Intratumoral Application of L19IL2 in Patients With Malignant Melanoma

Status Completed

Clinical Trial Summary

Phase II, non-randomized, multicenter, prospective study designed to test the efficacy and safety of intratumorally administered L19IL2 in patients suffering from metastatic melanoma.

Clinical Trial Description

Phase II, non-randomized, multicenter, prospective study designed to test the efficacy and safety of intratumorally administered L19IL2. L19IL2 binds with high affinity to the EDB domain of Fibronectin, a marker of angiogenesis which is strongly upregulated in malignant melanoma lesions. This binding leads to an increased residence time of the protein at the site of disease. The biologic effect of the IL2 moiety is identical to the one of free IL-2.

The study treatment is up to 20 MioIU L19IL2 per week in patients suffering from histopathologically-proven malignant melanoma with presence of injectable soft-tissue metastases either in clinical stage III or stage IV M1a without visceral metastases. The duration of treatment could be up to 20 weeks. After the end of study visit follow-up is performed every 6 weeks until 12 months from enrollment of each patient.

Tumor assessment will be performed within 2 weeks before start of treatment and at week 12 using immune-related response criteria and RECIST 1.1. To assure that patients do not develop visceral metastases under treatment, an additional tumor assessment will be performed already at week 6 after start of therapy. Assessments at week 24 and 36 will be performed according to RECIST vs. 1.1 criteria only.

Treatment emergent adverse events will be summarized by Common Toxicity Criteria (version 4.02, CTCAE) and worst grade for all treated patients. Laboratory values and change in vital signs will be summarized. ;

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT01253096
Study type	Interventional
Source	Philogen S.p.A.
Contact
Status	Completed
Phase	Phase 2
Start date	April 2010
Completion date	September 2013

View Details

See also
Status	Clinical Trial	Phase
Completed	`NCT04229277` - Fast Track Diagnosis of Skin Cancer by Advanced Imaging	N/A
Completed	`NCT03653819` - High Intensity Interval Training (HIIT) for Patients With Cancer-related Lymphedema in the Lower Limbs	N/A
Active, not recruiting	`NCT04074096` - Binimetinib Encorafenib Pembrolizumab +/- Stereotactic Radiosurgery in BRAFV600 Melanoma With Brain Metastasis	Phase 2
Completed	`NCT02935790` - Selective HDAC6 Inhibitor ACY-241 in Combination With Ipilimumab and Nivolumab	Phase 1
Recruiting	`NCT05478876` - Carbon Ion Radiation Therapy in the Treatment of Mucous Melanomas of the Female Lower Genital Tract	N/A
Completed	`NCT01211262` - Study to Assess the Tolerability of a Bispecific Targeted Biologic IMCgp100 in Malignant Melanoma	Phase 1
Recruiting	`NCT03649529` - Treatment of Malignant Melanoma With GPA-TriMAR-T Cell Therapy	Early Phase 1
Completed	`NCT03278665` - 4SC-202 in Combination With Pembrolizumab in Patients Primary Refractory/Non-responding to Prior Anti-PD-1 Therapy	Phase 1/Phase 2
Completed	`NCT04452214` - A Study of the Safety and Tolerance of CAN04 and Pembrolizumab in Combination With and Without Carboplatin and Pemetrexed in Subjects With Solid Tumors	Phase 1
Terminated	`NCT02709889` - Rovalpituzumab Tesirine in Delta-Like Protein 3-Expressing Advanced Solid Tumors	Phase 1/Phase 2
Completed	`NCT01455259` - Phase I/IIa AdCD40L Immunogene Therapy for Malignant Melanoma and Other Solid Tumors	Phase 1/Phase 2
Completed	`NCT00978913` - Transfected Dendritic Cell Based Therapy for Patients With Breast Cancer or Malignant Melanoma	Phase 1
Completed	`NCT00232726` - Clinical Study of Previously Untreated Patients With Malignant Melanoma	Phase 2
Completed	`NCT00350597` - GM-CSF as Adjuvant Therapy of Melanoma	Phase 2
Completed	`NCT00336986` - Efficacy Study of IL-21 to Treat Metastatic Melanoma	Phase 2
Completed	`NCT02523313` - Immunotherapy With Nivolumab or Nivolumab Plus Ipilimumab vs. Double Placebo for Stage IV Melanoma w. NED	Phase 2
Completed	`NCT03545334` - Lymph Node Identification in Skin Malignancy Using ICG Transcutaneously Study	N/A
Completed	`NCT04253574` - Comparison of PET/CT and Ultrasound in Staging of Malignant Melanoma
Completed	`NCT00179608` - Study of the Combination of Lenalidomide and DTIC (Dacarbazine) in Patients With Metastatic Malignant Melanoma Previously Untreated With Systemic Chemotherapy	Phase 1
Terminated	`NCT00104884` - FR901228 in Treating Patients With Unresectable Stage III or Stage IV Malignant Melanoma	Phase 2