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)

Sponsor
Centre Georges Francois Leclerc
Study ID
NCT05259319
Phase
PHASE1
Status
Unknown

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Atezolizumab 60 MG/1 ML Intravenous Solution [TECENTRIQ] — DRUG
    Treatment given every 21 days during 24 months or until progression
  • Tiragolumab — DRUG
    Treatment given every 21 days during 24 months or until progression
  • Stereotactic body radiation therapy (SBRT) — RADIATION
    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)

Study Details

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

Key Dates

Start date
Dec 5, 2022
Status verified
Oct 2023
Primary completion
Dec 5, 2024
Completion
Dec 5, 2024

Study Design

Enrollment
92 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Atezolizumab + Tiragolumab + SBRT
    Atezolizumab + Tiragolumab (every 21 days during 24 months or until progression) + SBRT (treatment will be delivered on 5 days). The combination of SBRT and Immunotherapies will be performed using to different schemes. For the 6 first inclusions the combination will use a sequential scheme. If the safety criteria are respected the following patients will be able to be treated by concomitant scheme.

Primary Outcome Measure

Phase I : to evaluate safety of SBRT [ Time Frame: The first 5 weeks (35 days) after the first dose of study treatment for sequential administration (3X8 Gy of radiotherapy and 3 dosing of immunotherapy) ]

Central Contacts

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