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TSR-042 as Maintenance Therapy for Patients With High-risk Locally Advanced Cervical Cancer After Chemo-radiation
Sponsor: Grupo Español de Investigación en Cáncer de Ovario
Summary
Patients with locally advanced cervical cancer (LACC) despite definitive chemo-radiotherapy, has a poor progression-free survival (PFS) and overall survival (OS). The hypothesis is that the use of TSR-042, checkpoint inhibitor, as consolidation therapy following concurrent chemo-radiation would increase PFS in these patients. The incorporation of immunotherapy after chemo-radiation is one the best scenarios for this approach, since takes advantages of "the ideal microenvironment" created after radiation. In a similar rationale, the phase 3 study that compared the anti-programmed death ligand 1 antibody durvalumab as consolidation therapy with placebo in patients with stage III NSCLC who did not have disease progression after two or more cycles of platinum-based chemoradiotherapy, showed that progression-free survival was significantly longer with durvalumab than with placebo in all sub-groups regardless of response obtained to chemotherapy, namely patients with stable disease (SD) gained the same benefit that patients with partial response (PR). Due to the aforementioned biology of cervical cancer, the proven activity of anti programmed cell death protein 1 (Anti-PD1) agents in metastatic and/or recurrent cervical cancer and the poor PFS and OS in patients with LACC despite definitive chemo-radiotherapy, we consider to analyze the Anti-PD1 agent, TSR-042 as maintenance therapy after concurrent chemo-radiation (CCRT)
Official title: A Randomized, Open Label, Phase II Trial of Anti-PD1, TSR-042, as Maintenance Therapy for Patients With High-risk Locally Advanced Cervical Cancer After Chemo-radiation
Key Details
Gender
FEMALE
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
134
Start Date
2019-06-28
Completion Date
2025-12
Last Updated
2025-05-21
Healthy Volunteers
No
Conditions
Interventions
No Further Treatment
No further treatment
TSR-042
Fixed 500 mg TSR-042 dose Q3W for the first 4 doses followed by a fixed 1000 mg TSR-042 dose Q6W for up to 24 months
Locations (29)
Hospital General Universitario de Elche
Elche, Alicante, Spain
Hospital Universitario Donostia- Donostia Unibertsitate Ospitalea
Donostia / San Sebastian, Gipuzkoa, Spain
ICO Girona
Girona, Girona, Spain
Hospital Universitario La Paz
Madrid, Madrid, Spain
Hospital Universitario 12 de Octubre
Madrid, Madrid, Spain
Hospital Álvaro Cunqueiro
Vigo, Pontevedra, Spain
Hospital Universitario Virgen del Rocío
Seville, Sevilla, Spain
Instituto Valenciano de Oncología
Valencia, Valencia, Spain
Hospital Clínico Universitario de Valencia
Valencia, Valencia, Spain
Hospital La Fe
Valencia, Valencia, Spain
H Vall d'Hebron
Barcelona, Spain
Hospital Clínic
Barcelona, Spain
H Reina Sofía Cordoba
Córdoba, Spain
ICO Hospitalet
Hospitalet Del Llobregat, Spain
Clinica Universitaria de Navarra
Madrid, Spain
Hospital Clínico San Carlos
Madrid, Spain
Hospital Ramon y Cajal
Madrid, Spain
Hospital Virgen de la Victoria
Málaga, Spain
Hospital Clinico Universitario Virgen Arrixaca
Murcia, Spain
Hospital Universitario Morales Meseguer
Murcia, Spain
Hospital Son Espases
Palma de Mallorca, Spain
Hospital Son Llatzer
Palma de Mallorca, Spain
H. Parc Taulí
Sabadell, Spain
Hospital Marqués de Valdecilla
Santander, Spain
Hospital de Terrassa
Terrassa, Spain
Ankara Oncology Training and Research Hospital
Ankara, Anadolu Bölgesi, Turkey (Türkiye)
Ankara City Hospital
Ankara, Anadolu Bölgesi, Turkey (Türkiye)
Hacettepe University
Ankara, Anadolu Bölgesi, Turkey (Türkiye)
Acibadem Maslak Hospital
Istanbul, Sarıyer, Turkey (Türkiye)