Study of L19IL2 or L19TNF with Pembrolizumab for Unresectable Melanoma
This study is testing new treatments for unresectable (cannot be removed by surgery) Stage III or IV melanoma. It combines an existing immunotherapy, KEYTRUDA® (pembrolizumab), with one of three investigational drugs: L19IL2, L19TNF, or a combination of L19IL2/L19TNF. These investigational drugs are injected directly into your tumors. The study aims to see how well these combinations shrink tumors compared to previous results with KEYTRUDA® alone. You may be eligible if you are 18 or older and have unresectable Stage III or IV melanoma. The main goal is to measure how many patients have their tumors shrink or disappear over two years.
- Study design
- This is a randomized, open-label study involving 162 participants. You would be assigned by chance to one of three treatment groups.
- What's involved
- You would receive weekly injections of L19IL2, L19TNF, or L19IL2/L19TNF for up to 4 weeks, along with KEYTRUDA® infusions every 3 weeks for about 2 years. You will have regular visits for up to 2 years to check your progress.
- Compensation
- Not stated in the trial record.
- Follow-up
- Your progress will be monitored for up to 2 years after your first treatment, and survival information will be collected for up to 3 years.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
Study of the Efficacy of Intratumoral L19IL2 or L19TNF or L19IL2/L19TNF, in Combination with Pembrolizumab, in Unresectable Melanoma Patients
At a glance
Conditions
Where it's being run
1 sites across 1 statesStudy leadership
- Danielle Bello · PRINCIPAL_INVESTIGATOR · Memorial Sloan Kettering Cancer Center
Who to contact
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What this trial measures
- Confirmed Objective Response Rate (ORR)Evaluated over a period of up to 2 years after first intralesional treatment. TA visits will be performed at week 12, 18, 24, 36, 48, 64, 80 and 96 after first intralesional treatment or until confirmed progression or death, whichever occurs first
Objective Response Rate (ORR = CR + PR) in all three arms to demonstrate the efficacy of intralesional treatment with immunocytokines (L19IL2, or L19TNF, or L19IL2/L19TNF), in combination with the systemic anti-PD1 pembrolizumab, to induce objective responses in advanced melanoma patients with resistance to or progressing upon anti-PD1 checkpoint inhibitors. The primary analysis will be performed in the Intention-to-Treat population (ITT). Assessed during Tumor Assessment (TA) visits.