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

Status

Not yet recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2024-519326-20-00

Acronym

PH-ICKPD1-02/21

Enrollment

Registered

2026-01-14

Start date

Unknown

Completion date

Unknown

Last updated

2026-01-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Patients with diagnosis of unresectable clinical stage III or IV metastatic melanoma, with presence of injectable cutaneous, subcutaneous or nodal lesions and resistant to or progressing upon anti-PD1 immunotherapy

Brief summary

Primary endpoint of the study is the Confirmed Objective Response Rate (ORR = CR + PR) over a period of up to 2 years after first intralesional treatment, according to RECIST v1.1 criteria in each arm of the study. The primary analysis will be performed in the Intention-to-Treat population (ITT).

Interventions

DRUGKEYTRUDA 25 mg/mL concentrate for solution for infusion.

DRUGDarleukin

DRUGFibromun

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Primary endpoint of the study is the Confirmed Objective Response Rate (ORR = CR + PR) over a period of up to 2 years after first intralesional treatment, according to RECIST v1.1 criteria in each arm of the study. The primary analysis will be performed in the Intention-to-Treat population (ITT).	—

Countries

Germany, Italy

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026