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

PHASE2CompletedINTERVENTIONAL
Enrollment

189

Participants

Timeline

Start Date

August 13, 2018

Primary Completion Date

February 26, 2024

Study Completion Date

May 13, 2025

Conditions
Locally Advanced Cervical Cancer
Interventions
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."

Trial Locations (1)

94805

Gustave Roussy, Villejuif

All Listed Sponsors
lead

Gustave Roussy, Cancer Campus, Grand Paris

OTHER

NCT03612791 - Trial Assessing the Inhibitor of Programmed Cell Death Ligand 1 (PD-L1) Immune Checkpoint Atezolizumab | Biotech Hunter | Biotech Hunter