Atezolizumab Combined With BDB001 AnD Immunogenic Radiotherapy in Patients With Advanced Solid Tumors
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Bladder Cancer
- Melanoma
- Non -Small Cell Lung Cancer
- Pancreatic Cancer
- Solid Tumor, Adult
- Triple -Negative Breast Cancer
- Virus-associated Tumors
- Type
- Interventional
- Phase
- Phase 2
- Design
- Allocation: Non-RandomizedIntervention Model: Parallel AssignmentIntervention Model Description: 6 independent single-arm, multicenter, phase II trials, based on 2-stage Simon's optimal design (Simon R, Controlled Clinical Trials 1989): Population 1: pancreatic cancer Population 2: virus-associated tumors Population 3: non-small lung cancer Population 4: soft-tissue sarcoma Population 5: bladder cancer Population 6: triple negative breast cancer Masking: None (Open Label)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Both males and females
Description
6 independent, multicenter, prospective, single-arm phase II trials, based on 2-stage Simon's optimal design, will be conducted in parallel to assess the efficacy of atezolimab + BDB001+ radiotherapy, separately, in distinct populations of solid tumors: Population 1: pancreatic cancer Population 2: ...
6 independent, multicenter, prospective, single-arm phase II trials, based on 2-stage Simon's optimal design, will be conducted in parallel to assess the efficacy of atezolimab + BDB001+ radiotherapy, separately, in distinct populations of solid tumors: Population 1: pancreatic cancer Population 2: virus-associated tumors Population 3: anti-PD-1/L1 refractory non-small lung cancer Population 4: soft-tissue sarcoma Population 5: anti-PD-1/L1 refractory bladder cancer Population 6: anti-PD-1/L1 refractory triple negative breast cancer
Tracking Information
- NCT #
- NCT03915678
- Collaborators
- Roche Pharma AG
- National Cancer Institute, France
- Seven and Eight Biopharmaceuticals Inc
- Investigators
- Not Provided