MelanomaBLOODNCT04473027
BLood Groups as Biomarker to Optimize Odds of Response to Anti-PD-1 Drugs
An observational study of Melanoma and Cancer, run by University Hospital, Ghent at 1 site in Belgium.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- What is being tested?
- Blood sample collection
- How many people
- 3 participants
- Where
- 1 siteBelgium
- Study dates
- 1 Sep 2020to 22 Apr 2021
- How long will I take part?
- 12 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with advanced melanoma
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Being tested
- Blood sample collection
- Keywords
- Immunotherapy, Anti-PD-1, Nivolumab, Pembrolizumab, Biomarker
- Medical subject headings
- Melanoma, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood sample collectionDiagnostic test
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.
| Study group | Role | What they receive |
|---|---|---|
| Patients with advanced melanoma | Patients receiving anti-PD-1 monotherapy (Nivolumab or Pembrolizumab) in the first-line setting Receives: Diagnostic Test: Blood sample collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
The association between ABO blood groups (specifically O vs A/B/AB) and anti-PD-1 monotherapy efficacy.
In terms of objective response rate (ORR) according to RECIST v1.1
Measured: 25 weeks
Descriptive data on real-life use of anti-PD-1 therapy.
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.
Measured: 3, 6, 12 months
Secondary outcomes (15)
The association between ABO blood groups and anti-PD-1 monotherapy efficacy.
In terms of Overall Response Rate (ORR) / Disease Control Rate (DCR) / Best Overall Response (BOR) (RECIST v1.1)
Measured: 12, 25 weeks
The association between ABO blood groups and anti-PD-1 monotherapy efficacy.
in terms of Progression-Free Survival (PFS) / Overall Survival (OS) (RECIST v1.1)
Measured: 3, 6, 12 months
The association between Kell, Kidd, Duffy, MNS, Rhesus, and Dombrock blood group antigens and anti-PD-1 monotherapy efficacy.
In terms of ORR/DCR/BOR (RECIST v1.1)
Measured: 12, 25 weeks
The association between Kell, Kidd, Duffy, MNS, Rhesus, and Dombrock blood group antigens and anti-PD-1 monotherapy efficacy.
In terms of PFS/OS (RECIST v1.1)
Measured: 3, 6, 12 months
The association between irregular antibodies and anti-PD-1 monotherapy efficacy.
In terms of ORR/DCR/BOR (RECIST v1.1)
Measured: 12, 25 weeks
The association between irregular antibodies and anti-PD-1 monotherapy efficacy.
In terms of PFS/OS (RECIST v1.1)
Measured: 3, 6, 12 months
To evaluate the association between overall survival and other endpoints as defined in the primary endpoints.
(i.e., ORR, DCR, BOR, and PFS)
Measured: 12 months
The association between steroid administration and anti-PD-1 monotherapy efficacy.
In terms of ORR/DCR/BOR (RECIST v1.1)
Measured: 12, 25 weeks
The association between steroid administration and anti-PD-1 monotherapy efficacy.
In terms of PFS/OS (RECIST v1.1)
Measured: 3, 6, 12 months
The association between immunosuppressant administration and anti-PD-1 monotherapy efficacy.
In terms of ORR/DCR/BOR (RECIST v1.1)
Measured: 12, 25 weeks
The association between immunosuppressant administration and anti-PD-1 monotherapy efficacy.
In terms of PFS/OS (RECIST v1.1)
Measured: 3, 6, 12 months
The association between antibiotics administration and anti-PD-1 monotherapy efficacy.
In terms of ORR/DCR/BOR (RECIST v1.1)
Measured: 12, 25 weeks
The association between antibiotics administration and anti-PD-1 monotherapy efficacy.
In terms of PFS/OS (RECIST v1.1)
Measured: 3, 6, 12 months
The association between selected baseline and intermediate data (as listed in Outcome 2) and anti-PD-1 monotherapy efficacy.
In terms of ORR/DCR/BOR (RECIST v1.1)
Measured: 12, 25 weeks
The association between selected baseline and intermediate data (as listed in Outcome 2) and anti-PD-1 monotherapy efficacy.
In terms of PFS/OS (RECIST v1.1)
Measured: 3, 6, 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2020
- Study start1 Sep 2020
- Primary completion22 Apr 2021
- Study completion22 Apr 2021
Why it stopped: Low patient inclusion
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MelanomaStudies of the same condition, open and under way.
