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

Conditions

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

      • 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

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
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
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

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.

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

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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