Trial · NCT04209114

A Study of Nivolumab Plus Bempegaldesleukin (Bempeg/NKTR-214) vs Nivolumab Alone vs Standard of Care in Participants With Bladder Cancer That May Have Invaded The Muscle Wall of the Bladder and Who Cannot Get Cisplatin, A Type of Medicine Given To Treat Bladder Cancer

NCT04209114, Phase 3, Completed, Bristol-Myers Squibb; results first posted 2024-06-27

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. A Study of Nivolumab Plus Bempegaldesleukin (Bempeg/NKTR-214) vs Nivolumab Alone vs Standard of Care in Participants With Bladder Cancer That May Have Invaded The Muscle Wall of the Bladder and Who Cannot Get Cisplatin, A Type of Medicine Given To Treat Bladder Cancer. Trials, record NCT04209114. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04209114

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: A Study of Nivolumab Plus Bempegaldesleukin (Bempeg/NKTR-214) vs Nivolumab Alone vs Standard of Care in Participants With Bladder Cancer That May Have Invaded The Muscle Wall of the Bladder and Who Cannot Get Cisplatin, A Type of Medicine Given To Treat Bladder Cancer
NCT number: NCT04209114
Status: Completed
Phases: Phase 3
Enrollment: 114 participants, actual
Lead sponsor: Bristol-Myers Squibb
Conditions: Bladder Cancer, Bladder Tumor, Muscle-Invasive Bladder Cancer
Interventions: Nivolumab, Radical cystectomy (RC), Bempegaldesleukin
First posted: 2019-12-23
Last updated: 2024-06-27
Other registries' IDs: eudract:2018-002676-40
Results first posted: 2024-06-27
Limitations and caveats: BMS and Nektar Therapeutics jointly decided to terminate the clinical development program for bempegaldesleukin (NKTR-214) in combination with nivolumab. Discontinued survival follow-up and the stopping of submission of local labs to vendors, imaging to the BICR vendor, and PROs have resulted in confounded and incomplete trial results.

Source ClinicalTrials.gov

Registered outcomes10

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Pathologic Complete Response (pCR) Rate- Nivolumab + Bempegaldesleukin Compared to Standard of Care	From time of radical cystectomy up to 100 days after last treatment (up to approximately 17 months)	Pathologic Complete Response (pCR) is defined as the percentage of randomized participants with absence of any cancer in pathology specimens after radical cystectomy, based on blinded independent pathology review (BIPR). Participants who do not undertake surgery will be counted as non-pCR.
Primary	Event Free Survival (EFS) - Nivolumab + Bempegaldesleukin Compared to Standard of Care	From randomization up to first EFS event (up to approximately 30 months)	Event Free Survival (EFS) is defined as the time from randomization to any of the following events: progression of disease that precludes surgery, local or distant recurrence based on blinded independent committee review (BICR) assessments, or death due to any cause. Participants who did not have an EFS event will be censored on the date of their last evaluable tumor assessment (imaging or biopsy) or at the date of radical surgery whichever occur last. Participants who did not have any baseline tumor assessments (imaging or biopsy) and did not undergo radical cystectomy for other reason than worsening/progression of disease will be censored on their date of randomization. Participants who did not have any on study tumor assessments (imaging or biopsy) and did not die will be censored on their date of radical cystectomy (or randomization date if no radical cystectomy performed).
Secondary	Pathologic Complete Response (pCR) Rate - Nivolumab Compared to Standard of Care	From time of radical cystectomy up to 100 days after last treatment (up to approximately 17 months)	Pathologic Complete Response (pCR) is defined as the percentage of randomized participants with absence of any cancer in pathology specimens after radical cystectomy, based on blinded independent pathology review (BIPR). Participants who do not undertake surgery will be counted as non-pCR.
Secondary	Event Free Survival (EFS) - Nivolumab Compared to Standard of Care	From randomization up to first EFS event (up to approximately 30 months)	Event Free Survival (EFS) is defined as the time from randomization to any of the following events: progression of disease that precludes surgery, local or distant recurrence based on blinded independent committee review (BICR) assessments, or death due to any cause. Participants who did not have an EFS event will be censored on the date of their last evaluable tumor assessment (imaging or biopsy) or at the date of radical surgery whichever occur last. Participants who did not have any baseline tumor assessments (imaging or biopsy) and did not undergo radical cystectomy for other reason than worsening/progression of disease will be censored on their date of randomization. Participants who did not have any on study tumor assessments (imaging or biopsy) and did not die will be censored on their date of radical cystectomy (or randomization date if no radical cystectomy performed).
Secondary	Overall Survival (OS)	From randomization to study completion, up to approximately 40 months	Overall Survival (OS) is defined as the time between the date of randomization and the date of death. For those without documentation of death, OS will be censored on the last date the participant was known to be alive. OS was not calculated for Arm A and Arm B because the number of events did not meet the threshold due to early study termination. In lieu of OS, time to death is reported as a Post-Hoc endpoint.
Secondary	The Number of Participants Experiencing Adverse Events (AEs)	from first dose to 100 days following last dose (up to approximately 20 months)	An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a pre-existing medical condition in a clinical investigation participant administered study treatment and that does not necessarily have a causal relationship with this treatment. Adverse events are graded on a scale from 1 to 5, with Grade 1 being mild and asymptomatic; Grade 2 is moderate requiring minimal, local or noninvasive intervention; Grade 3 is severe or medically significant but not immediately life-threatening; Grade 4 events are usually severe enough to require hospitalization; Grade 5 events are fatal.
Secondary	The Number of Participants Experiencing Serious Adverse Events (SAEs)	from first dose to 100 days following last dose (up to approximately 20 months)	A Serious Adverse Event (SAE) is defined as any untoward medical occurrence that, at any dose results in death, is life-threatening (defined as an event in which the participant was at risk of death at the time of the event; it does not refer to an event which hypothetically might have caused death if it were more severe), requires inpatient hospitalization or causes prolongation of existing hospitalization.
Secondary	The Number of Participants Experiencing Adverse Events (AEs) Leading to Discontinuation	from first dose to 100 days following last dose (up to approximately 20 months)	An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a pre-existing medical condition in a clinical investigation participant administered study treatment and that does not necessarily have a causal relationship with this treatment. Adverse events are graded on a scale from 1 to 5, with Grade 1 being mild and asymptomatic; Grade 2 is moderate requiring minimal, local or noninvasive intervention; Grade 3 is severe or medically significant but not immediately life-threatening; Grade 4 events are usually severe enough to require hospitalization; Grade 5 events are fatal.
Secondary	The Number of Participants Experiencing Immune-Mediated Adverse Events (IMAEs)	from first dose to 100 days following last dose (up to approximately 20 months)	IMAEs are specific AEs that include pneumonitis, diarrhea/colitis, hepatitis, nephritis/renal dysfunction, rash, endocrine (adrenal insufficiency, hypothyroidism/thyroiditis, hyperthyroidism, diabetes mellitus, and hypophysitis), and other specific events, considered as potential immune-mediated events by investigator that meet the definition summarized below: * those occurring within 100 days of the last dose, * regardless of causality, * treated with immune-modulating medication (of note, endocrine AEs such as adrenal insufficiency, hypothyroidism/thyroiditis, hyperthyroidism, diabetes mellitus, and hypophysitis are considered IMAEs regardless of immune-modulating medication use, since endocrine drug reactions are often managed without immune-modulating medication). * with no clear alternate etiology based on investigator assessment, or with an immune-mediated component.
Secondary	Worst Grade Clinical Laboratory Values	From first dose to 100 days following last dose (up to approximately 20 months)	Clinical laboratory values by worst CTC grade are graded on a scale from 1 to 5, with Grade 1 being mild and asymptomatic; Grade 2 is moderate requiring minimal, local or noninvasive intervention; Grade 3 is severe or medically significant but not immediately life-threatening; Grade 4 events are usually severe enough to require hospitalization; Grade 5 events are fatal.

