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Low patient inclusion
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| Name | Class |
|---|---|
| Jessa Hospital | OTHER |
| University Hospital, Antwerp | OTHER |
| Algemeen Ziekenhuis Maria Middelares | OTHER |
| GZA Ziekenhuizen Campus Sint-Augustinus |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients with advanced melanoma | Patients receiving anti-PD-1 monotherapy (Nivolumab or Pembrolizumab) in the first-line setting |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Blood sample collection | Diagnostic Test | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 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. | 3, 6, 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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) | 12, 25 weeks |
| The association between ABO blood groups and anti-PD-1 monotherapy efficacy. |
| Measure | Description | Time Frame |
|---|---|---|
| The relationship between anti-PD-1 monotherapy efficacy and red blood cell transfusions. | In terms of ORR/DCR/BOR/PFS/OS (RECIST v1.1) | 12, 25 weeks and 3, 6, 12 months |
| The relationship between anti-PD-1 monotherapy efficacy and vaccinations. |
Inclusion Criteria:
Exclusion Criteria:
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Patients with advanced melanoma
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| Name | Affiliation | Role |
|---|---|---|
| Hannelore Denys, MD, PhD | Medical Oncologist | Principal Investigator |
| Emiel De Jaeghere, MD | PhD Fellow | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital Gent | Ghent | 9000 | Belgium |
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| ID | Term |
|---|---|
| D008545 | Melanoma |
| D009369 | Neoplasms |
| ID | Term |
|---|---|
| D018358 | Neuroendocrine Tumors |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
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| OTHER |
| AZ Sint-Jan AV | OTHER |
| AZ Nikolaas | OTHER |
| AZ Sint-Lucas Gent | OTHER |
| AZ Sint-Lucas Brugge | OTHER |
| General Hospital Groeninge | OTHER |
| OLV van Lourdes Hospital Waregem | UNKNOWN |
| AZ Damiaan | UNKNOWN |
| AZ Delta | OTHER |
| ASZ Aalst | OTHER |
| Belgian Red Cross | OTHER |
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EDTA blood
in terms of Progression-Free Survival (PFS) / Overall Survival (OS) (RECIST v1.1) |
| 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) | 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) | 3, 6, 12 months |
| The association between irregular antibodies and anti-PD-1 monotherapy efficacy. | In terms of ORR/DCR/BOR (RECIST v1.1) | 12, 25 weeks |
| The association between irregular antibodies and anti-PD-1 monotherapy efficacy. | In terms of PFS/OS (RECIST v1.1) | 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) | 12 months |
| The association between steroid administration and anti-PD-1 monotherapy efficacy. | In terms of ORR/DCR/BOR (RECIST v1.1) | 12, 25 weeks |
| The association between steroid administration and anti-PD-1 monotherapy efficacy. | In terms of PFS/OS (RECIST v1.1) | 3, 6, 12 months |
| The association between immunosuppressant administration and anti-PD-1 monotherapy efficacy. | In terms of ORR/DCR/BOR (RECIST v1.1) | 12, 25 weeks |
| The association between immunosuppressant administration and anti-PD-1 monotherapy efficacy. | In terms of PFS/OS (RECIST v1.1) | 3, 6, 12 months |
| The association between antibiotics administration and anti-PD-1 monotherapy efficacy. | In terms of ORR/DCR/BOR (RECIST v1.1) | 12, 25 weeks |
| The association between antibiotics administration and anti-PD-1 monotherapy efficacy. | In terms of PFS/OS (RECIST v1.1) | 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) | 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) | 3, 6, 12 months |
In terms of ORR/DCR/BOR/PFS/OS (RECIST v1.1)
| 12, 25 weeks and 3, 6, 12 months |
| The relationship between anti-PD-1 monotherapy efficacy and previous pregnancies. | In terms of ORR/DCR/BOR/PFS/OS (RECIST v1.1) | 12, 25 weeks and 3, 6, 12 months |
| D009380 | Neoplasms, Nerve Tissue |
| D018326 | Nevi and Melanomas |
| D012878 | Skin Neoplasms |
| D009371 | Neoplasms by Site |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |