Trials / Unknown
UnknownNCT05259319
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)
An Open-label, Multi-centric, Phase I, Evaluating the Safety and the Efficacy of Combination of Atezolizumab, Tiragolumab and and Stereotactic Body Radiation Therapy in Patients With Oligometastatic Multiorgan (IMMUNOs-SBRT)
- Status
- Unknown
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 92 (estimated)
- Sponsor
- Centre Georges Francois Leclerc · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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
Detailed description
This study will be composed of 2 stepms. First step will be a phase I with the aim to establish the recommended safety scheme of administration (concomitant or sequential) of tiragolumab + atezolizumab + SBRT. The phase I will enrolled only patients from the cohort 1 (metastatic non-small cell lung cancer). The second step will be an expansion cohorts phase at the recommended scheme of administration. The second step will enrolled patients from 4 different cohorts (metastatic non-small cell lung cancer, metastatic bladder cancer, metastatic renal cell carcinoma, metastatic head and neck carcinoma).
Conditions
- Metastatic Non Small Cell Lung Cancer
- Metastatic Bladder Cancer
- Metastatic Renal Cell Carcinoma
- Metastatic Head and Neck Cancer
Interventions
| Type | Name | Description |
|---|---|---|
| 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) |
Timeline
- Start date
- 2022-12-05
- Primary completion
- 2024-12-05
- Completion
- 2024-12-05
- First posted
- 2022-02-28
- Last updated
- 2023-10-17
Locations
1 site across 1 country: France
Source: ClinicalTrials.gov record NCT05259319. Inclusion in this directory is not an endorsement.