NCT02909348

Immunophenotyping of Melanoma Patients on Treatment With Pembrolizumab

Phenotyping of Blood Samples to Detect Autoimmune Signature Following Immunotherapy With Pembrolizumab

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 25 (actual)
• Sponsor: Royal Free Hospital NHS Foundation Trust · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

There is a new form of cancer treatment called immunotherapy which does not attack cancer directly but works on the immune system to make it more effective. This type of treatment may have side effects which are called autoimmune side effects and are caused by the immune system attacking the normal parts of the body. At the moment doctors cannot predict which patients may be at more risk of developing such autoimmune side effects and doctors also cannot predict which patients are more likely to benefit. This study will analyse blood samples from patients receiving immunotherapy to see if markers can be identified to help make such predictions.

Detailed description

Immunotherapy is a new approach to treating cancers and the major side effects are classed as autoimmune because the immune system is targeting itself. Currently doctors are not able to identify patients at higher risk of developing such autoimmune toxicities and nor are doctors able to identify patients more likely to respond to such treatment. Markers in the immune system have already been identified which are associated with naturally occurring autoimmune diseases. In this study the investigators will examine immune cells from patients with advanced malignant melanoma receiving immunotherapy treatment with Pembrolizumab to see if similar immune system markers can be identified and if such markers may be related to the development of autoimmune side effects or response to treatment. This would enable better selection of patients for treatment with immunotherapy.

Conditions

• Neoplasms
• Melanoma

Interventions

Type	Name	Description
DRUG	Pembrolizumab	3mg/kg, intravenous and on day1 of each 21 day cycle until progression or unacceptable toxicity develops.

Timeline

• Start date: 2016-09-01
• Primary completion: 2019-10-01
• Completion: 2019-10-01
• First posted: 2016-09-21
• Last updated: 2023-03-02

Locations

2 sites across 1 country: United Kingdom