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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
EU CTIS ID: 2023-509265-21-00
What this study is testing
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, compared to isolated limb perfusion with placebo.
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Male or female aged above 18 years.
- 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 5 mm
- ECOG performance status of 0-2
You likely can't join if
- Life expectancy of less than 6 months
- 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
- Has evidence of interstitial lung disease or active, non-infectious pneumonitis
- 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.
- Has an active infection requiring systemic therapy
- Has received a live vaccine within 30 days prior to the first dose of trial treatment and 3 months after treatment
See the full eligibility criteria
- Male or female aged above 18 years.
- 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 5 mm
- ECOG performance status of 0-2
- Life expectancy of less than 6 months
- 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
- Has evidence of interstitial lung disease or active, non-infectious pneumonitis
- 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.
- Has an active infection requiring systemic therapy
- 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.
- 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 performed within 24 hours before the administration of study drug.
- Patients must agree to follow instructions for method of contraception for 5 months (women) and 7 months (males) after treatment, described in section 8.4
- Active cardiac conditions, including unstable coronary syndromes (unstable or severe angina, recent myocardial infarction), significant arrhythmias and severe valvular disease that precludes general anaesthesia.
- History or evidence of clinically significant pulmonary disease e.g., severe COPD that precludes general anesthesia.
- Reduced renal function defined as S-Creatinine >=1.5xULN.
- 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
- Reduced blood leukocytes or platelets defined as a leucocyte count < 2.0x109/L and thrombocyte count <100x109/L
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.