 4 weeks. A CR also required normalization of tumor marker levels and any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm. PR was defined as at least 30% decrease in the sum of the longest dimensions of target lesions taking as reference the baseline sum longest dimensions. |
| Secondary | Time to Tumor Response (TTR) as Assessed by Blinded Independent Central Review (BICR) | From the date of randomization to the first documentation of objective response (CR or PR) (for a maximum duration of 41 months) | TTR was defined, for participants with an objective response as the time from 'start date' to the first documentation of objective tumor response (CR or PR), which was confirmed subsequently. CR was defined as complete disappearance of all target and non-target lesions, with the exception of nodal disease and sustained for at least 4 weeks. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm. PR was defined as at least 30% decrease in the sum of the longest dimensions of target lesions taking as reference the baseline sum longest dimensions. |
| Secondary | Time to Tumor Response (TTR) as Assessed by Investigator | From the date of randomization to the first documentation of objective response (CR or PR) (for a maximum duration of 41 months) | TTR was defined, for participants with an objective response as the time from 'start date' to the first documentation of objective tumor response (CR or PR). CR was defined as complete disappearance of all target and non-target lesions, with the exception of nodal disease and sustained for at least 4 weeks. A CR also required normalization of tumor marker levels and any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm. PR was defined as at least 30% decrease in the sum of the longest dimensions of target lesions taking as reference the baseline sum longest dimensions. |
| Secondary | Duration of Response (DOR) as Assessed by Blinded Independent Central Review (BICR) | First response subsequently confirmed to progression of disease or start of new anti-cancer therapy or discontinuation from the study or death, whichever occurred first (for a maximum duration of 41 months) | BICR assessed DOR: time from first documentation of OR (confirmed CR or PR) to date of first documentation of PD or death due to any cause. As per RECIST version 1.1, CR: complete disappearance of all target and non-target lesions, with exception of nodal disease sustained for 4 weeks. Any pathological lymph nodes reduced in short axis to \<10 mm. PR: at least 30% decrease in sum of longest dimensions of target lesions taking as reference baseline sum longest dimensions. PD for target disease: at least a 20% increase in sum of diameters of target lesions, taking as reference smallest sum on study and relative increase of 20%, sum also demonstrated absolute increase of at least 5 mm. PD for non-target disease: unequivocal progression of pre-existing lesions and if overall tumor burden increased sufficiently to merit discontinuation of therapy. Appearance of any new unequivocal malignant lesion was also considered PD. |
| Secondary | Duration of Response (DOR) as Assessed by Investigator | First response subsequently confirmed to progression of disease or start of new anti-cancer therapy or discontinuation from the study or death, whichever occurred first (for a maximum duration of 41 months) | Investigator assessed DOR: time from first documentation of OR (confirmed CR or PR) to date of first documentation of PD or death due to any cause. As per RECIST version 1.1, CR: complete disappearance of all target and non-target lesions, with exception of nodal disease sustained for 4 weeks. Additionally, normalization of tumor marker levels and any pathological lymph nodes reduced in short axis to \<10 mm. PR: at least 30% decrease in sum of longest dimensions of target lesions taking as reference baseline sum longest dimensions. PD for target disease: at least a 20% increase in sum of diameters of target lesions, taking as reference smallest sum on study and relative increase of 20%, sum also demonstrated absolute increase of at least 5 mm. PD for non-target disease: unequivocal progression of pre-existing lesions and if overall tumor burden increased sufficiently to merit discontinuation of therapy. Appearance of any new unequivocal malignant lesion was also considered PD. |
