Atezolizumab Combined With BDB001 AnD Immunogenic Radiotherapy in Patients With Advanced Solid Tumors

PHASE2RecruitingINTERVENTIONAL
Enrollment

247

Participants

Timeline

Start Date

March 31, 2021

Primary Completion Date

December 31, 2026

Study Completion Date

December 31, 2027

Conditions
Solid Tumor, AdultPancreatic CancerVirus-associated TumorsNon Small Cell Lung CancerMelanomaBladder CancerTriple Negative Breast Cancer
Interventions
DRUG

Association atezolizumab + BDB001 + RT

"A treatment cycle consits of 3 weeks. Atezolizumab will be administered as a 1-hour infusion on day 1 every 3 weeks (1200 mg).~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.~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."

DRUG

Association atezolizumab + BDB001+ RT

"A treatment cycle consits of 3 weeks. Atezolizumab will be administered as a 1-hour infusion on day 1 every 3 weeks (1200 mg).~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.~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."

DRUG

Association atezolizumab + BDB001+ RT

"A treatment cycle consits of 3 weeks. Atezolizumab will be administered as a 1-hour infusion on day 1 every 3 weeks (1200 mg).~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.~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."

DRUG

Association atezolizumab + BDB001 + RT

"A treatment cycle consits of 3 weeks. Atezolizumab will be administered as a 1-hour infusion on day 1 every 3 weeks (1200 mg).~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.~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."

DRUG

Association atezolizumab + BDB001 + RT

"A treatment cycle consits of 3 weeks. Atezolizumab will be administered as a 1-hour infusion on day 1 every 3 weeks (1200 mg).~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.~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."

DRUG

Association atezolizumab + BDB001 + RT

"A treatment cycle consits of 3 weeks. Atezolizumab will be administered as a 1-hour infusion on day 1 every 3 weeks (1200 mg).~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.~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."

Trial Locations (11)

13005

NOT_YET_RECRUITING

Hôpital La Timone, Marseille

13273

RECRUITING

Institut Paoli Calmettes, Marseille

14076

RECRUITING

Centre François Baclesse, Caen

21079

RECRUITING

Centre Georges François Leclerc, Dijon

29200

RECRUITING

Chu Brest, Brest

31052

RECRUITING

IUCT Oncopôle, Toulouse

33076

RECRUITING

Institut Bergonié, Bordeaux

35042

RECRUITING

Centre Eugène Marquis, Rennes

59020

RECRUITING

Centre Oscar Lambret, Lille

75005

NOT_YET_RECRUITING

Institut Curie, Paris

86000

RECRUITING

CHU Poitiers, Poitiers

Sponsors

Lead Sponsor

Collaborators (1)

All Listed Sponsors
collaborator

Roche Pharma AG

INDUSTRY

collaborator

National Cancer Institute, France

OTHER_GOV

collaborator

Eikon Therapeutics

INDUSTRY

lead

Institut Bergonié

OTHER