A phase Ib/II randomized double-blind placebo controlled trial evaluating the effect of nivolumab for patients with in-transit melanoma metastases treated with isolated limb perfusion

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2023-509265-21-00

Acronym

the NivoILP trial

Enrollment

Registered

2024-02-19

Start date

2019-04-08

Completion date

Unknown

Last updated

2025-04-23

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

Conditions

In-transit metastasis of malignant melanoma

Brief summary

CR rate at 3 months after ILP measured according to RECIST 1.1 criteria.

Detailed description

Time to local progression (TTLP), Distant metastases-free survival (DMFS), Progression-free survival (PFS), Overall survival (OS), Melanoma-specific survival (MSS), Adverse Events (AE) and Serious Adverse Events (SAE), QoL (FACT-M and EQ-5D), The quantitative and qualitative effects of ILP vs. ILP + nivolumab on immune cell phenotypes and function

Interventions

DRUGSODIUM CHLORIDE

DRUGOPDIVO 10 mg/mL concentrate for solution for infusion.

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
CR rate at 3 months after ILP measured according to RECIST 1.1 criteria.	—

Secondary

Measure	Time frame
Time to local progression (TTLP), Distant metastases-free survival (DMFS), Progression-free survival (PFS), Overall survival (OS), Melanoma-specific survival (MSS), Adverse Events (AE) and Serious Adverse Events (SAE), QoL (FACT-M and EQ-5D), The quantitative and qualitative effects of ILP vs. ILP + nivolumab on immune cell phenotypes and function	—

Countries

Netherlands, Sweden

Outcome results

None listed

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