A Phase 2 Open-label, Two-cohort Study to Evaluate Patient Preference for nivolumab + relatlimab Fixed-dose Combination Subcutaneous versus nivolumab + relatlimab Fixed-dose Combination Intravenous and nivolumab Subcutaneous versus nivolumab Intravenous in Participants with Melanoma

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2023-504515-33-00

Acronym

CA224-1044

Enrollment

Registered

2024-01-16

Start date

2024-02-19

Completion date

Unknown

Last updated

2026-01-05

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

Conditions

Melanoma

Brief summary

The main endpoint in both groups is the percentage of participants who prefer having the treatment given as SC more than as IV.

Detailed description

The secondary endpoint in both groups is to see the side effects and abnormal laboratory tests during the study.

Interventions

DRUGFDC Nivolumab + Relatlimab + rHuPH20 Injection

DRUGNivolumab/Relatlimab

DRUGOPDIVO 10 mg/mL concentrate for solution for infusion.

DRUGNivolumab Subcutaneous

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
The main endpoint in both groups is the percentage of participants who prefer having the treatment given as SC more than as IV.	—

Secondary

Measure	Time frame
The secondary endpoint in both groups is to see the side effects and abnormal laboratory tests during the study.	—

Countries

Greece, Italy, Spain

Outcome results

None listed

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