Trial · NCT02387996
A Study of Nivolumab in Participants With Metastatic or Unresectable Bladder Cancer
NCT02387996, Phase 2, Completed, Bristol-Myers Squibb; results first posted 2017-05-24
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Study of Nivolumab in Participants With Metastatic or Unresectable Bladder Cancer. Trials, record NCT02387996. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02387996
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study of Nivolumab in Participants With Metastatic or Unresectable Bladder Cancer
- NCT number
- NCT02387996
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 270 participants, actual
- Lead sponsor
- Bristol-Myers Squibb
- Conditions
- Various Advanced Cancer
- Interventions
- Nivolumab
- First posted
- 2015-03-13
- Last updated
- 2022-11-01
- Results first posted
- 2017-05-24
Source ClinicalTrials.gov
Registered outcomes7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Objective Response Rate Per BIRC Assessment | From the date of first dose to the date of objectively documented progression or the date of subsequent therapy, whichever occurs first (assessed up to 14 months) | Objective Response Rate (ORR) was defined as the number of participants with a best overall response of confirmed Complete Response (CR) or Partial Response (PR) (per RECIST 1.1 criteria) divided by the number of all treated participants. RECIST 1.1 = Response Evaluation Criteria in Solid Tumors. CR= Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \< 10 mm. PR= At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. BIRC= blinded independent review committee |
| Primary | ORR Per BIRC Assessment by PD-L1 Expression Level | From the date of first dose to the date of objectively documented progression or the date of subsequent therapy, whichever occurs first (assessed up to 14 months) | Objective Response Rate (ORR) was defined as the number of participants with a best overall response of confirmed Complete Response (CR) or Partial Response (PR) (per RECIST 1.1 criteria) divided by the number of all treated participants. RECIST 1.1 = Response Evaluation Criteria in Solid Tumors. CR= Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \< 10 mm. PR= At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. BIRC= blinded independent review committee PD-L1 expression level= membranous staining in greater than or equal to 5% and greater than or equal to 1% tumor cells. n = Number of participants in each category |
| Primary | Time to Response (TTR) | From first dosing date to the date of the first confirmed response (up to approximately 14 months) | TTR is defined as the time from first dosing date to the date of the first confirmed complete response (CR) or partial response (PR), as assessed by the Blinded Independent Review Committee (BIRC). Complete response is defined as the disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \< 10 mm. Partial response is defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. |
| Primary | Duration of Response (DOR) | From the first confirmed response to the date of the first documented tumor progression or death due to any cause, whichever occurs first (up to approximately 14 months) | DOR is defined as the time from first confirmed response, complete response (CR) or partial response (PR) to the date of the first documented tumor progression as determined using RECIST 1.1 criteria or death due to any cause, whichever occurs first. Participants who start subsequent therapy without a prior reported progression will be censored at the last evaluable tumor assessments prior to initiation of the subsequent anticancer therapy. Participants who die without a reported prior progression will be considered to have progressed on the date of their death. Participants who neither progress nor die will be censored on the date of their last evaluable tumor assessment. |
| Secondary | Progression Free Survival (PFS) | From first dosing date to the date of the first documented tumor progression (up to approximately 6 months) | PFS was defined as the time from first dosing date to the date of the first documented tumor progression, based on Blinded Independent Review Committee (BIRC) assessments or death due to any cause. Progression was defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions. PD-L1 expression level is defined as membranous staining in greater than or equal to 5% and greater than or equal to 1% tumor cells. |
