BLood Groups as Biomarker to Optimize Odds of Response to Anti-PD-1 Drugs (BLOOD Trial)
Trial Snapshot
- Phase
- Not Applicable
- Status
- Terminated
- Sponsor
- University Hospital, Ghent
- Enrollment
- 3
- Locations
- 1
- Primary Endpoint
- The association between ABO blood groups (specifically O vs A/B/AB) and anti-PD-1 monotherapy efficacy.
Study Overview
Brief Summary
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 Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
- •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.
Outcomes
Primary Outcomes
The association between ABO blood groups (specifically O vs A/B/AB) and anti-PD-1 monotherapy efficacy.
Time Frame: 25 weeks
In terms of objective response rate (ORR) according to RECIST v1.1
Descriptive data on real-life use of anti-PD-1 therapy.
Time Frame: 3, 6, 12 months
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.
Secondary Outcomes
- The association between irregular antibodies and anti-PD-1 monotherapy efficacy.(3, 6, 12 months)
- The association between immunosuppressant administration and anti-PD-1 monotherapy efficacy.(3, 6, 12 months)
- The association between ABO blood groups and anti-PD-1 monotherapy efficacy.(3, 6, 12 months)
- The association between antibiotics administration and anti-PD-1 monotherapy efficacy.(3, 6, 12 months)
- The association between steroid administration and anti-PD-1 monotherapy efficacy.(3, 6, 12 months)
- The association between selected baseline and intermediate data (as listed in Outcome 2) and anti-PD-1 monotherapy efficacy.(3, 6, 12 months)
- The association between Kell, Kidd, Duffy, MNS, Rhesus, and Dombrock blood group antigens and anti-PD-1 monotherapy efficacy.(3, 6, 12 months)
- To evaluate the association between overall survival and other endpoints as defined in the primary endpoints.(12 months)