BLood Groups as Biomarker to Optimize Odds of Response to Anti-PD-1 Drugs

NCT04473027 | Terminated

• 1 other identifier: BC-5765
• Study Type: observational
• Target: 3
• Locations: 1 country
• Sites: 1

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.

Conditions

Melanoma; Cancer

Keywords

Immunotherapy; Anti-PD-1; Nivolumab; Pembrolizumab; Biomarker

Outcome Measures

Primary Outcomes (2)

• 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

  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.

  3, 6, 12 months

Secondary Outcomes (15)

• The association between ABO blood groups and anti-PD-1 monotherapy efficacy.

  12, 25 weeks

• The association between ABO blood groups and anti-PD-1 monotherapy efficacy.

  3, 6, 12 months

• The association between Kell, Kidd, Duffy, MNS, Rhesus, and Dombrock blood group antigens and anti-PD-1 monotherapy efficacy.

  12, 25 weeks

• The association between Kell, Kidd, Duffy, MNS, Rhesus, and Dombrock blood group antigens and anti-PD-1 monotherapy efficacy.

  3, 6, 12 months

• The association between irregular antibodies and anti-PD-1 monotherapy efficacy.

  12, 25 weeks

Other Outcomes (3)

• The relationship between anti-PD-1 monotherapy efficacy and red blood cell transfusions.

  12, 25 weeks and 3, 6, 12 months

• The relationship between anti-PD-1 monotherapy efficacy and vaccinations.

  12, 25 weeks and 3, 6, 12 months

• The relationship between anti-PD-1 monotherapy efficacy and previous pregnancies.

  12, 25 weeks and 3, 6, 12 months

Study Arms (1)

Patients with advanced melanoma

Patients receiving anti-PD-1 monotherapy (Nivolumab or Pembrolizumab) in the first-line setting

Diagnostic Test: Blood sample collection

Interventions

Blood sample collection DIAGNOSTIC_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.

Patients with advanced melanoma

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with advanced melanoma

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University Hospital, Ghent: lead
• Jessa Hospital: collaborator
• University Hospital, Antwerp: collaborator
• Algemeen Ziekenhuis Maria Middelares: collaborator
• GZA Ziekenhuizen Campus Sint-Augustinus: collaborator
• AZ Sint-Jan AV: collaborator
• AZ Nikolaas: collaborator
• AZ Sint-Lucas Gent: collaborator
• AZ Sint-Lucas Brugge: collaborator
• General Hospital Groeninge: collaborator
• OLV van Lourdes Hospital Waregem: collaborator
• AZ Damiaan: collaborator
• AZ Delta: collaborator
• ASZ Aalst: collaborator
• Belgian Red Cross: collaborator

Study Sites (1)

University Hospital Gent

Ghent, 9000, Belgium

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

EDTA blood

MeSH Terms

Conditions

Melanoma; Neoplasms

Condition Hierarchy (Ancestors)

Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Neoplasms; Neoplasms by Site; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Hannelore Denys, MD, PhD

  Medical Oncologist

  PRINCIPAL INVESTIGATOR

• Emiel De Jaeghere, MD

  PhD Fellow

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 12 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 13, 2020
• First Posted: July 16, 2020
• Study Start: September 1, 2020
• Primary Completion: April 22, 2021
• Study Completion: April 22, 2021
• Last Updated: May 10, 2021

Record last verified: 2020-07

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)