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ACTIVE NOT RECRUITING
NCT03833479
PHASE2

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

View on ClinicalTrials.gov

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

Interventions

OTHER

No Further Treatment

No further treatment

DRUG

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)