Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at San Francisco, California and other locations
Dates
study started
estimated completion

Description

Summary

The purpose of this study is to compare the drug levels of nivolumab administered subcutaneously versus intravenous administration in participants with melanoma following complete resection.

Official Title

A Phase 3, Open Label, Randomized, Non-Inferiority Pharmacokinetic Study of Nivolumab Administered Subcutaneously (Nivo SC) Versus Intravenous Administration of Nivolumab in Participants With Stage IIIA/B/C/D or Stage IV Adjuvant Melanoma Following Complete Resection

Keywords

Melanoma, Skin Cancer, rHuPH20, OPDIVO®, Nivolumab, Nivolumab/rHuPH20, Subcutaneous Nivolumab

Eligibility

You can join if…

Open to people ages 18 years and up

  • 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 CAN'T join 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

Other protocol-defined inclusion/exclusion criteria apply

Locations

  • UCSF Helen Diller Family Comprehensive Cancer Center not yet accepting patients
    San Francisco California 94158 United States
  • Local Institution - 0021 not yet accepting patients
    Edmonton Alberta T6G 1Z2 Canada

Details

Status
accepting new patients at some sites,
but this study is not currently recruiting here
Start Date
Completion Date
(estimated)
Sponsor
Bristol-Myers Squibb
Links
BMS Clinical Trial Information BMS Clinical Trial Patient Recruiting FDA Safety Alerts and Recalls Investigator Inquiry Form
ID
NCT05297565
Phase
Phase 3 research study
Study Type
Interventional
Participants
Expecting 286 study participants
Last Updated