A Study of Nivolumab Intravenous (IV) to Subcutaneous (SC... | NCT05496192

Studies
A Study of Nivolumab Intravenous (IV) to Subcutaneous (SC) Switch in Adjuvant Melanoma and Bladder Cancer

NCT05496192

Sponsor

Bristol-Myers Squibb

Status

Withdrawn

Last Update Posted

Apr 14, 2023Actual

Enrollment

0Actual

Phase

Phase 2

Conditions

Melanoma
Urothelial Carcinoma

Interventions

Nivolumab/rHuPH20
Nivolumab

Countries

Germany
Spain

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
2022-000294-67	EudraCT Number
U1111-1273-4725	Registry Identifier	WHO

Status Module

Record Verification Date

Apr 2023

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Replaced it with another clinical trial

Expanded Access Info

Start Date

May 31, 2023Estimated

Primary Completion Date

Jun 24, 2024Estimated

Completion Date

Jun 24, 2026Estimated

First Submitted Date

Aug 9, 2022

First Submission Date that Met QC Criteria

Aug 9, 2022

First Posted Date

Aug 11, 2022Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 12, 2023

Last Update Posted Date

Apr 14, 2023Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Yes

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The purpose of this study is to evaluate the switch from Nivolumab Intravenous (IV) infusions to Nivolumab Subcutaneous (SC) administration in participants with resected Stage IIIA/B/C/D or Stage IV melanoma or resected invasive Urothelial Carcinoma (UC) originating in the bladder who have high risk of recurrence.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Nivolumab IV followed by Nivolumab SC	Experimental		Drug: Nivolumab/rHuPH20 Drug: Nivolumab

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Nivolumab/rHuPH20	Drug	Specified dose on specified days	Nivolumab IV followed by Nivolumab SC

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Proportion of Participants That Prefer Nivolumab SC at the First Assessment of Patient Preference Using Patient Experience and Preference Questionnaire (PEPQ) (Question 1)		Up to 24 hours after first full dose at Cycle 4, Day 1 (98 Days)

Secondary Outcomes

Measure	Description	Time Frame
Number of Participants with Adverse Events (AEs)		Up to 100 days following last dose of nivolumab (Up to Day 465)
Proportion of Participants That Prefer Nivolumab SC at the Second Assessment of Patient Preference Using PEPQ (Question 1)		Up to 24 hours after fourth full dose at Cycle 5, Day 15 (140 Days)

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Participant must have Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1.
Participants must be eligible for adjuvant therapy for melanoma or muscle-invasive Urothelial Carcinoma (UC) originating from the bladder.
All participants must have disease-free status (DFS) documented by a complete physical examination and imaging studies within 4 weeks prior to treatment assignment.

Exclusion Criteria:

History of ocular or uveal or mucosal melanoma.
Upper tract UC (ureter, renal pelvis), non-muscle-invasive UC.
Concurrent malignancy (present during screening) requiring treatment or history of prior malignancy active within 2 years prior to treatment assignment.
Untreated/unresected Central Nervous System (CNS) or leptomeningeal metastases.

Other protocol-defined inclusion/exclusion criteria apply

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Bristol-Myers Squibb	Bristol-Myers Squibb	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Local Institution - 0020		Essen	North Rhine-Westphalia	45136	Germany
Local Institution - 0001

References Module

Citations

Not provided

Label	URL
BMS Clinical Trial Information	View source
BMS Clinical Trial Patient Recruiting	View source
FDA Safety Alerts and Recalls

ID	Term
D008545	Melanoma
D002295	Carcinoma, Transitional Cell

ID	Term
D018358	Neuroendocrine Tumors
D017599	Neuroectodermal Tumors
D009373	Neoplasms, Germ Cell and Embryonal
D009370	Neoplasms by Histologic Type

ID	Term
D061067	Antibodies, Monoclonal, Humanized
D000911	Antibodies, Monoclonal
D000906	Antibodies
D007136	Immunoglobulins