Clinical trial NCT03915678: Atezolizumab Combined With BDB001 AnD Immunogenic Radiotherapy in Patients With Advanced Solid Tumors
Official title: Atezolizumab Combined With BDB001 AnD Immunogenic Radiotherapy in Patients With Advanced Solid Tumors
Conditions: Solid Tumor, Adult
Pancreatic Cancer
Virus-associated Tumors
Non Small Cell Lung Cancer
Melanoma
Bladder Cancer
Triple Negative Breast Cancer
Summary: Basket trial concept to independently and simultaneously assess the effects of the association of atezolizumab + BDB001 + radiotherapy in multiple solid tumors.
Interventions:
description: A treatment cycle consits of 3 weeks. Atezolizumab will be administered as a 1-hour infusion on day 1 every 3 weeks (1200 mg).<br/>BDB001 will be administered by a 30-minute intravenous infusion before atezolizumab, on Days 1, 8, and 15 of cycles 1, 2, and 3. Then from cycle 4 BDB001 will be administered on Day 1 every 3 weeks.<br/>Radiotherapy will start at least one week after the first administration of atezolizumab and at the latest before the 2nd administration. All participants will be treated by high dose irradiation in stereotactic conditions on non-injected metastasis: 3 to 5 fractions for a total dose between 27 Gy and 60 Gy.
name: Association atezolizumab + BDB001 + RT
type: Drug
description: A treatment cycle consits of 3 weeks. Atezolizumab will be administered as a 1-hour infusion on day 1 every 3 weeks (1200 mg).<br/>BDB001 will be administered by a 30-minute intravenous infusion before atezolizumab, on Days 1, 8, and 15 of cycles 1, 2, and 3. Then from cycle 4 BDB001 will be administered on Day 1 every 3 weeks.<br/>Radiotherapy will start at least one week after the first administration of atezolizumab and at the latest before the 2nd administration. All participants will be treated by high dose irradiation in stereotactic conditions on non-injected metastasis: 3 to 5 fractions for a total dose between 27 Gy and 60 Gy.
name: Association atezolizumab + BDB001+ RT
type: Drug
description: A treatment cycle consits of 3 weeks. Atezolizumab will be administered as a 1-hour infusion on day 1 every 3 weeks (1200 mg).<br/>BDB001 will be administered by a 30-minute intravenous infusion before atezolizumab, on Days 1, 8, and 15 of cycles 1, 2, and 3. Then from cycle 4 BDB001 will be administered on Day 1 every 3 weeks.<br/>Radiotherapy will start at least one week after the first administration of atezolizumab and at the latest before the 2nd administration. All participants will be treated by high dose irradiation in stereotactic conditions on non-injected metastasis: 3 to 5 fractions for a total dose between 27 Gy and 60 Gy.
name: Association atezolizumab + BDB001+ RT
type: Drug
description: A treatment cycle consits of 3 weeks. Atezolizumab will be administered as a 1-hour infusion on day 1 every 3 weeks (1200 mg).<br/>BDB001 will be administered by a 30-minute intravenous infusion before atezolizumab, on Days 1, 8, and 15 of cycles 1, 2, and 3. Then from cycle 4 BDB001 will be administered on Day 1 every 3 weeks.<br/>Radiotherapy will start at least one week after the first administration of atezolizumab and at the latest before the 2nd administration. All participants will be treated by high dose irradiation in stereotactic conditions on non-injected metastasis: 3 to 5 fractions for a total dose between 27 Gy and 60 Gy.
name: Association atezolizumab + BDB001 + RT
type: Drug
description: A treatment cycle consits of 3 weeks. Atezolizumab will be administered as a 1-hour infusion on day 1 every 3 weeks (1200 mg).<br/>BDB001 will be administered by a 30-minute intravenous infusion before atezolizumab, on Days 1, 8, and 15 of cycles 1, 2, and 3. Then from cycle 4 BDB001 will be administered on Day 1 every 3 weeks.<br/>Radiotherapy will start at least one week after the first administration of atezolizumab and at the latest before the 2nd administration. All participants will be treated by high dose irradiation in stereotactic conditions on non-injected metastasis: 3 to 5 fractions for a total dose between 27 Gy and 60 Gy.
name: Association atezolizumab + BDB001 + RT
type: Drug
description: A treatment cycle consits of 3 weeks. Atezolizumab will be administered as a 1-hour infusion on day 1 every 3 weeks (1200 mg).<br/>BDB001 will be administered by a 30-minute intravenous infusion before atezolizumab, on Days 1, 8, and 15 of cycles 1, 2, and 3. Then from cycle 4 BDB001 will be administered on Day 1 every 3 weeks.<br/>Radiotherapy will start at least one week after the first administration of atezolizumab and at the latest before the 2nd administration. All participants will be treated by high dose irradiation in stereotactic conditions on non-injected metastasis: 3 to 5 fractions for a total dose between 27 Gy and 60 Gy.
name: Association atezolizumab + BDB001 + RT
type: Drug
Study arms:
design_group_description: Participants with pancreatic cancer will be treated with Atezolizumab combined with BDB001 and radiotherapy.
design_group_title: Population 1: Pancreatic cancer
design_group_type: Experimental
design_group_description: Participants with virus-associated tumors will be treated with Atezolizumab combined with BDB001 and radiotherapy.
design_group_title: Population 2: Virus-associated tumors
design_group_type: Experimental
design_group_description: Participants with anti-PD-1/L1 refractory non-small lung cancer will be treated with Atezolizumab combined with BDB001 and radiotherapy.
design_group_title: Population 3: anti-PD-1/L1 refractory non-small lung cancer
design_group_type: Experimental
design_group_description: Participants with soft-tissue sarcoma will be treated with Atezolizumab combined with BDB001 and radiotherapy.
design_group_title: Population 4: Soft-tissue sarcoma
design_group_type: Experimental
design_group_description: Participants with anti-PD-1/L1 refractory bladder cancer will be treated with Atezolizumab combined with BDB001 and radiotherapy.
design_group_title: Population 5: anti-PD-1/L1 refractory bladder cancer
design_group_type: Experimental
design_group_description: Participants with triple negative breast cancer will be treated with Atezolizumab combined with BDB001 and radiotherapy.
design_group_title: Population 6: Triple negative breast cancer
design_group_type: Experimental
Sponsor: Institut Bergonié
Collaborators: Eikon Therapeutics, Inc.
National Cancer Institute
Roche Pharma AG
Drug name mappings:
name: Resiquimod Sulfate
lang: EN
name: 阿替利珠单抗
lang: CN
name: Atezolizumab
lang: EN
name: アテゾリズマブ（遺伝子組換え）
lang: JP