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

Cancer Clinical Trial

— BLOOD  

Official title:

BLood Groups as Biomarker to Optimize Odds of Response to Anti-PD-1 Drugs (BLOOD Trial)

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04473027
• Other study ID #: BC-5765
• Status: Terminated
• Start date: September 1, 2020
• Est. completion date: April 22, 2021

Study information

• Verified date: July 2020
• Source: University Hospital, Ghent
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical 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. 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 3
• Est. completion date: April 22, 2021
• Est. primary completion date: April 22, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Cancer
• Melanoma

Intervention

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.

Locations

Country	Name	City	State
Belgium	University Hospital Gent	Gent

Sponsors (15)

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

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	The relationship between anti-PD-1 monotherapy efficacy and red blood cell transfusions.	In terms of ORR/DCR/BOR/PFS/OS (RECIST v1.1)	12, 25 weeks and 3, 6, 12 months
Other	The relationship between anti-PD-1 monotherapy efficacy and vaccinations.	In terms of ORR/DCR/BOR/PFS/OS (RECIST v1.1)	12, 25 weeks and 3, 6, 12 months
Other	The relationship between anti-PD-1 monotherapy efficacy and previous pregnancies.	In terms of ORR/DCR/BOR/PFS/OS (RECIST v1.1)	12, 25 weeks and 3, 6, 12 months
Primary	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
Primary	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	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)	12, 25 weeks
Secondary	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)	3, 6, 12 months
Secondary	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)	12, 25 weeks
Secondary	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)	3, 6, 12 months
Secondary	The association between irregular antibodies and anti-PD-1 monotherapy efficacy.	In terms of ORR/DCR/BOR (RECIST v1.1)	12, 25 weeks
Secondary	The association between irregular antibodies and anti-PD-1 monotherapy efficacy.	In terms of PFS/OS (RECIST v1.1)	3, 6, 12 months
Secondary	To evaluate the association between overall survival and other endpoints as defined in the primary endpoints.	(i.e., ORR, DCR, BOR, and PFS)	12 months
Secondary	The association between steroid administration and anti-PD-1 monotherapy efficacy.	In terms of ORR/DCR/BOR (RECIST v1.1)	12, 25 weeks
Secondary	The association between steroid administration and anti-PD-1 monotherapy efficacy.	In terms of PFS/OS (RECIST v1.1)	3, 6, 12 months
Secondary	The association between immunosuppressant administration and anti-PD-1 monotherapy efficacy.	In terms of ORR/DCR/BOR (RECIST v1.1)	12, 25 weeks
Secondary	The association between immunosuppressant administration and anti-PD-1 monotherapy efficacy.	In terms of PFS/OS (RECIST v1.1)	3, 6, 12 months
Secondary	The association between antibiotics administration and anti-PD-1 monotherapy efficacy.	In terms of ORR/DCR/BOR (RECIST v1.1)	12, 25 weeks
Secondary	The association between antibiotics administration and anti-PD-1 monotherapy efficacy.	In terms of PFS/OS (RECIST v1.1)	3, 6, 12 months
Secondary	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)	12, 25 weeks
Secondary	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)	3, 6, 12 months