Status:
TERMINATED
BLood Groups as Biomarker to Optimize Odds of Response to Anti-PD-1 Drugs
Lead Sponsor:
University Hospital, Ghent
Collaborating Sponsors:
Jessa Hospital
University Hospital, Antwerp
Conditions:
Melanoma
Cancer
Eligibility:
All Genders
18+ years
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" wil...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
September 1 2020
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
April 22 2021
Estimated Enrollment :
3 Patients enrolled
Trial Details
Trial ID
NCT04473027
Start Date
September 1 2020
End Date
April 22 2021
Last Update
May 10 2021
Active Locations (1)
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1
University Hospital Gent
Ghent, Belgium, 9000