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

Part of paid clinical trials in New York, New York.

Sponsor
Philogen S.p.A.
Study ID
NCT06284590
Phase
PHASE2
Status
Recruiting
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Conditions

  • Melanoma Stage III
  • Melanoma Stage IV

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • L19IL2 — DRUG
    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.
  • L19TNF — DRUG
    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.
  • L19IL2/L19TNF — DRUG
    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.
  • KEYTRUDA® — DRUG
    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®.

Study Details

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.

Key Dates

Start date
Jul 12, 2024
Status verified
Oct 2024
Primary completion
Jul 31, 2028
Completion
Jul 31, 2028

Study Design

Enrollment
162 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Systemic pembrolizumab in combination with intralesional L19IL2 (Arm 1)
    Two-weeks screening period and a 4-weeks open-label intralesional treatment period with L19IL2. Pembrolizumab will be administered by i.v. infusion on the first day of intralesional treatment with L19IL2, 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.
  • Experimental: Systemic pembrolizumab in combination with intralesional L19TNF (Arm 2)
    Two-weeks screening period and a 4-weeks open-label intralesional treatment period with L19TNF. Pembrolizumab will be administered by i.v. infusion on the first day of intralesional treatment with L19TNF, 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.
  • Experimental: Systemic pembrolizumab in combination with intralesional L19IL2/L19TNF (Arm 3)
    Two-weeks screening period and a 4-weeks open-label intralesional treatment period with L19IL2/L19TNF. Pembrolizumab will be administered by i.v. infusion on the first day of intralesional treatment with L19IL2/L19TNF, 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.

Primary Outcome Measure

Confirmed Objective Response Rate (ORR) [ Time Frame: 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 ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Memorial Sloan Kettering Cancer CenterNew YorkNew York10065
Danielle Marie Bello, MD
[email protected]
Danielle Marie Bello, MD

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By research site
Memorial Sloan Kettering Cancer Center· New York, NY

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