129
Participants
Start Date
February 4, 2025
Primary Completion Date
November 30, 2031
Study Completion Date
November 30, 2031
Zimberelimab
"Zimberelimab is a fully human IgG4 monoclonal antibody targeting human PD-1. PD-1 is a type I transmembrane protein that is part of the immunoglobulin gene superfamily and the CD28 family of cell surface receptors. PD-1 is an inhibitory immune checkpoint protein that is expressed on activated B cells, T cells, and myeloid cells, and it plays a key role in limiting the activity of effector T cells.~Zimberelimab is formulated at 30 mg/mL in a buffer solution containing histidine/histidine-HCl buffer solution, sucrose, sodium chloride, and polysorbate 80, at pH 5.5. The investigational product is supplied as a vial contains 120 mg of active Zimberelimab at a concentration of 30mg/mL.~No premedication nor profilaxis is needed before Zimberelimab administration. Zimberelimab doses are administered by IV infusion over 60 minutes, followed by a 30- to 60-minute observation period, on D1 of each 21-day cycle."
Sacituzumab govitecan
"Sacituzumab govitecan (SG) is an ADC composed of the following 3 components:~o The humanized monoclonal antibody hRS7 IgG1κ, which binds to Trop-2, a transmembrane calcium signal transducer that is overexpressed in many epithelial cancers.~o The camptothecin-derived agent SN-38, a topoisomerase I inhibitor. o A hydrolyzable linker, with the company designation as CL2A that links the humanized monoclonal antibody to SN-38.~Sacituzumab govitecan is approved globally for the treatment of unresectable locally advanced or metastatic triple-negative breast cancer (TNBC) and HR+ breast cancer."
Cisplatin
"Cisplatin-based adjuvant chemotherapy~Cisplatin - CAS 15663-27-1, is a platinum coordination complex with potent anti-neoplastic activity. Induces apoptosis in cancer cells, possibly via caspase-3 activation."
Carboplatin
Cisplatin-based adjuvant chemotherapy Structure: The cis-diamino (cyclobutane-1, 1 dicarboxylate) plating. Stability: 24 hours at ambient temperature in 5% glucose, glucosamine or physiologic saline. It is recommended not to dilute with chlorinated solutions for this could affect the carboplatin. Route of administration: Intravenous infusion. Guidelines of Carboplatin administration: According to the standard of each center. Other Name: ATC code: L01XA02
RECRUITING
Hospital Universitario Jerez De La Frontera, Jerez de la Frontera
RECRUITING
Hospitalario Universitario A Coruña, A Coruña
RECRUITING
Hospital Universitario de León, León
RECRUITING
Hospital Universitario Lucus Augusti, Lugo
RECRUITING
Hospital Clínico San Carlos, Madrid
RECRUITING
Hospital Universitario Fundación Jiménez Díaz, Madrid
NOT_YET_RECRUITING
Hospital Universitario la Paz, Madrid
RECRUITING
Hospital Universitario Puerta de Hierro, Majadahonda
RECRUITING
Hospital Santa María Nai, Ourense
RECRUITING
Hospital Universitari de Gran Canària Doctor Negrín, Las Palmas de Gran Canaria
RECRUITING
Complejo Hospitalario Universitario de Vigo, Vigo
RECRUITING
Hospital Universitario Salamanca, Salamanca
RECRUITING
Hospital Universitario Nuestra Señora La Candelaria, Santa Cruz de Tenerife
RECRUITING
Hospital Virgen del Rocío, Seville
RECRUITING
Hospital Universitari Sant Joan de Reus, Reus
RECRUITING
Hospital Clínico de Valencia, Valencia
RECRUITING
Hospital Universitario La Fe, Valencia
RECRUITING
Hospital Clínico Universitario de Valladolid, Valladolid
RECRUITING
Hospital De Basurto, Bilbao
NOT_YET_RECRUITING
Hospital General de Elche, Elche
NOT_YET_RECRUITING
ICO Badalona, Hospital Germans Trias i Pujol, Badalona
RECRUITING
ICO Hospitalet, L'Hospitalet de Llobregat
RECRUITING
Hospital de Son Espases, Palma de Mallorca
RECRUITING
Hospital General Universitario de Alicante, Alicante
RECRUITING
Hospital Universitari Vall d' Hebron, Barcelona
RECRUITING
Hospital Clínic De Barcelona, Barcelona
RECRUITING
Hospital de la Santa Creu i Sant Pau, Barcelona
RECRUITING
Hospital Parc Taulí, Barcelona
RECRUITING
Hospital Universitari Son Llatzer, Palma de Mallorca
RECRUITING
Consorci Sanitari de Terrassa, Terrassa
Fundación GECP
OTHER