NCT03685890 Evaluating the Effect of Nivolumab for Patients With In-transit Metastases Treated With Isolated Limb Perfusion
| NCT ID | NCT03685890 |
| Status | Recruiting |
| Phase | Phase 1, Phase 2 |
| Sponsor | Vastra Gotaland Region |
| Condition | Melanoma |
| Study Type | INTERVENTIONAL |
| Enrollment | 74 participants |
| Start Date | 2019-04-01 |
| Primary Completion | 2026-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 74 participants in total. It began in 2019-04-01 with a primary completion date of 2026-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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. 11. Has evidence of interstitial lung disease or active, non-infectious pneumonitis. 12. A condition requiring systemic treatment with either corticosteroids (\>10 mg daily prednisone equivalents) or other immunosuppressive medications within 30 days of study drug administration. Inhaled or topical steroids and adrenal replacement doses \>10 mg daily prednisone equivalents are permitted. 13. Has an active infection requiring systemic therapy. 14. Has received a live vaccine within 30 days prior to the first dose of trial treatment and 3 months after treatment. 15. Concomitant therapy with any of the following: IL 2 or other non-study immunotherapy regimens; cytotoxic chemotherapy except melphalan (ILP); other investigational therapies within 30 days before trial treatment and 3 months after trial treatment.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT03685890 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Melanoma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT03685890 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT03685890 currently recruiting?
Yes, NCT03685890 is actively recruiting participants. Contact the research team at roger.olofsson.bagge@gu.se for enrollment information.
Where is the NCT03685890 trial being conducted?
This trial is being conducted at Amsterdam, Netherlands, Groningen, Netherlands, Rotterdam, Netherlands, Gothenburg, Sweden.
Who is sponsoring the NCT03685890 clinical trial?
NCT03685890 is sponsored by Vastra Gotaland Region. The trial plans to enroll 74 participants.
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