MedDataX Logo

A Study to Compare Nivolumab Administered Subcutaneously vs Intravenous in Melanoma Participants Following Complete Resection

NCT ID: NCT05297565

Last Updated: 2025-02-27

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

14 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-08-02

Study Completion Date

2024-02-08

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The purpose of this study is to assess the safety and tolerability of subcutaneous nivolumab vs intravenous nivolumab in participants with completely resected Stage IIIA/B/C/D or Stage IV melanoma.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

A Study of Subcutaneous Nivolumab + Relatlimab Fixed-dose Combination (FDC) in Previously Untreated Metastatic or Unresectable Melanoma

NCT05625399

Melanoma
ACTIVE_NOT_RECRUITING PHASE3

A Study to Evaluate Whether Participants With Melanoma Prefer Subcutaneous vs Intravenous Administration of Nivolumab and Nivolumab + Relatlimab Fixed-dose Combinations

NCT06101134

Melanoma
ACTIVE_NOT_RECRUITING PHASE2

Neoadjuvant Trial of Nivolumab in Combination With HF10 Oncolytic Viral Therapy in Resectable Stage IIIB, IIIC, IVM1a Melanoma

NCT03259425

Melanoma
TERMINATED PHASE2

An Observational Study of Adjuvant (Post-surgery) Therapy With Nivolumab for Resected (Completely Removed) Melanoma in Australia

NCT04146324

Melanoma
COMPLETED

A Study to Assess Adjuvant Immunotherapy With Nivolumab Plus Relatlimab Versus Nivolumab Alone After Complete Resection of Stage III-IV Melanoma

NCT05002569

Melanoma
TERMINATED PHASE3

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Melanoma

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Arm A: Subcutaneous Nivolumab

Group Type EXPERIMENTAL

Nivolumab/rHuPH20

Intervention Type BIOLOGICAL

Specified dose on specified days

Arm B: Intravenous Nivolumab

Group Type ACTIVE_COMPARATOR

Nivolumab

Intervention Type BIOLOGICAL

Specified dose on specified days

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Nivolumab/rHuPH20

Specified dose on specified days

Intervention Type BIOLOGICAL

Nivolumab

Specified dose on specified days

Intervention Type BIOLOGICAL

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

BMS-986298 BMS-936558 Opdivo

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Stage IIIA/B/C/D or Stage IV melanoma and have histologically confirmed melanoma that is completely surgically resected (free of disease) with negative margins
* Complete resection performed within 12 weeks prior to randomization or treatment assignment
* Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 1

Exclusion Criteria

* History of uveal or mucosal melanoma
* Untreated/unresected CNS metastases or leptomeningeal metastases
* Active, known or suspected autoimmune disease
* Serious or uncontrolled medical disorder 4 weeks prior to screening
* Concurrent malignancy (present during screening) requiring treatment or history of prior malignancy active within 2 years prior to randomization or treatment assignment. Participants with history of prior early stage basal/squamous cell skin cancer or non-invasive or in situ cancers that have undergone definitive treatment at any time are eligible
* Prior immunotherapy treatments for any prior malignancies are not permitted
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Bristol-Myers Squibb

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Bristol-Myers Squibb

Role: STUDY_DIRECTOR

Bristol-Myers Squibb

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Local Institution - 0004

Fort Wayne, Indiana, United States

Site Status

Local Institution - 0044

Knoxville, Tennessee, United States

Site Status

Local Institution - 0038

Coffs Harbour, New South Wales, Australia

Site Status

Local Institution - 0003

Wollongong, New South Wales, Australia

Site Status

Local Institution - 0008

Bendigo, Victoria, Australia

Site Status

Local Institution - 0029

Ghent, , Belgium

Site Status

Local Institution - 0016

Milan, , Italy

Site Status

Local Institution - 0015

Napoli, , Italy

Site Status

Local Institution - 0034

Opole, Opole Voivodeship, Poland

Site Status

Local Institution - 0036

Bydgoszcz, , Poland

Site Status

Local Institution - 0026

Barcelona, , Spain

Site Status

Local Institution - 0002

Madrid, , Spain

Site Status

Local Institution - 0043

Madrid, , Spain

Site Status

Local Institution - 0005

Seville, , Spain

Site Status

Local Institution - 0030

Valencia, , Spain

Site Status

Local Institution - 0040

Leicester, Leicestershire, United Kingdom

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States Australia Belgium Italy Poland Spain United Kingdom

Provided Documents

Download supplemental materials such as informed consent forms, study protocols, or participant manuals.

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Related Links

Access external resources that provide additional context or updates about the study.