| Secondary | Overall Survival (OS) | From first dosing date to the date of death (up to approximately 23 months) | Overall Survival was defined as the time from first dosing date to the date of death. A participant who had not died was censored at last known date alive. PD-L1 expression level = membranous staining in greater than or equal to 5% and greater than or equal to 1% tumor cells. |
| Secondary | Objective Response Rate (ORR) Per Investigator | From the date of first dose to the date of objectively documented progression or the date of subsequent therapy, whichever occurs first (up to approximately 45 months) | Investigator-assessed ORR was defined as the percent of participants with a best overall response of confirmed complete response (CR) or partial response (PR). Complete response is defined as the disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \< 10 mm. Partial response is defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. PD-L1 expression level = Membranous staining in greater than or equal to 5% and greater than or equal to 1% tumor cells. |
Source ClinicalTrials.gov
Outcomes10
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Objective Response Rate Per BIRC Assessment | From the date of first dose to the date of objectively documented progression or the date of subsequent therapy, whichever occurs first (assessed up to 14 months) | All treated participants. Treated participants from Japan enrolled after main enrollment period were excluded from primary efficacy analysis. | Percent of participants | NUMBER |
| PRIMARY | ORR Per BIRC Assessment by PD-L1 Expression Level | From the date of first dose to the date of objectively documented progression or the date of subsequent therapy, whichever occurs first (assessed up to 14 months) | All treated participants. Treated participants from Japan enrolled after main enrollment period were excluded from primary efficacy analysis. | Percent of Participants | NUMBER |
| SECONDARY | Progression Free Survival (PFS) | From first dosing date to the date of the first documented tumor progression (up to approximately 6 months) | All treated participants | Months | MEDIAN |
| SECONDARY | Overall Survival (OS) | From first dosing date to the date of death (up to approximately 23 months) | All treated participants | Months | MEDIAN |
| SECONDARY | Objective Response Rate (ORR) Per Investigator | From the date of first dose to the date of objectively documented progression or the date of subsequent therapy, whichever occurs first (up to approximately 45 months) | All treated participants | Percent of Participants | NUMBER |
| POST_HOC | Time to Response (TTR) - Extended Collection | From first dosing date to the date of the first confirmed response (up to approximately 14 months) | All responders-includes responders who had neither progressed nor initiated subsequent therapy at the time of analysis, and excludes responders censored prior to 12 weeks of the clinical data cutoff date (if this cutoff date is before week 48) or prior to 18 weeks of the clinical data cutoff date (if this cutoff date is after or on week 48) | Months | MEDIAN |
| POST_HOC | Duration of Response (DOR) - Extended Collection | From the first confirmed response to the date of the first documented tumor progression or death due to any cause, whichever occurs first (up to approximately 32 months) | All responders-includes responders who had neither progressed nor initiated subsequent therapy at the time of analysis, and excludes responders censored prior to 12 weeks of the clinical data cutoff date (if this cutoff date is before week 48) or prior to 18 weeks of the clinical data cutoff date (if this cutoff date is after or on week 48) | Months | MEDIAN |
| PRIMARY | Time to Response (TTR) | From first dosing date to the date of the first confirmed response (up to approximately 14 months) | All responders-includes responders who had neither progressed nor initiated subsequent therapy at the time of analysis, and excludes responders censored prior to 12 weeks of the clinical data cutoff date (if this cutoff date is before week 48) or prior to 18 weeks of the clinical data cutoff date (if this cutoff date is after or on week 48) | Months | MEDIAN |
