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A phase II study to assess the efficacy of the anti-PD-L1 antibody atezolizumab (MPDL3280A) administered with stereotactic ablative radiotherapy (SABR) in patients with metastatic tumours (SABR-PDL1)

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2024-515678-29-00
Acronym
2015/2335
Enrollment
111
Registered
2024-10-25
Start date
2016-11-15
Completion date
Unknown
Last updated
2024-10-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

non-small cell lung, Patients with metastatic tumours (colorectal, renal and sarcoma)

Brief summary

One year-Progression-free survival rate is defined as the rate of patients alive and free of progression at one year. Progression is defined using RECIST 1.1. criteria, or death, whatever the cause of death, whichever occurs first

Detailed description

Efficacy: Progression-free survival (PFS) measured from the date of treatment initiation to date of progression or death whichever comes first. Patients alive and free of progression at the cut-off date will be censored at the last assessment date Tumour response indicators and clinical endpoints, assessed according to RECIST v 1.1 and modified RECIST (see synopsis), Toxicity : NCI- CTCAE V4.03 scale Toxicity is adverse events graded with the NCI-CTC-AE v4.03 scale, at least possibly related to the treatment., For patients with lung cancer and sarcoma receiving a second SABR course for oligoprogression(see synopsis)

Interventions

DRUGATEZOLIZUMAB

Sponsors

Institut Gustave Roussy
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
One year-Progression-free survival rate is defined as the rate of patients alive and free of progression at one year. Progression is defined using RECIST 1.1. criteria, or death, whatever the cause of death, whichever occurs first

Secondary

MeasureTime frame
Efficacy: Progression-free survival (PFS) measured from the date of treatment initiation to date of progression or death whichever comes first. Patients alive and free of progression at the cut-off date will be censored at the last assessment date Tumour response indicators and clinical endpoints, assessed according to RECIST v 1.1 and modified RECIST (see synopsis), Toxicity : NCI- CTCAE V4.03 scale Toxicity is adverse events graded with the NCI-CTC-AE v4.03 scale, at least possibly related to the treatment., For patients with lung cancer and sarcoma receiving a second SABR course for oligoprogression(see synopsis)

Countries

France

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026