For Healthcare Professionals

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

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About the study

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.
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Who can take part

You may be eligible to participate in the study if you meet the following criteria:

INCLUSION CRITERIA

Inclusion Criteria:


  1. 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
  2. Complete resection performed within 12 weeks prior to randomization or treatment assignment
  3. Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 1

EXCLUSION CRITERIA

Exclusion Criteria:


  1. History of uveal or mucosal melanoma
  2. Untreated/unresected CNS metastases or leptomeningeal metastases
  3. Active, known or suspected autoimmune disease
  4. Serious or uncontrolled medical disorder 4 weeks prior to screening
  5. 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
  6. Prior immunotherapy treatments for any prior malignancies are not permitted

Other protocol-defined inclusion/exclusion criteria apply


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Study Locations

Enter your ZIP code/Postal code/PIN code to locate study sites near you:

How to Apply


Contact the study center to learn if this study is a good match for you.

Study’s details


Contition

Melanoma

Age (in years)

18+

Phase

Phase 3

Participants needed

14

Est. Completion Date

Feb 28, 2024

Treatment type

Interventional


Sponsor

Bristol-Myers Squibb

ClinicalTrials.gov identifier

NCT05297565

Study number

CA2096GE

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