Trial · NCT03036098
Study of Nivolumab in Combination With Ipilimumab or Standard of Care Chemotherapy Compared to the Standard of Care Chemotherapy Alone in Treatment of Participants With Untreated Inoperable or Metastatic Urothelial Cancer
NCT03036098, Phase 3, Completed, Bristol-Myers Squibb; results first posted 2025-09-18
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Study of Nivolumab in Combination With Ipilimumab or Standard of Care Chemotherapy Compared to the Standard of Care Chemotherapy Alone in Treatment of Participants With Untreated Inoperable or Metastatic Urothelial Cancer. Trials, record NCT03036098. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03036098
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
Study of Nivolumab in Combination With Ipilimumab or Standard of Care Chemotherapy Compared to the Standard of Care Chemotherapy Alone in Treatment of Participants With Untreated Inoperable or Metastatic Urothelial Cancer
- NCT number
- NCT03036098
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 1,314 participants, actual
- Lead sponsor
- Bristol-Myers Squibb
- Conditions
- Urothelial Cancer
- Interventions
- Nivolumab, Ipilimumab, Gemcitabine, Cisplatin, Carboplatin
- First posted
- 2017-01-30
- Last updated
- 2026-11-02
- Other registries' IDs
- eudract:2016-003881-14
- Results first posted
- 2025-09-18
Source ClinicalTrials.gov
Registered outcomes12
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Overall Survival (OS) in Cisplatin-ineligible Randomized Participants for Primary Study | From the date of randomization to the date of death from any cause, or data cut-off date, whichever occurred first (up to approximately 89 months) | This measure looks at how long participants who cannot receive cisplatin (a type of chemotherapy) live after being placed into a treatment group in the primary study. Overall Survival (OS) is defined as the time between the date a participant is randomized (assigned to a treatment group) and the date of death from any cause. For participants without documentation of death, OS will be measured up to the last date the participant was known to be alive. If a participant was randomized but had no follow-up information, OS will be counted from the date of randomization. This helps to understand if the treatment can help people who are unable to receive cisplatin chemotherapy live longer. |
| Primary | Overall Survival (OS) in Programmed Death-Ligand 1 (PD-L1) Positive (≥ 1%) Randomized Participants by Immunohistochemistry (IHC) for Primary Study | From the date of randomization to the date of death from any cause, or data cut-off date, whichever occurred first (up to approximately 89 months) | This measure looks at how long participants with PD-L1 positive tumors (meaning their tumor cells have at least 1% PD-L1, as determined by a laboratory test called immunohistochemistry or IHC) live after being placed into a treatment group in the primary study. Overall Survival (OS) is defined as the time between the date a participant is randomized (assigned to a treatment group) and the date of death from any cause. For participants without documentation of death, OS will be measured up to the last date the participant was known to be alive. If a participant was randomized but had no follow-up information, OS will be counted from the date of randomization. This helps to understand whether the treatment can help people with PD-L1 positive tumors live longer. |
| Primary | Progression-Free Survival (PFS) by Blinded Independent Central Review (BICR) [Using Response Evaluation Criteria in Solid Tumors (RECIST) 1.1] in Cisplatin-eligible Participants for Sub-study | From the date of randomization to the date of first documented disease progression or death due to any cause, whichever occurs first (up to approximately 89 months) | This measure looks at how long people who can receive cisplatin chemotherapy live without their cancer getting worse after being assigned to a treatment group in the sub-study. Progression-Free Survival (PFS) is the time from when a participant is assigned to a group (randomization) until their cancer is first shown to get worse (progress), based on reviews by independent experts who do not know which treatment was given. These experts use standard rules (RECIST 1.1) to decide if the cancer has progressed. If a participant dies before their cancer is shown to get worse, the date of death will be used as the time their disease progressed. If a participant's cancer does not get worse and they do not die during the study, their PFS will be measured up to the date of their last tumor check. This helps to understand if the treatment helps people eligible for cisplatin live longer without their cancer progressing. |