Source ClinicalTrials.gov

Outcomes11

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Pathologic Complete Response (pCR) Rate- Nivolumab + Bempegaldesleukin Compared to Standard of Care	From time of radical cystectomy up to 100 days after last treatment (up to approximately 17 months)	All randomized participants in Arms A and C	Percentage of participants	NUMBER
PRIMARY	Event Free Survival (EFS) - Nivolumab + Bempegaldesleukin Compared to Standard of Care	From randomization up to first EFS event (up to approximately 30 months)	All randomized participants in Arms A and C	Months	MEDIAN
SECONDARY	Pathologic Complete Response (pCR) Rate - Nivolumab Compared to Standard of Care	From time of radical cystectomy up to 100 days after last treatment (up to approximately 17 months)	All randomized participants in Arms B and C	Percentage of participants	NUMBER
SECONDARY	Event Free Survival (EFS) - Nivolumab Compared to Standard of Care	From randomization up to first EFS event (up to approximately 30 months)	All randomized participants in Arms B and C	Months	MEDIAN
SECONDARY	Overall Survival (OS)	From randomization to study completion, up to approximately 40 months	All randomized participants	Months	MEDIAN
POST_HOC	Time to Death	From randomization to study completion, up to approximately 40 months	All randomized participants	Months	MEDIAN
SECONDARY	The Number of Participants Experiencing Adverse Events (AEs)	from first dose to 100 days following last dose (up to approximately 20 months)	All treated participants	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	The Number of Participants Experiencing Serious Adverse Events (SAEs)	from first dose to 100 days following last dose (up to approximately 20 months)	All treated participants	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	The Number of Participants Experiencing Adverse Events (AEs) Leading to Discontinuation	from first dose to 100 days following last dose (up to approximately 20 months)	All treated participants	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	The Number of Participants Experiencing Immune-Mediated Adverse Events (IMAEs)	from first dose to 100 days following last dose (up to approximately 20 months)	All treated participants	Participants	COUNT_OF_PARTICIPANTS

