Clinical trial · Observational
BLood Groups as Biomarker to Optimize Odds of Response to Anti-PD-1 Drugs
BLood Groups as Biomarker to Optimize Odds of Response to Anti-PD-1 Drugs (BLOOD Trial)
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Low patient inclusion
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cancer | Malignant Neoplasm | ALIAS | 0.90 |
| Melanoma | Melanoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Blood sample collection | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Patients with advanced melanoma
- description
- Patients receiving anti-PD-1 monotherapy (Nivolumab or Pembrolizumab) in the first-line setting
- interventionNames
- Diagnostic Test: Blood sample collection
Primary outcomes (2)
- measure
- The association between ABO blood groups (specifically O vs A/B/AB) and anti-PD-1 monotherapy efficacy.
- timeFrame
- 25 weeks
- description
- In terms of objective response rate (ORR) according to RECIST v1.1
- measure
- Descriptive data on real-life use of anti-PD-1 therapy.
- timeFrame
- 3, 6, 12 months
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically proven advanced melanoma. * Anti-PD-1 monotherapy of advanced (unresectable or metastatic) melanoma (prescribed within its approved indication as per usual practice according to RIZIV/INAMI regulations) in the first-line setting. * No prior systemic therapy for advanced melanoma. * Have measurable disease per Response Evaluation Criteria In Solid Tumors (RECIST) version 1.1. * At least 18 years of age. Exclusion Criteria: * Prior treatment with any drug specifically targeting T-cell co-stimulation or immune checkpoints (e.g., antibodies targeting PD-(L)1 or CTLA-4, chimeric antigen receptor T (CAR-T) cell therapy). * Metastasis-directed therapy (surgery or radiotherapy) with definitive intent (local therapy to address symptomatic sites of disease is permitted). * Previous systemic treatment for advanced melanoma. * Active central nervous system (CNS) metastases (previously treated brain metastases are permitted if stable) or carcinomatous meningitis. * Diagnosis of any other malignancy within 5 years prior to study inclusion, except for adequately treated basal cell or squamous cell skin cancer, carcinoma in situ of the breast or of the cervix, low-risk prostate cancer on surveillance without any plans for treatment intervention, or prostate cancer that has been adequately treated with prostatectomy or radiotherapy and currently with no evidence of disease and symptoms.
References
Publications (0)
Data not yet available