- More trials run by University Hospital, GhentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 3 participants (actual)
- Target duration
- 12 Months
Sponsor and investigators
- Lead sponsor
- University Hospital, Ghent
- Sponsor type
- University, hospital or other
- Collaborators
- Jessa Hospital, University Hospital, Antwerp, Algemeen Ziekenhuis Maria Middelares, GZA Ziekenhuizen Campus Sint-Augustinus, AZ Sint-Jan AV, AZ Nikolaas, AZ Sint-Lucas Gent, AZ Sint-Lucas Brugge, General Hospital Groeninge, OLV van Lourdes Hospital Waregem, AZ Damiaan, AZ Delta, ASZ Aalst, Belgian Red Cross
- Responsible party
- Sponsor
- Investigators
- Hannelore Denys, MD, PhD, Principal investigator, Medical OncologistEmiel De Jaeghere, MD, Study chair, PhD Fellow
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04473027
- Sponsor's protocol ID
- BC-5765
- Acronym
- BLOOD
- Status last verified
- Jul 2020
- First submitted
- 13 Jul 2020
- Last updated
- 10 May 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- BLood Groups as Biomarker to Optimize Odds of Response to Anti-PD-1 Drugs (BLOOD Trial)
- ClinicalTrials.gov ID
- NCT04473027
- Acronym / sponsor ID
- BLOOD / BC-5765
- Keywords
- Immunotherapy, Anti-PD-1, Nivolumab, Pembrolizumab, Biomarker
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Low patient inclusion
- Enrolment
- 3 participants (actual)
- Lead sponsor
- University Hospital, GhentUniversity, hospital or other
- Collaborators
- Jessa Hospital, University Hospital, Antwerp, Algemeen Ziekenhuis Maria Middelares, GZA Ziekenhuizen Campus Sint-Augustinus, AZ Sint-Jan AV, AZ Nikolaas, AZ Sint-Lucas Gent, AZ Sint-Lucas Brugge, General Hospital Groeninge, OLV van Lourdes Hospital Waregem, AZ Damiaan, AZ Delta, ASZ Aalst, Belgian Red Cross
- Study start
- 1 Sep 2020 (actual)
- Primary completion
- 22 Apr 2021 (actual)
- Study completion
- 22 Apr 2021 (actual)
- First posted
- 16 Jul 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 12 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with advanced melanoma | – | Diagnostic Test: Blood sample collectionPatients receiving anti-PD-1 monotherapy (Nivolumab or Pembrolizumab) in the first-line setting |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with advanced melanoma
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood sample collectionWhole 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. | Diagnostic test | Patients with advanced melanoma |
Primary outcome
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.
15 secondary outcomes
The association between ABO blood groups and anti-PD-1 monotherapy efficacy.
Time frame: 12, 25 weeks
The association between ABO blood groups and anti-PD-1 monotherapy efficacy.
Time frame: 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
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
The association between irregular antibodies and anti-PD-1 monotherapy efficacy.
Time frame: 12, 25 weeks
The association between irregular antibodies and anti-PD-1 monotherapy efficacy.
Time frame: 3, 6, 12 months
To evaluate the association between overall survival and other endpoints as defined in the primary endpoints.
Time frame: 12 months
The association between steroid administration and anti-PD-1 monotherapy efficacy.
Time frame: 12, 25 weeks
The association between steroid administration and anti-PD-1 monotherapy efficacy.
Time frame: 3, 6, 12 months
The association between immunosuppressant administration and anti-PD-1 monotherapy efficacy.
Time frame: 12, 25 weeks
The association between immunosuppressant administration and anti-PD-1 monotherapy efficacy.
Time frame: 3, 6, 12 months
The association between antibiotics administration and anti-PD-1 monotherapy efficacy.
Time frame: 12, 25 weeks
The association between antibiotics administration and anti-PD-1 monotherapy efficacy.
Time frame: 3, 6, 12 months
The association between selected baseline and intermediate data (as listed in Outcome 2) and anti-PD-1 monotherapy efficacy.
Time frame: 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
Results and safety
The study was stopped early (reason given: Low patient inclusion). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 May 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hannelore Denys, MD, PhD principal investigator
Medical Oncologist
Emiel De Jaeghere, MD study chair
PhD Fellow
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Melanoma and Cancer, run by University Hospital, Ghent at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 10 May 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Low patient inclusion). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The association between ABO blood groups (specifically O vs A/B/AB) and anti-PD-1 monotherapy efficacy. (time frame: 25 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 May 2021.