L19IL2/L19TNF in Patients With Cutaneous Squamous Cell Carcinoma
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-100
SponsorPhilogen S.p.A.
About this trial
Open-label, single-arm, multicenter study in patients with locally advanced, histologically confirmed Cutaneous Squamous Cell Carcinoma (LacSCC) amenable to intratumoral injection, who have progressed on or are intolerant to Immune Checkpoint Inhibitor (ICI). The primary objective of the study is to evaluate the activity of intratumoral L19IL2/L19TNF, while the secondary objective is to assess the safety and efficacy. The patients will receive multiple intratumoral administrations of combined L19IL2 and L19TNF to all injectable cutaneous and subcutaneous lesions once weekly for up to 4 weeks: for those who have a partial response or stable disease as their best response, a second 4-week course L19IL2/L19TNF of four weekly injections may be administered as per treating physician judgement. Patients will be followed for a maximum of 160 weeks after beginning of treatment.
Eligibility criteria
Qualifiers
Patients must have histologically documented, locally advanced cSCC.
Patients must have at least one injectable and measurable cutaneous or subcutaneous lesion.
Patients must have locally advanced cSCC that has progressed on or cannot tolerate ICI treatment (adjuvant or first line) as assessed by a local multidisciplinary tumor board.
Patients with nodal, regional or in transit injectable cSCC lesions.
Disqualifiers
Presence of concomitant malignancies, with the exception of any cancer curatively treated more than 3 years prior to study entry and of tumors with a negligible risk for metastasis or death, such as adequately treated basal cell carcinoma of the skin (surgically removed at least 4 weeks prior to study entry), ductal carcinoma in situ of the breast, or carcinoma in situ of the cervix, early-stage asymptomatic CLL and not under active treatment (Rai 0, Binet A) will be eligible for the study.
Radiation therapy on the tumor sites in the 4 weeks prior to study drug administration.
Current topical or systemic chemotherapy, immunotherapy.
Presence of visceral metastasis.
Trial design
Treatments tested in this trial
- L19IL2/L19TNF
Treatment groups
92 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov