Study of a DNA Immunotherapy to Treat Melanoma

Status Terminated

Clinical Trial Summary

The study is an investigation of a novel immunotherapy, SCIB1, for the treatment of melanoma. SCIB1 is a solution of plasmid DNA molecules which will express a modified antibody in human cells. The antibody modifications are designed to stimulate the patient's immune T cells to have a strong and specific reaction against melanoma cells which should then be eliminated. SCIB1 is injected into muscle using a device which simultaneously delivers an electrical impulse to enhance the transfer of SCIB1 into muscle cells. The trial will assess the safety and tolerability of SCIB1, the safety and performance of the injection device and the immunological effects of SCIB1. This is the first study of SCIB1 in humans and the trial has two parts, in the first part the dose will be escalated to determine a safe and tolerable level up to a maximum of 8 mg per dose. In the second part patients will receive the dose determined in the first part. Patients will have stage III or IV melanoma, be HLA type A2 and have a life expectancy of at least three months. All patients will receive 5 injections of SCIB1 over 5.5 months. At the discretion of the investigator, patients may continue to receive SCIB1 at 3-6 month intervals for 5 years. The study will be conducted at major cancer centres in the UK only and is expected to last for seven years. Patients will be followed up for five years after they have completed the trial.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT01138410
Study type	Interventional
Source	Scancell Ltd
Contact
Status	Terminated
Phase	Phase 1/Phase 2
Start date	May 2010
Completion date	July 7, 2017

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