Study Evaluating the Safety and the Efficacy of Combination of Atezolizumab, Tiragolumab and and Stereotactic Body Radiation Therapy in Patients With Oligometastatic Multiorgan (IMMUNOs-SBRT)
NCT05259319 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 92
Last updated 2023-10-17
Summary
This study (phase I clinical trial and expansion cohorts) will evaluate safety and efficacy of combination of atezolizumab and tiragolumab, with concomitant or sequential SBRT for four oligometastatic cancer cohorts. This study will allow to developpe one or several randomized Phase II clinical trials for the more promising indications
Conditions
- Metastatic Non Small Cell Lung Cancer
- Metastatic Bladder Cancer
- Metastatic Renal Cell Carcinoma
- Metastatic Head and Neck Cancer
Interventions
- DRUG
-
Atezolizumab 60 MG/1 ML Intravenous Solution [TECENTRIQ]
Treatment given every 21 days during 24 months or until progression
- DRUG
-
Tiragolumab
Treatment given every 21 days during 24 months or until progression
- RADIATION
-
Stereotactic body radiation therapy (SBRT)
Radiothérapy is delivered as a hypofractionated schedule of 3 doses of 8Gy (idealy on Monday, Wednesday and Friday, or 3 sessions over a week, respecting at least 24 hours between each fraction)
Sponsors & Collaborators
-
Centre Georges Francois Leclerc
lead OTHER
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2022-12-05
- Primary Completion
- 2024-12-05
- Completion
- 2024-12-05
Countries
- France
Study Locations
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