| Primary | Overall Survival (OS) in Cisplatin-eligible Participants for Sub-study | From the date of randomization to the date of death from any cause, or data cut-off date, whichever occurred first (up to approximately 89 months) | This measure looks at how long people who are able to receive cisplatin (a type of chemotherapy) live after being placed into a treatment group in the sub-study. Overall Survival (OS) is defined as the time between the date a participant is randomized (assigned to a treatment group) and the date of death from any cause. For participants without documentation of death, OS will be measured up to the last date the participant was known to be alive. If a participant was randomized but had no follow-up information, OS will be counted from the date of randomization. This helps to understand if the treatment can help people who are eligible for cisplatin chemotherapy live longer. |
| Secondary | Overall Survival (OS) in All Randomized Participants for Primary Study | From the date of randomization to the date of death from any cause, or data cut-off date, whichever occurred first (up to approximately 89 months) | This measure looks at how long all participants live after being placed into a treatment group in the primary study. Overall Survival (OS) is defined as the time between the date a participant is randomized (assigned to a treatment group) and the date of death from any cause. For participants without documentation of death, OS will be measured up to the last date the participant was known to be alive. If a participant was randomized but had no follow-up information, OS will be counted from the date of randomization. This helps to understand whether the treatment can help all participants in the study live longer. |
| Secondary | Progression-Free Survival (PFS) by Blinded Independent Central Review (BICR) [Using Response Evaluation Criteria in Solid Tumors (RECIST) 1.1] in Cisplatin-ineligible Randomized Participants for Primary Study | From the date of randomization to the date of first documented disease progression or death due to any cause, whichever occurs first (up to approximately 89 months) | This measure looks at how long people who cannot receive cisplatin chemotherapy live without their cancer getting worse after being assigned to a treatment group in the primary study. Progression-Free Survival (PFS) is the time from when a participant is assigned to a group (randomization) until their cancer is first shown to get worse (progress), based on reviews by independent experts who do not know which treatment was given. These experts use standard rules (RECIST 1.1) to decide if the cancer has progressed. If a participant dies before their cancer is shown to get worse, the date of death will be used as the time their disease progressed. If a participant's cancer does not get worse and they do not die during the study, their PFS will be measured up to the date of their last tumor check. This helps to understand if the treatment helps people unable to receive cisplatin live longer without their cancer progressing. |