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

BMS Clinical Trial Information

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

FDA Safety Alerts and Recalls

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

BMS Clinical Trial Patient Recruiting

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2021-003208-42

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

U1111-1266-6116

Identifier Type: REGISTRY

Identifier Source: secondary_id

CA209-6GE

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Nivolumab Combined With Ipilimumab Followed by Nivolumab Monotherapy as First-Line Treatment for Patients With Advanced Melanoma
NCT02599402 COMPLETED PHASE3
A Study to Compare Nivolumab Drug Product Process D to Nivolumab Drug Product Process C in Participants With Stage IIIa/b/c/d or Stage IV Melanoma After Complete Resection
NCT03980314 COMPLETED PHASE1
PH 1 Biomarker Study of Nivolumab and Ipilimumab and Nivolumab in Combination With Ipilimumab in Advanced Melanoma
NCT01621490 COMPLETED PHASE1
Effectiveness Study of Nivolumab Compared to Placebo in Prevention of Recurrent Melanoma After Complete Resection of Stage IIB/C Melanoma
NCT04099251 ACTIVE_NOT_RECRUITING PHASE3
A Safety and Efficacy Study of Multiple Administration Regimens for Nivolumab Plus Ipilimumab in Subjects With Melanoma
NCT02905266 COMPLETED PHASE3
Efficacy Study of Nivolumab Compared to Ipilimumab in Prevention of Recurrence of Melanoma After Complete Resection of Stage IIIb/c or Stage IV Melanoma
NCT02388906 COMPLETED PHASE3
Real-world Outcomes Among Patients With Melanoma Treated With Neoadjuvant Nivolumab+Relatlimab or Nivolumab+Ipilimumab
NCT07091695 COMPLETED
IL2 With Ipilimumab Followed by Nivolumab in Stage 3 or 4 Melanoma Patients
NCT04562129 RECRUITING PHASE2
Ipilimumab and Nivolumab Followed by Adjuvant Nivolumab in Locally Advanced or Limited Metastatic Melanoma
NCT06566391 ACTIVE_NOT_RECRUITING PHASE2
Neoadjuvant Nivolumab+Ipilimumab Followed by Adjuvant Nivolumab or Neoadjuvant Nivolumab+Ipilimumab Followed by Adjuvant Observation Compared With Adjuvant Nivolumab in Treatment-Naive High-risk Melanoma Participants
NCT04495010 WITHDRAWN PHASE2
Study of Combination of Ipilimumab and Nivolumab in Patients With Melanoma
NCT02970981 COMPLETED PHASE2
A Phase II Trial of Neoadjuvant Treatment With PD-1 Inhibition (Nivolumab) With or Without IDO Inhibition (BMS-986205) and With or Without CTLA-4 Inhibition (Ipilimumab) in Resectable Stage III or IV Melanoma
NCT04007588 WITHDRAWN PHASE2
A Study of Two Different Dose Combinations of Nivolumab in Combination With Ipilimumab in Subjects With Previously Untreated, Unresectable or Metastatic Melanoma
NCT02714218 COMPLETED PHASE3
A Single-Arm, Open-Label, Multicenter Clinical Trial With Nivolumab (BMS-936558) for Subjects With Histologically Confirmed Stage III (Unresectable) or Stage IV Melanoma Progressing Post Prior Treatment Containing an Anti-CTLA4 Monoclonal Antibody (CheckMate 172)
NCT02156804 COMPLETED PHASE2
A Trial Evaluating the Safety & Efficacy of Intra-Tumoral Ipilimumab in Combination With Intra-venous Nivolumab in Patients With Metastatic Melanoma
NCT02857569 COMPLETED PHASE1/PHASE2
Neoadjuvant Ipilimumab/Nivolumab for Patients With Recurrent, High Risk, Resectable Melanoma
NCT06365619 RECRUITING PHASE2
A Comparison of Nivolumab-based Treatments in a Real-world PD-L1 Positive Metastatic Melanoma Population in the US
NCT03732560 COMPLETED
Study of Nivolumab Given Sequentially With Ipilimumab in Subjects With Advanced or Metastatic Melanoma (CheckMate 064)
NCT01783938 COMPLETED PHASE2
A Phase 1b Study of the Selective HDAC Inhibitor Mocetinostat in Combination With Ipilimumab and Nivolumab in Patients With Unresectable Stage III or Stage IV Melanoma
NCT03565406 TERMINATED PHASE1
An Investigational Immuno-therapy Study of BMS-986205 Combined With Nivolumab, Compared to Nivolumab by Itself, in Patients With Advanced Melanoma
NCT03329846 COMPLETED PHASE3
Neoadjuvant Immunotherapy With Tavo + Electroporation in Combination With Nivo. in Melanoma Patients
NCT04526730 ACTIVE_NOT_RECRUITING PHASE2
A Study of Treatment Patterns and Outcomes in Participants With Stage IIIA Melanoma Receiving Adjuvant Systemic Therapy
NCT05432622 COMPLETED
A Prospective Non-Interventional Study in Participants Receiving Nivolumab in Adjuvant Setting for Resected Melanoma in Real-World Conditions in France
NCT04550247 ACTIVE_NOT_RECRUITING
Talimogene Laherparepvec and Pembrolizumab in Treating Patients With Stage III-IV Melanoma
NCT02965716 ACTIVE_NOT_RECRUITING PHASE2
A Study of NKTR-214 Combined With Nivolumab vs Nivolumab Alone in Participants With Previously Untreated Inoperable or Metastatic Melanoma
NCT03635983 COMPLETED PHASE3