Título: Estudio de fase II, abierto, aleatorizado, con diseño de plataforma que utiliza un protocolo maestro para evaluar nuevas combinaciones de inmunoterapia para el tratamiento en primera línea de pacientes con carcinoma de células escamosas de cabeza y cuello recurrente/metastásico con expresión positiva de PD-L1

Especialidad: Oncología

Código de protocolo: 219885

Número EudraCT: 2023-503428-24-00

Promotor: GSK

Investigador principal: Dr. Jesús Rodríguez Pascual

Más información:

Criterios de inclusión: Have histologically or cytologically-confirmed R/M HNSCC that is considered incurable by local therapies. a. Subjects must not have had prior systemic therapy administered in the R/M setting. Chemoradiation therapy which was completed more than 4 months prior to signing consent if given as part of multimodal treatment for locally advanced disease is allowed. b. The eligible primary tumor locations are oropharynx, oral cavity, hypopharynx, and larynx. c. Subjects may not have a primary tumor site of nasopharynx (any histology).
Has measurable (target) disease based on RECIST 1.1 (Section 10.10 of protocol), as determined by the investigator.
Has an ECOG PS (Section 10.6 of protocol) of 0 or 1.
Provides a tumor tissue sample obtained at the time of or after the initial diagnosis of R/M HNSCC. Although a fresh tumor tissue sample obtained within 90 days of screening is highly preferred, an archival tumor specimen (2 years old) is acceptable. Biopsies obtained prior to the administration of any systemic therapy administered for the treatment of a participants tumor (such as neoadjuvant/adjuvant therapy) are not acceptable. Needle or excisional biopsies or resected tissue is required. Cytological specimens such as fine needle aspirates, bone marrow samples, or cell blocks are not acceptable. Bone specimen is not acceptable.
Has tumor PD-L1 expression.
If the primary tumor site is oropharyngeal carcinoma, the participant must have HPV results.

Criterios de exclusión: Has received prior therapy with any immune checkpoint inhibitors, including antibodies or drugs targeting PD-1, PD-L1, CTLA-4, TIGIT, CD96, or other immune checkpoint pathways.
Participants with previous malignancies (except non-melanoma skin cancers, and the following in situ cancers: bladder, gastric, esophageal, colon, endometrial, cervical/dysplasia, melanoma, or breast) unless a complete remission was achieved at least 2 years prior to study entry AND no additional therapy is required during the study period. Note: Participants are allowed if they have low-risk early-stage prostate cancer defined as follows: Stage T1c or T2a with a Gleason score 6 and prostatic-specific antigen <10 ng/mL either treated with definitive intent or untreated in active surveillance that has been stable for the past year prior to randomization. Additionally, participants are allowed if they have low risk intrathyroidal differentiated thyroid cancer either treated with definitive intent or untreated in active surveillance that has been stable for the past year prior to randomization.
Have active tumor bleeding or a high risk of bleeding (examples include but are not limited to radiographic evidence of major blood vessel invasion/infiltration or tumor demonstrates >90 degree abutment or encasement of a major vessel [carotid, jugular, bronchial artery] and/or exhibits other high-risk features such as arteriovenous fistula). Note: Minimal bleeding or oozing not considered high risk, in oral/oropharyngeal tumors, is permitted.
Has PD within 4 months of completion of curatively intended treatment for locoregionally advanced HNSCC.
Participants with any carcinomatous meningitis or leptomeningeal spread and those with uncontrolled or symptomatic CNS metastases. Note: Participants with previously treated brain metastases may participate provided they are asymptomatic (any neurologic symptoms have returned to baseline [participants may be receiving stable doses of anticonvulsants]), radiographically stable (without evidence of progression by imaging for at least 4 weeks prior to the first dose of study treatment), have no evidence of new or enlarging brain metastases, and are clinically stable off steroids for at least 2 weeks prior to initiation of study treatment.
Active autoimmune disease that has required systemic disease-modifying or immunosuppressive treatment within the last 2 years. (Note: Stable, medically managed autoimmune endocrinopathies are acceptable if participant otherwise meets entry criteria.)

Fecha de firma: 11/10/2023

Estado: en marcha

Centro: Vithas Madrid La Milagrosa