Co-stimulatory Markers and Vitamin D Status in Anti-PD1 Treated Melanoma Patients
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03197636|
Recruitment Status : Enrolling by invitation
First Posted : June 23, 2017
Last Update Posted : June 23, 2017
An observational single center study designed to identify response-related biomarkers of anti-programmed death 1 (PD-1) therapy to advanced melanoma patients and to investigate if vitamin D levels are related to treatment response. 40 patients diagnosed with advanced melanoma will be included. Patients are included at the Department of Oncology, Aarhus University Hospital (AUH). All patients will be treated with Pembrolizumab as a standard procedure at the Department of Oncology. The protocol comprises blood samples at baseline, 3 and 6 weeks after treatment initiation with anti-PD1 therapy and three years of observational follow-up. A total amount of 217 ml blood will be drawn during the study period. The study period is 6 weeks followed by 3 years of follow-up. Medical history, symptoms, response to treatment regarding the RESIST criteria and side affects will be recorded at each visit in both the study period and in follow-up. Biochemical markers will be obtained according to normal procedure during study and follow-up visits.
20 Healthy volunteers (HV) are included, matched by age and gender. Collected blood samples (serum, plasma, peripheral blood mononuclear cells) will be analyzed after the last patient has ended the week 6 visit.
|Condition or disease||Intervention/treatment|
|Malignant Melanoma||Drug: Pembrolizumab|
|Study Type :||Observational|
|Estimated Enrollment :||40 participants|
|Official Title:||An Observational Study Design to Detect if Co-stimulatory Markers and Vitamin D Status in Anti-PD-1 Treated Advanced Melanoma Patients Can Predict Treatment Outcome|
|Estimated Study Start Date :||July 1, 2017|
|Estimated Primary Completion Date :||July 1, 2018|
|Estimated Study Completion Date :||January 2021|
Malignant melanoma patients
40 patients with metastatic melanoma are included. Patients are admitted to Department of Oncology, Aarhus University Hospital (AUH). The patients are recruited to the study from the outpatient clinic of the Department of Oncology when they are about to begin treatment with pembrolizumab.
Pembrolizumab is already approved for treatment of malignant melanoma in advanced stages. We will investigate if sPD-1 or vitamin D status is changed in patients receiving pembrolizumab.
20 Healthy volunteers (HV) are included, matched by age and gender.
- Plasma levels of sPD-1 [ Time Frame: 1-2 years ]Plasma levels compared to HC and correlation to disease outcome and vitamin D status (above or below the reference interval)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03197636
|Aarhus, Denmark, 8000|