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

NCT05297565 | Completed Phase 3 Results DMC FDA Drug

• 3 other identifiers: CA209-6GE2021-003208-42U1111-1266-6116
• Study Type: interventional
• Target: 14
• Locations: 7 countries
• Sites: 16

Brief Summary

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.

Conditions

Melanoma

Keywords

Skin Cancer; rHuPH20; OPDIVO®

Outcome Measures

Primary Outcomes (4)

• Number of Participants With Adverse Events

  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 that does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (such as an abnormal laboratory finding), symptom, or disease temporally associated with the use of study treatment, whether or not considered related to the study treatment.

  From first dose to 100 days post last dose (Approximately up to 14 Months)

• Number of Participants With Serious Adverse Events

  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.

  From first dose to 100 days post last dose (Approximately up to 14 Months)

• Number of Participants With Treatment Related Adverse Events

  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. An AE can therefore be any unfavorable and unintended sign (such as an abnormal laboratory finding), symptom or disease.

  From first dose to 100 days post last dose (Approximately up to 14 Months)

• Number of Participants With Treatment Related Serious Adverse Events

  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.

  From first dose to 100 days post last dose (Approximately up to 14 Months)

Study Arms (2)

Arm A: Subcutaneous Nivolumab

EXPERIMENTAL

Biological: Nivolumab/rHuPH20

Arm B: Intravenous Nivolumab

ACTIVE COMPARATOR

Biological: Nivolumab

Interventions

Nivolumab/rHuPH20 BIOLOGICAL

Specified dose on specified days

Also known as: BMS-986298

Arm A: Subcutaneous Nivolumab

Nivolumab BIOLOGICAL

Specified dose on specified days

Also known as: BMS-936558, Opdivo

Arm B: Intravenous Nivolumab

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Bristol-Myers Squibb: lead

Study Sites (16)

Local Institution - 0004

Fort Wayne, Indiana, 46804, United States

Location

Local Institution - 0044

Knoxville, Tennessee, 37920, United States

Location

Local Institution - 0038

Coffs Harbour, New South Wales, 2450, Australia

Location

Local Institution - 0003

Wollongong, New South Wales, 2500, Australia

Location

Local Institution - 0008

Bendigo, Victoria, 3550, Australia

Location

Local Institution - 0029

Ghent, 9000, Belgium

Location

Local Institution - 0016

Milan, 20141, Italy

Location

Local Institution - 0015

Napoli, 80131, Italy

Location

Local Institution - 0034

Opole, Opole Voivodeship, 45-061, Poland

Location

Local Institution - 0036

Bydgoszcz, 85-796, Poland

Location

Local Institution - 0026

Barcelona, 08003, Spain

Location

Local Institution - 0002

Madrid, 28036, Spain

Location

Local Institution - 0043

Madrid, 28050, Spain

Location

Local Institution - 0005

Seville, 41009, Spain

Location

Local Institution - 0030

Valencia, 46014, Spain

Location

Local Institution - 0040

Leicester, Leicestershire, LE1 5WW, United Kingdom

Location

Related Links

• BMS Clinical Trial Information
• FDA Safety Alerts and Recalls
• BMS Clinical Trial Patient Recruiting

MeSH Terms

Conditions

Melanoma; Skin Neoplasms

Interventions

Nivolumab

Condition Hierarchy (Ancestors)

Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue; Nevi and Melanomas; Neoplasms by Site; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Results Point of Contact

• Title: Bristol-Myers Squibb Study Director
• Organization: Bristol-Myers Squibb

Clinical.Trials@bms.com

1-855-907-3286

Study Officials

• Bristol-Myers Squibb

  Bristol-Myers Squibb

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR
• Expanded Access: Yes

Study Record Dates

• First Submitted: March 17, 2022
• First Posted: March 28, 2022
• Study Start: August 2, 2022
• Primary Completion: February 8, 2024
• Study Completion: February 8, 2024
• Last Updated: February 27, 2025
• Results First Posted: February 27, 2025

Record last verified: 2025-02

Locations

BE (1); PL (2); AU (3); ES (5); IT (2); GB (1); US (2)