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Recruiting Phase 2 NCT03915678

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

Trial Parameters

Condition Solid Tumor, Adult
Sponsor Institut Bergonié
Study Type INTERVENTIONAL
Phase Phase 2
Enrollment 247
Sex ALL
Min Age 18 Years
Max Age N/A
Start Date 2021-03-31
Completion 2026-12
Interventions
Association atezolizumab + BDB001 + RTAssociation atezolizumab + BDB001+ RTAssociation atezolizumab + BDB001+ RT

Brief Summary

Basket trial concept to independently and simultaneously assess the effects of the association of atezolizumab + BDB001 + radiotherapy in multiple solid tumors.

Eligibility Criteria

Inclusion criteria: 1. histologically confirmed pancreatic cancer, virus-associated tumors \[including papillomaviruses-related cancers (cervical, head and neck, and nasal), Epstein-Barr virus (nasopharyngeal carcinoma) and Kaposi's sarcoma-associated herpes virus), non-small cell lung cancer, soft-tissue sarcomas, bladder cancer, triple negative breast cancer. For population 4, diagnosis must be confirmed by the RRePS Network as recommended by the French NCI. For population 2, papillomavirus-related cancers must be eligible whatever the genotype but in case of viral genotype is not available, IHC p16 positive must be provided, hepatocellular carcinoma must be confirmed by Hepatite B or C infection, HHV-8 and Epstein-Barr virus related cancers must be confirmed by molecular analysis, 2. Metastatic disease, 3. Age ≥ 18 years, 4. ECOG ≤ 1, 5. At least two lesions: one extra cerebral lesion that can be treated by radiotherapy and one site of disease that must be uni-dimensionally ≥ 10 mm

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