| Secondary | Percentage of Participants With Disease Control (DC) as Assessed by Blinded Independent Central Review (BICR) | From randomization to PD, death or start of new anti-cancer therapy (for a maximum duration of 41 months) | Disease Control (DC) was defined as a best overall response of CR, PR, non-CR/non-PD or stable disease (SD) as assessed by BICR. CR was defined as complete disappearance of all target and non-target lesions, with the exception of nodal disease and sustained for at least 4 weeks. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm. PR was defined as at least 30% decrease in the sum of the longest dimensions of target lesions taking as reference the baseline sum longest dimensions. Non-CR/Non-PD was defined as persistence of any non-target lesions and/or tumor marker level above the normal limits. SD was defined as not to qualify for CR, PR or PD for target lesions and followed PR only if the sum increased by less than 20% from the nadir, but enough that a previously documented 30% decrease no longer holds. |
1 to 10 of 26Source ClinicalTrials.gov
See all 26 registered outcomesOutcomes26
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Overall Survival (OS) | From randomization to discontinuation from the study, death or date of censoring, whichever occurred first (for a maximum duration of 41 months) | The full analysis set included all randomized participants. | months | MEDIAN |
| SECONDARY | Progression-Free Survival (PFS) as Assessed by Blinded Independent Central Review (BICR) | From randomization to date of progression of disease, discontinuation from the study, death or date of censoring, whichever occurred first (for a maximum duration of 41 months) | The full analysis set included all randomized participants. | months | MEDIAN |
| SECONDARY | Progression-Free Survival (PFS) as Assessed by Investigator | From randomization to date of progression of disease, discontinuation from the study, death or date of censoring, whichever occurred first (for a maximum duration of 41 months) | The full analysis set included all randomized participants. | months | MEDIAN |
| SECONDARY | Percentage of Participants With Objective Response (OR) as Assessed by Blinded Independent Central Review (BICR) | From randomization to progression of disease, start of new anti-cancer therapy or discontinuation from study or death, whichever occurred first (for a maximum duration of 41 months) | The full analysis set included all randomized participants. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Objective Response as Assessed by Investigator | From randomization to progression of disease, start of new anti-cancer therapy or discontinuation from study or death, whichever occurred first (for a maximum duration of 41 months) | The full analysis set included all randomized participants. | percentage of participants | NUMBER |
| SECONDARY | Time to Tumor Response (TTR) as Assessed by Blinded Independent Central Review (BICR) | From the date of randomization to the first documentation of objective response (CR or PR) (for a maximum duration of 41 months) | The full analysis set included all randomized participants. Here, 'Overall Number of participants analyzed (N)' signifies participants who were evaluable for this outcome measure (OM). | months | MEDIAN |
| SECONDARY | Time to Tumor Response (TTR) as Assessed by Investigator | From the date of randomization to the first documentation of objective response (CR or PR) (for a maximum duration of 41 months) | The full analysis set included all randomized participants. Here, 'Overall Number of participants analyzed' signifies participants who were evaluable for this outcome measure. | months | MEDIAN |
| SECONDARY | Duration of Response (DOR) as Assessed by Blinded Independent Central Review (BICR) | First response subsequently confirmed to progression of disease or start of new anti-cancer therapy or discontinuation from the study or death, whichever occurred first (for a maximum duration of 41 months) | Analysis was performed on subset of randomized participants, who had objective response, as assessed by BICR. | months | MEDIAN |
| SECONDARY | Duration of Response (DOR) as Assessed by Investigator | First response subsequently confirmed to progression of disease or start of new anti-cancer therapy or discontinuation from the study or death, whichever occurred first (for a maximum duration of 41 months) | Analysis was performed on subset of randomized participants, who had objective response, as assessed by Investigator. | months | MEDIAN |
| SECONDARY | Percentage of Participants With Disease Control (DC) as Assessed by Blinded Independent Central Review (BICR) | From randomization to PD, death or start of new anti-cancer therapy (for a maximum duration of 41 months) | The full analysis set included all randomized participants. | percentage of participants | NUMBER |
