Safety, Tolerability & Efficacy of IV CT-011 in Metastatic Melanoma
Research type
Research Study
Full title
Phase II study to evaluate the safety, tolerability and efficacy of CT-011 administered intravenously to patients with metastatic melanoma
IRAS ID
98246
Contact name
Mark Middleton
Sponsor organisation
CureTech Ltd.
Eudract number
2011-004501-24
Clinicaltrials.gov Identifier
Research summary
This is a study for patients with metastatic melanoma, which is the most serious form of skin cancer causing the greatest number of skin cancer??related deaths in the world. The current care for this disease provides only infrequent cures and extends survival by approximately 4 months for the majority of the patients. Recently approved therapies including Ipilimumab and selective B-RAF inhibitors (anti-cancer drugs that inhibit a faulty B-RAF gene) are not expected to significantly change the unfavourable prognosis for the majority of the patients. The study aims to evaluate the safety, tolerability and efficacy of CT011. This drug is an antibody (mAb) that modulates the immune system and can inhibit tumour growth and the spread of metastases. CT-011 was studied in Phase I and Phase II studies in patients with blood cancers. In Phase I study, CT-011 was active and caused no serious or unexpected drug-related side effects. Results of the completed Phase II study are being analyzed. CT-011 is currently being tested in a number of clinical studies in a variety of cancers. The study could be of benefit to patients with metastatic melanoma. Two dosage levels will be administered, 1.5mg/kg or 6.0 mg/kg, as we are not clear which dose is best. Previous treatment by ipilimumab will be allowed in up to 25 patients per dose group. It is planned to enrol approximately 100 patients in to this study. Total study duration including enrolment and follow up will be approximately 28 months.
REC name
South Central - Oxford C Research Ethics Committee
REC reference
12/SC/0043
Date of REC Opinion
6 Mar 2012
REC opinion
Further Information Favourable Opinion