NCT03833479

TSR-042 as Maintenance Therapy for Patients With High-risk Locally Advanced Cervical Cancer After Chemo-radiation

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

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 134 (actual)
• Sponsor: Grupo Español de Investigación en Cáncer de Ovario · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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)

Conditions

• Cervical Cancer
• Advanced Cancer

Interventions

Type	Name	Description
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

Timeline

• Start date: 2019-06-28
• Primary completion: 2025-12-01
• Completion: 2025-12-01
• First posted: 2019-02-07
• Last updated: 2025-05-21

Locations

29 sites across 2 countries: Spain, Turkey (Türkiye)