Actively Recruiting
Evaluating the Effect of Nivolumab for Patients With In-transit Metastases Treated With Isolated Limb Perfusion
Led by Vastra Gotaland Region · Updated on 2024-04-25
74
Participants Needed
4
Research Sites
561 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Evaluating the Effect of Nivolumab for Patients With In-transit Metastases Treated With Isolated Limb Perfusion
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female aged above 18 years
- Signed and dated written informed consent before the start of specific protocol procedures
- Histologically or cytologically proven in-transit metastases of malignant melanoma with or without regional lymph node metastases (AJCC v8 stage N1c, N2c and N3c)
- Measurable disease with at least 1 metastasis measuring at least 5mm
- ECOG performance status of 0-2
You will not qualify if you...
- Life expectancy of less than 6 months
- Inability to understand given information or undergo study procedures according to protocol
- Pregnant or breast-feeding; women of childbearing potential must have a negative pregnancy test within 24 hours before study drug
- Must agree to contraception for 5 months (women) and 7 months (men) after treatment
- Active cardiac conditions preventing general anesthesia
- Clinically significant pulmonary disease preventing general anesthesia
- Reduced renal function (S-Creatinine ≥1.5xULN)
- Reduced liver function or history of liver cirrhosis or portal hypertension
- Low blood leukocytes (<2.0x10⁹/L) or platelets (<100x10⁹/L)
- Active autoimmune disease requiring systemic treatment, except certain specified conditions
- Evidence of interstitial lung disease or active non-infectious pneumonitis
- Need for systemic corticosteroids (>10 mg prednisone daily) or immunosuppressive meds within 30 days before study drug
- Active infection requiring systemic therapy
- Received live vaccine within 30 days before trial or within 3 months after treatment
- Concurrent therapy with IL-2, non-study immunotherapies, cytotoxic chemotherapy except melphalan, or other investigational therapies within 30 days before and 3 months after trial treatment
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 4 locations
1
Netherlands Cancer Institute
Amsterdam, Netherlands
Actively Recruiting
2
Erasmus MC Cancer Institute
Groningen, Netherlands
Not Yet Recruiting
3
Erasmus MC Cancer Institute
Rotterdam, Netherlands
Not Yet Recruiting
4
Sahlgrenska University Hospital
Gothenburg, Sweden, 413 45
Actively Recruiting
Research Team
R
Roger Olofsson Bagge, MD, PhD
CONTACT
T
Therese Bengtsson
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here