1 to 10 of 11Source ClinicalTrials.gov

See all 11 outcomes

Results by group314

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Spread	Units
Pathologic Complete Response (pCR) Rate- Nivolumab + Bempegaldesleukin Compared to Standard of Care	Arm A: Nivolumab + Bempegaldesleukin	10.8	95% Confidence Interval 3.0 to 25.4	Percentage of participants
Pathologic Complete Response (pCR) Rate- Nivolumab + Bempegaldesleukin Compared to Standard of Care	Arm C: Standard of Care	2.5	95% Confidence Interval 0.1 to 13.2	Percentage of participants
Event Free Survival (EFS) - Nivolumab + Bempegaldesleukin Compared to Standard of Care	Arm A: Nivolumab + Bempegaldesleukin	22.11	95% Confidence Interval 8.21 to NA	Months
Event Free Survival (EFS) - Nivolumab + Bempegaldesleukin Compared to Standard of Care	Arm C: Standard of Care	15.18	95% Confidence Interval 11.63 to NA	Months
Pathologic Complete Response (pCR) Rate - Nivolumab Compared to Standard of Care	Arm B: Nivolumab	10.8	95% Confidence Interval 3.0 to 25.4	Percentage of participants
Pathologic Complete Response (pCR) Rate - Nivolumab Compared to Standard of Care	Arm C: Standard of Care	2.5	95% Confidence Interval 0.1 to 13.2	Percentage of participants
Event Free Survival (EFS) - Nivolumab Compared to Standard of Care	Arm B: Nivolumab	NA	95% Confidence Interval 10.84 to NA	Months
Event Free Survival (EFS) - Nivolumab Compared to Standard of Care	Arm C: Standard of Care	15.18	95% Confidence Interval 11.63 to NA	Months
Overall Survival (OS)	Arm A: Nivolumab + Bempegaldesleukin	NA	95% Confidence Interval NA to NA	Months
Overall Survival (OS)	Arm B: Nivolumab	NA	95% Confidence Interval NA to NA	Months

1 to 10 of 314Source ClinicalTrials.gov

See all 314 results by group

Participant flow18

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Pre-Treatment Phase	STARTED	Arm A: Nivolumab + Bempegaldesleukin	37
Pre-Treatment Phase	STARTED	Arm B: Nivolumab	37
Pre-Treatment Phase	STARTED	Arm C: Standard of Care	40
Pre-Treatment Phase	COMPLETED	Arm A: Nivolumab + Bempegaldesleukin	37
Pre-Treatment Phase	COMPLETED	Arm B: Nivolumab	37
Pre-Treatment Phase	COMPLETED	Arm C: Standard of Care	32
Pre-Treatment Phase	NOT COMPLETED	Arm A: Nivolumab + Bempegaldesleukin	0
Pre-Treatment Phase	NOT COMPLETED	Arm B: Nivolumab	0
Pre-Treatment Phase	NOT COMPLETED	Arm C: Standard of Care	8
Treatment Phase	STARTED	Arm A: Nivolumab + Bempegaldesleukin	37

1 to 10 of 18Source ClinicalTrials.gov

See all 18 participant flow

Adverse events387

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
other	Anaemia	Blood and lymphatic system disorders	Arm A: Nivolumab + Bempegaldesleukin	4	37
other	Anaemia	Blood and lymphatic system disorders	Arm B: Nivolumab	7	37
other	Anaemia	Blood and lymphatic system disorders	Arm C: Standard of Care	2	32
other	Eosinophilia	Blood and lymphatic system disorders	Arm A: Nivolumab + Bempegaldesleukin	2	37
other	Eosinophilia	Blood and lymphatic system disorders	Arm B: Nivolumab	0	37
other	Eosinophilia	Blood and lymphatic system disorders	Arm C: Standard of Care	0	32
other	Hyperleukocytosis	Blood and lymphatic system disorders	Arm A: Nivolumab + Bempegaldesleukin	2	37
other	Hyperleukocytosis	Blood and lymphatic system disorders	Arm B: Nivolumab	0	37
other	Hyperleukocytosis	Blood and lymphatic system disorders	Arm C: Standard of Care	0	32
other	Bradycardia	Cardiac disorders	Arm A: Nivolumab + Bempegaldesleukin	1	37

1 to 10 of 387Source ClinicalTrials.gov

See all 387 adverse events

Adverse event totals9

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Arm A: Nivolumab + Bempegaldesleukin	8	37
Total, all-cause mortality	Arm B: Nivolumab	6	37
Total, all-cause mortality	Arm C: Standard of Care	12	40
Total, other adverse events	Arm A: Nivolumab + Bempegaldesleukin	32	37
Total, other adverse events	Arm B: Nivolumab	29	37
Total, other adverse events	Arm C: Standard of Care	18	32
Total, serious adverse events	Arm A: Nivolumab + Bempegaldesleukin	16	37
Total, serious adverse events	Arm B: Nivolumab	22	37
Total, serious adverse events	Arm C: Standard of Care	15	32

Source ClinicalTrials.gov

Papers0

The papers the trial lists on ClinicalTrials.gov.

None in this release.

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.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

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.

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Read this trial from software.

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