L19IL2/TNF in Patients With Basal Cell Carcinoma
NCT07227870 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 92
Last updated 2026-03-09
Summary
Open-label, single-arm, multicentre study in patients with locally advanced BCC amenable to intratumoral injection, who have progressed on or are intolerant to systemic therapy as determined by a local multidisciplinary tumor board. 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.
Conditions
- Locally Advanced Basal Cell Carcinoma
Interventions
- DRUG
-
L19IL2/L19TNF
intratumoral administrations
Sponsors & Collaborators
-
Philogen S.p.A.
lead INDUSTRY
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Max Age
- 100 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2026-02-28
- Primary Completion
- 2031-02-28
- Completion
- 2031-02-28
- FDA Drug
- Yes
Countries
- United States
Study Locations
More Related Trials
-
Neoadjuvant L19IL2/L19TNF- Pivotal Study
NCT02938299 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE3
-
Intratumoral Application of L19IL2 in Patients With Malignant Melanoma
NCT01253096 ·Status: COMPLETED ·Phase: PHASE2
-
Investigation of the Safety and Tolerability of BSCT (Anti-nf-P2X7) 10% Ointment
NCT02587819 ·Status: COMPLETED ·Phase: PHASE1
-
Proof of Concept Study to Access Superficial Basal Cell Carcinoma in Adults
NCT05713760 ·Status: COMPLETED ·Phase: PHASE2
-
Study to Compare the Efficacy and Safety of Two CC-5013 Dose Regimens in Subjects With Metastatic Malignant Melanoma
NCT00055562 ·Status: COMPLETED ·Phase: PHASE2/PHASE3
-
A Phase I/II Dose Escalation Study of the Tumor-targeting Human L19-IL2 Monoclonal Antibody-cytokine Fusion Protein in Combination With Dacarbazine for Patients With Metastatic Melanoma
NCT02076646 ·Status: UNKNOWN ·Phase: PHASE1/PHASE2
-
Phase 1 Dose-finding Study of L19TNFα Plus Melphalan Using Isolated Inferior Limb Perfusion (ILP) in Subjects With Intransit Stage III/IV Melanoma
NCT01213732 ·Status: COMPLETED ·Phase: PHASE1
-
Efficacy of Bevacizumab Monotherapy in Treatment of Metastatic Melanoma
NCT00139360 ·Status: COMPLETED ·Phase: PHASE2
-
RCT Treatment Versus Non Treatment of Low-risk BCCs in Elderly
NCT05110924 ·Status: TERMINATED ·Phase: NA
-
Laser Immunotherapy With and Without Topical Anti-PD1 in Basal Cell Carcinomas
NCT04570683 ·Status: UNKNOWN ·Phase: EARLY_PHASE1
-
Phase 2 Study of Intralesional PV-10 for Metastatic Melanoma
NCT00521053 ·Status: COMPLETED ·Phase: PHASE2
-
Clinical Study Phase II of L19IL2 in Combination With Dacarbazine in Patients With Metastatic Melanoma
NCT01055522 ·Status: TERMINATED ·Phase: PHASE2
-
Study of MDX-010 in Subjects With Unresectable Stage III or Stage IV Malignant Melanoma
NCT00729950 ·Status: COMPLETED ·Phase: PHASE1
-
A Study of ONCOS-102 in Combination With Other Novel Immune-therapies in Advanced Treatment-resistant Melanoma Patients
NCT05561491 ·Status: WITHDRAWN ·Phase: PHASE2
-
Study of the Efficacy of Intratumoral L19IL2 or L19TNF or L19IL2/L19TNF, in Combination with Pembrolizumab, in Unresectable Melanoma Patients
NCT06284590 ·Status: RECRUITING ·Phase: PHASE2
-
Cutaneous Squamous Cell Carcinoma Staging Study
NCT05695222 ·Status: RECRUITING
-
Efficacy Study of TLN-232 in Patients With Recurring Metastatic Melanoma
NCT00735332 ·Status: TERMINATED ·Phase: PHASE2
-
Study of ILX651 in Patients With Inoperable Locally Advanced or Metastatic Melanoma
NCT00068211 ·Status: COMPLETED ·Phase: PHASE2
-
Study to Compare the Efficacy and Safety of CC-5013 vs. Placebo in Subjects With Metastatic Malignant Melanoma.
NCT00057616 ·Status: COMPLETED ·Phase: PHASE3
-
Study of Efficacy and Safety of LXH254 Combinations in Patients With Previously Treated Unresectable or Metastatic Melanoma
NCT04417621 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE2
-
Use of Jet-injection in Photodynamic Therapy for Basal Cell Carcinoma
NCT04552990 ·Status: COMPLETED ·Phase: PHASE2
-
L19TNFα in Patients With Advanced Solid Tumors
NCT01253837 ·Status: COMPLETED ·Phase: PHASE1/PHASE2
-
Clinical Trial to Evaluate BO-112 in Patients With Basal Cell Carcinoma (BCC)
NCT06422936 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE2
-
A Study Evaluating the Safety and Antitumor Activity of IPI-504, in Patients With Metastatic Melanoma
NCT00627419 ·Status: TERMINATED ·Phase: PHASE2
-
An Analysis of Treatment Patterns and Outcomes for Basal Cell Carcinoma (BCC) Cancer Participants
NCT02100111 ·Status: COMPLETED