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Evaluating the Effect of Nivolumab for Patients With In-transit Metastases Treated With Isolated Limb Perfusion | Clinical Trials | Clareo Health

RECRUITINGPHASE1/PHASE2

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

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 - the NivoILP Trial

NCT03685890•Vastra Gotaland Region

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Male or female aged above 18 years.
•2. Signed and dated written informed consent before the start of specific protocol procedures.
•3. Histologically or cytologically proven in-transit metastases of malignant melanoma with or without regional lymph node metastases (AJCC v8 stage N1c, N2c and N3c).
•4. Measurable disease with at least 1 metastasis measuring at least 5mm
•5. ECOG performance status of 0-2

Exclusion Criteria

•1. 1\. Life expectancy of less than 6 months
•2. Inability to understand given information or undergo study procedures according to protocol.
•3. Pregnant or breast-feeding. Women of childbearing potential must have a negative pregnancy test performed within 24 hours before the administration of study drug.
•4. Patients must agree to follow instructions for method of contraception for 5 months (women) and 7 months (males) after treatment.
•5. Active cardiac conditions, including unstable coronary syndromes (unstable or severe angina, recent myocardial infarction), significant arrhythmias and severe valvular disease that precludes general anaesthesia.
•6. History or evidence of clinically significant pulmonary disease e.g., severe COPD that precludes general anesthesia.
•7. Reduced renal function defined as S-Creatinine \>=1.5xULN
•8. Reduced hepatic function (defined as ASAT, ALAT, bilirubin \>1.5 ULN and PK-INR \>1.5) or a medical history of liver cirrhosis or portal hypertension.
•9. Reduced blood leukocytes or platelets defined as a leucocyte count \< 2.0x109/L and thrombocyte count \<100x109/L.
•10. Active, autoimmune disease. Subjects are permitted to enrolment if they have vitiligo, type I diabetes mellitus, residual hypothyroidism due to autoimmune condition only requiring hormone replacement, psoriasis not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger.
+5 more criteria

Locations (4)

Netherlands Cancer Institute

Amsterdam, Netherlands

Erasmus MC Cancer Institute

Groningen, Netherlands

Erasmus MC Cancer Institute

Rotterdam, Netherlands

Sahlgrenska University Hospital

Gothenburg, Sweden

Key Dates

Start Date

April 1, 2019

Primary Completion Date

December 31, 2026

Completion Date

December 31, 2029

Last Updated

April 25, 2024

Enrollment

ESTIMATED participants

Conditions

MelanomaIn-Transit Metastasis

Interventions

Nivolumab

DRUG

Isolated limb perfusion (ILP)

PROCEDURE

Contacts

Roger Olofsson Bagge, MD, PhD

CONTACT

+46 31 3428207 roger.olofsson.bagge@gu.se

Therese Bengtsson

CONTACT

+46 31 3420000 therese.bengtsson@vgregion.se

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: April 25, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

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