| Secondary | Progression-Free Survival (PFS) by Blinded Independent Central Review (BICR) [Using Response Evaluation Criteria in Solid Tumors (RECIST) 1.1] in Programmed Death-Ligand 1 (PD-L1) Positive (≥ 1%) Participants for Primary Study | From the date of randomization to the date of first documented disease progression or death due to any cause, whichever occurs first (up to approximately 89 months) | This measure looks at how long people with PD-L1 positive tumors (meaning their tumor cells have at least 1% PD-L1, as determined by a lab test) live without their cancer getting worse after being assigned to a treatment group in the primary study. Progression-Free Survival (PFS) is the time from when a participant is assigned to a group (randomization) until their cancer is first shown to get worse (progress), based on reviews by independent experts who do not know which treatment was given. These experts use standard rules (RECIST 1.1) to decide if the cancer has progressed. If a participant dies before their cancer is shown to get worse, the date of death will be used as the time their disease progressed. If a participant's cancer does not get worse and they do not die during the study, their PFS will be measured up to the date of their last tumor check. This helps to understand if the treatment helps people with PD-L1 positive tumors live longer without their cancer progressing. |
| Secondary | Progression-Free Survival (PFS) by Blinded Independent Central Review (BICR) [Using Response Evaluation Criteria in Solid Tumors (RECIST) 1.1] in All Randomized Participants for Primary Study | From the date of randomization to the date of first documented disease progression or death due to any cause, whichever occurs first (up to approximately 89 months) | This measure looks at how long all participants in the primary study live without their cancer getting worse after being assigned to a treatment group. Progression-Free Survival (PFS) is defined as the time from when a participant is assigned to a treatment group (randomization) until their cancer is first shown to get worse (progress), based on reviews by independent experts who do not know which treatment the participant received. These experts use standard rules (called RECIST 1.1) to decide if the cancer has progressed. If a participant dies before their cancer is shown to get worse, the date of death will be used as the time their disease progressed. If a participant's cancer does not get worse and they do not die during the study, their PFS will be measured up to the date of their last tumor check. This helps to understand whether the treatment can help participants live longer without their cancer progressing. |
| Secondary | Change From Baseline in the European Organization for Research and Treatment of Care Quality-of-Life Questionnaire (EORTC QLQ-C30) Global Health Status Score in All Randomized Participants for Primary Study | At Baseline, Week 4, Week 10, Week 16, Week 20, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96, Week 108, Week 120, Week 144, Week 156, Week 168, Week 180 and Week 192 | The EORTC QLQ-C30 is a questionnaire used to assess the quality of life in cancer patients. It includes a global health status score, which is measured on a 4-point Likert scale: 1 = not at all, 2 = a little, 3 = quite a bit, and 4 = very much. Responses are combined and converted to scores ranging from 0 to 100. A high score for global health status or health-related quality of life (HRQoL) indicates a high overall HRQoL. |
| Secondary | Change From Baseline in the European Organization for Research and Treatment of Care Quality-of-Life Questionnaire (EORTC QLQ-C30) Global Health Status Score for Sub-study | At Baseline, Week 4, Week 10, Week 16, Week 20, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96, Week 108, and Week 120 | The EORTC QLQ-C30 is a questionnaire used to assess the quality of life in cancer patients. It includes a global health status score, which is measured on a 4-point Likert scale: 1 = not at all, 2 = a little, 3 = quite a bit, and 4 = very much. Responses are combined and converted to scores ranging from 0 to 100. A high score for global health status or health-related quality of life (HRQoL) indicates a high overall HRQoL. |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 registered outcomesOutcomes12
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Overall Survival (OS) in Cisplatin-ineligible Randomized Participants for Primary Study | From the date of randomization to the date of death from any cause, or data cut-off date, whichever occurred first (up to approximately 89 months) | All Cisplatin-ineligible Randomized Participants - Primary Study | Months | MEDIAN |
