BLOOD is an investigator-initiated, multicenter, prospective biomarker study in patients with advanced melanoma treated with anti-PD-1 monotherapy in the first-line setting. The "studied products" will be administered and managed within routine medical care in Belgium. The overall goal is (i) to investigate biomarkers for anti-PD-1 monotherapy and (ii) to gather evidence on real-life use of anti-PD-1 monotherapy in melanoma.
Study Type
OBSERVATIONAL
Enrollment
3
Whole venous blood of participants will be collected in EDTA tubes (max. 10 mL) at baseline, before start of first immunotherapy round. The Belgian Red Cross will perform serological blood group diagnostics, and molecular RBC typing.
University Hospital Gent
Ghent, Belgium
The association between ABO blood groups (specifically O vs A/B/AB) and anti-PD-1 monotherapy efficacy.
In terms of objective response rate (ORR) according to RECIST v1.1
Time frame: 25 weeks
Descriptive data on real-life use of anti-PD-1 therapy.
Based on demographics (age, ethnicity, sex, height, weight (and Body Mass Index), smoking status, and gravida/para/abortus (if female)), melanoma history, clinical profile of participant at time of anti-PD-1 initiation, prior and/or concomitant intervention(s), duration of treatment exposure during the study, and effectiveness and safety of anti-PD-1 therapy.
Time frame: 3, 6, 12 months
The association between ABO blood groups and anti-PD-1 monotherapy efficacy.
In terms of Overall Response Rate (ORR) / Disease Control Rate (DCR) / Best Overall Response (BOR) (RECIST v1.1)
Time frame: 12, 25 weeks
The association between ABO blood groups and anti-PD-1 monotherapy efficacy.
in terms of Progression-Free Survival (PFS) / Overall Survival (OS) (RECIST v1.1)
Time frame: 3, 6, 12 months
The association between Kell, Kidd, Duffy, MNS, Rhesus, and Dombrock blood group antigens and anti-PD-1 monotherapy efficacy.
In terms of ORR/DCR/BOR (RECIST v1.1)
Time frame: 12, 25 weeks
The association between Kell, Kidd, Duffy, MNS, Rhesus, and Dombrock blood group antigens and anti-PD-1 monotherapy efficacy.
In terms of PFS/OS (RECIST v1.1)
Time frame: 3, 6, 12 months
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The association between irregular antibodies and anti-PD-1 monotherapy efficacy.
In terms of ORR/DCR/BOR (RECIST v1.1)
Time frame: 12, 25 weeks
The association between irregular antibodies and anti-PD-1 monotherapy efficacy.
In terms of PFS/OS (RECIST v1.1)
Time frame: 3, 6, 12 months
To evaluate the association between overall survival and other endpoints as defined in the primary endpoints.
(i.e., ORR, DCR, BOR, and PFS)
Time frame: 12 months
The association between steroid administration and anti-PD-1 monotherapy efficacy.
In terms of ORR/DCR/BOR (RECIST v1.1)
Time frame: 12, 25 weeks
The association between steroid administration and anti-PD-1 monotherapy efficacy.
In terms of PFS/OS (RECIST v1.1)
Time frame: 3, 6, 12 months
The association between immunosuppressant administration and anti-PD-1 monotherapy efficacy.
In terms of ORR/DCR/BOR (RECIST v1.1)
Time frame: 12, 25 weeks
The association between immunosuppressant administration and anti-PD-1 monotherapy efficacy.
In terms of PFS/OS (RECIST v1.1)
Time frame: 3, 6, 12 months
The association between antibiotics administration and anti-PD-1 monotherapy efficacy.
In terms of ORR/DCR/BOR (RECIST v1.1)
Time frame: 12, 25 weeks
The association between antibiotics administration and anti-PD-1 monotherapy efficacy.
In terms of PFS/OS (RECIST v1.1)
Time frame: 3, 6, 12 months
The association between selected baseline and intermediate data (as listed in Outcome 2) and anti-PD-1 monotherapy efficacy.
In terms of ORR/DCR/BOR (RECIST v1.1)
Time frame: 12, 25 weeks
The association between selected baseline and intermediate data (as listed in Outcome 2) and anti-PD-1 monotherapy efficacy.
In terms of PFS/OS (RECIST v1.1)
Time frame: 3, 6, 12 months