NCT05496192

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.

Trial Health

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Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Timeline
0mo left

Started May 2023

Typical duration for phase_2

Geographic Reach
2 countries

3 active sites

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress99%
May 2023Jun 2026

First Submitted

Initial submission to the registry

August 9, 2022

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 11, 2022

Completed
10 months until next milestone

Study Start

First participant enrolled

May 31, 2023

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 24, 2024

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 24, 2026

Expected
Last Updated

April 14, 2023

Status Verified

April 1, 2023

Enrollment Period

1.1 years

First QC Date

August 9, 2022

Last Update Submit

April 12, 2023

Conditions

MelanomaUrothelial Carcinoma

Keywords

Resected Invasive Urothelial CarcinomaNivolumabBladderMelanomaAdjuvantSubcutaneous

Outcome Measures

Primary Outcomes (1)

  • 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 (2)

  • 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)

Study Arms (1)

Nivolumab IV followed by Nivolumab SC

EXPERIMENTAL
Drug: Nivolumab/rHuPH20Drug: Nivolumab

Interventions

Nivolumab/rHuPH20DRUG

Specified dose on specified days

Also known as: Opdivo, BMS-986298
Nivolumab IV followed by Nivolumab SC
NivolumabDRUG

Specified dose on specified days

Also known as: Opdivo, BMS-936558
Nivolumab IV followed by Nivolumab SC

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Local Institution - 0020

Essen, North Rhine-Westphalia, 45136, Germany

Location

Local Institution - 0001

Berlin, 10117, Germany

Location

Local Institution - 0002

Seville, 41013, Spain

Location

Related Links

MeSH Terms

Conditions

MelanomaCarcinoma, Transitional Cell

Interventions

Nivolumab

Condition Hierarchy (Ancestors)

Neuroendocrine TumorsNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasmsNeoplasms, Nerve TissueNevi and MelanomasSkin NeoplasmsNeoplasms by SiteSkin DiseasesSkin and Connective Tissue DiseasesCarcinomaNeoplasms, Glandular and Epithelial

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, HumanizedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulins

Study Officials

  • Bristol-Myers Squibb

    Bristol-Myers Squibb

    STUDY DIRECTOR
0

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 9, 2022

First Posted

August 11, 2022

Study Start

May 31, 2023

Primary Completion

June 24, 2024

Study Completion (Estimated)

June 24, 2026

Last Updated

April 14, 2023

Record last verified: 2023-04

Data Sharing

IPD Sharing
Will share

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

Shared Documents
STUDY PROTOCOL, SAP, CSR
Time Frame
See Plan Description
Access Criteria
See Plan Description

Locations

DE(2)ES(1)