| PRIMARY | Duration of Response (DOR) | From the first confirmed response to the date of the first documented tumor progression or death due to any cause, whichever occurs first (up to approximately 14 months) | All responders-includes responders who had neither progressed nor initiated subsequent therapy at the time of analysis, and excludes responders censored prior to 12 weeks of the clinical data cutoff date (if this cutoff date is before week 48) or prior to 18 weeks of the clinical data cutoff date (if this cutoff date is after or on week 48) | Months | MEDIAN |
| POST_HOC | Objective Response Rate (ORR) Per BIRC Assessment - Extended Collection | From the date of first dose to the date of objectively documented progression or the date of subsequent therapy, whichever occurs first (up approximately to 43 months) | All treated participants | Percent of Participants | NUMBER |
Source ClinicalTrials.gov
Results by group29
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Objective Response Rate Per BIRC Assessment | Nivolumab 3 mg/kg | 19.6 | 95% Confidence Interval 15.0 to 24.9 | Percent of participants | |
| ORR Per BIRC Assessment by PD-L1 Expression Level | Nivolumab 3 mg/kg | PD-L1 <1% | 16.1 | 95% Confidence Interval 10.5 to 23.1 | Percent of Participants |
| ORR Per BIRC Assessment by PD-L1 Expression Level | Nivolumab 3 mg/kg | PD-L1 >= 1% | 23.8 | 95% Confidence Interval 16.5 to 32.3 | Percent of Participants |
| ORR Per BIRC Assessment by PD-L1 Expression Level | Nivolumab 3 mg/kg | PD-L1 <5% | 15.8 | 95% Confidence Interval 10.8 to 21.8 | Percent of Participants |
| ORR Per BIRC Assessment by PD-L1 Expression Level | Nivolumab 3 mg/kg | PD-L1 >=5% | 28.4 | 95% Confidence Interval 18.9 to 39.5 | Percent of Participants |
| Progression Free Survival (PFS) | Nivolumab 3 mg/kg | All treated participants | 1.94 | 95% Confidence Interval 1.87 to 2.33 | Months |
| Progression Free Survival (PFS) | Nivolumab 3 mg/kg | PD-L1 <1% | 1.87 | 95% Confidence Interval 1.74 to 2.00 | Months |
| Progression Free Survival (PFS) | Nivolumab 3 mg/kg | PD-L1 >= 1% | 3.45 | 95% Confidence Interval 1.91 to 3.71 | Months |
| Progression Free Survival (PFS) | Nivolumab 3 mg/kg | PD-L1 <5% | 1.87 | 95% Confidence Interval 1.81 to 2.04 | Months |
| Progression Free Survival (PFS) | Nivolumab 3 mg/kg | PD-L1 >=5% | 3.68 | 95% Confidence Interval 1.91 to 5.52 | Months |
1 to 10 of 29Source ClinicalTrials.gov
See all 29 results by groupParticipant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Nivolumab 3 mg/kg | 270 | |
| Overall Study | COMPLETED | Nivolumab 3 mg/kg | 0 | |
| Overall Study | NOT COMPLETED | Nivolumab 3 mg/kg | 270 |
Source ClinicalTrials.gov
Adverse events206
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 | Nivolumab 3 mg/kg | 58 | 270 | |
| other | Hypothyroidism | Endocrine disorders | Nivolumab 3 mg/kg | 32 | 270 | |
| other | Abdominal pain | Gastrointestinal disorders | Nivolumab 3 mg/kg | 34 | 270 | |
| other | Constipation | Gastrointestinal disorders | Nivolumab 3 mg/kg | 60 | 270 | |
| other | Diarrhoea | Gastrointestinal disorders | Nivolumab 3 mg/kg | 60 | 270 | |
| other | Nausea | Gastrointestinal disorders | Nivolumab 3 mg/kg | 71 | 270 | |
| other | Vomiting | Gastrointestinal disorders | Nivolumab 3 mg/kg | 42 | 270 | |
| other | Asthenia | General disorders | Nivolumab 3 mg/kg | 43 | 270 | |
| other | Chills | General disorders | Nivolumab 3 mg/kg | 22 | 270 | |
| other | Fatigue | General disorders | Nivolumab 3 mg/kg | 97 | 270 |
1 to 10 of 206Source ClinicalTrials.gov
See all 206 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Nivolumab 3 mg/kg | 225 | 270 |
| Total, other adverse events | Nivolumab 3 mg/kg | 245 | 270 |
| Total, serious adverse events | Nivolumab 3 mg/kg | 199 | 270 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 28131785 | DERIVED |
Source PubMed
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 comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
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/NCT02387996
GET https://conductscience.org/api/trials/v1/NCT02387996/results?page=2