- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04473027
BLood Groups as Biomarker to Optimize Odds of Response to Anti-PD-1 Drugs (BLOOD)
May 6, 2021 updated by: University Hospital, Ghent
BLood Groups as Biomarker to Optimize Odds of Response to Anti-PD-1 Drugs (BLOOD Trial)
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 Overview
Status
Terminated
Intervention / Treatment
Study Type
Observational
Enrollment (Actual)
3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Gent, Belgium, 9000
- University Hospital Gent
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Patients with advanced melanoma
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Patients with advanced melanoma
Patients receiving anti-PD-1 monotherapy (Nivolumab or Pembrolizumab) in the first-line setting
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Whole venous blood of participants will be collected in EDTA tubes (max.
10 mL) at baseline, before start of first immunotherapy round.
The Belgian Red Cross will perform serological blood group diagnostics, and molecular RBC typing.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
25 weeks
|
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.
|
3, 6, 12 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The association between ABO blood groups and anti-PD-1 monotherapy efficacy.
Time Frame: 12, 25 weeks
|
In terms of Overall Response Rate (ORR) / Disease Control Rate (DCR) / Best Overall Response (BOR) (RECIST v1.1)
|
12, 25 weeks
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The association between ABO blood groups and anti-PD-1 monotherapy efficacy.
Time Frame: 3, 6, 12 months
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in terms of Progression-Free Survival (PFS) / Overall Survival (OS) (RECIST v1.1)
|
3, 6, 12 months
|
The association between Kell, Kidd, Duffy, MNS, Rhesus, and Dombrock blood group antigens and anti-PD-1 monotherapy efficacy.
Time Frame: 12, 25 weeks
|
In terms of ORR/DCR/BOR (RECIST v1.1)
|
12, 25 weeks
|
The association between Kell, Kidd, Duffy, MNS, Rhesus, and Dombrock blood group antigens and anti-PD-1 monotherapy efficacy.
Time Frame: 3, 6, 12 months
|
In terms of PFS/OS (RECIST v1.1)
|
3, 6, 12 months
|
The association between irregular antibodies and anti-PD-1 monotherapy efficacy.
Time Frame: 12, 25 weeks
|
In terms of ORR/DCR/BOR (RECIST v1.1)
|
12, 25 weeks
|
The association between irregular antibodies and anti-PD-1 monotherapy efficacy.
Time Frame: 3, 6, 12 months
|
In terms of PFS/OS (RECIST v1.1)
|
3, 6, 12 months
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To evaluate the association between overall survival and other endpoints as defined in the primary endpoints.
Time Frame: 12 months
|
(i.e., ORR, DCR, BOR, and PFS)
|
12 months
|
The association between steroid administration and anti-PD-1 monotherapy efficacy.
Time Frame: 12, 25 weeks
|
In terms of ORR/DCR/BOR (RECIST v1.1)
|
12, 25 weeks
|
The association between steroid administration and anti-PD-1 monotherapy efficacy.
Time Frame: 3, 6, 12 months
|
In terms of PFS/OS (RECIST v1.1)
|
3, 6, 12 months
|
The association between immunosuppressant administration and anti-PD-1 monotherapy efficacy.
Time Frame: 12, 25 weeks
|
In terms of ORR/DCR/BOR (RECIST v1.1)
|
12, 25 weeks
|
The association between immunosuppressant administration and anti-PD-1 monotherapy efficacy.
Time Frame: 3, 6, 12 months
|
In terms of PFS/OS (RECIST v1.1)
|
3, 6, 12 months
|
The association between antibiotics administration and anti-PD-1 monotherapy efficacy.
Time Frame: 12, 25 weeks
|
In terms of ORR/DCR/BOR (RECIST v1.1)
|
12, 25 weeks
|
The association between antibiotics administration and anti-PD-1 monotherapy efficacy.
Time Frame: 3, 6, 12 months
|
In terms of PFS/OS (RECIST v1.1)
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3, 6, 12 months
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The association between selected baseline and intermediate data (as listed in Outcome 2) and anti-PD-1 monotherapy efficacy.
Time Frame: 12, 25 weeks
|
In terms of ORR/DCR/BOR (RECIST v1.1)
|
12, 25 weeks
|
The association between selected baseline and intermediate data (as listed in Outcome 2) and anti-PD-1 monotherapy efficacy.
Time Frame: 3, 6, 12 months
|
In terms of PFS/OS (RECIST v1.1)
|
3, 6, 12 months
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The relationship between anti-PD-1 monotherapy efficacy and red blood cell transfusions.
Time Frame: 12, 25 weeks and 3, 6, 12 months
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In terms of ORR/DCR/BOR/PFS/OS (RECIST v1.1)
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12, 25 weeks and 3, 6, 12 months
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The relationship between anti-PD-1 monotherapy efficacy and vaccinations.
Time Frame: 12, 25 weeks and 3, 6, 12 months
|
In terms of ORR/DCR/BOR/PFS/OS (RECIST v1.1)
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12, 25 weeks and 3, 6, 12 months
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The relationship between anti-PD-1 monotherapy efficacy and previous pregnancies.
Time Frame: 12, 25 weeks and 3, 6, 12 months
|
In terms of ORR/DCR/BOR/PFS/OS (RECIST v1.1)
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12, 25 weeks and 3, 6, 12 months
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Hannelore Denys, MD, PhD, Medical Oncologist
- Study Chair: Emiel De Jaeghere, MD, PhD Fellow
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
September 1, 2020
Primary Completion (Actual)
April 22, 2021
Study Completion (Actual)
April 22, 2021
Study Registration Dates
First Submitted
July 13, 2020
First Submitted That Met QC Criteria
July 13, 2020
First Posted (Actual)
July 16, 2020
Study Record Updates
Last Update Posted (Actual)
May 10, 2021
Last Update Submitted That Met QC Criteria
May 6, 2021
Last Verified
July 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- BC-5765
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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