NCT03612791

Trial Assessing the Inhibitor of Programmed Cell Death Ligand 1 (PD-L1) Immune Checkpoint Atezolizumab

Randomized Phase II Trial Assessing the Inhibitor of Programmed Cell Death Ligand 1 (PD-L1) Immune Checkpoint Atezolizumab in Locally Advanced Cervical Cancer

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 189 (actual)
• Sponsor: Gustave Roussy, Cancer Campus, Grand Paris · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The primary objective of this randomized phase II trial is to evaluate the clinical benefits of the addition of atezolizumab to standard chemoradiotherapy (CRT) (first given concurrently with CRT, then continued as adjuvant treatment), compared with CRT alone, on investigator-assessed progression-free survival (PFS), as per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1).

Conditions

• Locally Advanced Cervical Cancer

Interventions

Type	Name	Description
DRUG	Atezolizumab	atezolizumab administered IV 1200 mg Q3W, starting one week before EBRT (Week -1) and continued as an adjuvant for a total maximum of 20 cycles.
RADIATION	Radiotherapy	* Pelvic +/- para-aortic EBRT (IMRT): 45 Gy in 25 fractions over 5 weeks (Weeks 1-5, with simultaneously integrated boosts to macroscopically involved lymph nodes, if any, in order to deliver a total dose of 60 Gy to macroscopic lymph nodes (including the dose delivered by brachytherapy). * Uterovaginal brachytherapy (Week 7; maximum interval between EBRT and brachytherapy: 14 days). If appropriate and feasible, dose escalation will be assumed, particularly for advanced disease, with the objective to deliver a total dose of 85 Gy (equivalent dose in 2-Gy fractions with α/β=10 Gy) to 80% of the High Risk-Clinical Target Volume (HR-CTV), including 45 Gy through EBRT. The total dose might be lower in case of close proximity to organs at risk (OARs). * Total duration of RT (including brachytherapy) should be ≤ 55 days.
DRUG	Cisplatin	* Cisplatin infused 40 mg/m2 (maximum 70 mg) weekly IV during EBRT (Weeks 1-5). * Not administered: during the interval between EBRT and brachytherapy, or during brachytherapy, or if radiotherapy is interrupted.

Timeline

• Start date: 2018-08-13
• Primary completion: 2024-02-26
• Completion: 2025-05-13
• First posted: 2018-08-02
• Last updated: 2026-04-03

Locations

1 site across 1 country: France