1443-0002 - A Study to Test Whether Different Combinations of BI 765063, Ezabenlimab, Chemotherapy, Cetuximab, and BI 836880 Help People With Head and Neck Cancer or Liver Cancer

Studio Clinico

Patologia: Epatocarcinoma, Tumori della testa e del collo

Osservazionale-Sperimentale: Sperimentale

Monocentrico-Multicentrico: Multicentrico

Randomizzato: Sì

Fase di studio: 1,

Richiesta mandatoria di tessuto: Sì

Linee di trattamento: Seconda linea

Criteri di inclusione: 

- Male or female aged ≥ 18 years at the time of ICF signature.
- ECOG performance status of 0 or 1 at screening visit.
- Patients homozygous for V1 allele (including V1-like alleles) of Singal Regulatory Protein-alpha (SIRPα) (V1/V1 SIRPα genotype). SIRPα polymorphism will be assessed in blood sampling (using patient Deoxyribonucleic Acid [DNA]) during Screening 1 Visit.
- Patients with at least one measurable lesion as per Response Evaluation Critiera In Solid Tumours (RECIST) version 1.1 (v1.1).
- Patients must agree to provide a mandatory pre treatment (baseline) biopsy and an ontreatment fresh tumour biopsy (unless medically contraindicated).

Criteri di esclusione: 

- Patients with at least one SIRPα V2 allele, i.e. SIRPα V1/V2 or V2/V2 individuals.
- Patients with symptomatic/active central nervous system (CNS) metastases.
- Patients with previously treated brain metastases are eligible, if there is no evidence of progression for at least 28 days before the first trial drug administration without requirement for treatment with corticosteroids, as ascertained by clinical examination and brain imaging (MRI (magnetic resonance imaging) or CT (computed tomography)) during the screening period.
- Prior allogeneic stem cell or solid organ transplantation.
- Any tumour location necessitating an urgent therapeutic intervention (e.g., palliative care, surgery or radiation therapy, such as spinal cord compression, other compressive mass, uncontrolled painful lesion, bone fracture).
- Presence of active invasive cancers other than the one treated in this trial within 5 years prior to screening, except appropriately treated basal cell carcinoma of the skin, or in situ carcinoma of uterine cervix, or other local tumours considered cured by local treatment.
- Patients with active autoimmune disease or a documented history of autoimmune disease, that requires systemic treatment, i.e. corticosteroids or immunosuppressive drugs, except patients with vitiligo, resolved childhood asthma/atopy, alopecia, or any chronic skin condition that does not require systemic therapy; patients with autoimmune-related hypothyroidism on a stable dose of thyroid replacement hormone and/or controlled Type 1 diabetes mellitus on a stable insulin regimen are eligible.
- History of severe hemorrhagic or thromboembolic event in the past 12 months (excluding central venous catheter thrombosis and peripheral deep vein thrombosis).
- Known prior history of severe infusion related reactions to monoclonal antibodies (Grade ≥ 3 National Cancer Institute [NCI] Common Terminology Criteria for Adverse Events (CTCAE) v5.0).

Trattamento sperimentale: 

Ezabenlimab
BI 836880
BI 765063
Cetuximab
Investigator choice chemotherapy (paclitaxel,docetaxel, methotrexate, capecitabine, 5-fluorouracil or combinations thereof).

Trattamento di controllo: 

NA

Centri partecipanti

Nord Italia

Centro Italia

Informazioni Generali

Protocollo

Numero di iscrizione a registro: 2021-003473-59

Data di inserimento: 21.07.2022

Promotore

Boehringer Ingelheim

CRO

IQVIA

Principal Investigator ITALIA

Ospedale Riuniti Ancona

Riferimento: Dr. Info non disponibile

Telefono: 00000

Email: nd@nd.it

Localita: Ancona