1 to 10 of 26Source ClinicalTrials.gov
See all 26 outcomesResults by group159
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Overall Survival (OS) | Avelumab + Best Supportive Care (BSC) | 21.4 | 95% Confidence Interval 18.9 to 26.1 | months | |
| Overall Survival (OS) | Best Supportive Care | 14.3 | 95% Confidence Interval 12.9 to 17.9 | months | |
| Progression-Free Survival (PFS) as Assessed by Blinded Independent Central Review (BICR) | Avelumab + Best Supportive Care (BSC) | 3.7 | 95% Confidence Interval 3.5 to 5.5 | months | |
| Progression-Free Survival (PFS) as Assessed by Blinded Independent Central Review (BICR) | Best Supportive Care | 2.0 | 95% Confidence Interval 1.9 to 2.7 | months | |
| Progression-Free Survival (PFS) as Assessed by Investigator | Avelumab + Best Supportive Care (BSC) | 5.5 | 95% Confidence Interval 4.2 to 7.2 | months | |
| Progression-Free Survival (PFS) as Assessed by Investigator | Best Supportive Care | 2.1 | 95% Confidence Interval 1.9 to 3.0 | months | |
| Percentage of Participants With Objective Response (OR) as Assessed by Blinded Independent Central Review (BICR) | Avelumab + Best Supportive Care (BSC) | 9.7 | 95% Confidence Interval 6.8 to 13.3 | percentage of participants | |
| Percentage of Participants With Objective Response (OR) as Assessed by Blinded Independent Central Review (BICR) | Best Supportive Care | 1.4 | 95% Confidence Interval 0.5 to 3.3 | percentage of participants | |
| Percentage of Participants With Objective Response as Assessed by Investigator | Avelumab + Best Supportive Care (BSC) | 12.3 | 95% Confidence Interval 9.0 to 16.2 | percentage of participants | |
| Percentage of Participants With Objective Response as Assessed by Investigator | Best Supportive Care | 3.4 | 95% Confidence Interval 1.8 to 5.9 | percentage of participants |
1 to 10 of 159Source ClinicalTrials.gov
See all 159 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Avelumab + Best Supportive Care (BSC) | 350 | |
| Overall Study | STARTED | Best Supportive Care | 350 | |
| Overall Study | COMPLETED | Avelumab + Best Supportive Care (BSC) | 16 | |
| Overall Study | COMPLETED | Best Supportive Care | 1 | |
| Overall Study | NOT COMPLETED | Avelumab + Best Supportive Care (BSC) | 334 | |
| Overall Study | NOT COMPLETED | Best Supportive Care | 349 |
Source ClinicalTrials.gov
Adverse events390
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Anaemia | Blood and lymphatic system disorders | Avelumab + Best Supportive Care (BSC) | 47 | 344 | |
| other | Anaemia | Blood and lymphatic system disorders | Best Supportive Care | 22 | 345 | |
| other | Hyperthyroidism | Endocrine disorders | Avelumab + Best Supportive Care (BSC) | 21 | 344 | |
| other | Hyperthyroidism | Endocrine disorders | Best Supportive Care | 1 | 345 | |
| other | Hypothyroidism | Endocrine disorders | Avelumab + Best Supportive Care (BSC) | 44 | 344 | |
| other | Hypothyroidism | Endocrine disorders | Best Supportive Care | 2 | 345 | |
| other | Asthenia | General disorders | Avelumab + Best Supportive Care (BSC) | 64 | 344 | |
| other | Asthenia | General disorders | Best Supportive Care | 19 | 345 | |
| other | Chills | General disorders | Avelumab + Best Supportive Care (BSC) | 29 | 344 | |
| other | Chills | General disorders | Best Supportive Care | 3 | 345 |
1 to 10 of 390Source ClinicalTrials.gov
See all 390 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Avelumab + Best Supportive Care (BSC) | 225 | 344 |
| Total, all-cause mortality | Best Supportive Care | 242 | 345 |
| Total, other adverse events | Avelumab + Best Supportive Care (BSC) | 321 | 344 |
| Total, other adverse events | Best Supportive Care | 214 | 345 |
| Total, serious adverse events | Avelumab + Best Supportive Care (BSC) | 111 | 344 |
| Total, serious adverse events | Best Supportive Care | 73 | 345 |
Source ClinicalTrials.gov
Papers11
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons3
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Avelumab + Best Supportive Care (BSC) vs Best Supportive Care: Number of Participants With Cluster of Differentiation 8 (CD8) T Lymphocytes (Cytotoxic T Lymphocytes) | Trial comparisons |
| Avelumab + Best Supportive Care (BSC) vs Best Supportive Care: deaths from any cause | Trial comparisons |
| Avelumab + Best Supportive Care (BSC) vs Best Supportive Care: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT02603432
GET https://conductscience.org/api/trials/v1/NCT02603432/registered?page=2