| PRIMARY | Overall Survival (OS) in Programmed Death-Ligand 1 (PD-L1) Positive (≥ 1%) Randomized Participants by Immunohistochemistry (IHC) for Primary Study | From the date of randomization to the date of death from any cause, or data cut-off date, whichever occurred first (up to approximately 89 months) | All PD-L1 \>= 1% Randomized Participants - Primary Study | Months | MEDIAN |
| SECONDARY | Overall Survival (OS) in All Randomized Participants for Primary Study | From the date of randomization to the date of death from any cause, or data cut-off date, whichever occurred first (up to approximately 89 months) | All Randomized Participants - Primary Study | Months | MEDIAN |
| SECONDARY | Progression-Free Survival (PFS) by Blinded Independent Central Review (BICR) [Using Response Evaluation Criteria in Solid Tumors (RECIST) 1.1] in Cisplatin-ineligible Randomized Participants for Primary Study | From the date of randomization to the date of first documented disease progression or death due to any cause, whichever occurs first (up to approximately 89 months) | All Cisplatin-ineligible Randomized Participants - Primary Study | Months | MEDIAN |
| SECONDARY | Progression-Free Survival (PFS) by Blinded Independent Central Review (BICR) [Using Response Evaluation Criteria in Solid Tumors (RECIST) 1.1] in Programmed Death-Ligand 1 (PD-L1) Positive (≥ 1%) Participants for Primary Study | From the date of randomization to the date of first documented disease progression or death due to any cause, whichever occurs first (up to approximately 89 months) | All PD-L1 \>= 1% Randomized Participants - Primary Study | Months | MEDIAN |
| SECONDARY | Progression-Free Survival (PFS) by Blinded Independent Central Review (BICR) [Using Response Evaluation Criteria in Solid Tumors (RECIST) 1.1] in All Randomized Participants for Primary Study | From the date of randomization to the date of first documented disease progression or death due to any cause, whichever occurs first (up to approximately 89 months) | All Randomized Participants - Primary Study | Months | MEDIAN |
| SECONDARY | Change From Baseline in the European Organization for Research and Treatment of Care Quality-of-Life Questionnaire (EORTC QLQ-C30) Global Health Status Score in All Randomized Participants for Primary Study | At Baseline, Week 4, Week 10, Week 16, Week 20, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96, Week 108, Week 120, Week 144, Week 156, Week 168, Week 180 and Week 192 | All Randomized Participants - Primary Study | Score on a Scale | MEAN |
| PRIMARY | Progression-Free Survival (PFS) by Blinded Independent Central Review (BICR) [Using Response Evaluation Criteria in Solid Tumors (RECIST) 1.1] in Cisplatin-eligible Participants for Sub-study | From the date of randomization to the date of first documented disease progression or death due to any cause, whichever occurs first (up to approximately 89 months) | All Cisplatin-eligible Randomized Participants - Sub-study | Months | MEDIAN |
| PRIMARY | Overall Survival (OS) in Cisplatin-eligible Participants for Sub-study | From the date of randomization to the date of death from any cause, or data cut-off date, whichever occurred first (up to approximately 89 months) | All Cisplatin-eligible Randomized Participants - Sub-study | Months | MEDIAN |
| SECONDARY | Change From Baseline in the European Organization for Research and Treatment of Care Quality-of-Life Questionnaire (EORTC QLQ-C30) Global Health Status Score for Sub-study | At Baseline, Week 4, Week 10, Week 16, Week 20, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96, Week 108, and Week 120 | All Randomized Participants - Sub-study | Score on a Scale | MEAN |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 outcomesResults by group70
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Overall Survival (OS) in Cisplatin-ineligible Randomized Participants for Primary Study | Treatment 1 | 19.06 | 95% Confidence Interval 13.47 to 22.60 | Months | |
| Overall Survival (OS) in Cisplatin-ineligible Randomized Participants for Primary Study | Treatment 2 | 13.21 | 95% Confidence Interval 11.63 to 15.24 | Months | |
| Overall Survival (OS) in Programmed Death-Ligand 1 (PD-L1) Positive (≥ 1%) Randomized Participants by Immunohistochemistry (IHC) for Primary Study | Treatment 1 | 16.30 | 95% Confidence Interval 11.53 to 21.82 | Months | |
