Evaluating the Effect of Nivolumab for Patients With In-transit Metastases Treated With Isolated Limb Perfusion

Phase 1

Recruiting

• Conditions: Melanoma; In-Transit Metastasis
• Interventions: Drug: Nivolumab; Procedure: Isolated limb perfusion (ILP)

• Registration Number: NCT03685890
• Lead Sponsor: Vastra Gotaland Region

Brief Summary

To evaluate safety and the effect of isolated limb perfusion together with nivolumab as a way to increase efficacy and give further insights in early immunological mechanisms.

In the first phase Ib part, 20 patients will be enrolled and followed for a minimum of 3 months. An independent data safety monitoring board (DSMB) will continuously review safety and judge the seriousness of the events and also recommend the study to stop if necessary. If the DSMB do not find safety issues, the trial will continue as a phase II trial.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2018-09-23
• Study First Submitted QC: 2018-09-24
• Study First Posted: 2018-09-26
• Study Start: 2019-04-01
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-24
• Last Update Posted: 2024-04-25
• Primary Completion: 2026-12-31
• Study Completion: 2029-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 74

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ILP + Nivolumab	Isolated limb perfusion (ILP)	The day before planned ILP, the patient will receive one infusion of nivolumab 480mg
ILP + Placebo	Isolated limb perfusion (ILP)	The day before planned ILP, the patient will receive one infusion of placebo
ILP + Nivolumab	Nivolumab	The day before planned ILP, the patient will receive one infusion of nivolumab 480mg

Primary Outcome Measures

Name	Time	Method
Complete response rate (CR)	3 months	To evaluate if melphalan based isolated limb perfusion (ILP) synergizes with nivolumab in inducing complete responses (CR) at 3 months after treatment in melanoma patients with in-transit metastasis.

Secondary Outcome Measures

Name	Time	Method
Progression-free survival (PFS)	36 months	Evaluation of PFS, defined as the number of months from the date of ILP to the date of the first documented disease recurrence or progression at any site.
Melanoma specific survival (MSS)	36 months	Evaluation of melanoma specific survival (MSS), MSS is calculated as the time from date of treatment to date of death due to any cause. Both median MSS and the per cent of patients alive at 36 months will be evaluated.
Quality of life measured by FACT-M	36 months	Quality of life (QoL) by FACT-M. Change from baseline for all subscales as well as for the total scores.
Time to local progression (TTLP)	36 months	Evaluation of local progression-free survival (LPFS). LPFS is defined as the number of months from the date of ILP to the date of the first documented disease recurrence or progression in the treated area (defined as the area below the tourniquet used for ILP). LPFS will be determined based on clinical assessments according to RECIST version 1.1 criteria.
Distant metastases-free survival (DMFS)	36 months	Evaluation of DMFS, defined as the number of months from the date of ILP to the date of the first documented distant disease recurrence.
Overall survival (OS)	36 months	Evaluation of overall survival (OS), OS is calculated as the time from date of treatment to date of death due to any cause. Both median OS and the per cent of patients alive at 36 months will be evaluated.
Quality of life measured by EQ-5D	36 months	Quality of life (QoL) by EQ-5D measured as the change from baseline

Trial Locations

Locations (3)

Erasmus MC Cancer Institute; 🇳🇱 Rotterdam, Netherlands

Sahlgrenska University Hospital; 🇸🇪 Gothenburg, Sweden

Netherlands Cancer Institute; 🇳🇱 Amsterdam, Netherlands