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

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ClinicalTrials.gov Identifier: NCT03197636
Recruitment Status : Enrolling by invitation
First Posted : June 23, 2017
Last Update Posted : June 23, 2017
Sponsor:
Information provided by (Responsible Party):
Henrik Schmidt, Aarhus University Hospital

Brief 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.


Condition or disease Intervention/treatment
Malignant Melanoma Drug: Pembrolizumab

Study Type : Observational
Estimated Enrollment : 40 participants
Observational Model: Cohort
Time Perspective: Retrospective
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


Group/Cohort Intervention/treatment
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.
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.

Healthy controls
20 Healthy volunteers (HV) are included, matched by age and gender.



Primary Outcome Measures :
  1. 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)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
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. Patients are informed that participation is voluntary and they can withdraw the informed consent at any time without a reason and without consequences.
Criteria

Inclusion Criteria:

In order to be eligible for participation in this trial, the subject must:

  1. Be willing and able to provide written informed consent/assent for the trial.
  2. About to be treated with pembrolizumab as standard of care and first line treatment
  3. Be ≥ 18 years of age on day of signing informed consent.
  4. Have measurable disease based on RECIST 1.1.
  5. Have a performance status of 0 or 1 on the ECOG Performance Scale.

Exclusion criteria

  1. Is currently participating and receiving study therapy or has participated in a study of an investigational agent and received study therapy or used an investigational device within 4 weeks of the first dose of treatment.
  2. Ocular metastatic melanoma
  3. Has a diagnosis of immunodeficiency or is receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of trial treatment.
  4. Has a known history of active TB (Bacillus Tuberculosis)
  5. Hypersensitivity to pembrolizumab or any of its excipients.
  6. Has had a prior anti-cancer monoclonal antibody (mAb) within 4 weeks prior to study Day 1 or who has not recovered (i.e., ≤ Grade 1 or at baseline) from adverse events due to agents administered more than 4 weeks earlier.
  7. Has a known additional malignancy that is progressing or requires active treatment. Exceptions include basal cell carcinoma of the skin or squamous cell carcinoma of the skin that has undergone potentially curative therapy or in situ cervical cancer.
  8. Has active autoimmune disease that has required systemic treatment in the past 2 years (i.e. with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (eg., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment.
  9. Has a history of (non-infectious) pneumonitis that required steroids or current pneumonitis.
  10. Has an active infection requiring systemic therapy.
  11. Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the subject's participation for the full duration of the trial, or is not in the best interest of the subject to participate, in the opinion of the treating investigator.
  12. Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.
  13. Is pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the trial, starting with the pre-screening or screening visit through 120 days after the last dose of trial treatment.
  14. Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent.
  15. Has a known history of Human Immunodeficiency Virus (HIV) (HIV 1/2 antibodies).
  16. Has known active Hepatitis B (e.g., HBsAg reactive) or Hepatitis C (e.g., HCV RNA [qualitative] is detected).
  17. Has received a live vaccine within 30 days of planned start of treatment. Note: Seasonal influenza vaccines for injection are generally inactivated flu vaccines and are allowed; however intranasal influenza vaccines (e.g., Flu-Mist®) are live attenuated vaccines, and are not allowed.

Information from the National Library of Medicine

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


Locations
Denmark
AUH
Aarhus, Denmark, 8000
Sponsors and Collaborators
Aarhus University Hospital

Responsible Party: Henrik Schmidt, Associate Professor, DMSc, Aarhus University Hospital
ClinicalTrials.gov Identifier: NCT03197636     History of Changes
Other Study ID Numbers: MSD-PD-1/vitD
First Posted: June 23, 2017    Key Record Dates
Last Update Posted: June 23, 2017
Last Verified: June 2017

Keywords provided by Henrik Schmidt, Aarhus University Hospital:
Vitamin D
Soluble PD-1

Additional relevant MeSH terms:
Melanoma
Nevi and Melanomas
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue
Vitamins
Vitamin D
Ergocalciferols
Pembrolizumab
Micronutrients
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents
Antineoplastic Agents