A Phase 3, Randomized, Open-label, Study of Subcutaneous Nivolumab + Relatlimab Fixed-dose Combination versus Intravenous Nivolumab + Relatlimab Fixed-dose Combination in Participants with Previously Untreated Metastatic or Unresectable Melanoma

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2022-500967-11-00

Acronym

CA224-127

Enrollment

423

Registered

2023-03-14

Start date

2023-07-06

Completion date

Unknown

Last updated

2026-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Previously Untreated Metastatic or Unresectable Melanoma

Brief summary

Co-Primary: The amount of study drug in your body when given SC is not worse than IV for both nivolumab and relatlimab.

Detailed description

Secondary: Percentage of participants whose disease (skin cancer) decreased (Partial response – PR) and/or disappeared (Complete response – CR) after treatment when given under the skin is not worse as compared to given into the vein.

Interventions

DRUGFDC Nivolumab + Relatlimab + rHuPH20 Injection

DRUGNivolumab/Relatlimab

Eligibility

Sex/Gender

All

Age

0 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Co-Primary: The amount of study drug in your body when given SC is not worse than IV for both nivolumab and relatlimab.	—

Secondary

Measure	Time frame
Secondary: Percentage of participants whose disease (skin cancer) decreased (Partial response – PR) and/or disappeared (Complete response – CR) after treatment when given under the skin is not worse as compared to given into the vein.	—

Countries

Austria, Belgium, Czechia, Finland, France, Germany, Italy, Norway, Poland, Spain, Sweden

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026