BLood Groups as Biomarker to Optimize Odds of Response to Anti-PD-1 Drugs (BLOOD)

Ghent University Hospital (UZ)

Status: Terminated

Conditions: Melanoma; Cancer

Treatments: Diagnostic Test: Blood sample collection

Study type: Observational

Funder types: Other

Identifiers

NCT04473027

BC-5765

Details and patient eligibility

About

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.

Enrollment: 3 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

3 participants in 1 patient group

Patients with advanced melanoma

Description:

Patients receiving anti-PD-1 monotherapy (Nivolumab or Pembrolizumab) in the first-line setting

Treatment:

Diagnostic Test: Blood sample collection