| Overall Survival (OS) in Programmed Death-Ligand 1 (PD-L1) Positive (≥ 1%) Randomized Participants by Immunohistochemistry (IHC) for Primary Study | Treatment 2 | 14.36 | 95% Confidence Interval 10.48 to 17.64 | Months | |
| Overall Survival (OS) in All Randomized Participants for Primary Study | Treatment 1 | 18.76 | 95% Confidence Interval 15.05 to 21.82 | Months | |
| Overall Survival (OS) in All Randomized Participants for Primary Study | Treatment 2 | 14.32 | 95% Confidence Interval 12.22 to 15.87 | Months | |
Progression-Free Survival (PFS) by Blinded Independent Central Review (BICR) [Using Response Evaluation Criteria in Solid Tumors (RECIST) 1.1] in Cisplatin-ineligible Randomized Participants for Primary Study | Treatment 1 | 5.29 | 95% Confidence Interval 3.78 to 5.95 | Months | |
Progression-Free Survival (PFS) by Blinded Independent Central Review (BICR) [Using Response Evaluation Criteria in Solid Tumors (RECIST) 1.1] in Cisplatin-ineligible Randomized Participants for Primary Study | Treatment 2 | 5.88 | 95% Confidence Interval 5.62 to 7.59 | Months | |
Progression-Free Survival (PFS) by Blinded Independent Central Review (BICR) [Using Response Evaluation Criteria in Solid Tumors (RECIST) 1.1] in Programmed Death-Ligand 1 (PD-L1) Positive (≥ 1%) Participants for Primary Study | Treatment 1 | 5.39 | 95% Confidence Interval 3.75 to 7.39 | Months | |
Progression-Free Survival (PFS) by Blinded Independent Central Review (BICR) [Using Response Evaluation Criteria in Solid Tumors (RECIST) 1.1] in Programmed Death-Ligand 1 (PD-L1) Positive (≥ 1%) Participants for Primary Study | Treatment 2 | 5.78 | 95% Confidence Interval 4.80 to 6.93 | Months |
1 to 10 of 70Source ClinicalTrials.gov
See all 70 results by groupParticipant flow28
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Pre-Treatment | STARTED | Treatment 1 | 349 | |
| Pre-Treatment | STARTED | Treatment 2 | 357 | |
| Pre-Treatment | STARTED | Treatment 3 | 304 | |
| Pre-Treatment | STARTED | Treatment 4 | 304 | |
| Pre-Treatment | COMPLETED | Treatment 1 | 345 | |
| Pre-Treatment | COMPLETED | Treatment 2 | 338 | |
| Pre-Treatment | COMPLETED | Treatment 3 | 304 | |
| Pre-Treatment | COMPLETED | Treatment 4 | 291 | |
| Pre-Treatment | NOT COMPLETED | Treatment 1 | 4 | |
| Pre-Treatment | NOT COMPLETED | Treatment 2 | 19 |
1 to 10 of 28Source ClinicalTrials.gov
See all 28 participant flowAdverse events1,788
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 | Treatment 1 | 82 | 345 | |
| other | Anaemia | Blood and lymphatic system disorders | Treatment 2 | 195 | 328 | |
| other | Anaemia | Blood and lymphatic system disorders | Treatment 3 | 193 | 304 | |
| other | Anaemia | Blood and lymphatic system disorders | Treatment 4 | 170 | 301 | |
| other | Leukopenia | Blood and lymphatic system disorders | Treatment 1 | 1 | 345 | |
| other | Leukopenia | Blood and lymphatic system disorders | Treatment 2 | 24 | 328 | |
| other | Leukopenia | Blood and lymphatic system disorders | Treatment 3 | 42 | 304 | |
| other | Leukopenia | Blood and lymphatic system disorders | Treatment 4 | 33 | 301 | |
| other | Neutropenia | Blood and lymphatic system disorders | Treatment 1 | 1 | 345 | |
| other | Neutropenia | Blood and lymphatic system disorders | Treatment 2 | 104 | 328 |
1 to 10 of 1,788Source ClinicalTrials.gov
See all 1,788 adverse eventsAdverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Treatment 1 | 257 | 349 |
| Total, all-cause mortality | Treatment 2 | 294 | 357 |
| Total, all-cause mortality | Treatment 3 | 172 | 304 |
| Total, all-cause mortality | Treatment 4 | 193 | 304 |
| Total, other adverse events | Treatment 1 | 322 | 345 |
| Total, other adverse events | Treatment 2 | 309 | 328 |
| Total, other adverse events | Treatment 3 | 298 | 304 |
| Total, other adverse events | Treatment 4 | 295 | 301 |
| Total, serious adverse events | Treatment 1 | 264 | 345 |
| Total, serious adverse events | Treatment 2 | 170 | 328 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse event totalsPapers2
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 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/NCT03036098
GET https://conductscience.org/api/trials/v1/NCT03036098/results?page=2