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

Primary Purpose

Melanoma, Urothelial Carcinoma

Status

Withdrawn

Phase

Phase 2

Locations

International

Study Type

Interventional

Intervention

Nivolumab/rHuPH20

Nivolumab

About this trial

This is an interventional treatment trial for Melanoma focused on measuring Resected Invasive Urothelial Carcinoma, Nivolumab, Bladder, Melanoma, Adjuvant, Subcutaneous

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Local Institution - 0020
Local Institution - 0001
Local Institution - 0002

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Nivolumab IV followed by Nivolumab SC

Arm Description

Outcomes

Primary Outcome Measures

Proportion of Participants That Prefer Nivolumab SC at the First Assessment of Patient Preference Using Patient Experience and Preference Questionnaire (PEPQ) (Question 1)

Secondary Outcome Measures

Number of Participants with Adverse Events (AEs)

Proportion of Participants That Prefer Nivolumab SC at the Second Assessment of Patient Preference Using PEPQ (Question 1)

Full Information

NCT ID

NCT05496192

First Posted

August 9, 2022

Last Updated

April 12, 2023

Sponsor

Bristol-Myers Squibb

1. Study Identification

Unique Protocol Identification Number

NCT05496192

Brief Title

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

Official Title

A Phase II Study of Adjuvant Nivolumab Switch From Intravenous (IV) to Subcutaneous (SC) Use in Participants With Resected Stage III or Stage IV Melanoma or High Risk Invasive Urothelial Carcinoma Originating in the Bladder

Study Type

Interventional

2. Study Status

Record Verification Date

April 2023

Overall Recruitment Status

Withdrawn

Why Stopped

Replaced it with another clinical trial

Study Start Date

May 31, 2023 (Anticipated)

Primary Completion Date

June 24, 2024 (Anticipated)

Study Completion Date

June 24, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Bristol-Myers Squibb

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Melanoma, Urothelial Carcinoma

Keywords

Resected Invasive Urothelial Carcinoma, Nivolumab, Bladder, Melanoma, Adjuvant, Subcutaneous

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

0 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Nivolumab IV followed by Nivolumab SC

Arm Type

Experimental

Intervention Type

Drug

Intervention Name(s)

Nivolumab/rHuPH20

Other Intervention Name(s)

Opdivo, BMS-986298

Intervention Description

Specified dose on specified days

Intervention Type

Drug

Intervention Name(s)

Nivolumab

Other Intervention Name(s)

Opdivo, BMS-936558

Intervention Description

Specified dose on specified days

Primary Outcome Measure Information:

Title

Proportion of Participants That Prefer Nivolumab SC at the First Assessment of Patient Preference Using Patient Experience and Preference Questionnaire (PEPQ) (Question 1)

Time Frame

Up to 24 hours after first full dose at Cycle 4, Day 1 (98 Days)

Secondary Outcome Measure Information:

Title

Number of Participants with Adverse Events (AEs)

Time Frame

Up to 100 days following last dose of nivolumab (Up to Day 465)

Title

Proportion of Participants That Prefer Nivolumab SC at the Second Assessment of Patient Preference Using PEPQ (Question 1)

Time Frame

Up to 24 hours after fourth full dose at Cycle 5, Day 15 (140 Days)

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Bristol-Myers Squibb

Organizational Affiliation

Bristol-Myers Squibb

Official's Role

Study Director

Facility Information:

Facility Name

Local Institution - 0020

City

Essen

State/Province

North Rhine-Westphalia

ZIP/Postal Code

45136

Country

Germany

Facility Name

Local Institution - 0001

City

Berlin

ZIP/Postal Code

10117

Country

Germany

Facility Name

Local Institution - 0002

City

Sevilla

ZIP/Postal Code

41013

Country

Spain

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing Plan Description

BMS will provide access to individual anonymized participant data upon request from qualified researchers, and subject to certain criteria. Additional information regarding Bristol Myer Squibb's data sharing policy and process can be found at: https://www.bms.com/researchers-and-partners/clinical-trials-and research/disclosurecommitment.html

IPD Sharing Time Frame

See Plan Description

IPD Sharing Access Criteria

See Plan Description

Links:

URL

https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html

Description

BMS Clinical Trial Information

URL

https://www.bmsstudyconnect.com/s/US/English/USenHome

Description

BMS Clinical Trial Patient Recruiting

URL

https://www.fda.gov/Safety/MedWatch/SafetyInformation/default.htm

Description

FDA Safety Alerts and Recalls

Learn more about this trial

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

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