RecruitingPhase 2NCT06284590

Study of the Efficacy of Intratumoral L19IL2 or L19TNF or L19IL2/L19TNF, in Combination with Pembrolizumab, in Unresectable Melanoma Patients

A Phase 2, Three-arm, Randomized Study of the Efficacy of Intratumorally Administered L19IL2 or L19TNF or L19IL2/L19TNF, All in Combination with Systemic Anti-PD1 Pembrolizumab, in Stage III and IV Unresectable Melanoma Patients with Resistance to or Progressing Upon Anti-PD1 Checkpoint Inhibitors and with Presence of Injectable Metastases

Sponsor

Philogen S.p.A.

Enrollment

162 participants

Start Date

Jul 12, 2024

Study Type

INTERVENTIONAL

Conditions

Melanoma Stage IV Melanoma Stage III

Summary

The trial aims to evaluate the efficacy of single agent L19IL2, single agent L19TNF, and combination L19IL2+L19TNF given concurrently with anti-PD1 therapy compared to historical control of anti-PD-1 re-challenge alone for anti-PD1 refractory unresectable stage III-IV melanoma.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether injecting immune-stimulating drugs (L19IL2 and/or L19TNF) directly into tumors, in combination with the immunotherapy drug pembrolizumab, can treat advanced melanoma that cannot be surgically removed. **You may be eligible if...** - You are 18 or older with confirmed advanced (unresectable) melanoma at stage IIIB, IIIC, IIID, or IV - Patients with a limited number of sites of spread (up to 10 lesions including lung, liver, bone, or brain) may also be eligible - Patients with acral lentiginous melanoma (a type affecting palms, soles, or under nails) may qualify **You may NOT be eligible if...** - You have brain lesions that are causing symptoms or growing rapidly - You have had certain prior treatments that would conflict with the study drugs - You are pregnant, breastfeeding, or have serious health conditions that make study participation unsafe Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGL19IL2

Arm 1: The amount of L19IL2 that is intratumorally administered into injectable cutaneous, subcutaneous, and nodal tumors once weekly for up to 4 weeks is dependent on the size of the tumor. The maximum dose to be administered in a single treatment visit is 13 MioIU/1 mL of L19IL2.

DRUGL19TNF

Arm 2: The amount of L19TNF that is intratumorally administered into injectable cutaneous, subcutaneous, and nodal tumors once weekly for up to 4 weeks is dependent on the size of the tumor. The maximum dose to be administered in a single treatment visit is 400 μg/1 mL of L19TNF.

DRUGL19IL2/L19TNF

Arm 3: The amount of L19IL2/L19TNF that is intratumorally administered into injectable cutaneous, subcutaneous, and nodal tumors once weekly for up to 4 weeks is dependent on the size of the tumor. The maximum dose to be administered in a single treatment visit is 13MioIU L19IL2 + 400 μg L19TNF in a combined total volume of approximate 2 mL. In case that study drug-related, grade ≥ γ AEs are recorded after the first L19IL2/L19TNF dose administration, the L19TNF dose is reduced to 200 μg for the following administrations.

DRUGKEYTRUDA®

KEYTRUDA® will be administered by i.v. infusion as a dose of 200 mg on the first day of intralesional treatment with ICKs and will continue every 3 weeks for approximately 2 years, 35 cycles, 2 year cap or until disease progression or unacceptable toxicity, whichever comes first. ICKs intralesional treatment will be administered 30-60 minutes post administration of KEYTRUDA®.