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Co-stimulatory Markers and Vitamin D Status in Anti-PD1 Treated Melanoma Patients

NCT03197636 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 40

Last updated 2022-03-03

No results posted yet for this study

Summary

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.

Conditions

  • Malignant Melanoma

Interventions

DRUG

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.

Sponsors & Collaborators

  • Aarhus University Hospital

    lead OTHER

Principal Investigators

  • Henrik Schmidt · AUH

Eligibility

Min Age
18 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-08-11
Primary Completion
2021-11-01
Completion
2022-02-01

Countries

  • Denmark

Study Locations

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03197636 on ClinicalTrials.gov