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

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
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

  • Belgium
      • Gent, Belgium, 9000
        • University Hospital Gent

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Patients with advanced melanoma
Patients receiving anti-PD-1 monotherapy (Nivolumab or Pembrolizumab) in the first-line setting
Diagnostic test: Blood sample collection
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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
The association between ABO blood groups and anti-PD-1 monotherapy efficacy.
Time Frame: 3, 6, 12 months
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
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)
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
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

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
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
In terms of ORR/DCR/BOR/PFS/OS (RECIST v1.1)
12, 25 weeks and 3, 6, 12 months
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)
12, 25 weeks and 3, 6, 12 months
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)
12, 25 weeks and 3, 6, 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University Hospital, Ghent

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Jessa Hospital
University Hospital, Antwerp
AZ Sint-Jan AV
AZ Delta
General Hospital Groeninge
AZ Nikolaas
Belgian Red Cross
Algemeen Ziekenhuis Maria Middelares
AZ Sint-Lucas Gent
GZA Ziekenhuizen Campus Sint-Augustinus
AZ Sint-Lucas Brugge
OLV van Lourdes Hospital Waregem
AZ Damiaan
ASZ Aalst

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 1, 2020

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 22, 2021

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 22, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 13, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 13, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 16, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 10, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 6, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings