Clinical trial NCT04473027: BLood Groups as Biomarker to Optimize Odds of Response to Anti-PD-1 Drugs
Official title: BLood Groups as Biomarker to Optimize Odds of Response to Anti-PD-1 Drugs (BLOOD Trial)
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Melanoma
Cancer
Keywords: Immunotherapy
Anti-PD-1
Nivolumab
Pembrolizumab
Biomarker
Lead sponsor: University Hospital, Ghent
Sponsor class: OTHER
Collaborators: name: Jessa Hospital
name: University Hospital, Antwerp
name: Algemeen Ziekenhuis Maria Middelares
name: GZA Ziekenhuizen Campus Sint-Augustinus
name: AZ Sint-Jan AV
name: AZ Nikolaas
name: AZ Sint-Lucas Gent
name: AZ Sint-Lucas Brugge
name: General Hospital Groeninge
name: OLV van Lourdes Hospital Waregem
name: AZ Damiaan
name: AZ Delta
name: ASZ Aalst
name: Belgian Red Cross
First posted: 2020-07-16
Enrollment: 3
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with advanced melanoma

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.


Eligibility criteria: 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.

Primary outcomes:
measure: The association between ABO blood groups (specifically O vs A/B/AB) and anti-PD-1 monotherapy efficacy.
timeFrame: 25 weeks
measure: Descriptive data on real-life use of anti-PD-1 therapy.
timeFrame: 3, 6, 12 months
Secondary outcomes:
measure: The association between ABO blood groups and anti-PD-1 monotherapy efficacy.
timeFrame: 12, 25 weeks
measure: The association between ABO blood groups and anti-PD-1 monotherapy efficacy.
timeFrame: 3, 6, 12 months
measure: The association between Kell, Kidd, Duffy, MNS, Rhesus, and Dombrock blood group antigens and anti-PD-1 monotherapy efficacy.
timeFrame: 12, 25 weeks
measure: The association between Kell, Kidd, Duffy, MNS, Rhesus, and Dombrock blood group antigens and anti-PD-1 monotherapy efficacy.
timeFrame: 3, 6, 12 months
measure: The association between irregular antibodies and anti-PD-1 monotherapy efficacy.
timeFrame: 12, 25 weeks
measure: The association between irregular antibodies and anti-PD-1 monotherapy efficacy.
timeFrame: 3, 6, 12 months
measure: To evaluate the association between overall survival and other endpoints as defined in the primary endpoints.
timeFrame: 12 months
measure: The association between steroid administration and anti-PD-1 monotherapy efficacy.
timeFrame: 12, 25 weeks
measure: The association between steroid administration and anti-PD-1 monotherapy efficacy.
timeFrame: 3, 6, 12 months
measure: The association between immunosuppressant administration and anti-PD-1 monotherapy efficacy.
timeFrame: 12, 25 weeks
measure: The association between immunosuppressant administration and anti-PD-1 monotherapy efficacy.
timeFrame: 3, 6, 12 months
measure: The association between antibiotics administration and anti-PD-1 monotherapy efficacy.
timeFrame: 12, 25 weeks
measure: The association between antibiotics administration and anti-PD-1 monotherapy efficacy.
timeFrame: 3, 6, 12 months
measure: The association between selected baseline and intermediate data (as listed in Outcome 2) and anti-PD-1 monotherapy efficacy.
timeFrame: 12, 25 weeks
measure: The association between selected baseline and intermediate data (as listed in Outcome 2) and anti-PD-1 monotherapy efficacy.
timeFrame: 3, 6, 12 months
Other outcomes:
measure: The relationship between anti-PD-1 monotherapy efficacy and red blood cell transfusions.
timeFrame: 12, 25 weeks and 3, 6, 12 months
measure: The relationship between anti-PD-1 monotherapy efficacy and vaccinations.
timeFrame: 12, 25 weeks and 3, 6, 12 months
measure: The relationship between anti-PD-1 monotherapy efficacy and previous pregnancies.
timeFrame: 12, 25 weeks and 3, 6, 12 months
Locations:
city: Gent
country: Belgium
facility: University Hospital Gent
Study officials:
affiliation: Medical Oncologist
name: Hannelore Denys, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: PhD Fellow
name: Emiel De Jaeghere, MD
role: STUDY_CHAIR
References: